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]

Company Announcements - Junsheng Electronics' subsidiary has recently secured a global automotive intelligence project with a total order value of approximately 15 billion yuan, expected to start mass production in 2027 [1] - Shangluo Electronics plans to acquire 88.79% of Ligon Technology for 700 million yuan, focusing on authorized distribution of storage chips and various IC products [2][3] - Xinda Zheng intends to purchase at least 51% of Jiaxin Liheng Facility Management (Shanghai) Co., Ltd., with the stock currently suspended [1] - Dingtong Technology plans to invest up to 15 million USD to establish a wholly-owned subsidiary in Vietnam for R&D and production of optical module liquid cooling products [1][3] - Kexing Pharmaceutical's shareholders are inquiring about transferring shares at an initial price of 30.88 yuan per share, which is a 28% discount compared to the closing price [4] - Zhongtai Automobile has been ordered to pay 29.5 million yuan plus overdue interest due to a court ruling, which may significantly impact its current or future performance [5] - Shoukai Co., Ltd. has seen a significant increase in shareholder numbers and some institutional shareholders have reduced their holdings [5] Investment and Contracts - Laofengxiang plans to jointly invest in establishing Laofengxiang Precision Materials Company to build a modern refining and testing laboratory [8] - Longci Technology intends to invest 210 million yuan in the second phase of its Vietnam project to localize the supply of permanent magnet ferrite raw materials [9] - Sileck has signed a 230 million yuan investment cooperation agreement for a new energy precision structural components project [10] Shareholding Changes - Jingchen Co. plans to acquire 316 million yuan for 100% of Chip Micro Semiconductor [6] - Beijing Junzheng has seen a reduction of 4.8254 million shares by its shareholder Beijing Yitang Shengxin [5] - Green Harmony's actual controllers have completed a reduction of 2.99% of their shares [7] - Hangke Technology's actual controller plans to transfer 3% of the total share capital [7] Stock Price Movements - Nanfeng Co. has reported that its 3D printing service project has not yet materialized, which may affect its current year's revenue and profit [3] Other Developments - Borui Pharmaceutical's BGM0504 tablets have been approved for clinical trials in overweight/obese adults, with no similar oral formulations approved globally [4] - Southwest Securities' subsidiary will lose its listing status on September 29 due to failure to meet resumption guidelines [20]

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。 白云山(600332.SH)发布公告，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。 ...

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。 智通财经APP讯，白云山(600332.SH)发布公告，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。 ...

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 ...

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。 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 本公司關於分公司藥物進入關鍵性臨床試驗的公告之中文全文，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15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：2025-070 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 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。 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、甲状腺髓样癌等晚期实 本公司 ...

每经AI快讯，9月15日，白云山（600332）(600332.SH)公告称，公司分公司白云山制药总厂研发的选择 性RET小分子抑制剂BYS10片近日收到国家药品监督管理局药品审评中心的反馈意见，同意未来采用Ⅱ 期单臂临床试验申请上市。BYS10片为非小细胞肺癌、甲状腺髓样癌等晚期实体瘤的治疗药物，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。截至2025年8月，该项目已投入研发费用人 民币14,609.35万元。创新药研发具有不确定性，后续研发费用预计将进一步增加，但短期内不会对公司 财务状况和经营成果产生重大影响。 ...

Core Viewpoint - Baiyunshan's subsidiary, Baiyunshan Pharmaceutical Factory, has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor, BYS10 tablets, which are intended for the treatment of advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] Summary by Categories Product Development - BYS10 tablets have undergone research and development with an investment of RMB 146 million [1] - The NMPA has agreed to allow BYS10 tablets to apply for market approval through a Phase II single-arm clinical trial [1] Market Context - Currently, only two RET inhibitors, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292), have been approved for market release globally [1]