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中关村(000931.SZ)下属公司北京华素盐酸纳曲酮片通过一致性评价
智通财经网· 2025-10-31 08:22
Core Viewpoint - Zhongguancun (000931.SZ) announced that its subsidiary Beijing Huasu Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the "Supplementary Application Approval Notice" for its product, "Naltrexone Hydrochloride Tablets" (50mg), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Information - Naltrexone hydrochloride can block the pharmacological effects of exogenous opioids and is used as an auxiliary drug for preventing relapse after detoxification in opioid-dependent individuals [1] - The original manufacturer of Naltrexone is TEVA WOMENS, which was approved for marketing in the U.S. in 1984 under the brand name REVIA, with a tablet form and a specification of 50mg [1] - Currently, there are no original or imported generic drugs of this product in the domestic market, with only Beijing Huasu having launched this product in specifications of 5mg and 50mg, registered under the trademark Noxins® [1] Group 2: Market Position - Beijing Huasu's Naltrexone hydrochloride tablets (50mg) are the first product to pass the consistency evaluation in this category [1] - As of the date of the announcement, a total of 11.7389 million yuan has been invested in the research and development of the consistency evaluation project for Naltrexone hydrochloride tablets [1]