智通财经APP获悉，石药集团(01093)涨超3%，截至发稿，涨3.39%，报9.15港元，成交额2.97亿港元。 消息面上，1月5日，据中国国家药品审评中心(CDE)官网最新公示，石药集团全资附属公司石药集团欧 意药业有限公司按化药注册分类4类申报的恩格列净片上市申请获受理。公开资料显示，恩格列净片作 为钠葡萄糖共转运体2(SGLT-2)抑制剂，主要用于治疗2型糖尿病、心力衰竭和慢性肾脏病。 公开资料显示，恩格列净是由德国勃林格殷格翰研发、与礼来联合推广的SGLT2抑制剂类药物。作为全 球三大SGLT2抑制剂之一，恩格列净凭借其独特的降糖机制和心血管、肾脏保护作用，成为糖尿病治疗 领域的明星药物。近年来，在中国的三大终端和六大市场中，恩格列净片的销售规模迅速扩大，尤其在 2024年达到了10亿元的里程碑，并在2025年第一季度实现了接近20%的同比增长。 ...

公开资料显示，恩格列净是由德国勃林格殷格翰研发、与礼来联合推广的SGLT2抑制剂类药物。作为全 球三大SGLT2抑制剂之一，恩格列净凭借其独特的降糖机制和心血管、肾脏保护作用，成为糖尿病治疗 领域的明星药物。近年来，在中国的三大终端和六大市场中，恩格列净片的销售规模迅速扩大，尤其在 2024年达到了10亿元的里程碑，并在2025年第一季度实现了接近20%的同比增长。 消息面上，1月5日，据中国国家药品审评中心(CDE)官网最新公示，石药集团全资附属公司石药集团欧 意药业有限公司按化药注册分类4类申报的恩格列净片上市申请获受理。公开资料显示，恩格列净片作 为钠葡萄糖共转运体2(SGLT-2)抑制剂，主要用于治疗2型糖尿病、心力衰竭和慢性肾脏病。 石药集团(01093)涨超3%，截至发稿，涨3.39%，报9.15港元，成交额2.97亿港元。 ...

格隆汇12月26日丨华森制药(002907.SZ)公布，近日收到重庆市药品监督管理局颁发的《药品生产许可 证》（许可证编号：渝20150018），本次变更主要涉及核减受托生产（仅限药品注册申报）和新增受托 生产。1.核减受托生产（仅限药品注册申报）：委托方是佑华医药科技有限公司，受托品种是恩格列净 片（10mg、25mg），生产场地是重庆市荣昌区昌州街道板桥路143号503车间片剂生产线，受托有效期 至2025年11月9日；2.新增受托生产：委托方是佑华医药科技有限公司，受托品种是恩格列净片（国药 准字H20255257、国药准字H20255258），生产场地是重庆市荣昌区昌州街道板桥路143号503车间片剂 生产线，受托有效期至2026年3月02日。 ...

Group 1: Investment and Capital Increase - On October 29, 2025, the company approved a capital increase of 3 million RMB to its subsidiary, Jinan Buchang Shengyuan Medical Equipment Co., Ltd., at a price of 1 RMB per share, raising its registered capital from 10 million RMB to 13 million RMB [2][3] - The capital increase agreement was formally signed on December 12, 2025, and the relevant details were disclosed on December 13, 2025 [2][3] Group 2: Business Operations and Licensing - Jinan Buchang Shengyuan Medical Equipment Co., Ltd. has completed the business registration changes and obtained a new business license, with the updated registered capital of 13 million RMB [3] - The company operates in various sectors, including the sale of medical devices, personal protective equipment, and health food, among others [3] Group 3: Drug Registration and Development - The company's wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., has withdrawn its application for the drug registration of "Empagliflozin Tablets" due to the need for further documentation [5][9] - The drug is intended for the treatment of type 2 diabetes, and the company has invested approximately 1.5 million RMB in its research and development [6][8]

Core Viewpoint - The company has decided to withdraw its drug registration application for "Empagliflozin Tablets" due to the need for further improvement of the submission materials, but this does not signify the termination of the project [1] Group 1 - The company's wholly-owned subsidiary, Shandong Danhong, received a termination notice from the National Medical Products Administration regarding the drug registration application for "Empagliflozin Tablets" [1] - The decision to withdraw the application was made after careful consideration and research [1] - The company plans to resubmit the drug registration application after completing the necessary research [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., received a termination notice from the National Medical Products Administration regarding the drug registration application for "Empagliflozin Tablets," which is used for the treatment of type 2 diabetes. The withdrawal of this application will not have a significant impact on the company's current performance [1]. Group 1 - The drug "Empagliflozin Tablets" is intended for the treatment of type 2 diabetes [1]. - The application for the drug's market approval has been officially withdrawn [1]. - The withdrawal of the drug registration application is not expected to materially affect the company's current financial results [1].

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., received a termination notice from the National Medical Products Administration regarding the drug registration application for "Empagliflozin Tablets," which is used for the treatment of type 2 diabetes. The withdrawal of this application will not have a significant impact on the company's current performance [1]. Group 1 - The drug "Empagliflozin Tablets" is intended for the treatment of type 2 diabetes [1]. - The application for the drug's market approval has been officially withdrawn [1]. - The withdrawal of the application is not expected to significantly affect the company's current financial results [1].

Core Viewpoint - The company announced the withdrawal of the drug registration application for "Empagliflozin Tablets" due to the need for further improvement of the submission materials [1] Group 1 - The company's wholly-owned subsidiary, Shandong Danhong, received a termination notice from the National Medical Products Administration regarding the drug registration application for "Empagliflozin Tablets" [1] - The decision to withdraw the application was made after careful consideration, indicating a strategic approach to ensure compliance with regulatory requirements [1] - The company plans to resubmit the drug registration application after completing the necessary research and improvements, clarifying that this withdrawal does not signify the termination of the project [1]

Core Viewpoint - The company, Bichang Pharmaceutical, announced the withdrawal of its drug registration application for "Empagliflozin Tablets" due to the need for further improvement of the application materials, but this does not signify the termination of the project [1] Group 1 - Bichang Pharmaceutical's wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., received a notice from the National Medical Products Administration regarding the termination of the drug registration application for "Empagliflozin Tablets" [1] - "Empagliflozin Tablets" are intended for the treatment of type 2 diabetes [1] - The company plans to resubmit the drug registration application after completing the necessary research [1]

每经AI快讯，12月17日，步长制药（603858）(603858.SH)公告称，公司全资子公司山东丹红制药有限 公司收到国家药品监督管理局签发的关于"恩格列净片"的《药品注册申请终止通知书》，同意药品注册 申请撤回，终止注册程序。恩格列净片适用于治疗2型糖尿病，2022年至2024年在中国市场的销售额逐 年增长。公司在该项目上投入的研发费用约为1,500.68万元。撤回申请是因为需要进一步完善申报资 料，待完善后将择期重新提交申请。本次撤回不会对当期业绩产生重大影响，但医药产品具有高科技、 高风险、高附加值的特点，存在诸多不确定性风险。 ...