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白云山:分公司口洁喷雾剂获药品补充申请批件
Xin Lang Cai Jing· 2026-02-10 08:16
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。 ...
白云山2月6日获融资买入5850.29万元,融资余额10.35亿元
Xin Lang Cai Jing· 2026-02-09 04:09
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].
医药生物行业跨市场周报(20260209):政策推动中药工业提质升级,中长期利好行业集中度提升-20260209
EBSCN· 2026-02-09 02:12
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].
广州白云山医药集团股份有限公司关于广州荔湾广药创业投资基金合伙企业(有限合伙)完成私募基金备案暨关联交易进展的公告
重要内容提示: 关于广州荔湾广药创业投资基金合伙企业(有限合伙) 完成私募基金备案暨关联交易进展的公告 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。 ■ 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:600332 证券简称:白云山 公告编号:2026-004 广州白云山医药集团股份有限公司 一、合作投资基本概述情况 2025 年12 月22 日,广州白云山医药集团股份有限公司("本公司")召 开第九届董事会第三十二次会议,审议通过了《关于广州广药二期基金股权投资合伙企业(有限合伙) 认购广州荔湾广药创业投资基金合伙企业(有限合伙)有 限合伙份额暨关联交易的议案》,同意本公司附属企业广州广药二期基金股权投 资合伙企业(有限合伙)("广药二期基金")与广州广药资本私募基金管理有 限公司("广药资本")、广州天使投资母基金创业投资合伙企业(有限合伙)("天使母基金")、广州 市荔湾区产业投资基金合伙企业(有限合伙)("荔 湾产投基金")合作设立广州荔湾广药创业投资基金合伙企业(有限合伙)( "广药荔湾基金")并签署 ...
白云山:关于子公司药品通过仿制药一致性评价的公告
Zheng Quan Ri Bao· 2026-02-06 13:11
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]
白云山(00874.HK):阿法骨化醇软胶囊(0.25μg、0.5μg)通过仿制药一致性评价
Ge Long Hui· 2026-02-06 10:02
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。 ...
白云山(00874):阿法骨化醇软胶囊通过仿制药质量和疗效一致性评价
智通财经网· 2026-02-06 10:02
智通财经APP讯,白云山(00874)发布公告,近日,广州白云山医药集团股份有限公司(以下简称"本公 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。 ...
白云山:阿法骨化醇软胶囊通过仿制药质量和疗效一致性评价
Zhi Tong Cai Jing· 2026-02-06 10:01
白云山(00874)发布公告,近日,广州白云山医药集团股份有限公司(以下简称"本公司")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。 ...
白云山(00874) - 海外监管公告
2026-02-06 09:55
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 本公司關於子公司藥品通過仿製藥一致性評價的公告之中文全文,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6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:2026-005 广州白云山医药集团股份有限公司 关于子公司药品通过仿制药一致性评价的公告 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 ...
白云山(600332.SH):子公司药品通过仿制药一致性评价
Ge Long Hui A P P· 2026-02-06 09:53
Core Viewpoint - The company Baiyunshan (600332.SH) announced that its 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 generic drug quality and efficacy [1] Group 1 - The approved Alfacalcidol soft capsules are available in dosages of 0.25μg and 0.5μg [1] - Alfacalcidol soft capsules are used to treat calcium metabolism disorders caused by insufficient endogenous 1,25-dihydroxyvitamin D3 production [1] - Indications for Alfacalcidol include renal osteodystrophy, postoperative or idiopathic hypoparathyroidism, pseudohypoparathyroidism, as an adjunctive treatment for tertiary hyperparathyroidism, and conditions such as vitamin D-dependent rickets, neonatal hypocalcemia, and osteoporosis [1]