After more than ten years of long-distance running, the world's first new diabetes drug "rushed" across the finish line! On October 8, the State Drug Administration approved the listing of the Class I innovative drug Doggliptin Tablets (trade name: Huatangning) declared by Hualing Pharmaceutical Technology (Shanghai) Co., Ltd. (hereinafter referred to as Hualing Pharmaceutical). This is the world's first approved glucokinase activator drug for the treatment of adult type II diabetes. It can reshape the blood glucose homeostasis of the human body, and has the potential to alleviate diabetes from the source. "Since taking root in Zhangjiang for 11 years, we have been adhering to the concept of basing ourselves on China and developing new drugs with global originality. The research of Dogaliptin tablets has been promoted for 10 years, and the data are piled up in three trucks. It is the first in the world, and there is no precedent to refer to." Dr. Chen Li, founder of Hualing Pharmaceutical, said. The approved Doggliptin acts on glucokinase targets in pancreatic islets, intestinal endocrine cells, liver and other glucose storage and output organs to improve the blood glucose homeostasis disorder of type II diabetes patients. The marketing of this drug provides a new treatment option for patients with type II diabetes. "Glucokinase is the blood glucose sensor in the human body, and its failure is the fundamental cause of type II diabetes." Chen Li introduced. Doggliptin tablets have been approved for two indications: one is to use alone to treat new type II diabetes patients without drug treatment; Second, it is used in combination with metformin to treat adult type II diabetic patients who have used metformin alone but have poor blood glucose control effect. The whole process from preclinical trial to phase I, phase II, phase III clinical trial and marketing of Dogaliptin tablets was led by Chinese scientists, clinical experts and Chinese enterprises. Zhangjiang's powerful drug R&D ecosystem provides a good environment for Hualing Pharmaceutical. The whole process from hundreds of experiments in drug research and development to the production of hundreds of millions of drugs has been greatly supported in Zhangjiang. Dogaliptin Tablets is a typical representative of "Zhangjiang R&D and Shanghai Production", and also a successful case of Shanghai Pilot Drug Marketing Authorization Holder System (MAH) promoting the rapid listing of innovative achievements. In the process of adhering to the global innovation of new drugs, the "joint" R&D model bloomed: the laboratory of Shanghai Institute of Pharmacy was used for technical research, the laboratory of WuXi AppTec opened its products and entrusted Shanghai Disenor Biomedical Co., Ltd. to produce them. Many problems in the process of drug development, such as animal experiment, cell experiment, biological test and product production, were solved. From the launch of the R&D project in Zhangjiang in 2012 to the approval for listing in 2022, Dogaliptin tablets have witnessed a decade of changes in the research and development environment of innovative drugs in Shanghai. During the Phase II clinical trial of Doggliptin tablets, Chen Li was most troubled by the question of whether to build a production base by himself: "It is impossible to invest 200 million yuan to build a production plant before the Phase II clinical trial is completed, but if the plant is started after the Phase II clinical trial, it will definitely delay two or three years." The implementation of MAH has made this dilemma clear. As one of the first batch of pilot units for MAH system reform, Hualing Pharmaceutical saved hundreds of millions of yuan in the cost of building its own factory and accelerated the process of clinical research. "MAH enables Hualing to adopt a cooperative innovation model and cooperate with WuXi AppTec and Di Sanuo
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