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Registration and Development - The company's wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., has withdrawn its application for the drug registration of "Empagliflozin Tablets" due to the need for further documentation [5][9] - The drug is intended for the treatment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]

证券代码：603858 证券简称：步长制药 公告编号：2025-236 山东步长制药股份有限公司 关于拟向控股子公司增资的进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、交易概述 2025 年 10 月 29 日，山东步长制药股份有限公司（以下简称"公司"或"步 长制药"）召开第五届董事会第三十四次会议，审议通过了《关于拟增资济南步 长晟源医疗器械有限公司的议案》，公司拟与济南步长晟源医疗器械有限公司（以 下简称"步长晟源医疗"）其他股东按照现有持股比例，按 1 元/股的价格以现金 方式向步长晟源医疗合计增资 300 万元人民币。本次增资完成后，步长晟源医疗 的注册资本将由 1,000 万元人民币增加至 1,300 万元人民币。具体内容详见公司 2025 年 10 月 30 日披露于上海证券交易所网站（www.sse.com.cn）的《关于拟 向控股子公司增资的公告》（公告编号：2025-204）。 2025 年 12 月 12 日，公司与有关各方正式签署了《关于济南步长晟源医疗 器械有限公司之增资协议》《关于济 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，山东步长制药股份有限公司（以下简称"公司"）全资子公司山东丹 红制药有限公司（以下简称"山东丹红"）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》。现将有关信息披露如下： 一、药品基本情况 药品名称：恩格列净片 证券代码：603858 证券简称：步长制药 公告编号：2025-237 山东步长制药股份有限公司 关于全资子公司撤回药品上市许可注册申请的公告 恩格列净片适用于治疗 2 型糖尿病。 根据米内网数据，中国（城市公立，县级公立，城市社区，乡镇卫生）样本 医院年度销售趋势显示,2022 年至 2024 年恩格列净片年度销售额依次为 46,567 万元、61,763 万元和 83,414 万元；中国城市实体药店年度销售趋势显示，2022 年至 2024 年恩格列净片年度销售额依次为 10,774 万元、13,903 万元和 16,678 万元。 剂型：中国药典剂型：片剂 规格：10mg 注册分类：化学药品：4 类 申请事项：境内生产药品注册上市 ...

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 - Buchang Pharma (603858.SH) has announced that Buchang Shengyuan Medical has completed the business change registration procedures and obtained a new business license from the Laiwu High-tech Industrial Development Zone Market Supervision Administration [1] Group 1 - Buchang Shengyuan Medical has successfully completed the necessary registration for business changes [1] - The company has received a renewed business license, indicating compliance with regulatory requirements [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]

Core Viewpoint - Recently, Buchang Pharmaceutical (603858.SH) announced that Buchang Shengyuan Medical has completed the business change registration procedures and obtained a new business license from the Laiwu High-tech Industrial Development Zone Market Supervision Administration [1] Group 1 - Buchang Shengyuan Medical has successfully completed the necessary registration for business changes [1] - The company has received a new business license, indicating compliance with regulatory requirements [1]