Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced the initiation of Phase III clinical trials for HB0025, an innovative anti-PD-L1/VEGF bispecific fusion protein targeting squamous and non-squamous non-small cell lung cancer [1] Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd. (referred to as "Huatai"), has completed discussions with the National Medical Products Administration (NMPA) regarding the transition from Phase II to Phase III clinical trials for HB0025 [1] - HB0025 is designed to target both the PD-L1 immune evasion pathway and the VEGF angiogenesis pathway, providing a dual mechanism of action for anti-tumor effects [1] Group 2: Drug Mechanism - The drug achieves high-affinity binding to two targets, which helps in the coordinated regulation of the tumor immune microenvironment and angiogenesis [1] - The dual mechanism of action includes both immune enhancement and anti-angiogenesis properties, positioning HB0025 as a promising candidate in cancer therapy [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received the drug registration certificate for Naloxone Hydrochloride Injection from the National Medical Products Administration, indicating a significant regulatory approval for the company [1] Group 1: Product Approval - The approval allows the company to market Naloxone Hydrochloride Injection, which is indicated for multiple uses including reversing respiratory depression caused by opioid drugs [1] - The drug is also indicated for the treatment of opioid overdose, acute ethanol poisoning, and for diagnostic purposes in cases of acute opioid overdose [1]

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-132 | | --- | --- | --- | --- | | 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 关于子公司 HB0025 注射液启动 III 期临床试验的公告 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。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）的下 属子公司上海华奥泰生物药业股份有限公司（以下简称"华奥泰"）就 HB0025 联 合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审评中 心（以下简称"CDE"）Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司 将正式启动 HB0025 注射液的 III 期临床试验。现将相关情况公告如下： 一、药物基本情况 药物名称：HB0025 注射液 剂型：注射液 注册分类：治疗用生物制品 1 类 申请人：上海华奥泰生物药业股份有限公司、华博生物医药技术（上海）有限 公司 二、药物的其他相关情况 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-133 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 规格：2ml:2mg 申请事项：药品注册（境内生产） 注册分类：化学药品 3 类 关于获得药品注册证书的公告 浙江华海药业股份有限公司 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"）核准签发的盐酸纳洛酮注射液的《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：盐酸纳洛酮注射液 剂型：注射剂 三、对公司的影响 根据国家相关政策，公司盐酸纳洛酮注射液按化学药品 3 类批准生产可视同通 过一致性评价。该产品的获批进一步丰富了公司的产品线，有助于提升公司产品的 市场竞争力。 四、风险提示 公司高度重视药品研发，严格控制药品研发、生产、销售环节的质量和安全。 但产品的生产和销售容易受国家政策、市 ...

Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced the initiation of Phase III clinical trials for HB0025 injection, an innovative anti-PD-L1/VEGF bispecific fusion protein aimed at treating squamous and non-squamous non-small cell lung cancer in combination with chemotherapy [1] Group 1: Product Development - The HB0025 injection is designed to enhance immune response and inhibit blood vessel growth, providing a dual mechanism for tumor treatment [1] - The ongoing Phase III study targets advanced squamous lung cancer and lung adenocarcinoma, with the potential to become a PD-L1/VEGF bispecific drug that is effective regardless of PD-L1 expression levels [1] - The company has invested approximately 326 million yuan in the research and development of this project [1] Group 2: Market Considerations - The pharmaceutical product development cycle is lengthy, with inherent uncertainties related to technology and regulatory approvals [1] - Future competitive dynamics in the market are expected to evolve, impacting the landscape for similar therapeutic agents [1]

华海药业12月26日公告，公司于近日收到国家药品监督管理局核准签发的盐酸纳洛酮注射液的《药品注 册证书》。盐酸纳洛酮注射液的适应症为：1、用于阿片类药物复合麻醉术后，拮抗该类药物所致的呼 吸抑制，促使病人苏醒；2、用于阿片类药物过量，完全或部分逆转阿片类药物引起的呼吸抑制；3、解 救急性乙醇中毒；4、用于急性阿片类药物过量的诊断。 ...

Core Viewpoint - The company, Huahai Pharmaceutical, has announced the initiation of Phase III clinical trials for HB0025, a novel PD-L1/VEGF dual-specific fusion protein aimed at treating squamous and non-squamous non-small cell lung cancer [1][2]. Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration [1]. - HB0025 is designed to target both PD-L1 and VEGF pathways, enhancing anti-tumor mechanisms through dual action on immune evasion and tumor angiogenesis [1][2]. - The Phase III trials will include two confirmatory studies, which are expected to provide new first-line treatment options for advanced non-small cell lung cancer patients, regardless of PD-L1 expression levels [2]. Group 2: Competitive Landscape - Currently, other PD-1/VEGF dual antibodies, such as Ivosidenib by Kangfang Biotech and PM8002 by BMS, have entered clinical Phase III, indicating a competitive market for dual-target therapies [2]. - The promising Phase II clinical data for HB0025, presented at the 2025 ESMO conference, showed good objective response rates and disease control rates, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 32.597 million in the research and development of the HB0025 project to date [3].

Core Viewpoint - Company Huahai Pharmaceutical (600521.SH) has announced the initiation of Phase III clinical trials for HB0025, an innovative anti-PD-L1/VEGF bispecific fusion protein targeting non-small cell lung cancer [1][2]. Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration [1]. - HB0025 is designed to target both PD-L1 and VEGF pathways, enhancing tumor immunity and inhibiting angiogenesis, thus providing a dual mechanism for cancer treatment [1][2]. - Two confirmatory Phase III clinical trials will be launched for HB0025 [1]. Group 2: Competitive Landscape - Competing products include Kangfang Biotech's Ivosidenib (PD-1/VEGF bispecific), BMS's PM8002 (PD-L1/VEGF bispecific), and Pfizer's SSGJ-707 (PD-1/VEGF bispecific), which are in various stages of clinical development [2]. - The promising Phase II clinical data for HB0025 presented at the 2025 ESMO conference indicates a good objective response rate and disease control rate, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 325.97 million in the development of the HB0025 project to date [3].

Core Viewpoint - The company announces the right for holders of "Huahai Convertible Bonds" to sell back part or all of their unconverted bonds, with a buyback price set at RMB 100.30 per bond, including accrued interest and tax [1][4]. Group 1: Buyback Terms - Holders of "Huahai Convertible Bonds" can exercise their right to sell back the bonds if the company's stock price remains below 70% of the conversion price for 30 consecutive trading days during the last two interest years of the bond [2]. - The buyback price is calculated to include accrued interest, which for the sixth year at a coupon rate of 2.00% over 54 days amounts to approximately RMB 0.30 per bond, leading to a total buyback price of RMB 100.30 [5][10]. Group 2: Buyback Period and Procedures - The buyback period is set from December 22, 2025, to December 26, 2025, with funds to be disbursed on December 31, 2025 [4][11]. - During the buyback period, "Huahai Convertible Bonds" will continue to trade but will not be convertible into shares [13]. Group 3: Additional Information - If the total face value of the convertible bonds in circulation falls below RMB 30 million due to the buyback, trading will continue until the end of the buyback period, after which an announcement will be made [13]. - The company will disclose the results of the buyback and its impact on the company after the buyback period concludes [12].

证券代码：600521 证券简称：华海药业 公告编号：临 2025-131 号 债券代码：110076 债券简称：华海转债 浙江华海药业股份有限公司 关于"华海转债"可选择回售的第九次提示性公告 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。 重要内容提示： 浙江华海药业股份有限公司（以下简称"公司"）的股票自 2025 年 11 月 2 日 至 2025 年 12 月 12 日连续 30 个交易日收盘价格低于公司可转换公司债券（以下 简称"华海转债"）当期转股价格的 70%。根据《浙江华海药业股份有限公司公开 发行可转换公司债券募集说明书》（以下简称"《募集说明书》"）的约定，可转债 回售条款生效。 现依据《上市公司证券发行管理办法》《可转换公司债券管理办法》《上海证 券交易所股票上市规则》和《募集说明书》等有关规定，就回售有关事项向全体 "华海转债"持有人公告如下： 一、回售条款 1 / 3 回售价格：100.30 元人民币/张（含当期利息、含税） 回售期：2025 年 12 月 22 日至 2025 年 12 月 26 ...