Core Viewpoint - The company announced that its subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the injection of Lincomycin Hydrochloride, which has passed the consistency evaluation of generic drug quality and efficacy [1][6]. Group 1: Drug Approval Information - The drug name is Lincomycin Hydrochloride Injection, with an acceptance number of CYHB2450368 and a notification number of 2025B04301 [1]. - The drug is classified as a chemical drug and is in injection form with a specification of 2ml:0.6g [1]. - The approval is based on various regulations, including the Drug Administration Law of the People's Republic of China and relevant announcements regarding the consistency evaluation of generic drugs [1]. Group 2: Drug Usage and Market Context - Lincomycin Hydrochloride Injection is primarily used to treat severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus [2]. - The original product was developed by Pharmacia & Upjohn and was approved by the FDA in December 1964, marketed under the name Lincocin [2]. - As of the announcement date, the project has incurred a cumulative investment of approximately 6.08 million RMB (unaudited) [4]. Group 3: Market Competition and Sales Data - More than ten companies, including Ruiyang Pharmaceutical Co., Ltd. and Hainan Puli Pharmaceutical Co., Ltd., have passed or are deemed to have passed the consistency evaluation for this drug [5]. - The estimated sales revenue for the drug in public hospitals and grassroots medical terminals in China for 2024 is approximately 77 million RMB, with the company's projected sales for the drug being around 15.32 million RMB [5].
中国医药健康产业股份有限公司 关于子公司药品通过仿制药一致性评价的公告