Market Performance - The pharmaceutical sector experienced a decline of -1.91% on September 9, 2025, underperforming the CSI 300 index by 1.21 percentage points, ranking 28th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, pharmaceutical distribution (-0.52%), blood products (-0.62%), and in vitro diagnostics (-0.73%) performed relatively better, while medical R&D outsourcing (-3.63%), medical devices (-2.47%), and medical consumables (-2.06%) lagged behind [1] - Top three gainers included Rongchang Bio (+11.92%), Hehua Co. (+10.07%), and Zhend Medical (+10.00%), while the largest decliners were Yifang Bio (-11.74%), Huahai Pharmaceutical (-10.00%), and Chenxin Pharmaceutical (-8.42%) [1] Industry News - BMS announced positive results from the Phase II clinical trial of Pumitamig, a bispecific antibody developed in collaboration with BioNTech for the treatment of extensive-stage small cell lung cancer (ES-SCLC), showing a confirmed objective response rate (cORR) of 76.3% and a disease control rate (DCR) of 100% [2] - Pumitamig targets PD-L1 and VEGF-A, designed to restore the function of effector T cells in the tumor microenvironment while locally neutralizing the effects of VEGF-A [2] Company News - Heng Rui Medicine (600276) announced that its subsidiary Chengdu Shengdi Pharmaceutical received approval from the National Medical Products Administration for its product, Eicosapentaenoic Acid Ethyl Ester Soft Capsules, to lower triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) [3] - Taiji Group (600129) reported that its subsidiary Fuling Pharmaceutical Factory received a clinical trial approval notice for Semaglutide injection for the treatment of type 2 diabetes [3] - Huahai Pharmaceutical (600521) disclosed that its subsidiary Huahai Jiancheng underwent a pre-approval inspection by the FDA from July 14 to 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin, which met the CGMP requirements [3] - Dongfang Bio (688298) announced that its subsidiary Laihe Bio obtained a Class III medical device registration certificate for its influenza virus antigen detection kit (colloidal gold method), enhancing the company's product portfolio in the respiratory joint detection field [3]

Group 1 - The company Zhejiang Huahai Pharmaceutical Co., Ltd. announced that its subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., passed the FDA pre-approval inspection, confirming compliance with CGMP requirements [1][2] - The inspection took place from July 14 to July 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin [1][2] - Gabapentin is a widely prescribed medication for epilepsy and neuropathic pain, indicating its significant role in the global pharmaceutical market [1][2] Group 2 - The successful FDA inspection enhances the company's core competitiveness and supports its ongoing international market expansion [2] - The company has registered its Gabapentin products in multiple countries, including Europe, the United States, and South Korea, ensuring a stable market presence [1][2]

Group 1 - The core point of the announcement is that Zhejiang Huahai Pharmaceutical Co., Ltd.'s subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspection, indicating compliance with the FDA's quality management system requirements [1][2] - The inspection took place from July 14 to July 18, 2025, covering the overall quality management system of the factory and the active pharmaceutical ingredient Gabapentin [1] - The inspection result was classified as NAI (No Action Indicated), which signifies zero defects in the inspection [1] Group 2 - The successful FDA inspection enhances the company's ability to expand in international markets and positively impacts its core competitiveness and sustainable development [2] - Gabapentin, primarily used for treating epilepsy and neuropathic pain, is one of the most prescribed drugs globally, indicating its significant role in the pharmaceutical market [1][2] - The company's Gabapentin active pharmaceutical ingredient is already registered in multiple countries, including Europe, the United States, and South Korea [1]

Group 1 - The chemical pharmaceutical sector experienced a downturn on September 9, with several companies facing significant declines [1] - Huahai Pharmaceutical hit the daily limit down, indicating a severe drop in stock price [1] - Other companies such as Yifang Bio-U, Chenxin Pharmaceutical, Jiankai Technology, Huana Pharmaceutical, Lifang Pharmaceutical, and Baili Tianheng also saw declines in their stock prices [1]

Core Viewpoint - Huahai Pharmaceutical (600521) experienced a significant drop in stock price, reaching the daily limit down, with a trading volume of 22.27 billion yuan and a turnover rate of 5.97% [2] Trading Activity - The stock saw a net institutional sell-off of 46.65 million yuan, while the Shanghai-Hong Kong Stock Connect recorded a net buy of 45.52 million yuan [2] - The top five trading departments accounted for a total transaction of 637 million yuan, with a net sell of 53.10 million yuan [2] - The main buying department was the Shanghai-Hong Kong Stock Connect, with a buy amount of 149.14 million yuan and a sell amount of 103.62 million yuan [3][4] Fund Flow - The stock experienced a net outflow of 423 million yuan in main funds, with a large single net outflow of 376 million yuan and a net outflow of 46.57 million yuan from large orders [2] - Over the past five days, the main funds have seen a net outflow of 320 million yuan [2] Margin Trading Data - As of September 8, the stock's margin trading balance was 1.05 billion yuan, with a financing balance of 1.03 billion yuan and a securities lending balance of 17.19 million yuan [3] - The financing balance increased by 121 million yuan over the past five days, representing a growth of 13.19%, while the securities lending balance rose by 340.49 million yuan, a growth of 24.71% [3] Financial Performance - For the first half of the year, the company reported a revenue of 4.52 billion yuan, a year-on-year decrease of 11.93%, and a net profit of 409 million yuan, down 45.30% year-on-year [3]

华海药业（600521）(600521.SH)发布公告，公司子公司浙江华海建诚药业有限公司(以下简称"华海建 诚")于2025年7月14日至2025年7月18日接受了美国食品药品监督管理局(以下简称"FDA")的现场批准前 检查，检查范围涵盖工厂整体质量管理体系及原料药加巴喷丁。近日，公司通过查询FDA官方网站的 OII办公室数据库获悉，华海建诚生产基地符合美国药品CGMP(现行药品生产质量管理规范)要求，通过 了本次批准前检查。 ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Zhejiang Huahai Jiancheng Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspection for its manufacturing facility, confirming compliance with CGMP standards for the production of Gabapentin [1] Group 1 - The FDA conducted a pre-approval inspection from July 14 to July 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin [1] - The inspection results indicate that the production base of Huahai Jiancheng meets the requirements of current Good Manufacturing Practice (CGMP) for pharmaceuticals [1]

| 股票代码：600521 | 公告编号：临 | 号 2025-098 | | --- | --- | --- | | 债券代码：110076 | | | | 股票简称：华海药业 债券简称：华海转债 | | | 一、FDA 现场检查的相关信息 浙江华海药业股份有限公司 关于子公司通过美国 FDA 现场检查的公告 浙江华海药业股份有限公司（以下简称"公司"）子公司浙江华海建诚药业有限 公司（以下简称"华海建诚"）于 2025 年 7 月 14 日至 2025 年 7 月 18 日接受了美国 食品药品监督管理局（以下简称"FDA"）的现场批准前检查，检查范围涵盖工厂整 体质量管理体系及原料药加巴喷丁。近日，公司通过查询 FDA 官方网站的 OII 办公 室数据库获悉，华海建诚生产基地符合美国药品 CGMP（现行药品生产质量管理规范） 要求，通过了本次批准前检查。现将相关信息公告如下： 1、名称：浙江华海建诚药业有限公司 7、检查结论：NAI（零缺陷） 二、对上市公司影响及风险提示 本次 FDA CGMP 检查涉及范围为工厂整体质量管理体系及原料药加巴喷丁。加 巴喷丁主要用于治疗癫痫、神经病理性疼痛等，是全球处方量 ...

每经AI快讯，9月9日，华海药业（600521）(600521.SH)公告称，公司子公司浙江华海建诚药业有限公 司于2025年7月14日至18日接受了美国FDA的现场批准前检查，检查范围包括工厂整体质量管理体系及 原料药加巴喷丁。近日，公司通过查询FDA官方网站获悉，华海建诚生产基地符合美国药品CGMP要 求，通过了本次批准前检查。此次检查为公司持续拓展国际市场提供了保障，对公司核心竞争力的提升 及持续健康发展产生积极影响。 ...

华海药业公告，子公司浙江华海建诚药业有限公司于2025年7月14日至7月18日接受了美国食品药品监督 管理局的现场批准前检查。检查范围涵盖工厂整体质量管理体系及原料药加巴喷丁。近日，公司通过查 询FDA官方网站的OII办公室数据库获悉，华海建诚生产基地符合美国药品CGMP要求，通过了本次批 准前检查。本次检查结论为NAI（零缺陷），表明其质量管理体系和生产环境设施等方面符合美国FDA 要求，为公司持续拓展国际市场提供了坚实的保障。 ...