Core Viewpoint - Heng Rui Medicine's subsidiary has two products, SHR-A1811 and Abedilizumab, included in the list of proposed breakthrough therapies by the National Medical Products Administration, marking the ninth inclusion for SHR-A1811 [1] Group 1: Market Context - Breast cancer is the second most common malignant tumor globally, with approximately 2.297 million new cases reported in 2022 [1] - In China, breast cancer accounts for 15.6% of all malignant tumors, with around 357,000 new cases and 75,000 deaths in 2022 [2] - Triple-negative breast cancer (TNBC) represents 10%-15% of all breast cancer cases, predominantly affecting younger women and exhibiting high invasiveness and poor prognosis [2] Group 2: Product Information - SHR-A1811 is an injectable drug that targets HER2-positive tumors, approved for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior systemic therapy [3] - The global sales of similar products, Kadcyla and Enhertu, are projected to reach approximately $6.557 billion in 2024 [3] - The total R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [3] Group 3: Competitive Landscape - Abedilizumab is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment of extensive-stage small cell lung cancer [4] - Similar products like Atezolizumab, Avelumab, and Durvalumab are projected to have a combined global sales of approximately $9.648 billion in 2024 [4] - The total R&D investment for Abedilizumab has reached approximately 901 million yuan [4]

Core Viewpoint - Heng Rui Medicine's subsidiary has two products included in the list of proposed breakthrough therapies by the National Medical Products Administration, indicating significant progress in their development pipeline [1] Group 1: Product Development - The injection of SHR-A1811 (Rui Kang Qu Mo Zhu) has been included in the proposed breakthrough therapy list for the ninth time, highlighting its potential in treating non-small cell lung cancer (NSCLC) [1] - SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release within the tumor cells [1] - The product has received approval for market launch in May 2025, specifically for adult patients with unresectable locally advanced or metastatic NSCLC who have previously undergone at least one systemic therapy [1] Group 2: New Drug Approvals - The injection of Adalimumab (Aide Beili) is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adalimumab was approved for market launch in March 2023, with its indication for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [1]

格隆汇8月11日丨恒瑞医药(01276.HK)发布公告，近日，公司子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国 ...

智通财经APP讯，恒瑞医药(01276)发布公告，近日公司子公司苏州盛迪亚生物医药有限公司、上海盛迪 医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国家药品监督管理局药品 审评中心纳入拟突破性治疗品种公示名单，公示期7日，这也是瑞康曲妥珠单抗第9 次纳入拟突破性治 疗品种公示名单。 注射用瑞康曲妥珠单抗可通过与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。公司注射用瑞康曲妥珠单抗已于2025年 5月获 批上市，适用于治疗存在 HER2 (ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚 期或转移性非小细胞肺癌(NSCLC)成人患者。 阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体，能通过特异性结合PD-L1分子从而 阻断导致肿瘤免疫耐受的PD-1/PD-L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目 的。公司阿得贝利单抗注射液(商品名：艾瑞利)已于2023年3月获批上市，获批的适应症为与卡铂和依 托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-113 江苏恒瑞医药股份有限公司 | 药品名称 | 注射用瑞康曲妥珠单抗 | 阿得贝利单抗注射液 | | --- | --- | --- | | 受理号 | CXSL2300823 | CXSL2300824 | | 注册分类 | 治疗用生物制品1类 | 治疗用生物制品2.2类 | | 申请日期 | 2025年7月10日 | | | 拟定适应症 | SHR-A1811联合阿得贝利单抗用于PD-L1阳性（CPS≥1） | | | （或功能主治） | 局部复发不可切除或转移性三阴性乳腺癌的一线治疗。 | | | 理由及依据 | 经审核，本申请符合《药品注册管理办法》和《国 | | | | 家药监局关于发布＜突破性治疗药物审评工作程序（试 | | | | 行）＞等三个文件的公告》（2020年第82号）有关要 | | | | 求，同意纳入突破性治疗药物程序。 | | 一、药品的基本情况 二、药品的其他相关情况 根据2022年世界卫生组织国际癌症研究机构（IARC）的统计数据，乳腺癌为 全球第二大恶性肿瘤，是女性最常见的恶性肿瘤，2022年全球女性乳腺癌 ...

恒瑞医药（600276）(600276.SH)发布公告，近日,公司子公司苏州盛迪亚生物医药有限公司、上海盛迪 医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国家药品监督管理局药品 审评中心(简称"药审中心")纳入拟突破性治疗品种公示名单，公示期7日，这也是瑞康曲妥珠单抗第9次 纳入拟突破性治疗品种公示名单。 ...

智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日,公司子公司苏州盛迪亚生物医药有限公司、上 海盛迪医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国家药品监督管理 局药品审评中心(简称"药审中心")纳入拟突破性治疗品种公示名单，公示期7日，这也是瑞康曲妥珠单 抗第9次纳入拟突破性治疗品种公示名单。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had their injection products SHR-A1811 and Adalimumab injection included in the National Medical Products Administration's list of proposed breakthrough therapeutic varieties, marking the ninth inclusion for SHR-A1811 [1] Company Summary - The inclusion of SHR-A1811 and Adalimumab injection in the proposed breakthrough therapeutic varieties list indicates a significant recognition of their potential in the market [1] - This marks the ninth time SHR-A1811 has been recognized in this capacity, suggesting ongoing confidence in its therapeutic efficacy and market potential [1] Industry Summary - The recognition by the National Medical Products Administration highlights the growing focus on breakthrough therapies within the biopharmaceutical industry, which may lead to increased investment and development in this sector [1] - The inclusion of these products may enhance the competitive positioning of Heng Rui Medicine in the biopharmaceutical market, particularly in the area of innovative therapies [1]

每经AI快讯，8月11日，恒瑞医药(600276.SH)公告称，公司子公司苏州盛迪亚生物医药有限公司、上海 盛迪医药有限公司的注射用瑞康曲妥珠单抗（SHR-A1811）、阿得贝利单抗注射液被国家药品监督管理 局药品审评中心纳入拟突破性治疗品种公示名单。注射用瑞康曲妥珠单抗适用于治疗存在HER2 （ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌 （NSCLC）成人患者；阿得贝利单抗注射液获批的适应症为与卡铂和依托泊苷联合用于广泛期小细胞 肺癌患者的一线治疗。 （文章来源：每日经济新闻） ...

张凌表示，欧洲已不再是Biotech等生物科技融资的热门区域，很多欧洲企业更倾向去美国融资，甚至 有不少大型药企如 阿斯利康等，考虑将上市地区，从伦敦转去美国。 不过他也提到一个值得关注的趋势，在过去一到两年，企业首选美国，目标进入美国资本市场，做 Crossover融资，甚至部分公司为了在美上市而转移注册地。 据瑞恩小编统计，今年(截至8月11日)香港新上市的55家中，14家来自医疗健康行业、占比25.5%。 来源：MoneyDJ 花旗集团投资银行医疗健康部亚太区主管 (Managing Director, Head of Asia Pacific Healthcare Investment Banking at Citigroup)张凌(Ling Zhang)周一(8月11日)在亚太生物科技投资论坛上表示，欧洲 生物科技融资热度下降，企业首选是去美国以及亚太市场，十二个月以前首选都是美国，但过去六个月 发生天翻地覆改变，出现东升西降趋势，不仅有中国资金的北水，国际资金也有积极参与。 但过去6个月出现东升西降趋势，香港资本市场突发猛进，美国生物科技资本市场反而相对安静。 他以指数举例，香港生物科技ETF今年 ...