Core Viewpoint - Heng Rui Medicine's product, injection of Ruikang Trastuzumab combined with Adebeli monoclonal antibody and chemotherapy, has received orphan drug designation from the FDA for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization [1][3] Group 1: Product and Market Context - Injection of Ruikang Trastuzumab targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [2] - The global incidence of gastric cancer ranked 5th in 2022, with 968,400 new cases and 659,900 deaths, while China reported 358,700 new cases and 260,400 deaths, ranking 5th and 3rd respectively in cancer incidence and mortality [1] - Current first-line treatment standards have shown some clinical effectiveness but still face unmet clinical needs due to short survival periods and poor prognosis [1] Group 2: Competitive Landscape - Similar products available in the market include Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), with combined global sales projected at approximately $6.557 billion for 2024 [2] - Ruikang Trastuzumab has accumulated R&D investment of about 1.259 billion yuan to date [2] Group 3: Regulatory and Developmental Advantages - The orphan drug designation allows for expedited clinical trial and registration processes, along with benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [3]

北京商报讯（记者 王寅浩 实习记者 宋雨盈）8月6日，恒瑞医药发布公告称，公司注射用瑞康曲妥珠单 抗获得美国食品药品监督管理局（简称"美国FDA"）授予的孤儿药资格认定。孤儿药又称罕见病药，是 指用于预防、治疗、诊断罕见病的药品。 ...

Market Overview - The Shanghai Composite Index rose by 0.45% on August 6, with 24 out of 28 sectors experiencing gains. The top-performing sectors were defense and military industry, and machinery equipment, with increases of 3.07% and 1.98% respectively [1] - The pharmaceutical and biological industry had the largest decline, falling by 0.65% [1] Capital Flow Analysis - The net outflow of capital from the two markets was 9.652 billion yuan, with seven sectors seeing net inflows. The machinery equipment sector led with a net inflow of 4.367 billion yuan, followed closely by the defense and military industry with a net inflow of 4.283 billion yuan [1] - The pharmaceutical and biological industry had the highest net outflow, totaling 9.049 billion yuan, followed by the telecommunications sector with a net outflow of 2.949 billion yuan [1] Pharmaceutical and Biological Sector Performance - Within the pharmaceutical and biological sector, there were 474 stocks, with 85 gaining and 383 declining. One stock reached the daily limit up [2] - The top three stocks with the highest net inflow were: - Borui Pharmaceutical with a net inflow of 222 million yuan and a gain of 9.96% - Runda Medical with a net inflow of 206 million yuan and a gain of 5.10% - Qianhong Pharmaceutical with a net inflow of 129 million yuan and a gain of 4.48% [2] - The stocks with the largest net outflows included: - Hengrui Medicine with a net outflow of 778 million yuan and a decline of 1.16% - Hanyu Pharmaceutical with a net outflow of 256 million yuan and a decline of 8.91% - Guangsheng Tang with a net outflow of 189 million yuan and a decline of 6.56% [3]

Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the FDA for its product, injection of Rukang Qutuzumab combined with Adebeli monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, which will provide significant support in product development and commercialization [1] Group 1 - The product has been granted orphan drug status, which is aimed at drugs for rare diseases, allowing the company to benefit from U.S. policy support in various aspects [1] - The orphan drug designation will expedite the clinical trial and market registration process for the product [1] - The company will enjoy several policy benefits, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [1]

Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Qutuzumab combined with Adebali monoclonal antibody and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma, which will provide various policy supports for product development and commercialization [1] Group 1 - The product has been granted orphan drug status, which is aimed at drugs for rare diseases [1] - This designation will accelerate the clinical trial and market registration process for the product [1] - The company will benefit from policy supports such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [1]

Core Viewpoint - Heng Rui Medicine's product, injection of Rukang Trastuzumab combined with Atezolizumab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) [1] Group 1 - The orphan drug designation is aimed at drugs used for the prevention, treatment, or diagnosis of rare diseases [1] - The company will have opportunities to benefit from U.S. policy support in product development, registration, and commercialization [1]

Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the FDA for its product, injection of Rukang Qutuzumab combined with Adebali monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization [1] Group 1 - The product received orphan drug designation, which is aimed at drugs for rare diseases [1] - This designation will accelerate the clinical trial and market registration process [1] - The company will benefit from various policy supports, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-112 江苏恒瑞医药股份有限公司 关于获得美国 FDA 孤儿药资格认定的公告 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法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）产品注射用瑞康曲 妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症 获得美国食品药品监督管理局（以下简称"美国 FDA"）授予的孤儿药资格认定。 孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本次公司获 得美国 FDA 孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受 美国的政策支持。现将相关情况公告如下： 一、药品的基本情况 申请人：江苏恒瑞医药股份有限公司 审批结论：根据美国《联邦食品、药品和化妆品法案》第 526 条,授予注射 用瑞康曲妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺 癌适应症的孤儿药资格。 二、药品的其他情况 2022 年，胃癌居全球癌症发病率的第 5 位和死亡率的第 5 位，全球新发病 例数为 96.84 万 ...

格隆汇8月6日丨恒瑞医药(600276.SH)公布，公司产品注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液 和化疗用于胃癌或胃食管结合部腺癌适应症获得美国食品药品监督管理局（称"美国FDA"）授予的孤儿 药资格认定。孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本次公司获得美国FDA 孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受美国的政策支持。适应症：联合阿得 贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Qutuzumab combined with Adebali injection and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma [1] Group 1 - The orphan drug designation allows for expedited clinical trials and market registration processes [1] - The company will benefit from various policy supports, including tax credits for clinical trial costs and exemption from new drug application fees [1] - Upon approval, the product will enjoy seven years of market exclusivity [1]