| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2026-013 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 注册分类：化学药品 4 类 申请人：长兴制药股份有限公司 浙江华海药业股份有限公司 关于子公司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"）下属控股子公司长兴制药股 份有限公司（以下简称"长兴制药"）于近日收到国家药品监督管理局（以下简称 "国家药监局"）核准签发的硫酸镁钠钾口服用浓溶液的《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：硫酸镁钠钾口服用浓溶液 剂型：口服溶液剂 规格：177ml：硫酸镁（按 MgSO₄计）1.6g、硫酸钠 17.5g 与硫酸钾 3.13g 申请事项：药品注册（境内生产） 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 ...

Core Viewpoint - The article discusses the ongoing reforms in China's medical procurement and price governance, emphasizing the need for optimization to balance cost control and innovation in the healthcare sector [3]. Group 1: Medical Procurement and Price Governance - The government work report highlights the optimization of centralized medical procurement and price governance, aiming to deepen the reform of medical insurance payment methods and improve the use of surplus funds [3]. - The "volume-based procurement" mechanism has significantly reduced price margins in the medical supply chain, prompting discussions on further optimization among representatives at the National People's Congress [3]. - The implementation of volume-based procurement has accelerated the process of domestic substitution, effectively lowering patient burdens and regulating market competition [3]. Group 2: Challenges and Recommendations - Challenges such as protecting historical volumes and malicious low-price competition remain in the execution of procurement policies, necessitating adjustments to reporting rules and price constraints [4]. - Suggestions include optimizing procurement reporting rules to balance efficiency and market innovation, and establishing a mechanism to curb malicious low-price competition [4]. - A recommendation was made to create a balance between cost control and innovation, proposing differentiated medical insurance payment policies and an "innovation technology exemption channel" for high-value diagnostic projects [4]. Group 3: Payment Mechanism and Innovation - Concerns were raised about the disconnect between procurement and payment, where high-priced generic and original drugs still enjoy high medical insurance payment standards despite not being selected in procurement [5]. - A proposal was made to establish a direct linkage mechanism between procurement prices and medical insurance payment standards, ensuring that selected drugs have their prices reflected in payment standards [5]. - The National Medical Insurance Administration has redirected savings from procurement to pay for clinically valuable innovative drugs, encouraging pharmaceutical companies to invest in research and development [5]. Group 4: Strategic Purchasing and Negotiation Mechanism - Suggestions were made to enhance the strategic purchasing of innovative products by the medical insurance fund, expanding the coverage of innovative drugs while maintaining basic insurance [6]. - The negotiation mechanism for including drugs in the medical insurance directory needs optimization to better reflect the value of innovative drugs and align domestic and international pricing [7]. - It was recommended to consider multiple factors in negotiations to ensure reasonable pricing and innovation returns, potentially allowing for a window of autonomous pricing to stabilize market expectations [8].

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2026-011 号 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 上市公司及其子公司所处的当事人地位：被上诉人。 涉诉金额：上诉人未明确具体金额。 是否会对上市公司损益产生负面影响：上述诉讼事项对公司损益无影响。 浙江华海药业股份有限公司 关于公司及下属子公司涉及诉讼的进展公告 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: 案件所处的诉讼阶段：美国联邦第三巡回上诉法院驳回 Gaston Roberts （以下简称"上诉人"或"原告"）就 Gaston Roberts 人身损害赔偿案件（以下 简称"Gaston Roberts 案件"）一审判决所提起的上诉。 浙江华海药业股份有限公司（以下简称"公司"）2026 年 2 月 27 日收到公司 聘请的 KIRKLAND & ELLIS LLP 律师事务所通知，美国联邦第三巡回上诉法院 正式驳回上诉人就 Gast ...

重要内容提示: 债券简称：华海转债 债券代码：110076 是否会对上市公司损益产生影响：如按本次仲裁裁决履行，预计将增加 本公司营业外收入约 700 万美元以及需冲回原先针对该仲裁事项计提的预计负 债 4,847 万元人民币。鉴于公司尚不能确定申请人对裁决的履行情况，因此该裁 决结果对公司的损益影响以及具体的会计处理最终以审计机构审计确认后的结 果为准，敬请投资者注意投资风险。 股票简称：华海药业 股票代码：600521 公告编号：临 2026-012 号 浙江华海药业股份有限公司 关于公司涉及仲裁案件的进展公告 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。 该裁决为终局裁决，不得上诉。根据德国法律，山德士及其下属两家企业有 权于收到纸质版本《最终裁决书》后 3 个月内（在特定情况下可获得不超过 1 个 月的延期）基于以下理由在德国法院申请撤销该仲裁裁决：（1）特定的程序事由 或（2）争议事项根据德国法律不具有可仲裁性或（3）承认或执行该裁决将导致 违反公共政策。 三、对公司的影响 浙江华海药业股份有限公司（以下简称 ...

Core Viewpoint - Huahai Pharmaceutical has received the drug registration certificate for Maleate Trimebutine Tablets from the National Medical Products Administration, indicating a significant regulatory approval for the company [2] Group 1 - The company announced the receipt of the drug registration certificate on February 24 [2] - The approval is for Maleate Trimebutine Tablets, which suggests potential market entry and revenue generation opportunities for the company [2]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the drug registration certificate of Trimebutine Maleate Tablets, which are intended to improve symptoms related to gastrointestinal motility disorders [1] Group 1 - The approved drug, Trimebutine Maleate Tablets, is used for the treatment of symptoms such as loss of appetite, nausea, vomiting, belching, abdominal distension, borborygmi, abdominal pain, diarrhea, and constipation [1] - The medication is also indicated for the management of Irritable Bowel Syndrome (IBS) [1]

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 ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the drug Trimebutine Maleate Tablets, which is expected to generate approximately 340 million yuan in domestic market sales by 2025 [1] Group 1: Product Approval - The drug Trimebutine Maleate Tablets has been granted a drug registration certificate with approval number H20263372 [1] - This medication is intended to improve gastrointestinal motility disorders and symptoms of irritable bowel syndrome [1] Group 2: Financial Investment - The company has invested approximately 10.1 million yuan in the research and development of this drug [1] Group 3: Market Impact - The approved product is considered to have passed the consistency evaluation, which will enrich the product line and enhance competitiveness [1] - However, production and sales may be influenced by policies and market factors [1]

Group 1 - The core point of the article is that Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of Trimebutine Maleate Tablets [1] - Trimebutine Maleate Tablets are indicated for the improvement of symptoms related to gastrointestinal motility disorders, including loss of appetite, nausea, vomiting, belching, abdominal distension, borborygmi, abdominal pain, diarrhea, and constipation, as well as for irritable bowel syndrome [1]

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]