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China medical industry
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Landmark birth employs gene screening
By Cang Wei in Nanjing | China Daily | Updated: 2019-07-10 08:04
A newborn baby. [Photo/IC]
Nanjing hospital uses innovative tech to help woman bear a healthy child
A woman who used preimplantation genetic testing (PGT) to prevent congenital skeletal dysplasia recently gave birth to the world's first baby to be born under such conditions at the Nanjing Maternity and Child Health Care Hospital.
According to the hospital, the baby weighed 4.6 kilograms and was given a 10 Apgar score at birth.
The mother, surnamed Zhang, has tried for years with her husband to have babies. She had to have three abortions due to the fetuses' severe congenital spinal deformity.
In 2018, the couple went to Nanjing Maternity and Child Health Care Hospital, Jiangsu province, for treatment. The hospital found that both of them are carriers of the BMPER gene mutation.
The mutation of the gene - BMPER - can lead to a rare autosomal recessive skeletal dysplasia called DSD (Diaphanospondylodysostosis). Patients exhibit severe symptoms including ossification, abnormal kidney structure and somite defects.
Ling Xiufeng, director of the hospital's reproductive medical center, suggested to the couple that the PGT technology could be used to screen out the mutation so that they could have healthy babies.
"In other words, the method is to fertilize the egg in vitro, test the fertilized egg without the gene mutation and implant the healthy embryos into the uterus," Ling said.
The center made a specific plan for Zhang, who had three healthy embryos out of the seven fertilized eggs that received genetic testing. One embryo was implanted successfully in her uterus and developed into a healthy baby.
"The PGT technology can greatly reduce the chances of having genetically defective babies by selecting normal embryos," Ling said. "The couples who want to have children, especially those with genetic diseases, should first take genetic tests to clarify the pathogenic genes.
"Then, PGT technology should be adopted to screen the chromosomes and genes to avoid birth defects and block the heredity of genetic diseases in the families," she added.
Zhang Junqiang, director of the center's embryology laboratory, said that the PGT technology has been used at the center for more than three years to help families with genetic and chromosomal diseases.
"Though prenatal examination and genetic testing are common in some countries, few Chinese couples have such tests before having babies," Zhang said.
"Recessive pathogenic genes are not unusual, and every person has such genes," he said. "It's important for people to have prenatal examinations."
Guo Jun contributed to this story.
By Cang Wei in Nanjing | China Daily | Updated: 2019-07-10 08:04
Nanjing hospital uses innovative tech to help woman bear a healthy child
A woman who used preimplantation genetic testing (PGT) to prevent congenital skeletal dysplasia recently gave birth to the world's first baby to be born under such conditions at the Nanjing Maternity and Child Health Care Hospital.
According to the hospital, the baby weighed 4.6 kilograms and was given a 10 Apgar score at birth.
The mother, surnamed Zhang, has tried for years with her husband to have babies. She had to have three abortions due to the fetuses' severe congenital spinal deformity.
In 2018, the couple went to Nanjing Maternity and Child Health Care Hospital, Jiangsu province, for treatment. The hospital found that both of them are carriers of the BMPER gene mutation.
The mutation of the gene - BMPER - can lead to a rare autosomal recessive skeletal dysplasia called DSD (Diaphanospondylodysostosis). Patients exhibit severe symptoms including ossification, abnormal kidney structure and somite defects.
Ling Xiufeng, director of the hospital's reproductive medical center, suggested to the couple that the PGT technology could be used to screen out the mutation so that they could have healthy babies.
"In other words, the method is to fertilize the egg in vitro, test the fertilized egg without the gene mutation and implant the healthy embryos into the uterus," Ling said.
The center made a specific plan for Zhang, who had three healthy embryos out of the seven fertilized eggs that received genetic testing. One embryo was implanted successfully in her uterus and developed into a healthy baby.
"The PGT technology can greatly reduce the chances of having genetically defective babies by selecting normal embryos," Ling said. "The couples who want to have children, especially those with genetic diseases, should first take genetic tests to clarify the pathogenic genes.
"Then, PGT technology should be adopted to screen the chromosomes and genes to avoid birth defects and block the heredity of genetic diseases in the families," she added.
Zhang Junqiang, director of the center's embryology laboratory, said that the PGT technology has been used at the center for more than three years to help families with genetic and chromosomal diseases.
"Though prenatal examination and genetic testing are common in some countries, few Chinese couples have such tests before having babies," Zhang said.
"Recessive pathogenic genes are not unusual, and every person has such genes," he said. "It's important for people to have prenatal examinations."
Guo Jun contributed to this story.
JSCh
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China starts latest trial of long-lasting HIV vaccine
By Wang Xiaodong | China Daily | Updated: 2019-07-19 07:30
[Photo/VCG]
An HIV vaccine being developed by Chinese scientists will be given to 160 volunteers in a second-phase clinical trial, a medical scientist at the Chinese Center for Disease Control and Prevention said on Monday.
The candidate vaccine, DNA-rTV, relies on replication of the DNA of HIV to stimulate effective immunization, according to Shao Yiming, a chief HIV researcher at the center.
He said the vaccine, based on the one used to prevent smallpox, is the first such HIV vaccine to begin a second-phase clinical trial.
"With significant reduction of virulence, the vaccine will not cause infection in healthy receivers," Shao said.
The vaccine under development does not contain the full human immunodeficiency virus. Rather, it contains DNA segments from HIV so it will not cause an infection.
The HIV DNA will keep replicating during the initial period of injection of the vaccine, so it will constantly stimulate the immune system to produce antibodies, meaning the effect will be stronger and longer lasting. This is similar to how vaccines for some other diseases work.
Most of the other HIV vaccines under development in China and abroad are inactivated vaccines, which do not include HIV DNA that can replicate, so they will not produce a long-lasting immunization effect.
The vaccine is also designed to target the HIV strains that are most common in China, he said.
Its first-phase clinical trial, which started in 2007, proved its safety, Shao said. The second-phase trial will determine the vaccination procedure, he said.
Shao Yiming. [Photo/China Daily]
"Hopefully the second-phase trial will be completed in the latter half of 2021, and the third-phase clinical trial may start at the end of that year, which will involve thousands of volunteers in a trial to test the effectiveness of the vaccine to protect people against HIV," Shao said.
More than 130 volunteers have been recruited so far for the second-phase trial, and the initial work is underway at a hospital in Beijing and another hospital in Hangzhou, Zhejiang province, he said.
Chuang Chuang, who runs Hangzhou Sunflower, a charity organization promoting LGBT rights that helped recruit volunteers in Hangzhou, said more than 100 volunteers had approached the organization to register after hearing about the second-phase trial.
"Some of them were disqualified after our selection process, and the rest were referred to the hospital in Hangzhou," he said. "They must pass physical tests before formally becoming volunteers.
"Most of the volunteers I know are students or (other) young men. Some signed up initially, but withdrew after being informed they would have to participate the whole trial, which lasts nearly two years.
Nuan Yang, a volunteer from Hangzhou, said he registered through the organization as soon as he heard about the second-phase trial.
"I hope to see the vaccine available for us as early as possible. Although HIV can be controlled and AIDS is almost a chronic disease now, many people with HIV are living under heavy pressure and have to endure discrimination from others," he said.
"If a vaccine is available to prevent the infection, fewer people will fear HIV and discriminate against carriers."
Shao said developing HIV vaccines was much harder than developing vaccines for other diseases because of the constantly evolving nature of HIV, but progress has been made around the world in the past decade.
"AIDS is one of the most serious threats to human health, and we should never lose faith we will conquer it, even though it is very difficult," he said.
The number of people living with HIV in China was estimated at around 1.25 million at the end of last year, and about 80,000 people become infected each year, according to the National Health Commission.
Although the prevalence of HIV infection in China is lower than in many other countries, China faces severe challenges in prevention and control due to the large number of cases, it said.
Sustained efforts, including improved public education, are needed, the commission said.
By Wang Xiaodong | China Daily | Updated: 2019-07-19 07:30
An HIV vaccine being developed by Chinese scientists will be given to 160 volunteers in a second-phase clinical trial, a medical scientist at the Chinese Center for Disease Control and Prevention said on Monday.
The candidate vaccine, DNA-rTV, relies on replication of the DNA of HIV to stimulate effective immunization, according to Shao Yiming, a chief HIV researcher at the center.
He said the vaccine, based on the one used to prevent smallpox, is the first such HIV vaccine to begin a second-phase clinical trial.
"With significant reduction of virulence, the vaccine will not cause infection in healthy receivers," Shao said.
The vaccine under development does not contain the full human immunodeficiency virus. Rather, it contains DNA segments from HIV so it will not cause an infection.
The HIV DNA will keep replicating during the initial period of injection of the vaccine, so it will constantly stimulate the immune system to produce antibodies, meaning the effect will be stronger and longer lasting. This is similar to how vaccines for some other diseases work.
Most of the other HIV vaccines under development in China and abroad are inactivated vaccines, which do not include HIV DNA that can replicate, so they will not produce a long-lasting immunization effect.
The vaccine is also designed to target the HIV strains that are most common in China, he said.
Its first-phase clinical trial, which started in 2007, proved its safety, Shao said. The second-phase trial will determine the vaccination procedure, he said.
"Hopefully the second-phase trial will be completed in the latter half of 2021, and the third-phase clinical trial may start at the end of that year, which will involve thousands of volunteers in a trial to test the effectiveness of the vaccine to protect people against HIV," Shao said.
More than 130 volunteers have been recruited so far for the second-phase trial, and the initial work is underway at a hospital in Beijing and another hospital in Hangzhou, Zhejiang province, he said.
Chuang Chuang, who runs Hangzhou Sunflower, a charity organization promoting LGBT rights that helped recruit volunteers in Hangzhou, said more than 100 volunteers had approached the organization to register after hearing about the second-phase trial.
"Some of them were disqualified after our selection process, and the rest were referred to the hospital in Hangzhou," he said. "They must pass physical tests before formally becoming volunteers.
"Most of the volunteers I know are students or (other) young men. Some signed up initially, but withdrew after being informed they would have to participate the whole trial, which lasts nearly two years.
Nuan Yang, a volunteer from Hangzhou, said he registered through the organization as soon as he heard about the second-phase trial.
"I hope to see the vaccine available for us as early as possible. Although HIV can be controlled and AIDS is almost a chronic disease now, many people with HIV are living under heavy pressure and have to endure discrimination from others," he said.
"If a vaccine is available to prevent the infection, fewer people will fear HIV and discriminate against carriers."
Shao said developing HIV vaccines was much harder than developing vaccines for other diseases because of the constantly evolving nature of HIV, but progress has been made around the world in the past decade.
"AIDS is one of the most serious threats to human health, and we should never lose faith we will conquer it, even though it is very difficult," he said.
The number of people living with HIV in China was estimated at around 1.25 million at the end of last year, and about 80,000 people become infected each year, according to the National Health Commission.
Although the prevalence of HIV infection in China is lower than in many other countries, China faces severe challenges in prevention and control due to the large number of cases, it said.
Sustained efforts, including improved public education, are needed, the commission said.
JSCh
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China to launch clinical trial of new lupus drug
Source: Xinhua| 2019-07-21 18:27:02|Editor: Li Xia
SHANGHAI, July 21 (Xinhua) -- Chinese scientists will conduct the second-phase clinical trial of a new drug to treat lupus, an autoimmune disease, the Chinese Academy of Sciences (CAS) said.
The new drug SM934 is a water-soluble artemisinin derivative developed by researchers with the Shanghai Institute of Materia Medica under the CAS. It has been patent protected.
Approved by the National Medical Products Administration, China's pharmaceutical watchdog, the new drug has completed the first human trial and will begin its second-phase trial at a hospital in Shanghai.
Systemic lupus erythematosus, simply known as lupus, is an autoimmune disorder in which the human immune system mistakenly attacks healthy tissues. It can damage joints, skin, kidneys, blood cells, the brain, heart and lungs.
The most distinctive sign of lupus is a facial rash that resembles the wings of a butterfly unfolding across both cheeks.
Nearly 1 million people in China are suffering from lupus.
Since the origin and development of the disease remain unclear, new drug development has proven challenging.
The CAS said SM934 is an oral medicine with low dosage but strong effect which can modulate autoimmune responses and restore the body's immune balance.
The second-phase trial will be carried out in patients diagnosed with mild to moderate lupus.
Source: Xinhua| 2019-07-21 18:27:02|Editor: Li Xia
SHANGHAI, July 21 (Xinhua) -- Chinese scientists will conduct the second-phase clinical trial of a new drug to treat lupus, an autoimmune disease, the Chinese Academy of Sciences (CAS) said.
The new drug SM934 is a water-soluble artemisinin derivative developed by researchers with the Shanghai Institute of Materia Medica under the CAS. It has been patent protected.
Approved by the National Medical Products Administration, China's pharmaceutical watchdog, the new drug has completed the first human trial and will begin its second-phase trial at a hospital in Shanghai.
Systemic lupus erythematosus, simply known as lupus, is an autoimmune disorder in which the human immune system mistakenly attacks healthy tissues. It can damage joints, skin, kidneys, blood cells, the brain, heart and lungs.
The most distinctive sign of lupus is a facial rash that resembles the wings of a butterfly unfolding across both cheeks.
Nearly 1 million people in China are suffering from lupus.
Since the origin and development of the disease remain unclear, new drug development has proven challenging.
The CAS said SM934 is an oral medicine with low dosage but strong effect which can modulate autoimmune responses and restore the body's immune balance.
The second-phase trial will be carried out in patients diagnosed with mild to moderate lupus.
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JULY 25, 2019
Drug trial shows efficacy in treating anemia in chronic kidney disease patients without dialysis
by FibroGen
FibroGen, Inc. today announced publication of results from the Phase 3 trial of the efficacy and safety of roxadustat treatment compared to placebo for anemia in non-dialysis patients (NDD) with chronic kidney disease (CKD) in the People's Republic of China (China) in the New England Journal of Medicine(NEJM). In this study, roxadustat met its primary efficacy endpoint for anemia correction by achieving a statistically significant increase in mean hemoglobin level from baseline to hemoglobin level averaged over weeks seven through 9. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the open-label period of weeks nine through 26.
...
Drug trial shows efficacy in treating anemia in chronic kidney disease patients without dialysis | MedicalXpress
Drug trial shows efficacy in treating anemia in chronic kidney disease patients without dialysis
by FibroGen
FibroGen, Inc. today announced publication of results from the Phase 3 trial of the efficacy and safety of roxadustat treatment compared to placebo for anemia in non-dialysis patients (NDD) with chronic kidney disease (CKD) in the People's Republic of China (China) in the New England Journal of Medicine(NEJM). In this study, roxadustat met its primary efficacy endpoint for anemia correction by achieving a statistically significant increase in mean hemoglobin level from baseline to hemoglobin level averaged over weeks seven through 9. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the open-label period of weeks nine through 26.
...
Drug trial shows efficacy in treating anemia in chronic kidney disease patients without dialysis | MedicalXpress
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China's diagnostic technology gets U.S. FDA approval
Source: Xinhua| 2019-07-29 23:12:43|Editor: yan
BEIJING, July 29 (Xinhua) -- A new diagnostic technology developed by Chinese scientists for improving coronary heart disease treatment has received market approval from the U.S. Food and Drug Administration (FDA), according to China's Ministry of Science and Technology Monday.
The technology, called Quantitative Flow Ratio (QFR) measurement system, was jointly developed by Pulse Medical Imaging Technology (Shanghai) Co and a group of researchers with Shanghai Jiaotong University.
Based on the computational analysis of X-ray coronary angiography, the system is able to obtain QFR noninvasively, which can evaluate coronary artery blockage and function and then help doctors decide whether a patient needs to have surgical and interventional heart procedures.
The QFR technology can assess coronary function within four minutes and increase diagnosis accuracy by 33 percent compared with conventional coronary angiography. It also has a higher accuracy rate than optical coherence tomography, a common imaging technique, said a statement released by the ministry.
The QFR was approved by China's National Medical Products Administration in July 2018.
Coronary heart disease is a condition in which the heart's blood supply is narrowed or blocked due to the build-up of plaque in the coronary artery. Since 2004, the annual growth rate of hospitalization expenses for heart diseases is much higher than the growth rate of GDP. The economic burden of Chinese patients is increasing.
The approval of QFR technology will provide a more accurate and non-invasive diagnostic device and better treatment for patients with coronary heart disease worldwide, the ministry said.
Source: Xinhua| 2019-07-29 23:12:43|Editor: yan
BEIJING, July 29 (Xinhua) -- A new diagnostic technology developed by Chinese scientists for improving coronary heart disease treatment has received market approval from the U.S. Food and Drug Administration (FDA), according to China's Ministry of Science and Technology Monday.
The technology, called Quantitative Flow Ratio (QFR) measurement system, was jointly developed by Pulse Medical Imaging Technology (Shanghai) Co and a group of researchers with Shanghai Jiaotong University.
Based on the computational analysis of X-ray coronary angiography, the system is able to obtain QFR noninvasively, which can evaluate coronary artery blockage and function and then help doctors decide whether a patient needs to have surgical and interventional heart procedures.
The QFR technology can assess coronary function within four minutes and increase diagnosis accuracy by 33 percent compared with conventional coronary angiography. It also has a higher accuracy rate than optical coherence tomography, a common imaging technique, said a statement released by the ministry.
The QFR was approved by China's National Medical Products Administration in July 2018.
Coronary heart disease is a condition in which the heart's blood supply is narrowed or blocked due to the build-up of plaque in the coronary artery. Since 2004, the annual growth rate of hospitalization expenses for heart diseases is much higher than the growth rate of GDP. The economic burden of Chinese patients is increasing.
The approval of QFR technology will provide a more accurate and non-invasive diagnostic device and better treatment for patients with coronary heart disease worldwide, the ministry said.
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'First of its kind' treatment for psoriasis born in China
By Jiang Wei and Li Danqing | chinadaily.com.cn | Updated: 2019-08-02 16:33
[Photo/Official website of Wenfeng Tianji Pharma Ltd]
On July 12, the Ministry of Science and Technology said Benvitimod cream used for treating mild to moderate psoriasis had been approved by the National Medical Products Administration, China Economy Weekly reported.
The cream is a global first-in-class drug for the disease developed by Beijing Wenfeng Tianji Pharma Ltd and supported by China's major new drug development program.
Benvitimod is categorised as a "first-in-class" drug, as it uses a new and unique mechanism of action for treating a medical condition. Such drugs are considered to be at the highest-level in terms of breakthrough in the pharmaceutical industry.
The birth of China-made Benvitimod highlights the fast development of an innovation-driven bio-pharmaceutical industry, said Song Ruilin, executive president of China Pharmaceutical Innovation and Research Development Association, at a conference on drug innovation and development on July 16.
Psoriasis is a chronic skin condition that can cause red, scaly patches of skin to appear and there is no cure. More than eight million people in China and more than 125 million worldwide suffer from psoriasis.
Calcipotriol, a form of vitamin D, is the first choice for many patients. It is called the gold-standard therapy for psoriasis patients. Compared with Calcipotriol, Benvitimod should be called the diamond-standard therapy, industry insiders said.
Chen Genghui
The Phase III clinical trial showed that Benvitimod has the same and even better curative effect as Calcipotriol, according to the Ministry of Science and Technology. There were no systemic adverse reaction in Phase III study, and Benvitimod has significant advantages over Calcipotriol as it has a rapid onset of effect and long duration of action, as well as a low recurrence rate when patients stop using the medicine.
Behind the new drug are years of continuous efforts by Chen Genghui, co-inventor of Benvitimod and CEO of Beijing Wenfeng Tianji Pharma Ltd, and Zhang Jianzhong, head of the dermatology department of Peking University People's Hospital, who led the clinical trial of Benvitimod.
In 1999, Chen Genghui's team obtained the patent for Benvitimod. After 10 years of research and development of Benvitimod, Chen received approval to begin clinical trials in 2009.
After dermatologists of several top hospitals turned him down, he met Zhang Jianzhong at Peking University People's Hospital.
"At first, I also doubted what he said," Zhang said, "Over the years, I have seen too many people claiming to have the cure to psoriasis." But ambition and tenacity eventually brought the two together.
Between 2009 and 2016, Zhang led the clinical trial of Phases I, II and III on more than 1,200 patients. The Phase III clinical trial covered more than 730 patients from 22 major hospitals across China.
Zhang Jianzhong
During the Phase III clinical trial, the Center for Drug Evaluation under NMPA required them to compare Benvitimod with the gold-standard Calcipotriol and conduct a double blind experiment. "When the result was announced, my heart was about to pop out," said Chen. The double blind experiment showed that Benvitimod is more effective.
At the annual meeting of American Academy of Dermatology in 2017, Zhang was invited to deliver a speech on their research on Benvitimod, drawing much attention from international counterparts.
"New drug research and development is mainly conducted in Western countries, but China also has advantages in some domains, like Benvitimod," said Zhang. "We should have faith in ourselves."
Researching and developing new drugs is widely considered to be the biggest gamble in the world. A report issued by Deloitte shows that the spending on a new drug, from research and development to putting it on sale, has risen from $1.2 billion in 2010 to $2 billion in 2017.
"The success rate in the pharmaceutical industry is 0.01 percent, and the chance of being rated as a first-in-class drug shrinks to 0.003 percent," Chen said.
"I never gave up because I always had faith that the drug is going to work," Chen said. "I thought, when we succeed, future generations will always remember Benvitimod cream is developed by the Chinese."
On July 19, the production of Benvitimod cream officially began.
"Theoretically speaking, doctors will be able to write prescriptions for the Benvitimod in the very near future," Chen said.
By Jiang Wei and Li Danqing | chinadaily.com.cn | Updated: 2019-08-02 16:33
On July 12, the Ministry of Science and Technology said Benvitimod cream used for treating mild to moderate psoriasis had been approved by the National Medical Products Administration, China Economy Weekly reported.
The cream is a global first-in-class drug for the disease developed by Beijing Wenfeng Tianji Pharma Ltd and supported by China's major new drug development program.
Benvitimod is categorised as a "first-in-class" drug, as it uses a new and unique mechanism of action for treating a medical condition. Such drugs are considered to be at the highest-level in terms of breakthrough in the pharmaceutical industry.
The birth of China-made Benvitimod highlights the fast development of an innovation-driven bio-pharmaceutical industry, said Song Ruilin, executive president of China Pharmaceutical Innovation and Research Development Association, at a conference on drug innovation and development on July 16.
Psoriasis is a chronic skin condition that can cause red, scaly patches of skin to appear and there is no cure. More than eight million people in China and more than 125 million worldwide suffer from psoriasis.
Calcipotriol, a form of vitamin D, is the first choice for many patients. It is called the gold-standard therapy for psoriasis patients. Compared with Calcipotriol, Benvitimod should be called the diamond-standard therapy, industry insiders said.
The Phase III clinical trial showed that Benvitimod has the same and even better curative effect as Calcipotriol, according to the Ministry of Science and Technology. There were no systemic adverse reaction in Phase III study, and Benvitimod has significant advantages over Calcipotriol as it has a rapid onset of effect and long duration of action, as well as a low recurrence rate when patients stop using the medicine.
Behind the new drug are years of continuous efforts by Chen Genghui, co-inventor of Benvitimod and CEO of Beijing Wenfeng Tianji Pharma Ltd, and Zhang Jianzhong, head of the dermatology department of Peking University People's Hospital, who led the clinical trial of Benvitimod.
In 1999, Chen Genghui's team obtained the patent for Benvitimod. After 10 years of research and development of Benvitimod, Chen received approval to begin clinical trials in 2009.
After dermatologists of several top hospitals turned him down, he met Zhang Jianzhong at Peking University People's Hospital.
"At first, I also doubted what he said," Zhang said, "Over the years, I have seen too many people claiming to have the cure to psoriasis." But ambition and tenacity eventually brought the two together.
Between 2009 and 2016, Zhang led the clinical trial of Phases I, II and III on more than 1,200 patients. The Phase III clinical trial covered more than 730 patients from 22 major hospitals across China.
During the Phase III clinical trial, the Center for Drug Evaluation under NMPA required them to compare Benvitimod with the gold-standard Calcipotriol and conduct a double blind experiment. "When the result was announced, my heart was about to pop out," said Chen. The double blind experiment showed that Benvitimod is more effective.
At the annual meeting of American Academy of Dermatology in 2017, Zhang was invited to deliver a speech on their research on Benvitimod, drawing much attention from international counterparts.
"New drug research and development is mainly conducted in Western countries, but China also has advantages in some domains, like Benvitimod," said Zhang. "We should have faith in ourselves."
Researching and developing new drugs is widely considered to be the biggest gamble in the world. A report issued by Deloitte shows that the spending on a new drug, from research and development to putting it on sale, has risen from $1.2 billion in 2010 to $2 billion in 2017.
"The success rate in the pharmaceutical industry is 0.01 percent, and the chance of being rated as a first-in-class drug shrinks to 0.003 percent," Chen said.
"I never gave up because I always had faith that the drug is going to work," Chen said. "I thought, when we succeed, future generations will always remember Benvitimod cream is developed by the Chinese."
On July 19, the production of Benvitimod cream officially began.
"Theoretically speaking, doctors will be able to write prescriptions for the Benvitimod in the very near future," Chen said.
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Ascletis Opens Clinical Development Shanghai Center
NEWS PROVIDED BY Ascletis Pharma Inc.
Aug 12, 2019, 06:00 ET
HANGZHOU and SHAOXING, China, Aug. 12, 2019 /PRNewswire/ -- Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today the opening of its Clinical Development Shanghai Center, signalling the further expansion of R&D capability, especially in Oncology and Non-alcoholic steatohepatitis (NASH).
Ascletis' Clinical Development Shanghai Center is at the heart of Shanghai, located at Jing'an Kerry Centre near Nanjing West Road. The opening ceremony was held on Aug 11, 2019 in conjunction with Hepatitis and NASH Drug Research and Development Forum. Academician Chen Kaixian and Academician Jiang Hualiang, both from Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wang Lei, Executive Vice President of AstraZeneca attended the forum. Leading physicians from Shanghai also attended the forum, including Professors Weng Xinhua, Lu Hongzhou, Zhang Wenhong, Chen liang.
"As an innovative R&D driven biotech with two commercial products (Ganovo®and Pegasys®), we have successfully attracted talents of clinical development," said Jinzi J. Wu, PhD, Founder, Chairman and CEO. "With the opening of Clinical Development Shanghai Center, we continue to expand our clinical development for three core therapeutic areas: anti-viral, oncology and NASH. Strategic location of the Shanghai Center will help us attract more talents in the Shanghai region and beyond."
Dr. Wu continues, "As we invest more effort in the first-in-class drug development, we want to welcome talents to join us from multi-national companies and innovative biotechs on a global basis. Developing first-in-class medicines is key for China-based innovative biotechs to compete at global level."
About Ascletis
Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis' mission is to address unmet medical needs in three therapeutic areas: viral, cancer and fatty liver diseases. Led by a management team with deep expertise and a proven track record, Ascletis has developed a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now commercializing two drugs, Ganovo® (Danoprevir), the first direct-acting anti-viral agent for hepatitis C developed domestically for China, and Pegasys® (Peginterferon alfa-2a), a well-established pegylated interferon for hepatitis B&C partnered with Roche. Ascletis' R&D pipeline consists of antibody-based immunotherapy, first/best-in-class small molecules and siRNA at various clinical development stages. For more information, please visit www.ascletis.com.
SOURCE Ascletis Pharma Inc.
https://www.prnewswire.com/news-rel...al-development-shanghai-center-300899748.html
NEWS PROVIDED BY Ascletis Pharma Inc.
Aug 12, 2019, 06:00 ET
HANGZHOU and SHAOXING, China, Aug. 12, 2019 /PRNewswire/ -- Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today the opening of its Clinical Development Shanghai Center, signalling the further expansion of R&D capability, especially in Oncology and Non-alcoholic steatohepatitis (NASH).
Ascletis' Clinical Development Shanghai Center is at the heart of Shanghai, located at Jing'an Kerry Centre near Nanjing West Road. The opening ceremony was held on Aug 11, 2019 in conjunction with Hepatitis and NASH Drug Research and Development Forum. Academician Chen Kaixian and Academician Jiang Hualiang, both from Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wang Lei, Executive Vice President of AstraZeneca attended the forum. Leading physicians from Shanghai also attended the forum, including Professors Weng Xinhua, Lu Hongzhou, Zhang Wenhong, Chen liang.
"As an innovative R&D driven biotech with two commercial products (Ganovo®and Pegasys®), we have successfully attracted talents of clinical development," said Jinzi J. Wu, PhD, Founder, Chairman and CEO. "With the opening of Clinical Development Shanghai Center, we continue to expand our clinical development for three core therapeutic areas: anti-viral, oncology and NASH. Strategic location of the Shanghai Center will help us attract more talents in the Shanghai region and beyond."
Dr. Wu continues, "As we invest more effort in the first-in-class drug development, we want to welcome talents to join us from multi-national companies and innovative biotechs on a global basis. Developing first-in-class medicines is key for China-based innovative biotechs to compete at global level."
About Ascletis
Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis' mission is to address unmet medical needs in three therapeutic areas: viral, cancer and fatty liver diseases. Led by a management team with deep expertise and a proven track record, Ascletis has developed a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now commercializing two drugs, Ganovo® (Danoprevir), the first direct-acting anti-viral agent for hepatitis C developed domestically for China, and Pegasys® (Peginterferon alfa-2a), a well-established pegylated interferon for hepatitis B&C partnered with Roche. Ascletis' R&D pipeline consists of antibody-based immunotherapy, first/best-in-class small molecules and siRNA at various clinical development stages. For more information, please visit www.ascletis.com.
SOURCE Ascletis Pharma Inc.
https://www.prnewswire.com/news-rel...al-development-shanghai-center-300899748.html
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China self-developed full-digital PET completes multiple brain imagingChina’s Self-Developed Medical Imaging Device PET/CT Enters Final Clinical Trial
DOU SHICONG
DATE: FRI, 05/04/2018 - 14:28 / SOURCE:YICAI
China’s Self-Developed Medical Imaging Device PET/CT Enters Final Clinical Trial
(Yicai Global) May 4 -- The world’s first fully-digital PET/CT has entered the final phase of clinical tests. PET/CT is a new type of medical imaging device that combines positron emission tomography with computed tomography, two diagnosis and treatment technologies.
A team led by Prof. Xie Qingguo of Huazhong University of Science and Technology in Wuhan, china's central Hubei province developed the device.
The First Affiliated Hospital of Sun Yat-sen University and Sun Yat-sen University Cancer Center are soliciting volunteers from the public to clinically test the equipment’s safety and efficacy during imaging diagnosis, Chinese Science News reported yesterday. After 120 cases of clinical trials conclude, registration documents will be submitted to relevant authorities.
The new PET/CT device is fully digital and able to precisely sample. It can detect tumors earlier and more accurately than conventional PET/CT devices. It also finds wide use in early detection of senile dementia and Alzheimer's.
The five-year survival rate of Chinese cancer patients is a mere 31 percent, less than half of that in the US. This low ratio is in part to blame on delayed detection and treatment, and the PET/CT device can significantly improve the capability of early cancer detection through its advantages in imaging performance, noted Zhang Xiangsong, director of nuclear medicine department of the First Affiliated Hospital, Sun Yat-sen University.
Xie’s team started research into fully-digital PET/CT in 2001 and developed the new device in 2016, which solved the technical problem of the inability of traditional PET devices to digitize scintillating pulse signals, and thus it significantly reduces detection time and costs.
Source: Xinhua| 2019-08-16 16:06:06|Editor: Li Xia
WUHAN, Aug. 16 (Xinhua) -- China's first home-developed full-digital positron emission tomography (PET) scanner has completed multiple clinical cases of brain imaging.
It was recently installed in the First Affiliated Hospital of Sun Yat-Sen University in the southern Chinese city of Guangzhou, Guangdong Province.
Mainly used for early diagnosis and accurate treatment of neurological diseases such as brain tumors and Parkinson's disease, the equipment is believed to be the world's first full-digital PET exclusively developed for cerebral imaging.
It was developed after 19 years of efforts by a team led by Xie Qingguo, a biomedical engineering professor at the Huazhong University of Science and Technology in Wuhan, capital of central China's Hubei Province.
"Multiple clinical trials have provided clear images of brain sulci and gyri and legible pictures of ventricles of the brain," said Zhang Xiangsong, chief physician of the Department of Nuclear Medicine at the hospital.
The brain imaging results reflected an ultra-high biochemical sensitivity of the PET system, which has great potential for exploring brain science and studying brain diseases, he added.
A 30-year-old female patient of the hospital was recently diagnosed with Parkinson's disease by the equipment. "With early detection and proper therapy and medication, she can still expect to live as long as a healthy person," Zhang said.
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Chinese researchers find new target for treatment of polycystic ovary syndrome
Source: Xinhua| 2019-08-21 00:34:13|Editor: Mu Xuequan
BEIJING, Aug. 20 (Xinhua) -- Chinese researchers have found that gut microbiota plays an important role in regulating polycystic ovary syndrome, a common health problem in women of childbearing age, providing a new perspective for the prevention and treatment of the symptom.
Polycystic ovary syndrome is a hormonal disorder that can affect women's periods and lead to difficulties in getting pregnant. It is often accompanied by insulin resistance. The mechanism of ovulatory dysfunction and insulin resistance in the symptom remains elusive, thus limiting the development of therapeutics.
Researchers from Peking University Third Hospital and Peking University Health Science Center have investigated the impact of the gut microbiota and its metabolites on the regulation of polycystic ovary syndrome-associated ovarian dysfunction and insulin resistance. They found that the gut bacteria Bacteroides vulgatus was markedly elevated in the gut microbiota of individuals with the symptom.
Further experiments suggest that modifying the gut microbiota and altering bile acid metabolism may be of value for the treatment of the symptom.
Qiao Jie, the leading researcher, said the study was an interdisciplinary research that combines bioinformatics, metabolomics and immunology.
"Our research team will recruit volunteers to conduct large-scale multi-center joint clinical trials in the future to further verify the treatment target," Qiao said.
The research was published in the journal Nature Medicine.
Source: Xinhua| 2019-08-21 00:34:13|Editor: Mu Xuequan
BEIJING, Aug. 20 (Xinhua) -- Chinese researchers have found that gut microbiota plays an important role in regulating polycystic ovary syndrome, a common health problem in women of childbearing age, providing a new perspective for the prevention and treatment of the symptom.
Polycystic ovary syndrome is a hormonal disorder that can affect women's periods and lead to difficulties in getting pregnant. It is often accompanied by insulin resistance. The mechanism of ovulatory dysfunction and insulin resistance in the symptom remains elusive, thus limiting the development of therapeutics.
Researchers from Peking University Third Hospital and Peking University Health Science Center have investigated the impact of the gut microbiota and its metabolites on the regulation of polycystic ovary syndrome-associated ovarian dysfunction and insulin resistance. They found that the gut bacteria Bacteroides vulgatus was markedly elevated in the gut microbiota of individuals with the symptom.
Further experiments suggest that modifying the gut microbiota and altering bile acid metabolism may be of value for the treatment of the symptom.
Qiao Jie, the leading researcher, said the study was an interdisciplinary research that combines bioinformatics, metabolomics and immunology.
"Our research team will recruit volunteers to conduct large-scale multi-center joint clinical trials in the future to further verify the treatment target," Qiao said.
The research was published in the journal Nature Medicine.
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Published: September 2, 2019
New study reveals ‘smart’ approach to detecting common heart condition - News - University of Liverpool
A new study, presented as ‘Late Breaking Science’ at the European Society of Cardiology (ESC)annual congress and published in the Journal of the American College of Cardiology, highlights the feasible use of mobile health (mHealth) devices to help with the screening and detection of a common heart condition.
Atrial fibrillation (AF) is a heart rhythm condition that causes an irregular and sometimes, abnormally fast heart rate. In AF, the heart’s upper chambers (atria) contract randomly and sometimes so fast that the heart muscle cannot relax properly between contractions. This reduces the heart’s efficiency and performance – but also leads to a higher risk of blood clots.
AF is the most common heart rhythm disturbance, affecting around one million people in the UK. People with AF are at increased risk of having a stroke and dying, as well as heart failure and dementia.
Currently, low detection due to lack of visible symptoms and nonadherence are major problems in current management approaches for patients with suspected AF.
Photoplethysmography technology
mHealth devices, such as fitness trackers, smart watches and mobile phones, may enable earlier AF detection, and improved AF management through the use of photoplethysmography (PPG) technology.
PPG is a simple and low-cost optical technique that can be used to detect blood volume changes in the microvascular bed of tissue. It is often used non-invasively to make measurements at the skin surface.
Researchers, led by Associate Professor Guo from Chinese PLA General Hospital in Beijing, and Professor Gregory Lip, Lead for the Liverpool Centre for Cardiovascular Science/Price-Evans Chair of Cardiovascular Medicine at University of Liverpool, aimed to determine the feasibility of AF screening in a large population-based cohort using smart devices with PPG technology, combined with a clinical care AF management pathway.
As part of the study AF screening was performed with smart wristbands* or watches** using PPG technology*** made available for the population aged over 18 years across China for approximately seven months (October 26, 2018 to May 20, 2019).
Results
Overall 187,912 participants used smart devices to monitor their pulse rhythm. During this time 424 (0.23%) of the individuals received a ‘suspected AF’ notification. Of those 227 (87%) were confirmed as having AF by health providers and other secondary examinations. These patients were provided with therapy and successfully anticoagulated.
Associate Professor Guo, said: “Based on our present study, continuous home-monitoring with smart device based PPG technology could be a feasible, cost-effective approach for AF screening. There were 95% patients following entry into a programme of integrated AF care, and approximately 80% of high risk patients were successfully anticoagulated. This would help efforts at screening and detection of AF, as well as early interventions to reduce stroke and other AF-related complications.”
Professor Lip, said: “Improved AF care requires early detection and the opportunity for streamlined management decision-making. Better detection can be followed by implementing the priorities of AF management, which is as ‘easy as ABC’: Avoid stroke; Better symptom optimisation; Cardiovascular and risk factor management.”
The full study, entitled ‘Mobile Health technology for atrial fibrillation screening using photoplethysmography-based smart devices: The HUAWEI Heart study’, can be found here.
This research project was funded by the National Natural Science Foundation of China and the Health and Family Planning Commission of Heilongjiang Province, China, and partly supported by the NIHR Global Health Research Group on Atrial Fibrillation management.
https://doi.org/10.1016/j.jacc.2019.08.019
*HONOR BAND 4
**HUAWEI WATCH GT, HONOR WATCH
*** Huawei Technologies Co., Ltd., Shenzhen, China
New study reveals ‘smart’ approach to detecting common heart condition - News - University of Liverpool
A new study, presented as ‘Late Breaking Science’ at the European Society of Cardiology (ESC)annual congress and published in the Journal of the American College of Cardiology, highlights the feasible use of mobile health (mHealth) devices to help with the screening and detection of a common heart condition.
Atrial fibrillation (AF) is a heart rhythm condition that causes an irregular and sometimes, abnormally fast heart rate. In AF, the heart’s upper chambers (atria) contract randomly and sometimes so fast that the heart muscle cannot relax properly between contractions. This reduces the heart’s efficiency and performance – but also leads to a higher risk of blood clots.
AF is the most common heart rhythm disturbance, affecting around one million people in the UK. People with AF are at increased risk of having a stroke and dying, as well as heart failure and dementia.
Currently, low detection due to lack of visible symptoms and nonadherence are major problems in current management approaches for patients with suspected AF.
Photoplethysmography technology
mHealth devices, such as fitness trackers, smart watches and mobile phones, may enable earlier AF detection, and improved AF management through the use of photoplethysmography (PPG) technology.
PPG is a simple and low-cost optical technique that can be used to detect blood volume changes in the microvascular bed of tissue. It is often used non-invasively to make measurements at the skin surface.
Researchers, led by Associate Professor Guo from Chinese PLA General Hospital in Beijing, and Professor Gregory Lip, Lead for the Liverpool Centre for Cardiovascular Science/Price-Evans Chair of Cardiovascular Medicine at University of Liverpool, aimed to determine the feasibility of AF screening in a large population-based cohort using smart devices with PPG technology, combined with a clinical care AF management pathway.
As part of the study AF screening was performed with smart wristbands* or watches** using PPG technology*** made available for the population aged over 18 years across China for approximately seven months (October 26, 2018 to May 20, 2019).
Results
Overall 187,912 participants used smart devices to monitor their pulse rhythm. During this time 424 (0.23%) of the individuals received a ‘suspected AF’ notification. Of those 227 (87%) were confirmed as having AF by health providers and other secondary examinations. These patients were provided with therapy and successfully anticoagulated.
Associate Professor Guo, said: “Based on our present study, continuous home-monitoring with smart device based PPG technology could be a feasible, cost-effective approach for AF screening. There were 95% patients following entry into a programme of integrated AF care, and approximately 80% of high risk patients were successfully anticoagulated. This would help efforts at screening and detection of AF, as well as early interventions to reduce stroke and other AF-related complications.”
Professor Lip, said: “Improved AF care requires early detection and the opportunity for streamlined management decision-making. Better detection can be followed by implementing the priorities of AF management, which is as ‘easy as ABC’: Avoid stroke; Better symptom optimisation; Cardiovascular and risk factor management.”
The full study, entitled ‘Mobile Health technology for atrial fibrillation screening using photoplethysmography-based smart devices: The HUAWEI Heart study’, can be found here.
This research project was funded by the National Natural Science Foundation of China and the Health and Family Planning Commission of Heilongjiang Province, China, and partly supported by the NIHR Global Health Research Group on Atrial Fibrillation management.
https://doi.org/10.1016/j.jacc.2019.08.019
*HONOR BAND 4
**HUAWEI WATCH GT, HONOR WATCH
*** Huawei Technologies Co., Ltd., Shenzhen, China
JSCh
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Innovent Biologics Study Results of IBI303 in Patients with Ankylosing Spondylitis was Published in "The Lancet Rheumatology"
NEWS PROVIDED BY Innovent Biologics, Inc.
Aug 30, 2019, 05:36 ET
SUZHOU, China, Aug. 30, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the clinical trial results of IBI303, an anti-tumor necrosis factor-alpha (anti-TNF-alpha) monoclonal antibody injection developed by Innovent, has been published in The Lancet Rheumatology, a leading international medical journal, with comment by Stanley Cohen, professor of University of Texas Southwestern Medical Center.
Led by Professor Huji Xu of the School of Medicine at Tsinghua University, the Phase III trial was a multi-centre, randomized, double-blind, parallel-controlled trial that compared the efficacy and safety of IBI303 and the originator drug adalimumab (Humira®), on ankylosing spondylitis (AS) patients; it is the first large-scale head-to-head Phase III clinical trial comparing a biosimilar and adalimumab in AS patients. It is also the first time a highly-regarded top-tier medical journal has featured the major phase III clinical trial results of a China-developed biosimilar.
The originator, adalimumab, has been among the world's best-selling drugs for several consecutive years, with sales revenue of USD 19.9 billion in 2018. Adalimumab was approved for treating rheumatoid arthritis, AS and plaque psoriasis in China.
AS is a chronic inflammatory disease that primarily affects spinal joints and peripheral joints and in severe cases can cause spinal deformity and ankylosis. According to the reported studies, China has a prevalence rate of approximately 0.3%, which translates into a potential total patient number of over 4 million AS patients. The occurrence of the disease is dominant in adolescent males, with an onset age of 20 to 30 and a disability rate of 15-20%. The Anti-tumor necrosis factor-alpha inhibitors exhibit satisfactory anti-inflammatory activity and effects in preventing disease progression, which represent the most widely used biologics with the extensive clinical trial data for the treatment of AS worldwide.
Twenty hospitals across China participated in the Phase III trial. All enrolled patients received at least four weeks of NSAIDs treatment and were either treatment ineffective, resistant or intolerable. Patients treated with either IBI303 or Humira® subcutaneous injection of 40 mg/0.8 ml once every two weeks for 22 weeks. The primary endpoint was the ASAS20 response rate (a standard tool to evaluate the clinical improvement of AS) at week 24.
Among 438 patients recruited in total, 220 were treated with IBI303, while those in the control group received Humira®. The initial results concluded ASAS20 response rates of 75% and 72.5% respectively at week 24, indicating clinical equivalency between IBI303 and Humira®. The secondary endpoints were met, including AS assessment points such as ASAS20 response rate at week 12, ASAS40 response rate at week 24, ASAS partial response rates, ASAS5/6 response rate, and BASDAI etc. The overall data indicate the comparable effects to the originator drug in terms of disease activity, improvement of physical functions, spinal mobility, tendonitis, overall patient assessment, and improvement of the quality of life. Moreover, the results showed that IBI303 was well tolerated in patients with safety and immunogenicity comparable to those of Humira®.
"Autoimmune diseases such as AS severely impact on patients' quality of life and pose significant economic burden to the society and the patients. Antibodies targeting TNF-alpha currently play an important role in treating autoimmune diseases such as AS. However, the imported TNF-alpha inhibitor drug is far beyond affordable for most patients in China. IBI303, a biosimilar to adalimumab, was solely developed by Innovent. The Phase III clinical trial proved its equivalence in safety and efficacy to the originator Humira®. The IBI303 trial results were recognized and published in The Lancet Rheumatology, which is exciting news for the China Rheumatic community and indicates that Innovent has reached international standard in process development and clinical research of biosimilars," said Professor Huji Xu, a prominent physician scientist in the area of rheumatic diseases and the leading PI of the trial from the School of Medicine at Tsinghua University.
In 2015, the "Technical Guidance for the Research, Development and Evaluation of Biosimilars (Trial)" issued by the National Medical Products Administration (NMPA), greatly fostered the development of biosimilars in China. Adhering to institutional guidance, Innovent independently developed adalimumab biosimilar IBI303. The NMPA accepted and granted with priority review status the new drug application (NDA) of IBI303 based on the preclinical pharmacokinetics (PK) and pharmacodynamics (PD), toxicology, PK equivalence trial data as well as the results of this Phase III clinical trial.
The launch of IBI303 is expected to reduce medical expenditure of patients in China and enhance the affordability and accessibility of the treatment.
"We are very excited about the publication of IBI303 Phase III clinical trial results in The Lancet Rheumatology, which further validated our clinical results, the drug's efficacy , safety and Innovent's development capability," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "Professor Xu Huji set a great example manifesting the leading standard of Chinese researchers in the clinical science of the related diseases. Although autoimmune diseases such as AS are not fatal, if not treated in time, they can seriously affect patients' quality of life. We sincerely hope this high-quality drug could be approved and launched soon so that it can benefit patients and their families," added Dr. Yu.
To view the article from Lancet in full, please click the link below:
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30013-X/fulltext
To view professor Stephen Cohen's Comment, please click the link below:
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30021-9/fulltext
NEWS PROVIDED BY Innovent Biologics, Inc.
Aug 30, 2019, 05:36 ET
SUZHOU, China, Aug. 30, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the clinical trial results of IBI303, an anti-tumor necrosis factor-alpha (anti-TNF-alpha) monoclonal antibody injection developed by Innovent, has been published in The Lancet Rheumatology, a leading international medical journal, with comment by Stanley Cohen, professor of University of Texas Southwestern Medical Center.
Led by Professor Huji Xu of the School of Medicine at Tsinghua University, the Phase III trial was a multi-centre, randomized, double-blind, parallel-controlled trial that compared the efficacy and safety of IBI303 and the originator drug adalimumab (Humira®), on ankylosing spondylitis (AS) patients; it is the first large-scale head-to-head Phase III clinical trial comparing a biosimilar and adalimumab in AS patients. It is also the first time a highly-regarded top-tier medical journal has featured the major phase III clinical trial results of a China-developed biosimilar.
The originator, adalimumab, has been among the world's best-selling drugs for several consecutive years, with sales revenue of USD 19.9 billion in 2018. Adalimumab was approved for treating rheumatoid arthritis, AS and plaque psoriasis in China.
AS is a chronic inflammatory disease that primarily affects spinal joints and peripheral joints and in severe cases can cause spinal deformity and ankylosis. According to the reported studies, China has a prevalence rate of approximately 0.3%, which translates into a potential total patient number of over 4 million AS patients. The occurrence of the disease is dominant in adolescent males, with an onset age of 20 to 30 and a disability rate of 15-20%. The Anti-tumor necrosis factor-alpha inhibitors exhibit satisfactory anti-inflammatory activity and effects in preventing disease progression, which represent the most widely used biologics with the extensive clinical trial data for the treatment of AS worldwide.
Twenty hospitals across China participated in the Phase III trial. All enrolled patients received at least four weeks of NSAIDs treatment and were either treatment ineffective, resistant or intolerable. Patients treated with either IBI303 or Humira® subcutaneous injection of 40 mg/0.8 ml once every two weeks for 22 weeks. The primary endpoint was the ASAS20 response rate (a standard tool to evaluate the clinical improvement of AS) at week 24.
Among 438 patients recruited in total, 220 were treated with IBI303, while those in the control group received Humira®. The initial results concluded ASAS20 response rates of 75% and 72.5% respectively at week 24, indicating clinical equivalency between IBI303 and Humira®. The secondary endpoints were met, including AS assessment points such as ASAS20 response rate at week 12, ASAS40 response rate at week 24, ASAS partial response rates, ASAS5/6 response rate, and BASDAI etc. The overall data indicate the comparable effects to the originator drug in terms of disease activity, improvement of physical functions, spinal mobility, tendonitis, overall patient assessment, and improvement of the quality of life. Moreover, the results showed that IBI303 was well tolerated in patients with safety and immunogenicity comparable to those of Humira®.
"Autoimmune diseases such as AS severely impact on patients' quality of life and pose significant economic burden to the society and the patients. Antibodies targeting TNF-alpha currently play an important role in treating autoimmune diseases such as AS. However, the imported TNF-alpha inhibitor drug is far beyond affordable for most patients in China. IBI303, a biosimilar to adalimumab, was solely developed by Innovent. The Phase III clinical trial proved its equivalence in safety and efficacy to the originator Humira®. The IBI303 trial results were recognized and published in The Lancet Rheumatology, which is exciting news for the China Rheumatic community and indicates that Innovent has reached international standard in process development and clinical research of biosimilars," said Professor Huji Xu, a prominent physician scientist in the area of rheumatic diseases and the leading PI of the trial from the School of Medicine at Tsinghua University.
In 2015, the "Technical Guidance for the Research, Development and Evaluation of Biosimilars (Trial)" issued by the National Medical Products Administration (NMPA), greatly fostered the development of biosimilars in China. Adhering to institutional guidance, Innovent independently developed adalimumab biosimilar IBI303. The NMPA accepted and granted with priority review status the new drug application (NDA) of IBI303 based on the preclinical pharmacokinetics (PK) and pharmacodynamics (PD), toxicology, PK equivalence trial data as well as the results of this Phase III clinical trial.
The launch of IBI303 is expected to reduce medical expenditure of patients in China and enhance the affordability and accessibility of the treatment.
"We are very excited about the publication of IBI303 Phase III clinical trial results in The Lancet Rheumatology, which further validated our clinical results, the drug's efficacy , safety and Innovent's development capability," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "Professor Xu Huji set a great example manifesting the leading standard of Chinese researchers in the clinical science of the related diseases. Although autoimmune diseases such as AS are not fatal, if not treated in time, they can seriously affect patients' quality of life. We sincerely hope this high-quality drug could be approved and launched soon so that it can benefit patients and their families," added Dr. Yu.
To view the article from Lancet in full, please click the link below:
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30013-X/fulltext
To view professor Stephen Cohen's Comment, please click the link below:
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30021-9/fulltext
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China Focus: Artificial heart powered by China's aerospace technology to undergo clinical research
Source: Xinhua| 2019-09-03 16:57:22|Editor: ZX
BEIJING, Sept. 3 (Xinhua) -- A Chinese artificial heart design used in patients with aerospace technology will go into clinical research by the end of this year, according to its developer. Once reaching the market, it may help millions of people in China suffering from weak hearts.
Developed by scientists from the No. 18 Research Institute under the China Academy of Launch Vehicle Technology, the country's leading rocket maker, the artificial heart called HeartCon weighs only 180 grams and is smaller than the size of a fist.
After being implanted into a human to replace the original heart organ, it will function as a pump that delivers blood to the whole body, said Xu Jian, chief engineer of the project.
The artificial heart works similarly to a rocket's servomechanism, which is driven by a hydraulic pump, Xu said.
A servomechanism is a device used to provide control of a desired operation through the use of feedback.
"The servomechanism on a rocket has higher requirements in speed and power, while the artificial heart demands more focus on safety and comfort as it is small and needs to be implanted," Xu said.
Scientists from the institute began developing the artificial heart in 2009. They used magnetic and fluid levitation, which are used in rocket servo technology, to produce an implantable third-generation ventricular assistive device, a mechanical pump to support heart function while causing less damage to patients' blood than previous types.
The HeartCon was tested in many animal experiments. In 2013, a sheep with the implanted artificial heart lived for 120 days. Two years later, the hearts were placed in three sheep, and all survived, indicating that the device was ready for batch production.
In 2017, scientists implanted the HeartCons into six sheep and set a new record as one of them survived for 180 days.
The success was also achieved in humans. A 39-year-old male and a 62-year-old female were the first two patients implanted with HeartCons in March this year in Tianjin. Both of them are in good health.
This is not the first Chinese artificial heart to save patients. In 2017, doctors from Beijing's Fuwai Hospital, China's leading hospital specializing in cardiovascular diseases, saved three patients with artificial hearts they developed.
There are at least 10 million people in China with failing hearts, and the number is growing due to the aging population.
Drugs have little effect, and heart transplants used to be the only solution. However, organ transplants are limited by a lack of donors, said Ren Wanfeng, a cardiovascular specialist at the Peking University Health Science Center.
Many patients had to travel abroad to get an imported artificial heart, which cost as high as 100,000 U.S. dollars. According to researchers, the HeartCon will be cheaper, bringing benefits to more patients in China.
The HeartCon is expected to be approved for sale within two years.
Source: Xinhua| 2019-09-03 16:57:22|Editor: ZX
BEIJING, Sept. 3 (Xinhua) -- A Chinese artificial heart design used in patients with aerospace technology will go into clinical research by the end of this year, according to its developer. Once reaching the market, it may help millions of people in China suffering from weak hearts.
Developed by scientists from the No. 18 Research Institute under the China Academy of Launch Vehicle Technology, the country's leading rocket maker, the artificial heart called HeartCon weighs only 180 grams and is smaller than the size of a fist.
After being implanted into a human to replace the original heart organ, it will function as a pump that delivers blood to the whole body, said Xu Jian, chief engineer of the project.
The artificial heart works similarly to a rocket's servomechanism, which is driven by a hydraulic pump, Xu said.
A servomechanism is a device used to provide control of a desired operation through the use of feedback.
"The servomechanism on a rocket has higher requirements in speed and power, while the artificial heart demands more focus on safety and comfort as it is small and needs to be implanted," Xu said.
Scientists from the institute began developing the artificial heart in 2009. They used magnetic and fluid levitation, which are used in rocket servo technology, to produce an implantable third-generation ventricular assistive device, a mechanical pump to support heart function while causing less damage to patients' blood than previous types.
The HeartCon was tested in many animal experiments. In 2013, a sheep with the implanted artificial heart lived for 120 days. Two years later, the hearts were placed in three sheep, and all survived, indicating that the device was ready for batch production.
In 2017, scientists implanted the HeartCons into six sheep and set a new record as one of them survived for 180 days.
The success was also achieved in humans. A 39-year-old male and a 62-year-old female were the first two patients implanted with HeartCons in March this year in Tianjin. Both of them are in good health.
This is not the first Chinese artificial heart to save patients. In 2017, doctors from Beijing's Fuwai Hospital, China's leading hospital specializing in cardiovascular diseases, saved three patients with artificial hearts they developed.
There are at least 10 million people in China with failing hearts, and the number is growing due to the aging population.
Drugs have little effect, and heart transplants used to be the only solution. However, organ transplants are limited by a lack of donors, said Ren Wanfeng, a cardiovascular specialist at the Peking University Health Science Center.
Many patients had to travel abroad to get an imported artificial heart, which cost as high as 100,000 U.S. dollars. According to researchers, the HeartCon will be cheaper, bringing benefits to more patients in China.
The HeartCon is expected to be approved for sale within two years.
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China Prepares to Put African Swine Fever Vaccine Through Clinical Trials
LIAO SHUMIN
DATE : SEP 11 2019/SOURCE : YICAI
China Prepares to Put African Swine Fever Vaccine Through Clinical Trials
(Yicai Global) Sept. 11 -- China's Academy of Agricultural Sciences is readying to put its African swine fever vaccination through clinical trials after the pig-killing disease wiped out thousands of hogs across the country and jacked up the price of pork.
The academy's Harbin Veterinary Research Institute has screened a live vaccine for ASF and completed laboratory research, state broadcaster CCTV reported. The institute has filed an application for biosafety evaluation so it can start clinical trials.
"We have also solved the issues with the manufacturing process for an African swine fever vaccine through product research at our lab," said Bu Zhigao, director of the institute, adding that the organization has established quality standards for such inoculations.
Pork prices soared 46.7 percent annually last month, one year on from the first confirmed outbreak of the disease, according to data published yesterday by the National Bureau of Statistics. They rose an average 15 percent over the first eight months of 2019 as the nation struggled to maintain adequate supplies.
Reports have been circulating online suggesting some Chinese farms have been using pilot-tested, self-grown or smuggled vaccines to protect their swine, but an official at the Veterinary Bureau of the Ministry of Agriculture and Rural Affairs believes this is hogwash. ASF immunizations are a worldwide problem, not a single country has approved one for use or sale, he said.
One of the biggest struggles with developing a vaccine for ASF lies in insufficient fundamental research of the pathogen itself and the limitations of biosafety conditions. The biological characteristics of the virus are complex and its genome is huge, with more than half of its genes possessing unknown functions.
LIAO SHUMIN
DATE : SEP 11 2019/SOURCE : YICAI
China Prepares to Put African Swine Fever Vaccine Through Clinical Trials
(Yicai Global) Sept. 11 -- China's Academy of Agricultural Sciences is readying to put its African swine fever vaccination through clinical trials after the pig-killing disease wiped out thousands of hogs across the country and jacked up the price of pork.
The academy's Harbin Veterinary Research Institute has screened a live vaccine for ASF and completed laboratory research, state broadcaster CCTV reported. The institute has filed an application for biosafety evaluation so it can start clinical trials.
"We have also solved the issues with the manufacturing process for an African swine fever vaccine through product research at our lab," said Bu Zhigao, director of the institute, adding that the organization has established quality standards for such inoculations.
Pork prices soared 46.7 percent annually last month, one year on from the first confirmed outbreak of the disease, according to data published yesterday by the National Bureau of Statistics. They rose an average 15 percent over the first eight months of 2019 as the nation struggled to maintain adequate supplies.
Reports have been circulating online suggesting some Chinese farms have been using pilot-tested, self-grown or smuggled vaccines to protect their swine, but an official at the Veterinary Bureau of the Ministry of Agriculture and Rural Affairs believes this is hogwash. ASF immunizations are a worldwide problem, not a single country has approved one for use or sale, he said.
One of the biggest struggles with developing a vaccine for ASF lies in insufficient fundamental research of the pathogen itself and the limitations of biosafety conditions. The biological characteristics of the virus are complex and its genome is huge, with more than half of its genes possessing unknown functions.
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Chinese chronic pain reliever begins clinical trial
Source: Xinhua| 2019-09-17 19:02:57|Editor: Xiang Bo
BEIJING, Sept. 17 (Xinhua) -- A new Chinese drug to alleviate patients' neuropathic pain, or nerve pain, has entered clinical trials, according to the Ministry of Science and Technology Tuesday.
The pain reliever SR419 was developed by scientists from the Chinese Academy of Sciences (CAS) and Shanghai SIMR Biotechnology Co., Ltd.
Neuropathic pain, often described as sharp, stinging or burning, is chronic pain caused by damaged nerves or a problem with the nervous system. It is also the result of or accompanied by viral infection, diabetes, chemotherapy and surgeries.
Data shows that the incidence of neuropathic pain among Chinese elderly is 49.8 percent and more than 50 percent in cancer patients. Conventional painkillers are largely ineffective.
Zhang Xu, a CAS academician and lead researcher, has been studying neuropathic pain for almost 30 years. Based on Zhang's research, the Shanghai company established China's first complete neuropharmaceutical research and development platform.
According to the research group, the candidate drug proved effective in relieving chronic pain caused by nerve damage. It reduced potential side effects on central nerves and could replace opioid drugs which produce morphine-like effects.
Preclinical data show that SR419 has a strong analgesic effect and no side effects, with the potential to become the world's first analgesic drug for specific targets.
Source: Xinhua| 2019-09-17 19:02:57|Editor: Xiang Bo
BEIJING, Sept. 17 (Xinhua) -- A new Chinese drug to alleviate patients' neuropathic pain, or nerve pain, has entered clinical trials, according to the Ministry of Science and Technology Tuesday.
The pain reliever SR419 was developed by scientists from the Chinese Academy of Sciences (CAS) and Shanghai SIMR Biotechnology Co., Ltd.
Neuropathic pain, often described as sharp, stinging or burning, is chronic pain caused by damaged nerves or a problem with the nervous system. It is also the result of or accompanied by viral infection, diabetes, chemotherapy and surgeries.
Data shows that the incidence of neuropathic pain among Chinese elderly is 49.8 percent and more than 50 percent in cancer patients. Conventional painkillers are largely ineffective.
Zhang Xu, a CAS academician and lead researcher, has been studying neuropathic pain for almost 30 years. Based on Zhang's research, the Shanghai company established China's first complete neuropharmaceutical research and development platform.
According to the research group, the candidate drug proved effective in relieving chronic pain caused by nerve damage. It reduced potential side effects on central nerves and could replace opioid drugs which produce morphine-like effects.
Preclinical data show that SR419 has a strong analgesic effect and no side effects, with the potential to become the world's first analgesic drug for specific targets.
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