格隆汇2月10日丨白云山(00874.HK)公布，近日，公司分公司广州白云山医药集团股份有限公司白云山 何济公制药厂("何济公制药厂")收到国家药品监督管理局("国家药监局")签发的《药品补充申请批准通知 书》。 截至公告日，何济公制药厂在口洁喷雾剂研发项目上已投入研发费用合计约人民币 241.36 万元(未审 计)。根据米内网数据显示，2024 年口洁喷雾剂在国内市场的销售额为人民币 5,064 万元。2024 年何济 公制药厂该药品的销售收入为人民币 1,894 万元。 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准本品变更药品规格的补充申请。同意将本品规格由"每瓶装 20ml"规范为"每 1ml 相当于饮片 240mg，含薄荷脑 13mg、桉油 2.5μl"。 何济公制药厂于 2025 年 11 月 4 日向国家药监局递交本药品补充申请，申请变更药品规格，于 2025 年 11 月 17 日获得受理。口洁喷雾剂用于口舌生疮，牙龈、咽喉肿痛。 ...

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，2026年2月10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、陳傑輝先生、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：2026－006 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 ...

证券代码：600332 证券简称：白云山 公告编号：2026－006 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。 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 云山何济公制药厂；（2）地址：广州市白云区新市街萧岗大马路 52 号 近日，广州白云山医药集团股份有限公司（"本公司"）分公司广州 白云山医药集团股份有限公司白云山何济公制药厂（"何济公制药厂"） 收到国家药品监督管理局（"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 药品通用名称：口洁喷雾剂 剂型：喷雾剂 规格：每 1ml 相当于饮片 240mg，含薄荷脑 13mg、桉油 2.5μl 注册分类：中药 通知书编号：2026B00717 受理号：CYZB2502658 药品注册标准编号：WS-11406(ZD-1406)-2002-2011Z 原药品批准文号：国药准字 Z20027494 生产企业：（1）名称：广州白云山医药集团股份有限 ...

白云山公告称，其分公司何济公制药厂收到国家药监局签发的口洁喷雾剂《药品补充申请批准通知 书》，批准变更药品规格，将其由"每瓶装20ml"规范为"每1ml相当于饮片240mg，含薄荷脑13mg、桉油 2.5μl"。何济公制药厂于2025年11月4日递交申请，11月17日获受理。截至公告日，该药品研发已投入约 241.36万元。2024年国内市场销售额5064万元，何济公制药厂销售收入1894万元。此次获批对当期业绩 无重大影响。 ...

Group 1 - The core viewpoint of the news is that Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited has shown stable financial performance with a slight increase in revenue and net profit for the first nine months of 2025, alongside notable trading activity in its stock [2][3]. - On February 6, Baiyunshan's stock price increased by 0.23%, with a trading volume of 616 million yuan. The financing buy-in amount for the day was 58.50 million yuan, while the financing repayment was 48.63 million yuan, resulting in a net financing buy of 9.88 million yuan [1]. - As of February 6, the total balance of margin trading for Baiyunshan was 1.037 billion yuan, with the financing balance accounting for 2.88% of the circulating market value, indicating a high level compared to the past year [1]. Group 2 - Baiyunshan's main business segments include traditional Chinese and Western medicine, chemical raw materials, natural medicines, and health management services, with the largest revenue contribution coming from the commercial sector at 69.32% [2]. - For the period from January to September 2025, Baiyunshan achieved an operating income of 61.61 billion yuan, representing a year-on-year growth of 4.31%, and a net profit attributable to shareholders of 3.31 billion yuan, up 4.78% year-on-year [2]. - The company has distributed a total of 10.91 billion yuan in dividends since its A-share listing, with 4.36 billion yuan distributed over the past three years [3].

Investment Rating - The report maintains a "Buy" rating for key companies in the pharmaceutical sector, including Innovent Biologics, Efang Biologics, Tianshili, WuXi AppTec, and Mindray Medical [4][28]. Core Insights - The policy-driven upgrade of traditional Chinese medicine (TCM) industry is expected to enhance industry concentration in the medium to long term, benefiting companies with strong quality control and innovative capabilities [2][24]. - The implementation plan for high-quality development of the TCM industry aims to establish a collaborative development system by 2030, focusing on raw material supply, innovation, production quality control, and internationalization [2][23]. - The investment strategy emphasizes the importance of clinical value in the pharmaceutical sector, recommending a focus on innovative drugs and high-end medical devices [3][26]. Summary by Sections Market Review - The A-share pharmaceutical index rose by 0.14%, outperforming the CSI 300 index by 1.47 percentage points [1][16]. - The Hong Kong Hang Seng Medical Health Index fell by 1.41%, but still outperformed the Hang Seng Index by 1.65 percentage points [1][16]. Policy Insights - The Ministry of Industry and Information Technology and other departments issued a plan to enhance the TCM industry, which includes fostering leading enterprises and establishing high-standard raw material production bases [2][24]. - The plan emphasizes digitalization and sustainability, aiming to raise compliance standards and accelerate the exit of smaller companies from the market [2][25]. Company Updates - Recent clinical progress includes the NDA submission for HRS-9531 by Heng Rui Medicine and the initiation of clinical trials for various drugs by other companies [1][31][32]. - Key companies such as Yunnan Baiyao, Baiyunshan, and Taiji Group are highlighted for their strong positions in raw material supply [2][25]. Financial Forecasts - The report provides earnings per share (EPS) forecasts for key companies, with Innovent Biologics projected to have an EPS of 0.49 in 2025 and WuXi AppTec expected to reach an EPS of 5.07 in the same year [4][28]. - The pharmaceutical manufacturing industry reported a revenue decline of 1.2% year-on-year for 2025, with total revenue reaching 2,487 billion yuan [51].

Investment Cooperation Overview - On December 22, 2025, the company approved a proposal for its subsidiary to invest in the Guangzhou Liwan Guangyao Venture Capital Fund, establishing a partnership with several entities to create the Guangzhou Liwan Guangyao Venture Capital Fund [2] - The partnership agreement was officially signed on December 31, 2025, with the fund's establishment aimed at enhancing investment scale and efficiency [2][3] Investment Progress - The Guangzhou Liwan Fund completed its business registration and obtained a business license on January 7, 2026, with a total initial capital contribution of 120 million yuan [3] - The fund was registered with the Asset Management Association of China on February 5, 2026, and received a private investment fund registration certificate [3] Impact on the Company - This investment aligns with the strategic direction of the company's second-phase fund, facilitating risk diversification and accelerating investment pace in innovative pharmaceuticals and high-end medical devices [4] - The company aims to transition from traditional business models to technology-driven development, laying a solid foundation for high-quality growth [4] Drug Consistency Evaluation - The company's subsidiary, Guangzhou Baiyunshan Xingqun Pharmaceutical Co., Ltd., received approval for its Alfacalcidol soft capsules to pass the consistency evaluation for generic drugs [5][6] - The product is used for treating calcium metabolism disorders and has a significant market presence, with sales figures indicating a competitive position [7] Financial Investment in Drug Development - Approximately 10.36 million yuan has been invested in the research and development of the Alfacalcidol soft capsules consistency evaluation project [7]

Core Viewpoint - The company has received approval for its product, which is expected to generate significant revenue in 2024 [1] Group 1: Company Announcement - The company announced that its subsidiary, Guangzhou Baiyunshan Xingqun Pharmaceutical Co., Ltd., has received the approval notice from the National Medical Products Administration for the supplementary application of the drug [1] - The product, Alfacalcidol soft capsules (0.25μg, 0.5μg), has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2: Financial Impact - The expected sales revenue for the product in 2024 is projected to be 25.61 million yuan [1]

格隆汇2月6日丨白云山(00874.HK)发布公告，近日，公司控股子公司广州白云山星群(药业)股份有限公 司(以下简称"星群药业")收到国家药品监督管理局核准签发的《药品补充申请批准通知书》，阿法骨化 醇软胶囊(0.25μg、0.5μg)已通过仿制药质量和疗效一致性评价。 ...

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Xingqun Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplementary application of Alfacalcidol soft capsules, which have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product is Alfacalcidol soft capsules available in dosages of 0.25μg and 0.5μg [1] - The approval signifies a successful step in the company's efforts to enhance its product portfolio and market presence in the pharmaceutical industry [1]