近日，"大批中成药将退出市场"成为公共议题。国家药品监督管理局《中药注册管理专门规定》明确， 自2026年7月1日起，凡药品说明书"禁忌""不良反应""注意事项"中任意一项仍标注为"尚不明确"的中成 药，其再注册申请将不予通过。这意味着，现存约5.7万个中成药批准文号中，超七成批文面临整改或 淘汰，一场关乎中药产业未来的深度调整已进入最后半年的攻坚阶段。 与此同时，将于2026年3月1日起施行的《中药生产监督管理专门规定》，将中药监管范围从药品说明书 延伸至生产全流程，标志着对行业质量监管的全面趋严。 对此，宋珏娴谈道，一些中成药虽有批文，但因生产企业众多，部分企业存在生产不规范问题，导致质 量良莠不齐，"一张方子，多地抓药，疗效不同"。就拿药材三七来说，现在市场上存在硫磺熏蒸等不合 规的炮制行为，亟需通过规范监管解决问题。 "《中药生产监督管理专门规定》能够把不规范、不成熟的产品筛选掉，提升和统一市面上的药材质 量，对消费者而言是件好事。"宋珏娴说，质量的提升和疗效的验证，将有助于中医药走向国际舞台。 这些法规会为医生、患者带来哪些实际影响？如何写好、用好一份中成药说明书？近年来中药在临床治 疗中的实际应用 ...

Core Insights - Green Leaf Pharmaceutical (02186) experienced a stock price increase of over 5%, reaching HKD 3.52 with a trading volume of HKD 93.39 million following the release of its interim results [1] Financial Performance - For the six months ending June 30, 2025, the company reported revenue of RMB 3.181 billion, a year-on-year increase of 3.46% [1] - The profit attributable to the parent company was RMB 313 million, reflecting a year-on-year decrease of 19.33% [1] - Earnings per share stood at 8.32 cents [1] Market Segmentation - In the Chinese market, the company holds a competitive position in four major therapeutic areas: oncology, central nervous system, cardiovascular, and metabolism [1] - The main product portfolio in China includes six oncology drugs, five central nervous system drugs, three cardiovascular drugs, and two metabolism drugs [1] Revenue Breakdown by Therapeutic Area - Revenue from the oncology segment increased by 13.5%, reaching RMB 1.295 billion [2] - Revenue from the central nervous system segment grew by 5.4%, totaling RMB 868 million [2] - Revenue from the cardiovascular segment decreased by 9.2%, amounting to RMB 693 million [2] - Revenue from the metabolism segment declined by 7.9%, totaling RMB 180 million [2]

Core Viewpoint - Green Leaf Pharmaceutical (02186) experienced a stock price increase of over 5% following the release of its interim results for the six months ending June 30, 2025, with a reported revenue of RMB 3.181 billion, reflecting a year-on-year increase of 3.46% [1][2] Financial Performance - The company reported a profit attributable to shareholders of RMB 313 million, a decrease of 19.33% year-on-year [1] - Earnings per share were reported at 8.32 cents [1] Revenue Breakdown by Therapeutic Area - Revenue in the oncology treatment sector increased by 13.5%, reaching RMB 1.295 billion [2] - Revenue in the central nervous system treatment sector grew by 5.4%, totaling RMB 868 million [2] - Revenue in the cardiovascular treatment sector decreased by 9.2%, amounting to RMB 693 million [2] - Revenue in the metabolic treatment sector declined by 7.9%, reaching RMB 180 million [2] Product Portfolio - The company's main products in China include six oncology drugs, five central nervous system drugs, three cardiovascular drugs, and two metabolic drugs [1] - Internationally, the company focuses on central nervous system treatments, offering various formulations and delivery methods [1]

Core Viewpoint - Green Leaf Pharmaceutical (02186) reported a revenue of 6.061 billion RMB for the fiscal year ending December 31, 2024, reflecting a year-on-year decrease of 1.33% and a net profit attributable to shareholders of 472 million RMB, down 11.4% from the previous year [1][2] Group 1: Financial Performance - The company's revenue for the reporting period was 6.061 billion RMB, a decrease of 1.33% year-on-year [1] - Net profit attributable to shareholders was 472 million RMB, representing a decline of 11.4% year-on-year [1] - Basic earnings per share were reported at 12.54 cents [1] Group 2: Market Position and Product Portfolio - The company holds a competitive position in four major therapeutic areas in the Chinese market: oncology, central nervous system, cardiovascular, and metabolism [1] - According to IQVIA, oncology, metabolism, central nervous system, and cardiovascular drugs accounted for the first, second, fourth, and fifth largest drug markets in China, respectively [1] - The main product portfolio in China includes six oncology drugs, five central nervous system drugs, three cardiovascular drugs, and one metabolism drug [1] Group 3: Sales Performance by Therapeutic Area - Sales in the central nervous system therapeutic area decreased by 4.8%, totaling 1.613 billion RMB [2] - Sales in the oncology therapeutic area decreased by 1.8%, amounting to 2.085 billion RMB [2] - Sales in the cardiovascular therapeutic area decreased by 1.6%, reaching 1.660 billion RMB [2] - Sales in the metabolism therapeutic area saw a decline of 13.7%, totaling 389 million RMB [2] Group 4: Competitive Advantage - The company's 17 major products have established a strong competitive advantage in global high-prevalence disease areas, with market share expected to grow steadily or maintain current levels [2]