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Highlights
Recently, Kangyuan Pharmaceutical announced that its Class 1 chemical drug AAPB for injection (two specifications) was approved for clinical use, which is intended to be used for the treatment of acute ischemic stroke. According to data from Minenet, in 2022, the sales of cardiovascular and cerebrovascular system drugs (chemical drugs + biological drugs) in China's three major terminals and six major markets (see the statistical scope at the end of this article for details) will be close to 130 billion yuan.
AAPB for injection is a new type of anti-ischemic stroke neuroprotective agent jointly developed by Kangyuan Pharmaceutical and China Pharmaceutical University, and is the company's first Class 1 new drug approved for clinical trial in 2024, and its clinical application was accepted by CDE in January 2024, and obtained the implied approval for clinical trials in March of the same year, which is intended to be used for the treatment of acute ischemic stroke.
According to data from Minenet, in recent years, the sales of cardiovascular and cerebrovascular system drugs (chemical drugs + biological drugs) in China's three major terminal and six major markets (see the end of this article for details) have been increasing year by year, approaching 130 billion yuan in 2022 and exceeding 67 billion yuan in the first half of 2023.
In recent years, the sales of cardiovascular and cerebrovascular drugs (chemical drugs + biological drugs) in China's three major terminals and six major markets (unit: 100 million yuan)
Source: Minenet Grid Bureau Database
In terms of cardiovascular and cerebrovascular systemic drugs, Kangyuan Pharmaceutical has more than 10 varieties of production approvals, including nimodipine sustained-release tablets, captopril tablets, amlodipine besylate tablets and other hypertension drugs, ethyl polyenoate soft capsules, simvastatin tablets and other blood lipid regulators. In addition, the company also has 2 hypertension drugs under review with new registration classification, namely furosemide oral solution and telmisartan amlodipine tablets, both of which currently only have production approval from one domestic enterprise, and one class of new drug SIPI-2011 tablets is in phase I clinical trial for the treatment of ventricular arrhythmia.
Some of the cardiovascular and cerebrovascular system chemical drugs declared by Kangyuan Pharmaceutical
Source: Minenet China Declaration Progress (MED) database
As a leading enterprise in traditional Chinese medicine innovation in China, Kangyuan Pharmaceutical Co., Ltd. continues to focus on the research and development of new traditional Chinese medicine drugs, and also has a layout in chemical drugs and biological drugs.
In the past 2023, Kangyuan Pharmaceutical has applied for NDA for 1 new Chinese medicine drug and successfully approved, which is Jichuan Granules, a compound preparation of ancient classic Chinese medicine, in addition, 5 new drugs of traditional Chinese medicine Category 1 Gardenia Huang Patch, Wu Turtle Huan Boudoir Granules, Pediatric Buddha Peony and Zhong Granules, Pediatric Spleen Jian Granules, Wuwei Yixin Granules, 2 chemical drugs Class 1 new drugs KY0135 tablets and KY1702 capsules, and 1 biological drug Class 1 new drug KYS202002A injection have been applied for IND and approved. In terms of generic drugs, three varieties of perampanel tablets, ipratropium bromide solution for inhalation, and minoxidil liniment were approved for marketing and deemed to have been evaluated, and four varieties, lenvatinib mesylate capsules, sumatriptan succinate naproxen sodium tablets, telmisartan amlodipine tablets, and sitagliptin metformin tablets (II.) were reported for production under review with new classifications.
Entering 2024, Kangyuan Pharmaceutical's R&D dynamics are frequent, and at present, 2 class 1 new drugs of traditional Chinese medicine, Qiwei Lipoliver Granules, Qiangqin Granules, 1 class 1 new drug AAPB for injection, and 1 class 1 new drug KYS202003A injection of biological drugs, have been declared for IND, of which AAPB for injection has been approved for clinical use.
Sources: Minenet database, CDE official website, etc
Note: The statistical scope of "China's Three Terminals and Six Major Markets" is as follows: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, and county and rural pharmacies; The statistics are as of March 28, if there are any omissions, please correct!