Mr. Wang, who was diagnosed with type 2 diabetes for ten years, had never thought that oral hypoglycemic drugs could be taken only once every two weeks... diabetes patients like Mr. Wang are not few in China. According to the statistics of the International diabetes Alliance in 2021, the number of patients with diabetes of all types in China exceeded 140 million. Almost all of these diabetes patients need lifelong medication control, but many studies show that the more medication times, the worse the drug treatment compliance. This has also become one of the important reasons for the unsatisfactory treatment rate and control rate of diabetes patients in China. Before Hisense Scientific Research issued the world's first ultra long-acting DPP-4i and the first fortnightly oral hypoglycemic drug Beichangping (commonly known as Cougliptin), if these patients with diabetes chose to take oral hypoglycemic drugs, they could only take them before or after meals every day. The cumbersome and uninterrupted drug use was also the main reason for the poor treatment compliance of many patients. So, is it really reliable to take hypoglycemic drugs every two weeks? How does this medicine achieve long-term hypoglycemic effects? This starts with its R&D story - in October 2012, Hisilicon Pharmaceutical Group launched a ten-year R&D campaign towards DPP-4i with better effectiveness and safety through screening and project approval. After three years of development, R&D personnel have finally identified HSK7653 as a candidate compound for this project in the emerging direction of global drug research and development. They applied for a new drug clinical trial application in December 2016 and began a 5-year clinical development. This study confirms that HSK7653 has four major advantages: a long administration interval of once every 2 weeks, comparable hypoglycemic efficacy to daily preparations, the ability to be used in combination therapy or for simultaneous treatment of multiple comorbidities, and the need for dose adjustment for special patients. It meets the requirements of China's drug regulatory authorities for the launch of new hypoglycemic drugs and has the conditions to conduct clinical trials. Due to extensive and meticulous preparation in advance, HSK7653 progressed smoothly throughout the clinical approval process, completing the enrollment of approximately 900 patients in less than a year. Based on pre market clinical research data, HSK7653 has innovative mechanisms of action, therapeutic effects, and safety advantages compared to traditional DPP-4i: its single drug hypoglycemic efficacy is comparable to that of daily formulations; Administer once every two weeks, at any time throughout the day, absorption is not affected by eating, and patient compliance is high; Good safety tolerance, no risk of weight gain or hypoglycemia; Suitable for a wide range of people, patients with liver and kidney dysfunction do not need to adjust the dosage. At the end of 2022, Hisilicon officially submitted a new drug marketing application to the National Medical Products Administration using the generic name of HSK7653, Cogliptin (trade name Beichangping). In January 2023, the Drug Evaluation Center of the National Medical Products Administration accepted the application. As the world's first ultra long-acting DPP-4i, Beichangping has been introduced in China, which means that China has taken the lead in innovative research and development of hypoglycemic drugs and has filled the gap in efficacy and safety data of DPP-4i ultra long-acting preparations in the Chinese population. I believe that with the approval and listing of Beichangping in China in the future, it will have an ultra long effect
Edit：GuoGuo Responsible editor：FangZhiYou
Source：gmw.cn
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