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"）核准签发的卡格列净片的《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：卡格列净片 剂型：片剂 规格：100mg（按 C₂₄H₂₅FO₅S 计） 申请事项：药品注册（境内生产） 注册分类：化学药品 4 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 H20255777 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 卡格列净片适应症：1、本品与盐酸二甲双胍联用：当单独使用盐酸二甲双胍 血糖控制不佳时，可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿 病患者的血糖控制；2、本品与盐酸二甲双胍和磺脲类药物联用：当联用盐酸二甲 双胍和磺脲类药物血糖控制不佳时，可与盐酸二甲双胍和磺脲类药物联合使用，配 合饮食和运动改 ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration certificate of Canagliflozin tablets, which can be used in combination with Metformin and Sulfonylureas to improve blood sugar control in adults with type 2 diabetes [1] Company Summary - The approved Canagliflozin tablets can be used alone or in combination with Metformin when blood sugar control is inadequate with Metformin alone [1] - The product can also be used in conjunction with Metformin and Sulfonylureas when blood sugar control remains inadequate with the combination of Metformin and Sulfonylureas [1] Industry Summary - The approval of Canagliflozin tablets highlights the ongoing development and regulatory progress in the diabetes treatment sector, particularly for type 2 diabetes management [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Canagliflozin tablets, which are primarily used to improve blood sugar control in adults with type 2 diabetes [1] Summary by Relevant Sections Product Development - Canagliflozin tablets are expected to generate approximately 370 million yuan in sales in the domestic market by 2024, according to data from Meini Network [1] - The company has invested around 5.64 million yuan in the research and development of this drug [1] Market Impact - The approval of the registration certificate will enrich the company's product line and enhance its market competitiveness [1] - The introduction of Canagliflozin tablets is anticipated to have a positive impact on the company's operating performance [1]

Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. will begin paying interest on its convertible bonds on November 3, 2025, for the period from November 2, 2024, to November 1, 2025 [2][13] - The total issuance amount of the convertible bonds is RMB 1.8426 billion, with a total of 18,426,000 bonds issued at a face value of RMB 100 each [3][10] - The bond has a maturity period of six years, from November 2, 2020, to November 1, 2026 [2][3] Interest Payment Details - The annual interest rate for the fifth year is set at 1.8%, resulting in a payment of RMB 1.80 per bond (including tax) [3][17] - The interest payment record date is October 31, 2025, with the interest payment date being November 3, 2025 [15][16] - The interest income for individual investors is subject to a 20% personal income tax, leading to a net payment of RMB 1.44 per bond after tax [17][18] Bond Characteristics - The bond is convertible into the company's A-shares, with an initial conversion price of RMB 34.66 per share, and the latest conversion price is RMB 33.06 per share [14] - The bond does not provide any guarantees [7] - The bond's credit rating is "AA" with a stable outlook, as assessed by Shanghai New Century Credit Rating Co., Ltd. [10][11] Payment Method - The company has appointed China Securities Depository and Clearing Corporation Limited Shanghai Branch to handle the payment and settlement of the bond interest [16] - If the company fails to transfer the interest payment on time, it will be responsible for the subsequent payment process [16] Contact Information - The company is located at 88 Xunda Road, Xunqiao Town, Linhai City, Taizhou, Zhejiang Province [19] - The underwriter and trustee for the convertible bonds is Zheshang Securities Co., Ltd. [20]

浙江华海药业股份有限公司 | | | 关于可转换公司债券 2025 年付息公告 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： 浙江华海药业股份有限公司于 2020 年 11 月 2 日公开发行的可转换公司债券 (以下简称"华海转债")将于 2025 年 11 月 3 日开始支付自 2024 年 11 月 2 日至 2025 年 11 月 1 日期间的利息。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》"）有关条款的规定，现将有 关事项公告如下： 一、华海转债发行上市概况 1、债券名称：浙江华海药业股份有限公司可转换公司债券 7、票面金额和发行价格：按面值发行，每张面值为人民币 100 元 8、债券期限：本次发行的可转换公司债券的期限为自发行之日起 6 年，即 2020 年 11 月 2 日至 2026 年 11 月 1 日。 1 可转债付息债权登记日：2025 年 10 月 31 日 可转债除息日：2025 年 11 月 3 日 可转债兑息日：2025 年 ...

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry in China [5]. Core Insights - The ESMO conference showcased significant breakthroughs in both foreign and domestic innovative drugs, highlighting the competitive strength of Chinese pharmaceutical companies on the international stage [3][12]. - The report emphasizes the potential of domestic innovative drugs to redefine standard therapies, particularly in the context of PD-1/VEGF dual antibodies and antibody-drug conjugates (ADCs) [8][29]. Summary by Sections 1. PD-1 plus and Domestic Dual Antibodies - The PD-(L)1/VEGF dual antibody, Ivosidenib, demonstrated strong positive results in a Phase III trial for first-line treatment of advanced squamous non-small cell lung cancer (NSCLC), showing a progression-free survival (PFS) improvement of 4.2 months compared to the PD-1 group [13][16]. - SSGJ-707, a PD-1/VEGF dual antibody, showed promising results in treating microsatellite stable (MSS) colorectal cancer, with an overall response rate (ORR) of 68.7% and a disease control rate (DCR) of 98.5% [18][19]. - HB0025, another PD-L1/VEGF dual antibody, reported an ORR of 83.3% in squamous NSCLC patients, indicating strong anti-tumor efficacy [20][21]. 2. ADCs: Accelerated Breakthroughs - SKB264, an ADC, has shown significant PFS and overall survival (OS) benefits in a Phase III trial for EGFR-mutant NSCLC, with PFS HR of 0.49 and OS HR of 0.60, indicating its potential as a new standard therapy [29][30]. - In the breast cancer domain, SKB264 demonstrated an ORR of 41.5% in CDK4/6i pre-treated HR+/HER2- advanced breast cancer, significantly outperforming chemotherapy [31][32]. - The report highlights the global potential of SKB264, with ongoing studies expected to further validate its efficacy and safety profile [23][29].

Core Viewpoint - Huahai Pharmaceutical's stock has experienced a decline in recent trading sessions, with a notable drop of 21.55% over the past 20 days, indicating potential concerns regarding its financial performance and market sentiment [1][2]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported a revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - The company has cumulatively distributed 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed over the past three years [3]. Stock Market Activity - As of October 23, Huahai Pharmaceutical's stock price was 18.53 yuan per share, with a market capitalization of 27.744 billion yuan. The stock has seen a year-to-date increase of 5.16% but has declined by 6.79% in the last five trading days [1]. - The company has appeared on the "龙虎榜" (a trading board for stocks with significant trading activity) twice this year, with the most recent appearance on September 9, where it recorded a net buy of -531.01 million yuan [1]. Shareholder Information - As of September 19, the number of shareholders for Huahai Pharmaceutical increased by 28.47% to 67,300, while the average circulating shares per person decreased by 22.16% to 21,624 shares [2]. - Major shareholders include China Europe Medical Health Mixed Fund, which increased its holdings by 12.23 million shares, and Hong Kong Central Clearing Limited, which reduced its holdings by 4.92 million shares [3]. Business Overview - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1]. - The company's revenue composition includes 61.86% from finished drug sales, 36.75% from raw materials and intermediates, 0.78% from other sources, and 0.62% from technical services [1].

Core Insights - Levodopa is a key medication for treating Parkinson's disease, alleviating symptoms such as muscle stiffness, tremors, and slow movement. It also shows potential for treating Alzheimer's disease, chronic pain, and constipation, with broad applications in biomedical and materials science fields [1][3][4]. Industry Overview - The levodopa market has seen continuous growth in demand due to an aging population and increasing Parkinson's disease cases. The market was negatively impacted by the pandemic from 2020 to 2022, but sales began to recover in 2023, reaching 31.83 million yuan in 2024 [1][7][8]. Industry Chain - The levodopa industry chain consists of upstream suppliers of chemical raw materials and excipients, midstream research and manufacturing processes, and downstream applications in medical institutions, pharmacies, and patients. The number of Parkinson's patients significantly influences the industry's development, with over 3 million patients aged 65 and above in China [6][7]. Competitive Landscape - The global levodopa market is dominated by a few large pharmaceutical companies, such as Merck & Co. and Pfizer, while domestic companies primarily focus on generic drugs. Key players in China include Shandong Xinhua Pharmaceutical Co., Zhejiang Huahai Pharmaceutical Co., and others [8][9]. Industry Development Trends - Market demand for levodopa is expected to continue increasing due to the rising incidence of Parkinson's disease and improvements in healthcare systems in emerging countries [10]. - Technological advancements in biopharmaceuticals are likely to enhance levodopa production processes, leading to improved efficiency and product quality. Companies are expected to develop various formulations, such as sustained-release and controlled-release preparations, to enhance patient experience [11]. - The globalization of the levodopa industry presents opportunities for companies to expand into international markets, increasing brand recognition and competitiveness [12].

Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. announced the release of share pledges by its major shareholder, Mr. Zhou Minghua, who holds 14.99% of the company's total shares [2][3] - Following the release of 30 million shares from pledge, Mr. Zhou has a total of 63,980,000 shares pledged, which is 28.51% of his holdings and 4.27% of the company's total shares [2][3] Group 1 - As of the announcement date, Mr. Zhou Minghua holds a total of 224,418,890 shares in the company [2] - The shares released from pledge were previously pledged to Hangzhou Bank Co., Ltd., Shaoxing Branch [3] - The company will fulfill its information disclosure obligations if there are any future pledge plans by Mr. Zhou [3] Group 2 - The announcement was made by the Board of Directors of Zhejiang Huahai Pharmaceutical Co., Ltd. on October 17, 2025 [5]

Core Viewpoint - Huahai Pharmaceutical announced the release of 30 million shares previously pledged to Hangzhou Bank Shaoxing Branch by shareholder Zhou Minghua [2] Group 1 - The company received notification from shareholder Zhou Minghua regarding the release of the pledged shares [2] - A total of 30 million shares were involved in the pledge [2]