Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX43 and HLX07 in treating advanced/metastatic solid tumors [1] Group 1: Clinical Trial Approval - The company has been granted permission to initiate clinical trials for the combination treatment of HLX43 and HLX07 [1] - The clinical trials will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] Group 2: Drug Details - HLX43 is a targeted PD-L1 antibody-drug conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1]

Core Viewpoint - The company announced the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a targeted PD-L1 antibody-drug conjugate (ADC) developed by the company, utilizing a novel DNA topoisomerase I inhibitor small molecule toxin linked to a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical trial results for HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability [1] - Multiple phase 2 clinical studies for HLX07 are currently underway in China, including studies for HLX07 as a monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and in combination with Hanshu® for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]

HLX07为公司自主研发的针对EGFR靶点的创新型生物药，计划用于晚期实体瘤治疗。2023年2月， HLX07联合化疗用于晚期实体瘤治疗的1b/2期临床研究结果显示其安全性及耐受性良好。目前，多项关 于HLX07的2期临床研究正于中国境内开展，主要包括HLX07单药用于治疗晚期皮肤鳞状细胞癌(CSCC) 等实体瘤的2期临床试验及汉斯状联合HLX07用于治疗晚期或转移性鳞状非小细胞肺癌(sqNSCLC)等实 体瘤的2期临床试验。 复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)联合HLX07(重组抗 EGFR人源化单克隆抗体注射液)(HLX07)用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药品 监督管理局(NMPA)批准。 HLX43是由公司利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与公司自主研发的 靶向PD-L1的抗体进行偶联开发的靶向PD-L1的抗体偶联药物(ADC)，拟用于晚期/转移性实体瘤的治 疗。 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors [1] Group 1 - The approved treatment plan involves HLX43, a targeted PD-L1 antibody-drug conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug independently developed by the company, targeting EGFR for the treatment of advanced solid tumors [1] - The clinical trials for this treatment plan will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1]

对于此次合作，盟科药业副总经理、首席技术官王星海表示："我们很高兴与蓬勃生物达成此次战略合 作。蓬勃生物作为国际领先的生物药开发解决方案提供者，拥有高效的创新生物药发现、开发和产业化 能力，以及完善的国际质量体系。此次与蓬勃生物合作开发若干创新型ADC药物，将最大限度地发挥 STOPIN平台技术的适用性及竞争力，并在全球范围内开发更具竞争优势的新型ADC药物。" 据了解，此次合作方蓬勃生物（ProBio），致力于为生物科技公司及制药公司提供一站式CDMO服务， 帮助全球客户加速新药研发进程，服务涵盖临床试验到商业化生产。 对于此次合作，蓬勃生物CEO国璋表示："我们非常高兴与盟科药业展开此次战略合作。盟科药业在小 分子药物研发领域积累了深厚经验，其创新的STOPIN平台为新一代ADC的安全性和疗效提升提供了突 破性的解决方案。蓬勃生物在抗体发现、CMC工艺开发及GMP生产方面拥有丰富的经验和国际领先的 技术平台。通过强强联合，我们将把双方的技术优势和资源整合，携手推进多款创新型ADC产品的开 发与全球化布局，为患者带来更安全、更有效的治疗选择，推动全球肿瘤治疗领域的发展。" （文章来源：证券时报网） 近日，上 ...

关于与Glenmark Specialty公司签署 瑞康曲妥珠单抗项目授权许可协议的公告 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-153 江苏恒瑞医药股份有限公司 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法律责任。 江苏恒瑞医药股份有限公司（以下简称"恒瑞"或"公司"）与Glenmark Specialty S.A.（以下简 称"Glenmark Specialty"）达成协议，将公司具有自主知识产权的1类创新药瑞康曲妥珠单抗（SHR- A1811）项目有偿许可给Glenmark Specialty。 一、许可产品基本信息 1、首付款 Glenmark Specialty 将向恒瑞支付1800万美元首付款。 瑞康曲妥珠单抗是恒瑞自主研发的以HER2为靶点的抗体偶联药物（ADC），可通过与HER2表达的肿 瘤细胞结合并内吞，在肿瘤细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细 胞凋亡。其释放的毒素具有高透膜性，可发挥旁观者杀伤效应，进一步 ...

每经AI快讯，9月24日，恒瑞医药（600276）公告，公司与Glenmark Specialty S.A.签署瑞康曲妥珠单抗 项目授权许可协议。根据协议，Glenmark Specialty将向恒瑞支付1800万美元首付款，并有资格获得最高 10.93亿美元的里程碑付款，以及根据销售情况支付的提成。瑞康曲妥珠单抗是恒瑞自主研发的以HER2 为靶点的抗体偶联药物，已获批上市用于治疗HER2突变非小细胞肺癌。此次合作有助于拓宽该药物的 海外市场，提升恒瑞医药的创新品牌形象和海外业绩。 ...

Core Viewpoint - 康弘药业 has made significant progress during the "14th Five-Year Plan" period, focusing on core technologies and expanding its product matrix in ophthalmology, psychiatry/neuroscience, and oncology, leading to a steady increase in performance and high-quality development [1] Financial Performance - The company's operating revenue increased from 3.605 billion yuan in 2021 to 4.453 billion yuan in 2024, while the non-net profit rose from 301 million yuan to 1.184 billion yuan during the same period [1] - In the first half of 2025, the operating revenue was 2.453 billion yuan, a year-on-year increase of 6.95%, and the non-net profit was 723 million yuan, up 6.51% [1] Development Philosophy - The company adheres to a development philosophy centered on market orientation, innovation, quality, and talent, aiming to create innovative products and services that benefit the public [2] Risk Management and Innovation - 康弘药业 balances innovation and risk management by conducting thorough research and making accurate judgments, focusing on policy risk assessment, market demand validation, and a well-structured R&D pipeline [3] Product Strategy - 康弘药业 aims to develop long-lifecycle blockbuster products, with 康柏西普 being a prime example, generating 1.345 billion yuan in revenue in the first half of 2025, accounting for 54.83% of total revenue [3] - The company has launched 利非司特滴眼液, the first of its kind in China, targeting the large dry eye patient population [4] Market Potential - The dry eye medication market in China is projected to reach 4.79 billion yuan in 2024, with a compound annual growth rate of 16% from 2020 to 2024, providing 康弘药业 with significant growth opportunities [5] Technological Advancements - 康弘药业 is investing in cutting-edge technologies such as gene therapy, antibody-drug conjugates, and synthetic biology, with ongoing clinical trials for various innovative products [6][7]

本研究为一项评估HLX43在晚期非小细胞肺癌(NSCLC)患者的开放、国际多中心2期临床试验，旨在评 估HLX43在晚期非小细胞肺癌(NSCLC)患者中的有效性和安全性。研究分为两个阶段：第一阶段将进行 剂量探索，以选择合适的HLX43剂量进行第二阶段研究;第二阶段为单臂、多中心2期临床研究。本研究 的主要研究目的为评估HLX43在晚期非小细胞肺癌(NSCLC)中的临床疗效;主要研究终点为由盲态独立 中心审查委员会(BICR)根据RECIST v1.1标准评估的客观缓解率。 复宏汉霖(02696)发布公告，近日，一项注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43)在晚期非小细 胞肺癌(NSCLC)患者中开展的国际多中心2期临床研究已完成澳大利亚首例患者给药。该2期临床研究亦 正同步于中国境内(不包括港澳台地区，下同)与美国开展。 2025年9月，HLX43的1期临床更新数据于2025年世界肺癌大会(WCLC)大会上发布。研究结果显示， HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂(CPI)和化疗治疗并失败的后线耐药非小细 胞肺癌(NSCLC)患者中，持续表现出高应答率，同时在所有剂量水 ...

Core Viewpoint - 康弘药业 has made significant progress in its core therapeutic areas, particularly with its flagship product 康柏西普, which now accounts for a substantial portion of the company's revenue. The company aims to achieve international market presence and continuous innovation over the next decade [1][4]. Group 1: Financial Performance - The company's revenue increased from 36.05 billion in 2021 to 44.53 billion in 2024, while the net profit rose from 3.01 billion to 11.84 billion during the same period [1]. - In the first half of 2025, 康弘药业 reported a revenue of 24.53 billion, a year-on-year growth of 6.95%, and a net profit of 7.23 billion, reflecting a 6.51% increase [2]. Group 2: R&D and Innovation Strategy - 康弘药业 has invested a total of 25.21 billion in R&D over the past few years, emphasizing the importance of innovation and market-driven development [1][2]. - The company maintains a balanced approach to innovation and risk management, focusing on "controllable risks under innovative breakthroughs" [3]. Group 3: Product Development and Market Position - 康柏西普 has generated 13.45 billion in revenue in the first half of 2025, representing 54.83% of the company's total revenue, and has maintained a leading market share in the hospital sector [4][5]. - The company has introduced a new product, 利非司特滴眼液, which is expected to tap into a market with a projected size of 47.9 billion by 2024, indicating a significant growth opportunity [5]. Group 4: Future Growth and Technological Advancements - 康弘药业 is focusing on cutting-edge technologies such as gene therapy and synthetic biology, with ongoing clinical trials for its gene therapy products [6][7]. - The company aims to establish a strong position in the next-generation antibody-drug conjugates (ADC) market, with its product KH815 being the first of its kind to enter clinical trials [8].