白云山 2025 年第二次临时股东大会 广州白云山医药集团股份有限公司 2025 年第二次临时股东大会会议资料 2025 年 9 月 26 日 第 1 页 共 141 页 白云山 2025 年第二次临时股东大会 目 录 | 一、会议须知……………………………………………………3 | | --- | | 二、会议议程……………………………………………………5 | | 三、会议议案……………………………………………………6 | 第 2 页 共 141 页 白云山 2025 年第二次临时股东大会 广州白云山医药集团股份有限公司 2025 年第二次临时股东大会会议须知 为了维护广州白云山医药集团股份有限公司（以下简称"本公司"或"公司"） 全体股东的合法权益，确保本公司 2025 年第二次临时股东大会（以下简称"临 时股东大会"或"本次临时股东大会"）正常秩序和议事效率，保证临时股东大 会的顺利进行，依据有关法律法规、《广州白云山医药集团股份有限公司章程》 （以下简称"《公司章程》"）及《广州白云山医药集团股份有限公司股东大 会议事规则》（以下简称"《股东大会议事规则》"）的有关规定，特制订本 须知。 一、本次临时股 ...

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received approval for supplementary applications for several drugs, enhancing their safety information and specifications, which is expected to improve market competitiveness [1][17]. Drug Information 1. Abukuan Tablets - Generic Name: Abukuan Tablets - Dosage Form: Tablets - Specification: Each tablet weighs 0.25g (equivalent to 3.33g of raw material) - Approval Notification Number: 2025B03040 - Application Content: Changes to safety information in the drug instructions and specifications [1][8]. - Market Sales: In 2024, the domestic sales amounted to RMB 27.74 million, with Baiyunshan's sales at RMB 6.3754 million [9]. 2. Kunling Pills - Generic Name: Kunling Pills - Dosage Form: Pills (Concentrated Pills) - Specification: Each 10 pills weigh 2.7g (equivalent to 2.6g of raw material) - Approval Notification Number: 2025B03908 - Application Content: Changes to safety information in the drug instructions [2][11]. - Market Sales: In 2024, the domestic sales amounted to RMB 13.15 million, with no sales recorded for Baiyunshan [11]. 3. Shenxidan - Generic Name: Shenxidan - Dosage Form: Pills (Water Pills) - Approval Notification Number: 2025B03811 - Application Content: Changes to safety information in the drug instructions [4][12]. - Market Sales: No sales recorded for Baiyunshan in 2024 [13]. 4. Yiganling Tablets - Generic Name: Yiganling Tablets - Dosage Form: Tablets - Specification: Each tablet contains 38.5mg of Silybin - Approval Notification Number: 2025B04192 - Application Content: Changes to safety information in the drug instructions [5][14]. - Market Sales: In 2024, the domestic sales amounted to RMB 13.71 million, with no sales recorded for Baiyunshan [15]. 5. Maian Granules - Generic Name: Maian Granules - Dosage Form: Granules - Specification: Each bag contains 20g - Approval Notification Number: 2025B04164 - Application Content: Changes to safety information in the drug instructions [7][16]. - Market Sales: In 2024, the domestic sales amounted to RMB 9.28 million, with no sales recorded for Baiyunshan [16]. Company Impact - The approval of supplementary applications for the drugs is expected to enhance their safety and effectiveness, thereby improving the market competitiveness of the products. However, the approval is not expected to have a significant impact on the company's current performance [17].

Core Viewpoint - Recently, the company’s subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical Factory, received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety information of several products [1] Group 1 - The approved products include Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules, which will improve the safety, effectiveness, and rational use of these drugs [1] - The approval is expected to enhance the market competitiveness of the products [1] - The approval will not have a significant impact on the company's current performance [1]

Core Viewpoint - Recently, Baiyunshan Pharmaceutical Group Co., Ltd. received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety information of several drugs and improving market competitiveness [1] Group 1 - Baiyunshan Pharmaceutical's total factory received approval for the following drugs: Abdominal Ankang Tablets, Kunling Pills, Shenxi Dan, Yiganling Tablets, and Mai'an Granules [1] - The approval aims to improve the safety, effectiveness, and rational use of the mentioned drugs [1] - The approval is not expected to have a significant impact on the company's current performance [1]

Core Viewpoint - Recently, the company announced that its subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration, enhancing the safety and effectiveness information of several drugs [1] Group 1 - The company obtained approval for the following drugs: Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules [1] - The approval is expected to improve the safety, effectiveness, and rational use of these drugs, thereby enhancing their market competitiveness [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出的。 茲刊載廣州白雲山醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(www.sse.com.cn)刊登的 本公司關於分公司獲得藥品補充申請批件的公告之中文全文，僅供參考。 廣州白雲山醫藥集團股份有限公司 董事會 中國廣州，2025年9月16日 於本公告日，本公司董事會成員包括執行董事李小軍先生、程寧女士、程洪進先生、唐和平先生與 黎洪先生，及獨立非執行董事陳亞進先生、黃民先生、黃龍德先生與孫寶清女士。 证券代码：600332 证券简称：白云山 公告编号：2025－071 广州白云山医药集团股份有限公司 关于分公司获得药品补充申请批件的公告 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。 近日，广州白云山医药集团股份有限公司（以下简 ...

证券代码：600332 证券简称：白云山 公告编号：2025－071 受理号：CYZB2500393 药品注册标准编号：WS3-B-2255-96 及药典业发(2001)第 172 号文 近日，广州白云山医药集团股份有限公司（以下简称"本公司"）分 公司广州白云山医药集团股份有限公司白云山制药总厂（以下简称"白云 山制药总厂"）收到国家药品监督管理局（以下简称"国家药监局"）签 发的《药品补充申请批准通知书》。现将有关情况公告如下： 一、药品的基本情况 （一）腹可安片 药品通用名称：腹可安片 剂型：片剂 规格：每片心重 0.25g(相当于饮片 3.33g) 通知书编号：2025B03040 广州白云山医药集团股份有限公司 关于分公司获得药品补充申请批件的公告 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。 原药品批准文号：国药准字 Z44020949 上市许可持有人：（1）名称：广州白云山医药集团股份有限公司白 云山制药总厂；（2）地址：广州市白云区同和街云祥路 88 号 生产企业：（1）名称：广州白云山医药集团股份有限公司白 ...

Group 1 - The company Baiyunshan Pharmaceutical has received approval from the National Medical Products Administration for several drug products [1] - The approved drugs include Abukuan Tablets, Kunling Pills, Shenxidan, Yiganling Tablets, and Maian Granules [1] - Projected sales for Abukuan Tablets in the domestic market for 2024 are estimated at 27.74 million yuan, with Baiyunshan's sales for this product at 6.3754 million yuan [1] - Projected sales for Kunling Pills in the domestic market for 2024 are estimated at 13.15 million yuan [1] - Projected sales for Yiganling Tablets in the domestic market for 2024 are estimated at 13.71 million yuan [1] - Projected sales for Maian Granules in the domestic market for 2024 are estimated at 9.28 million yuan [1]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its selective RET small molecule inhibitor BYS10 has received feedback from the National Medical Products Administration, allowing it to proceed to Phase II clinical trials, indicating a significant step towards becoming a representative product in the field of innovative anti-tumor drugs in China [2][4]. Group 1: Clinical Development - BYS10 is a selective RET small molecule inhibitor developed by Baiyunshan Pharmaceutical, with specifications of 25mg and 100mg, targeting advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [4]. - The drug has shown strong and durable anti-tumor activity in Phase I clinical trials, demonstrating good clinical efficacy and tolerability in patients with various RET gene mutations [4]. - The project has invested nearly 150 million RMB in research and development as of August 2025 [6]. Group 2: Market Context - Approximately 70,000 new RET mutation cancer patients are diagnosed annually in China, including 8,000 to 16,000 cases of RET fusion lung cancer, highlighting a significant unmet medical need [4]. - Currently, only two RET inhibitors, Pralsetinib and Selpercatinib, have been approved for sale in China, with projected sales of 154.91 million RMB and 65.45 million RMB respectively in 2024 [5]. - There are no other drugs with a similar structure to BYS10 currently on the market or under registration in China [5]. Group 3: Company Strategy - Baiyunshan Pharmaceutical is transitioning from a traditional pharmaceutical company to a technology-driven enterprise, actively engaging with high-end resource platforms and research teams [6]. - The company has over 200 projects in development, with 22 of them being innovative drug projects [6]. - In the past five years, Baiyunshan has obtained over 60 authorized invention patents, including 7 international patents, and has 6 Class 1 new drugs under research [6].

Core Viewpoint - Baiyunshan's BYS10, a selective RET inhibitor, has received feedback from the National Medical Products Administration (NMPA) allowing it to proceed to Phase II clinical trials, marking a significant step towards market approval [1][2]. Group 1: Product Development - BYS10 is a high-selectivity RET inhibitor developed by Baiyunshan Pharmaceutical, with formulations of 25mg and 100mg, targeting advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1]. - The project has incurred nearly 150 million yuan in R&D expenses as of August 2025, with the first patient signing informed consent in January 2023 [1]. - Phase I clinical trial results indicate strong and durable anti-tumor activity in various RET mutation solid tumors, demonstrating good clinical efficacy and tolerability [1]. Group 2: Clinical Efficacy and Safety - BYS10 shows a 62.5% objective response rate (ORR) and nearly 90% disease control rate in 51 evaluable patients, with specific efficacy rates of 60% for RET fusion lung cancer, 83.3% for thyroid cancer, and 50% for medullary thyroid carcinoma [2]. - Most drug-related adverse reactions are mild (grade 1-2) and manageable, with significant improvements noted in patients with brain metastases [2]. Group 3: Market Context and Competition - Currently, only two RET inhibitors, Pralsetinib and Selpercatinib, have been approved in China, with projected sales of 155 million yuan and 65.45 million yuan respectively for 2024 [3]. - Baiyunshan aims for BYS10 to become a representative product of domestic innovative anti-tumor drugs, addressing a significant treatment gap for RET mutation solid tumors [3]. - The company has secured over 60 authorized invention patents in the past five years and is recognized for its strong R&D capabilities in the field of TRK inhibitors [3].