CONBA(SH:600572) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-07-31 23:15Core Viewpoint - Zhejiang Kangnbei Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Tranexamic Acid Tablets (0.25g), which is expected to positively impact the company's performance [1][5]. Group 1: Drug Registration Details - The drug name is Tranexamic Acid Tablets, in tablet form, with a specification of 0.25g, classified as a Class 4 chemical drug [1]. - The registration certificate was issued under the approval number H20255025, confirming that the product meets the registration requirements [1][2]. Group 2: R&D and Market Context - The original manufacturer of Tranexamic Acid Tablets is Daiichi Sankyo Co., Ltd., which has both 0.25g and 0.5g specifications approved in Japan, with the 0.5g version already available in China [2]. - The drug is primarily used for various bleeding conditions caused by excessive fibrinolysis [2]. - As of now, approximately 6.27 million RMB has been invested in the research and development of this drug by Hangzhou Kangnbei [3]. - There are a total of 12 approved drug registration numbers for Tranexamic Acid Tablets in China, with 4 having passed or been deemed to have passed the consistency evaluation [4]. - The overall sales amount for Tranexamic Acid Tablets in the domestic retail and medical terminal market is projected to be 263 million RMB in 2024, reflecting a year-on-year growth of 12.24% [4]. Group 3: Impact on the Company - The approval of Tranexamic Acid Tablets as a Class 4 chemical drug indicates that it is considered to have passed the consistency evaluation for generic drugs, which is expected to have a positive impact on the company's performance [5]. - The company emphasizes the importance of drug research and development, maintaining strict quality and safety controls throughout the drug development, production, and sales processes [5].