Just last month, Tianci's “Science & Innovation Dream Works”, the first sharing pharmaceutical platform in China, settled in Zhangjiang Hi-Tech Park, where a new drug against Alzheimer's disease (commonly known as senile dementia), sodium oligo-mannurarate (GV-971), will be produced and fully marketed.
From R&D to manufacturing, GV-971, a new star drug, has been widely known for its "Zhangjiang" production, and is expected to become the first oligosaccharide multi-target innovative drug in the world against Alzheimer's disease, providing a Chinese solution for the treatment of complex diseases.
The R & D process of new drugs cannot be separated from a trial-and-error process. The whole cycle will take at least 10 years. Geng Meiyu's team has been working for 22 years since the discovery of the first Alzheimer's disease-related compound in 1997.
"From drug discovery, preclinical research, clinical research, production to the ultimate commercialization, continuous investment is needed." Geng Meiyu told reporters that in 2009, GV-971 was transferred to Shanghai Green Valley Pharmaceutical Co., Ltd. of Zhangjiang Medicine Valley. "Without the sustained and persistent investment of enterprises for many years, this innovative drug could never be created at all."
According to the World Alzheimer Annual Report issued by the Alzheimer's Disease International, 1 case of Alzheimer's Disease appears every 3 seconds in the world. Last year, there were about 50 million patients in the world, including more than 10 million Chinese patients. It is estimated that by 2050, the number of Alzheimer's disease patients worldwide will increase to 152 million. However, there is still a lack of effective treatment in the world. Since the marketing of cholinesterase inhibitors in 2002, despite the investment of hundreds of billions of dollars, all the relevant clinical trials in the world have failed, and no new drugs for this disease have been marketed for 17 years.
At the 11th Clinical Trial on Alzheimer's Disease held in Barcelona, Spain last year, the data of phase III clinical trial of GV-971 was first disclosed to the world. The results showed that after 36 weeks of oral treatment, GV-971 can significantly improve cognitive impairment of patients, and is expected to become the world's first innovative multi-target carbohydrate drug against Alzheimer's disease, thus marking the end of the history when the Alzheimer’s disease is treated without specific drugs.
At present, phase II and III clinical studies on GV-971, as well as important mechanisms of remodeling intestinal flora and reducing brain inflammation have been completed. Shanghai Green Valley Pharmaceutical Co., Ltd. submitted its application for new drug marketing in China on October 16 last year, and plans to conduct global clinical trials in the future.
Speaking of 22 years of perseverance, Geng Meiyu said, “Scientific researchers should have dreams and be able to ‘calm down’ and ‘dive in’ the field. We hope to apply for the National Laboratory of Pharmaceutical Science and strive to deliver affordable medicines to the ordinary people as quickly as possible.”
Explore Sharing Manufacturing Mode and Build “Zhangjiang Medicine” Brand
The reporter noted that Green Valley Pharmaceutical recently signed a cooperation agreement with Shanghai Tianci International Pharmaceuticals Co., Ltd. and GV-971 will be formally produced and fully marketed in Tianci "Science & Innovation Dream Works", which is the first sharing pharmaceutical platform in China.
Located in the south of Zhangjiang Hi-Tech Park and covering 211 mu, Tianci “Science & Innovation Dream Works” has 20 standard workshops and can undertake 80 GMP production lines at most. Li Hanpu, Chairman of Tianci International Tianci, said, “Every new drug cannot be marketed without the support of pharmaceutical factories. Traditional pharmaceutical factories are more insular while the sharing pharmaceutical platform can greatly improve the pharmaceutical productivity efficiency and reduce the overall cost of the industry, but is also expected to improve the transformation rate of innovative R&D results.”
In November 2015, China began to try out the Marketing Authorization Holder (MAH) system. After the pilot implementation, the separation of marketing license and production license makes new drug industrialization much easier and cheaper, and it has become a successful path for new drug R&D enterprises to achieve rapid approval of high-quality innovative drugs.
As of November last year, Pudong New Area has accepted MAH pilot applications of 58 kinds submitted by 36 applicants. Among them, 31 class I innovative drugs have not been marketed at home and abroad, accounting for 97% of the city, most of which come from Zhangjiang.
But with so many new drugs coming out, how can Zhangjiang guarantee the production of original and innovative drugs when the production resources are very scarce? How can it transform "Zhangjiang R&D" into "Zhangjiang Intelligent Manufacturing"?
Lou Qi, the general manager of Zhangjiang Biomedical Base Development Co., Ltd., said that sharing pharmaceutical platform is becoming a new trend and is expected to solve this bottleneck. The next step is to strategically introduce high-end capacity of contract development manufacture organization (CDMO) in the Hi-Tech Park. "Through high technology level, great supply scale and well-developed business model of CDMO, the platform will become the mainstream way for biotechnology companies to realize industrialization."
In addition, government departments are expected to focus on and support the sharing pharmaceutical platform, and comprehensively improve the service level and promote the professional capacity building of the entire industry. They aim to not only greatly reduce the financial pressure of R&D teams through Tianci sharing platform, but also utilize the professional ability of this platform to improve the quality management and cost control level, so as to make the “Zhangjiang medicine” brand and new drugs manufactured in Shanghai truly go global.