Investment Rating - The report does not explicitly state an investment rating for the industry Core Insights - The proportion of driver gene-negative non-small cell lung cancer (NSCLC) patients is approximately 31% in both China and the United States, indicating a significant market opportunity for treatments targeting this demographic [2][15] - The estimated market size for immune drugs used in first-line treatment of driver gene-negative NSCLC is projected to be around 7.5 billion CNY (approximately 1.1 billion USD) in China and 18 billion CNY (approximately 2.7 billion USD) in the United States by 2030 [2] - The current first-line treatment for advanced driver gene-negative NSCLC primarily relies on PD(L)-1 inhibitors combined with chemotherapy, but there are limitations in long-term efficacy and options for patients intolerant to chemotherapy [3] Summary by Sections Section 1: NSCLC Global Overview - Lung cancer is the leading cancer type globally, with new cases accounting for approximately 12% of all cancer cases in 2022, translating to about 2.5 million new lung cancer cases [10] - In China, lung cancer represents about 22% of new cancer cases, with approximately 1.06 million new cases in 2022 [10] Section 2: Market Potential for Driver Gene-Negative NSCLC - The report highlights the significant market potential for immune therapies in treating driver gene-negative NSCLC, with a focus on the limitations of current treatment options [2][3] Section 3: Next-Generation Immunotherapy Approaches - The report discusses the advancements in dual (multi) antibody therapies and immune-oncology (IO) combined with antibody-drug conjugates (ADC), emphasizing their potential to improve treatment outcomes for patients with driver gene-negative NSCLC [5][8] - The clinical data supporting these new therapies is expected to catalyze further investment and development in this area [5] Section 4: Treatment Guidelines Comparison - The report compares treatment guidelines for driver gene-negative NSCLC between the United States and China, noting differences in treatment stratification and recommended therapies [32][34] - The U.S. guidelines emphasize PD-L1 expression levels, while Chinese guidelines focus more on performance status (PS) [32][34] Section 5: Future Catalysts - Key upcoming clinical data releases and studies are highlighted as potential catalysts for investment opportunities in the sector, particularly regarding dual antibodies and ADC therapies [5][8]

债券简称：华海转债 债券代码：110076 股票简称：华海药业 股票代码：600521 公告编号：临 2026-009 号 浙江华海药业股份有限公司 关于下属子公司获得药物临床试验许可的公告 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"）及华博生物医 药技术（上海）有限公司（以下简称"华博生物"，华奥泰下属全资子公司）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 HB0056 注射液项目 新增适应症的《药物临床试验批准通知书》，现将相关情况公告如下： 一、药物基本情况 药物名称：HB0056 注射液 适应症：特应性皮炎 剂型：注射液 2025 年 2 月，华奥泰获得国家药监局批准开展 HB0056 注射液关于哮喘适应症 的临床试验。具体内容详见公司于 2025 年 2 月 22 日刊登在中国证券报、上海证券 报、证券时报、证券日报及上海证券交易所网站（www.sse.com. ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary Shanghai Huao Tai Biopharmaceutical Co., Ltd. and Huabo Biopharmaceutical Technology (Shanghai) Co., Ltd. have received approval from the National Medical Products Administration for a new indication for the HB0056 injection project, specifically for atopic dermatitis [1] Group 1 - The HB0056 injection is intended for the treatment of atopic dermatitis and is in the form of an injection [1] - The clinical trial application for the new indication has been accepted and approved by the National Medical Products Administration [1] - The company has invested approximately RMB 91.69 million in the HB0056 project to date [1]

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for a supplementary application to produce a new specification (0.1g) of injectable cytarabine, expanding its product line and enhancing market competitiveness [1][4]. Group 1: Drug Information - The drug name is injectable cytarabine, with a new specification of 0.1g approved for domestic production [1]. - The drug is classified as a chemical drug and is used for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, with efficacy against other types of leukemia as well [2]. - The injectable cytarabine was first developed by Upjohn and launched in the U.S. in June 1969, with domestic approval in September 1988 [2]. Group 2: Financial and Market Impact - The company has invested approximately RMB 8.17 million in the research and development of injectable cytarabine [3]. - The domestic market sales for injectable cytarabine are projected to reach approximately RMB 306 million by 2025 [2]. Group 3: Company Impact - The approval of the 0.1g specification is considered equivalent to passing a consistency evaluation, which will further enrich the company's product line and enhance its market competitiveness [4].

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for a supplemental application to produce a new specification (0.1g) of the injectable drug Cytarabine, expanding its product line and enhancing market competitiveness [1][4]. Group 1: Drug Information - The drug approved is Cytarabine for injection, with a new specification of 0.1g, which is a chemical drug registered under the approval number H20269025 [1]. - Cytarabine is used for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, and it is effective against other types of leukemia as well [2]. - The company had previously obtained a registration certificate for the 0.5g specification of Cytarabine in March 2025, with a projected domestic market sales amount of approximately RMB 306 million for 2025 [2]. Group 2: R&D Investment - The company has invested approximately RMB 8.17 million in the research and development of the Cytarabine project to date [3]. Group 3: Impact on the Company - The approval of the 0.1g specification is considered equivalent to passing a consistency evaluation, which will enrich the company's product line and improve its market competitiveness [4].

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2026-008 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 注册分类：化学药品 申请人：浙江华海药业股份有限公司 浙江华海药业股份有限公司 关于获得药品补充申请批准通知书的公告 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"）核准签发的注射用阿糖胞苷的《药品补充申请批 准通知书》。该产品是在公司已获批的注射用阿糖胞苷（规格：0.5g）基础上，申 请新增规格 0.1g。现将相关情况公告如下： 一、药品的基本情况 药品名称：注射用阿糖胞苷 剂型：注射剂 规格：0.1g 申请事项：境内生产药品补充申请 药品批准文号：国药准字 H20269025 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，本品此 次申请事项符合药品注册的有关要求，批准本品增加 0.1g 规格 ...

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for a supplemental application for injectable Ara-C, adding a new specification of 0.1g to the already approved 0.5g version [1] Group 1 - The injectable Ara-C is used for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children [1] - The product also has therapeutic effects on other types of leukemia, such as acute lymphocytic leukemia and chronic myeloid leukemia (blast crisis) [1] - The drug can be used alone or in combination with other antitumor agents, with better efficacy observed in combination therapy [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for a supplemental application for injectable Ara-C, adding a new specification of 0.1g to the already approved 0.5g version [1] Group 1 - The newly approved injectable Ara-C is indicated for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children [1] - The product also shows efficacy in treating other types of leukemia, such as acute lymphocytic leukemia and chronic myeloid leukemia (blast crisis) [1] - Injectable Ara-C can be used alone or in combination with other antitumor drugs, with improved efficacy observed in combination therapy [1]

Core Insights - The Chinese generic drug industry is undergoing significant changes due to policy factors, including the implementation of the drug marketing authorization holder system and early resolution mechanisms for patent disputes, which are reshaping the competitive landscape [1][11]. Industry Overview - The number of generic drug products that have passed or are deemed to have passed evaluations in China reached 2,998 in 2024, an increase of 1,008 from 2023, representing a year-on-year growth of 50.65% [1][11]. - The proportion of contract manufacturing among these evaluated generic drug products reached 33% in 2024, up from 12% in 2020, indicating a trend towards deeper industry collaboration and resource allocation [1][11]. Generic Drug Consistency Evaluation - The consistency evaluation of generic drugs ensures that they meet the same quality and efficacy standards as original drugs, which is crucial for patient safety and effective treatment [2][3]. - The evaluation process includes determining reference formulations, conducting pharmaceutical research, and ongoing monitoring to ensure compliance with quality and safety standards [2][3]. Industry Policies - Recent policies have been introduced to enhance the quality of generic drugs and promote their market acceptance, including the 2025 guidelines for deepening drug regulation reforms [5][6]. - The establishment of a reference formulation directory is essential for conducting consistency evaluations, with 87 batches published by the National Medical Products Administration by the end of 2024 [9]. Market Dynamics - The market for chemical generic drugs in China is projected to be 868.3 billion yuan in 2024, showing a decline of 3% year-on-year, with the market share of chemical generics in the overall drug market decreasing from 60% in 2018 to 50% in 2024 [7][8]. - The competitive landscape is becoming increasingly polarized, with leading pharmaceutical companies gaining significant market share while smaller firms face challenges due to funding and research limitations [11]. Key Companies - Notable companies in the generic drug consistency evaluation sector include Tigermed Pharmaceutical Technology Co., Ltd., Huahai Pharmaceutical Co., Ltd., and Hengrui Medicine Co., Ltd., among others [1][11]. - Tigermed reported a revenue of 1.71 billion yuan in clinical trial services for the first half of 2025, reflecting a 3.07% increase year-on-year, while Hengrui Medicine achieved a revenue of 13.693 billion yuan, up 12.85% [12][14]. Future Trends - The focus of generic drug evaluations is expected to shift towards high-tech barrier products, such as controlled-release formulations and complex injectables, requiring enhanced reverse engineering and pharmaceutical research capabilities [15][16]. - The production model is transitioning from batch production to continuous manufacturing, which aims to ensure consistent quality and compliance with evaluation standards [15][16]. - Companies are encouraged to adopt a full lifecycle management approach for their products, emphasizing ongoing research and optimization post-evaluation to maintain market leadership [16].

Core Viewpoint - The healthcare index (980016) closed at 6173.05 points, down 0.98%, with a trading volume of 32.835 billion yuan and a turnover rate of 1.29% [1] Group 1: Index Performance - Among the index constituents, 11 stocks rose while 39 stocks fell, with Sangfor Technologies leading the gainers at a 10.93% increase and Huahai Pharmaceutical leading the decliners with a 3.79% drop [1] - The top ten constituents of the healthcare index include major companies such as WuXi AppTec, Hengrui Medicine, and Mindray Medical, with respective weights of 10.23%, 9.85%, and 8.23% [1] Group 2: Market Capitalization and Price Movements - WuXi AppTec has a market capitalization of 285.814 billion yuan, while Hengrui Medicine and Mindray Medical have market capitalizations of 379.648 billion yuan and 232.983 billion yuan, respectively [1] - The latest prices for the top ten constituents range from 11.12 yuan for Aier Eye Hospital to 192.16 yuan for Mindray Medical, with varying price changes [1] Group 3: Capital Flow - The net outflow of main funds from the healthcare index constituents totaled 1.252 billion yuan, while retail investors saw a net inflow of 1.093 billion yuan [1] - Detailed capital flow data indicates that Junshi Biosciences experienced a net inflow of 1.93 million yuan from main funds, while other companies like Dong'e Ejiao and Tigermed saw mixed capital flows [2]