lovebingo| Hengrui Pharmaceutical's two drugs were approved for clinical trials
editor 2024-05-09 07:22:02 Home 38
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On the evening of May 8th, Hengrui Pharmaceutical (600276) announced that its subsidiaries Chengdu Shengdi Pharmaceutical Co., Ltd. and Fujian Shengdi Pharmaceutical Co., Ltd. had received approval and issuance from the State Drug Administration respectively.LovebingoNotice of approval of drug clinical trials, and clinical trials will be carried out in the near future.
One of the drugs is HRS5580 for injection. The announcement shows that the application for clinical trials of HRS5580 for injection accepted on February 7 meets the relevant requirements for drug registration, and the State Drug Administration has agreed to carry out clinical trials of this product, and the indication of the application is to prevent postoperative nausea and vomiting.
Hengrui Medicine said that HRS5580 for injection plays an antiemetic effect by antagonizing NK-1 receptors and has the advantages of high solubility and safety. At present, there are no similar injection products on the market in China. The cumulative R & D expenditure of related projects of HRS5580 for injection is about 20.87 million yuan.
Another drug, HRS-5965 capsule, has also been approved for clinical trials. The indications for application for the drug areLovebingoIt is intended to be used for the treatment of primary or secondary glomerular disease mediated by complement, such as IgA nephropathy, idiopathic membranous nephropathy, C3 nephropathy and lupus nephritis, and complement involved in hemolytic anemia.
HRS-5965 capsules can inhibit complement system-mediated hemolysis by inhibiting overactivation of the complement system, the company said. Preclinical showed that it played a significant inhibitory role in the complement-mediated hemolysis model, and the safety was good. After inquiry, no similar products have been approved to go on the market in China. Up to now, the cumulative R & D cost of HRS-5965-related projects is about 64.07 million yuan.
Hengrui Pharmaceutical said that according to the requirements of relevant laws and regulations, after obtaining the notice of approval of clinical trials, drugs still need to carry out clinical trials and be reviewed and approved by the State Drug Administration before they can be produced and put on the market. At the same time, the period from drug development, clinical trial approval to production is long and there are many links, so drug research and development and marketing are easily affected by some uncertain factors.