Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received the drug registration certificate for Carbetocin Injection from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][4]. Drug Basic Information - Drug Name: Carbetocin Injection - Dosage Form: Injection - Specification: 5ml: 25mg (calculated as C??H??N?NaO?S·3H?O) - Registration Category: Class 3 Chemical Drug - Approval Number: National Drug Approval Number H20255532 - The drug is approved for domestic production [1][2]. Market Potential - Carbetocin Injection is used for treating bleeding diseases in the urinary system, upper digestive tract, respiratory tract, and gynecology, with significant efficacy in the urinary system. It can also be used for the prevention and treatment of surgical bleeding [2]. - The domestic market sales forecast for Carbetocin Injection in 2024 is approximately RMB 250 million [2]. R&D Investment - The company has invested approximately RMB 7.12 million in the R&D project for Carbetocin Injection [3]. Impact on the Company - The approval of Carbetocin Injection as a Class 3 Chemical Drug is equivalent to passing the consistency evaluation, which enriches the company's product line and positively impacts its operational development [4].

Core Viewpoint - The company is accelerating its investment in innovative drugs to achieve its third industrial transformation and upgrade strategy, emphasizing cash flow management and resource optimization [1] Group 1: Innovation and Development - The company has increased its investment in innovative drugs through multiple channels and resources to expedite development [1] - HB0025, a dual antibody developed by the company's subsidiary, has submitted an application for a confirmatory phase III clinical trial for advanced or recurrent endometrial cancer, marking a critical step towards domestic phase III clinical development [1] - The phase II clinical data for non-small cell lung cancer shows significant efficacy, with expectations to initiate phase III clinical trials domestically within the year [1] Group 2: Financial Management - The company maintains a stable cash flow from its core business, providing continuous support for research and development [1] - The financial structure is robust, with smooth financing channels that ensure strong backing for R&D investments [1] - Continuous optimization of resource allocation is aimed at maximizing the value of potential research pipelines [1] Group 3: Market Strategy - The overseas rights transfer of innovative drug products is part of the company's long-term strategy to expand into international markets and realize the value of R&D achievements [1]

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-103 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 浙江华海药业股份有限公司 关于获得药品注册证书的公告 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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的卡络磺钠注射液的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 药品名称：卡络磺钠注射液 剂型：注射剂 规格：5ml：25mg（按 C₁₀H₁₁N₄NaO₅S·3H₂O 计） 申请事项：药品注册（境内生产） 注册分类：化学药品 3 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20255532 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，批准注册，发给药品注册证书。 二、药品其他相关情况 截至目前，公司在卡络磺钠注射液研 ...

Core Viewpoint - Huahai Pharmaceutical has received the drug registration certificate for Carbenoxolone Sodium Injection from the National Medical Products Administration, which is expected to impact its revenue positively in the upcoming year [1] Company Summary - Huahai Pharmaceutical's revenue composition for the year 2024 is as follows: finished drug sales account for 60.32%, raw materials and intermediates sales account for 38.19%, technical services account for 0.66%, other businesses account for 0.55%, and other industries account for 0.28% [1] - As of the report date, Huahai Pharmaceutical has a market capitalization of 33.6 billion yuan [1]

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the marketing of Carbetocin Injection, which is indicated for various bleeding disorders in the urinary system, upper digestive tract, respiratory tract, and obstetrics [1] Group 1 - The approved product, Carbetocin Injection, is effective for treating bleeding diseases, particularly in the urinary system [1] - The injection can also be used for the prevention and treatment of surgical bleeding [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received the drug registration certificate for Carbetocin Injection from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product in the market [1] Group 1: Product Information - Carbetocin Injection is indicated for bleeding diseases in the urinary system, upper digestive tract, respiratory tract, and gynecology [1] - The product shows notable efficacy in treating urinary system conditions and can also be used for the prevention and treatment of surgical bleeding [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing of Carbetocin Injection, which is indicated for various bleeding disorders in the urinary system, upper digestive tract, respiratory tract, and gynecology [1] Group 1 - The approved product, Carbetocin Injection, is effective for urinary system conditions and can also be used for the prevention and treatment of surgical bleeding [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing of Caroverine Sodium Injection, which is expected to enhance its product line and market competitiveness [1] Summary by Categories Product Approval - The company has obtained the drug registration certificate for Caroverine Sodium Injection, which is primarily used for bleeding diseases in the urinary system, upper digestive tract, respiratory tract, and obstetrics and gynecology [1] Market Potential - The estimated domestic market sales for Caroverine Sodium Injection in 2024 is approximately 250 million yuan [1] R&D Investment - The company has invested around 7.12 million yuan in the research and development of this project [1]

Core Viewpoint - Huahai Pharmaceutical's stock has experienced a decline of 5.04% over the past three days, closing at 22.43 CNY per share with a market capitalization of 33.583 billion CNY [1] Company Overview - Zhejiang Huahai Pharmaceutical Co., Ltd. was established on February 28, 2001, and listed on March 4, 2003. The company specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1] - The revenue composition of the company is as follows: finished drug sales account for 61.86%, raw materials and intermediates sales for 36.75%, other sales for 0.78%, and technical services for 0.62% [1] Fund Holdings - According to data, one fund under Jiashi Fund holds a significant position in Huahai Pharmaceutical. Jiashi Xinhe One-Year Holding Period Mixed A (008664) held 50,300 shares in the second quarter, representing 0.39% of the fund's net value, making it the sixth-largest holding [2] - The fund has incurred a floating loss of approximately 26,700 CNY today, with a total floating loss of 59,900 CNY during the three-day decline [2] Fund Manager Information - The fund manager of Jiashi Xinhe One-Year Holding Period Mixed A (008664) is Yang Yechao, who has been in the position for 9 years and 303 days. The total asset size of the fund is 1.878 billion CNY [3] - During Yang Yechao's tenure, the best fund return was 40.38%, while the worst return was -4.07% [3]

Group 1 - The core point of the article is that Huahai Pharmaceutical (600521) announced a non-public offering of shares, with a total of 41,152,263 shares to be listed [1] - The subscription method for the shares is offline, indicating a targeted approach to raising capital [1] - The listing date for the shares is set for September 25, 2025, marking a future event for investors to consider [1]