Core 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].

Core Viewpoint - Kang En Bei's stock price experienced a decline of 1.06% on July 31, closing at 4.65 yuan, with a trading volume of 367,000 hands and a transaction amount of 171 million yuan [1] Company Overview - Kang En Bei operates in the pharmaceutical manufacturing industry, specifically within the traditional Chinese medicine sector, focusing on drug research, production, and sales [1] - The company's product range includes traditional Chinese medicine preparations, chemical raw materials and preparations, and biological products, indicating a comprehensive pharmaceutical industry chain [1] Recent Developments - On July 31, Kang En Bei announced that its wholly-owned subsidiary, Hangzhou Kang En Bei Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the drug registration certificate of Aminocaproic Acid Tablets, which are used to treat various bleeding symptoms caused by hyperfibrinolysis [1] - The research and development investment for this drug was approximately 6.27 million yuan, and it is considered to have passed the consistency evaluation for generic drugs [1] Market Activity - On the same day, the main funds for Kang En Bei saw a net outflow of 1.6435 million yuan, accounting for 0.01% of the circulating market value [1]

证券日报网讯7月31日晚间，康恩贝（600572）发布公告称，近日，公司全资子公司杭州康恩贝制药有 限公司收到国家药品监督管理局核准签发的规格为0.25g的氨甲环酸片《药品注册证书》。 ...

Group 1 - The core point of the article is that Kang En Bei Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its 0.25g tranexamic acid tablets [2] - Kang En Bei's revenue composition for the year 2024 is as follows: manufacturing (pharmaceutical industry) accounts for 86.86%, commercial sales for 11.77%, and other businesses for 1.37% [2]

Core Viewpoint - Kangnibei (600572.SH) has received approval from the National Medical Products Administration for its subsidiary Hangzhou Kangnibei Pharmaceutical Co., Ltd. to market a 0.25g specification of Tranexamic Acid Tablets [1] Group 1 - The original manufacturer of Tranexamic Acid Tablets is Daiichi Sankyo Co., Ltd. from Japan, which has approved both 0.25g and 0.5g specifications in Japan, with the 0.5g specification already approved for sale in China [1] - Tranexamic Acid Tablets are primarily used for treating various bleeding conditions caused by acute or chronic, localized or systemic primary fibrinolysis, as well as secondary hyperfibrinolytic states due to disseminated intravascular coagulation [1]

氨甲环酸片的原研厂家为日本第一三共株式会社，其在日本获批上市的氨甲环酸片有0.25g规格和0.5g规 格，其中0.5g规格在中国获批上市。氨甲环酸片主要用于急性或慢性、局限性或全身性原发性纤维蛋白 溶解亢进所致的各种出血;弥散性血管内凝血所致的继发性高纤溶状态。 智通财经APP讯，康恩贝(600572.SH)发布公告，近日，公司全资子公司杭州康恩贝制药有限公司("杭州 康恩贝")收到国家药品监督管理局(以下简称"国家药监局")核准签发的规格为0.25g的氨甲环酸片《药品 注册证书》。 ...

Core Viewpoint - 康恩贝's subsidiary, Hangzhou Kang En Bei, has received approval from the National Medical Products Administration for the drug Aminocaproic Acid Tablets, which is expected to positively impact the company's performance [1] Group 1: Drug Approval Details - The approved drug is specified as 0.25g Aminocaproic Acid Tablets, primarily used for various bleeding conditions caused by primary fibrinolysis and secondary hyperfibrinolysis due to disseminated intravascular coagulation [1] - The registration application was submitted in April 2024 and has now been approved, indicating a successful regulatory process [1] Group 2: Financial Implications - Hangzhou Kang En Bei has invested approximately 6.27 million yuan in research and development for this drug [1] - The drug is considered to have passed the consistency evaluation for generic drugs according to national policies, which is expected to have a positive impact on the company's financial performance [1]

Core Viewpoint - Kang En Bei (600572.SH) has received approval from the National Medical Products Administration for its subsidiary Hangzhou Kang En Bei Pharmaceutical Co., Ltd. to market Tranexamic Acid Tablets, which are primarily used for various bleeding conditions caused by hyperfibrinolysis [1] Group 1 - The approved specification for Tranexamic Acid Tablets is 0.25g [1] - The drug is indicated for both acute and chronic bleeding, whether localized or systemic, due to primary hyperfibrinolysis [1] - It is also used for secondary hyperfibrinolytic states caused by disseminated intravascular coagulation [1]