Core Viewpoint - The announcement details the results of the "Huahai Convertible Bond" repurchase option, indicating that no investors submitted repurchase requests during the designated period, resulting in no financial impact on the company [2][5][6]. Group 1: Repurchase Announcement - The repurchase period for the "Huahai Convertible Bond" was from December 22, 2025, to December 26, 2025 [2][4]. - The repurchase price was set at RMB 100.30 per bond, including current interest and tax [4][5]. - The company published multiple announcements regarding the repurchase from December 15 to December 26, 2025 [3]. Group 2: Repurchase Results - During the repurchase period, the effective number of repurchase requests was 0 bonds, resulting in a total repurchase amount of RMB 0 [2][5]. - As no repurchase requests were made, the company is not required to process any payments to investors [5]. Group 3: Impact of the Repurchase - The repurchase of the "Huahai Convertible Bond" will not affect the company's cash flow, asset status, or share capital [6]. - The unrepurchased bonds will continue to be traded on the Shanghai Stock Exchange [7].

Core Viewpoint - HB0025, an innovative PD-L1/VEGF bispecific fusion protein developed by Huyao Tai, targets tumor immune evasion and angiogenesis, with plans for two confirmatory Phase III clinical trials [3][4]. Group 1: Drug Development Status - HB0025 has shown promising results in Phase II clinical trials for advanced lung squamous cell carcinoma and lung adenocarcinoma, particularly in PD-L1 negative populations, with a good objective response rate (ORR) and low incidence of grade 3 or higher immune-related adverse events (irAEs) [4][8]. - Huyao Tai has invested approximately RMB 325.97 million in the development of HB0025 [8]. Group 2: Competitive Landscape - Competing drugs include KANGFANG BIO's Ivoris monoclonal antibody (PD-1/VEGF dual antibody) which has been approved in China, and BMS's PM8002 and Pfizer's SSGJ-707, both of which are in Phase III clinical trials [4].

| 股票简称：华海药业 股票代码：600521 | 公告编号：临 | 2025-134 号 | | --- | --- | --- | | 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"华海转债"可选择回售结果的公告 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。 重要内容提示： 一、本次可转债回售的公告情况 浙江华海药业股份有限公司（以下简称"公司"）于 2025 年 12 月 15 日披露了 《浙江华海药业股份有限公司关于"华海转债"可选择回售的公告》（公告编号： 临 2025-121 号），并分别于 2025 年 12 月 16 日、2025 年 12 月 17 日、2025 年 12 月 18 日、2025 年 12 月 19 日、2025 年 12 月 20 日、2025 年 12 月 23 日、2025 年 12 月 24 日、2025 年 12 月 25 日、2025 年 12 月 26 日披露了关于"华海转债"回 售的提示性公告（公告编号分别为：临 2025-12 ...

Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced the initiation of Phase III clinical trials for HB0025, an innovative dual-specificity fusion protein targeting PD-L1 and VEGF for the treatment of squamous and non-squamous non-small cell lung cancer [1] Group 1 - The subsidiary Shanghai Huatai Biopharmaceutical Co., Ltd. will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration's Center for Drug Evaluation (CDE) [1] - HB0025 is designed to target both tumor immune evasion pathways (PD-L1) and tumor angiogenesis pathways (VEGF), providing a dual mechanism of action for anti-tumor effects [1] - The drug achieves high-affinity binding to both targets, which helps in the coordinated regulation of the tumor immune microenvironment and angiogenesis [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’s product line [1] Group 1: Product Approval - The approval is for Naloxone Hydrochloride Injection, which is indicated for multiple uses including reversing respiratory depression caused by opioid drugs during anesthesia recovery [1] - The product can also be used to partially or completely reverse respiratory depression due to opioid overdose, rescue acute ethanol poisoning, and diagnose acute opioid overdose [1]

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]