Guangzhou Innogen Pharmaceutical Group Co., Ltd. successfully held the Isupaglutide α Phase III investigator meeting
On December 29, 2021, Shanghai Guangzhou Innogen Pharmaceutical Group Co., Ltd. Technology Co., Ltd. successfully held the "Multi-center, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of exupaglutide α injection in patients with type 2 diabetes with poor blood sugar control after metformin treatment" at the Shanghai Greenland Marriott Hotel (Protocol No. YN011-302).
The YN011-302 project plans to enroll more than 600 patients with type 2 diabetes to study the effectiveness and safety of exupaglutide α in the treatment of type 2 diabetes, and provide key clinical data for the new drug application for exupaglutide α. Dozens of large research centers across the country were invited to participate in this study. The team leader is Shanghai Sixth People's Hospital. Professor Jia Weiping, an academician of the Chinese Academy of Engineering, serves as the chief clinical scientist of the isupaglutide α project.
This meeting was held in an on-site and online format, and was attended by more than 300 researchers, IDMC members, clinical experts and colleagues from the project team of the sponsoring unit from dozens of participating research centers across the country. At the beginning of the meeting, Professor Wang Qinghua, the inventor of isupaglutide α and chairman and CEO of Guangzhou Innogen Pharmaceutical Group Co., Ltd., delivered a welcome speech, and Professor Jia Weiping, an academician of the Chinese Academy of Engineering, gave an opening speech to the guests.
At the meeting, Professor Wang Qinghua, the inventor of isupaglutide α, introduced the research background, development process and prospects for GLP-1 drug treatment to the participating experts in detail. The medical team of Guangzhou Innogen Pharmaceutical Group Co., Ltd. gave a detailed explanation of the phase III clinical research plan, and the clinical operation partner Northrop's team introduced the project implementation and pharmacovigilance management plan. Experts attending the meeting showed great concern and enthusiasm for exupaglutide α, a new biopharmaceutical independently designed and developed in my country. They learned in detail about the early development of the drug from the sponsor and actively discussed the details and precautions of the trial operation.
Isupaglutide α (Dabigan) is China's first domestically produced long-acting human-derived GLP-1 drug with independent intellectual property rights. It is used to treat type 2 diabetes (T2DM) and related metabolic diseases. Isupaglutide α can promote the secretion of insulin, promote the regeneration of pancreatic islet β cells, and improve the quality of pancreatic islet β cells. It is a treatment method that treats both the symptoms and the root cause. It will enter Phase III clinical trials in 2021. Compared with similar benchmark drugs, it has stronger efficacy, good tolerability and low side effects. Research results show that exupaglutide α has excellent hypoglycemic effect. The successful holding of this Isupaglutide α Injection Phase III clinical trial investigators meeting has greatly enhanced the confidence and enthusiasm of all parties involved. Guangzhou Innogen Pharmaceutical Group Co., Ltd. will work together with researchers from various centers to strictly comply with the latest regulatory requirements, complete this research with high quality, efficiency, and closeness, speed up the drug launch process, and allow diabetic patients to obtain safer, better clinical effects, and cost-effective new innovative drugs for the treatment of diabetes as early as possible, and contribute to the realization of the Healthy China strategy!
According to the "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China (2020)" issued by the Drug Evaluation Center of the State Food and Drug Administration, among the registered clinical trials in 2020, less than half (45.4%) started subject recruitment within one year after the clinical trial was approved, indicating that domestic clinical trials have the problem of low implementation efficiency after approval.
It is worth mentioning that this clinical study was fully promoted by Guangzhou Innogen Pharmaceutical Group Co., Ltd. and CRO. The team leader's unit quickly obtained the approval of the Office of Human Rights after obtaining the ethics approval. The first research center was launched in a short period of time. 50% of the centers were activated within 2 months after the launch of the first research center, and 90% of the centers were activated within the next 2 months. At the same time, in December 2021, it successfully completed the important milestone of enrolling subjects for interim analysis, efficiently completed the enrollment plan, and created a "Yinnuo Speed" that is worthy of pride.
About Guangzhou Innogen Pharmaceutical Group Co., Ltd.
Guangzhou Innogen Pharmaceutical Group Co., Ltd., established in 2015, is a high-tech, innovation-driven international pharmaceutical R&D and production enterprise. Committed to the research and development and industrialization of biopharmaceuticals for diabetes and metabolic diseases, it has a core management team led by well-known domestic and foreign diabetes and endocrinology experts, senior experts in new drug research and development, and comprehensive talents in corporate operations. The company has a technology platform for the production and production of biopharmaceutical genetic engineering recombinant protein technology. It has a number of new drugs and new technologies for the treatment of diabetic metabolic diseases with global intellectual property rights. Diabetes translational medicine is at an internationally advanced level.