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].

Core Viewpoint - Baiyunshan Pharmaceutical Group's BYS10 tablets, a selective RET small molecule inhibitor, have received feedback from the National Medical Products Administration (NMPA) for future clinical trials and potential market application [1] Group 1: Product Development - BYS10 tablets are developed for treating advanced solid tumors, including non-small cell lung cancer (NSCLC) and medullary thyroid carcinoma (MTC) [1] - The formulation specifications for BYS10 tablets are 25mg and 100mg [1] - The clinical trial approval for BYS10 was granted in January 2022, with the first patient signing the informed consent in January 2023 [1] Group 2: Clinical Trial Results - Phase I clinical trial data indicate that BYS10 tablets exhibit strong and durable anti-tumor activity in patients with RET gene mutations across various solid tumors [1] - The drug has shown good clinical activity and tolerability in patients with advanced NSCLC, thyroid cancer, and MTC [1] - Based on the safety and efficacy data from Phase I trials, the NMPA has agreed to the application for a Phase II single-arm clinical trial for BYS10 tablets [1]

Core Viewpoint - Baiyunshan Pharmaceutical Group Co., Ltd. has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor BYS10 tablets, indicating progress in the clinical evaluation of the drug for treating advanced solid tumors with RET gene fusions or mutations [1] Group 1: Clinical Research Details - The clinical study is an open-label, multi-center Phase I/II trial aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets in patients with advanced solid tumors harboring RET gene fusions or mutations [1]

Core Viewpoint - Baiyunshan Pharmaceutical Group's subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor, BYS10 tablets, which are undergoing clinical trials for treating advanced solid tumors with RET gene fusions or mutations [1] Group 1 - The clinical study is an open-label, multi-center Phase I/II trial aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets [1] - The trial specifically targets advanced solid tumors associated with RET gene fusions or mutations [1]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor BYS10 tablets, which are currently undergoing clinical trials for treating advanced solid tumors with RET gene fusions or mutations [1] Clinical Trial Information - The clinical trial registration number is CTR20220752, and the trial protocol number is BYS10-001 [1] - The trial aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets in treating advanced solid tumors with RET gene fusions or mutations [1] - This is an open-label, multi-center Phase I/II clinical study [1] Product Overview - BYS10 tablets are developed by Baiyunshan Pharmaceutical's manufacturing plant and are selective RET small molecule inhibitors [1] - The formulation specifications are 25mg and 100mg, with indications for non-small cell lung cancer and medullary thyroid carcinoma among other advanced solid tumors [1] - As of August 2025, the project has incurred research and development expenses amounting to RMB 146 million [1]

经查询，目前全球仅有Pralsetinib(BLU-667)和Selpercatinib (LOXO-292)两款RET抑制剂新药获批上市， 该两款药物分别于2021 年3月及2022年10月在国内获批上市。米内网数据显示，2024年 Pralsetinib及 Selpercatinib在国内市场销售金额分别为人民币 15,491万元及人民币6,545万元。目前，国内外暂无与 BYS10片结构一致的药物上市或注册申报信息。 白云山（600332）(00874)公布，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")研发的选择性RET小分子抑制剂BYS10片于近日收到国家药品监督管理局药品审 评中心(以下简称"CDE")的反馈意见。 BYS10片是白云山制药总厂研发的选择性RET小分子抑制剂，制剂规格25mg、100mg，适应症为非小细 胞肺癌、甲状腺髓样癌等晚期实体瘤。白云山制药总厂于2022年1月获得国家药品监督管理局签发的 《药物临床试验批准通知书》。2022年4月，BYS10片临床试验首次在CDE公示，2023年1月，第一例受 试者签署知情同意书。 BYS10片I期临 ...

证券代码：600332 证券简称：白云山 公告编号：2025-070 广州白云山医药集团股份有限公司 关于分公司药物进入关键性临床试验的公告 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。 广州白云山医药集团股份有限公司（以下简称"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"）研发的选择性RET小分子抑制剂BYS10片于近日收到国 家药品监督管理局药品审评中心（以下简称"CDE"）的反馈意见， 现将相关情况公告如下： 一、临床试验相关情况 试验登记号：CTR20220752 试验方案编号：BYS10-001 试验专业题目：评价BYS10片治疗RET基因融合或突变的晚期实体 瘤的安全性、耐受性、药代动力学特征及有效性的开放、多中心Ⅰ/ Ⅱ期临床研究 试验通俗题目：BYS10片治疗RET基因融合或突变的晚期实体瘤的 Ⅰ/Ⅱ期临床研究 二、BYS10片主要情况介绍 BYS10片是白云山制药总厂研发的选择性RET小分子抑制剂，制剂 规格25mg、100mg，适应症为非小细胞肺癌、甲状腺髓样 ...