Market Overview - The convertible bond market showed positive performance with the Zhongzheng Convertible Bond Index rising by 1.23% to 480.25, with a total trading volume of 76.871 billion [1] - A total of 437 convertible bonds were traded, with 409 increasing in value, 1 remaining flat, and 27 declining [1] Top Performing Convertible Bonds - The top five performing convertible bonds included: - Fushi Convertible Bond (123217) with a rise of 20.0% - Jing 23 Convertible Bond (113669) also up by 20.0% - Jiazhe Convertible Bond (113039) increasing by 17.69% - Chongda Convertible Bond 2 (128131) up by 14.01% - Outong Convertible Bond (not specified) rising by 11.67% [2] Underperforming Convertible Bonds - The five convertible bonds with the largest declines were: - Kaizhong Convertible Bond (113698) down by 3.29% - Yaoshi Convertible Bond (123145) decreasing by 2.92% - Titan Convertible Bond (127096) falling by 2.69% - Huicheng Convertible Bond (not specified) down by 2.04% [2] Corresponding Stock Performance - Among the stocks corresponding to the convertible bonds, 352 stocks rose, 16 remained flat, and 69 declined [1] - The top five performing stocks included: - Si Hui Fushi (300852) with a rise of 19.99% - Jingke Technology (601778) increasing by 10.05% - Chongda Technology (002815) up by 10.01% - Luxshare Precision (not specified) rising by 10.00% - Jingwang Electronics (not specified) also up by 10.00% [4] Declining Stocks - The stocks with the largest declines included: - Titan Shares (not specified) down by 5.64% - Huahai Pharmaceutical (not specified) decreasing by 4.26% - Nenghui Technology (not specified) down by 3.88% - Shouhua Gas (not specified) falling by 2.99% - Shandong Zhanggu (not specified) down by 2.98% [5]

Group 1 - Dematech won a 900 million yuan overseas smart logistics project from a well-known e-commerce giant in Latin America, focusing on intelligent logistics cross-belt sorting systems and related services [1] - Kang En Bei received approval for the registration of short-term financing bonds and medium-term notes, with a total registration amount of 1 billion yuan, valid for two years [1][2] - Zhi Xiang Jin Tai's GR1803 injection for systemic lupus erythematosus clinical trial has been approved by the National Medical Products Administration [2] Group 2 - Jin Da Wei's subsidiary received approval for a veterinary drug product, pyridone, valid from September 3, 2025, to September 2, 2030 [4] - Fu Li Wang's subsidiary plans to invest 500 million yuan in a high-end wire material project, focusing on high-strength prestressed steel strands for various applications [5] - He Li Biological's subsidiary's Class III medical device registration application has been accepted, focusing on natural bone repair materials [12] Group 3 - Lin Yang Energy won a 244 million yuan metering equipment project from Southern Power Grid, expected to positively impact its 2025 and 2026 performance [20] - Sanxia Water plans to absorb its wholly-owned subsidiary, Chongqing Changdian United Energy, with all assets and liabilities to be inherited by Sanxia Water [13] - Tian Cheng Technology canceled the use of 91 million yuan of raised funds for permanent working capital, ensuring no impact on the normal operation of investment projects [24] Group 4 - Baosteel received approval to publicly issue bonds totaling 20 billion yuan to professional investors, valid for 24 months [52] - Tian Kang Biological reported a 10.15% year-on-year increase in pig sales in August, with a total of 263,800 pigs sold [53] - Xinjiang Construction won multiple major projects totaling 4.506 billion yuan, including a 2.4 billion yuan photovoltaic hydrogen synthesis project [18]

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 ...