证券日报网讯 2月24日，华海药业发布公告称，公司于近日收到国家药品监督管理局核准签发的马来酸 曲美布汀片的《药品注册证书》。 （文章来源：证券日报） ...

华海药业（600521）(600521.SH)公告，公司近日收到国家药品监督管理局核准签发的马来酸曲美布汀 片的《药品注册证书》。马来酸曲美布汀片用于胃肠道运动功能紊乱引起的食欲不振、恶心、呕吐、嗳 气、腹胀、腹鸣、腹痛、腹泻、便秘等症状的改善和肠易激综合征。 ...

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"）核准签发的马来酸曲美布汀片的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2026-010 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 药品名称：马来酸曲美布汀片 浙江华海药业股份有限公司 剂型：片剂 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。 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 H20263372 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 马来酸曲美布汀片用于胃肠道运动功能紊乱引起的食欲不振、恶心、呕吐、嗳 气、腹胀、腹鸣、腹痛、腹泻、便秘等症状的改善和肠易激综合征。马来 ...

华海药业公告称，近日收到国家药监局核准签发的马来酸曲美布汀片的《药品注册证书》，批准文号为 国药准字H20263372。该药品用于改善胃肠道运动功能紊乱症状和肠易激综合征，2025年国内市场销售 金额预计约3.4亿元。截至目前，公司在该药品研发上已投入约1010万元。获批产品可视同通过一致性 评价，将丰富产品线、提升竞争力，但生产和销售易受政策、市场等因素影响。 ...

智通财经APP讯，华海药业(600521.SH)公告，公司近日收到国家药品监督管理局核准签发的马来酸曲 美布汀片的《药品注册证书》。马来酸曲美布汀片用于胃肠道运动功能紊乱引起的食欲不振、恶心、呕 吐、嗳气、腹胀、腹鸣、腹痛、腹泻、便秘等症状的改善和肠易激综合征。 ...

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].