据介绍，孤儿药资格认定是FDA为鼓励针对罕见病治疗药物研发而设立的特殊激励政策。将有助于该药 物在美国的后续研发及商业化开展等方面享受众多积极的政策支持，包括享有临床试验费用税收减免、 免除BLA申请费用、获得研发资助，以及该适应症批准上市后可获得美国市场7年独占权等。获得该资 格认定，是FDA对莱法利单抗临床价值潜力的认可和期许。 康方生物(09926)早盘涨近3%，截至发稿，涨1.98%，报133.5港元，成交额1.5亿港元。 消息面上，据康方生物官微消息，近日，美国食品药品监督管理局(FDA)授予了康方生物自主研发的新 一代抗CD47人源化IgG4单克隆抗体莱法利单抗(AK117)孤儿药资格认定(Orphan Drug Designation， ODD)，适应症为急性髓系白血病(AML)。 莱法利单抗是一种抗CD47人源化IgG4单克隆抗体，它可特异性结合肿瘤细胞表面表达的CD47，阻断其 与SIRPα受体的相互作用，解除"别吃我"信号，增强巨噬细胞对肿瘤细胞的吞噬作用，从而抑制肿瘤生 长。值得注意的是，得益于独特的药物设计，莱法利单抗不诱导红细胞凝集，药物安全性和有效性均显 著优于其他同靶点药物，疗效 ...

智通财经APP获悉，康方生物(09926)早盘涨近3%，截至发稿，涨1.98%，报133.5港元，成交额1.5亿港 元。 莱法利单抗是一种抗CD47人源化IgG4单克隆抗体，它可特异性结合肿瘤细胞表面表达的CD47，阻断其 与SIRPα受体的相互作用，解除"别吃我"信号，增强巨噬细胞对肿瘤细胞的吞噬作用，从而抑制肿瘤生 长。值得注意的是，得益于独特的药物设计，莱法利单抗不诱导红细胞凝集，药物安全性和有效性均显 著优于其他同靶点药物，疗效、安全性和用药便利性显著提高。 据介绍，孤儿药资格认定是FDA为鼓励针对罕见病治疗药物研发而设立的特殊激励政策。将有助于该药 物在美国的后续研发及商业化开展等方面享受众多积极的政策支持，包括享有临床试验费用税收减免、 免除BLA申请费用、获得研发资助，以及该适应症批准上市后可获得美国市场7年独占权等。获得该资 格认定，是FDA对莱法利单抗临床价值潜力的认可和期许。 消息面上，据康方生物官微消息，近日，美国食品药品监督管理局(FDA)授予了康方生物自主研发的新 一代抗CD47人源化IgG4单克隆抗体莱法利单抗(AK117)孤儿药资格认定(Orphan Drug Designati ...

Group 1: Company Performance - BeiGene reported a total revenue of $1.3 billion for Q2 2025, a 42% increase from $929 million in the same period last year, driven primarily by the sales growth of Brukinsa® in the US and Europe [1] - Hengrui Medicine received orphan drug designation from the FDA for its product, injection of Rukangqumab, which will enjoy 7 years of market exclusivity upon approval [2] - Dizh Pharmaceutical's investigational product DZD8586 received Fast Track Designation from the FDA, potentially accelerating its development and market entry [3] - Novo Nordisk's sales grew by 16% to 154.9 billion Danish Kroner in the first half of 2025, with a notable 56% increase in the obesity treatment segment [4] - Gan Li Pharmaceutical achieved a revenue of 2.067 billion Yuan in the first half of 2025, a 57.18% increase year-on-year, with significant growth in domestic sales [5][6] - Innovent Biologics reported a revenue of over 5.2 billion Yuan in the first half of 2025, reflecting a strong growth of over 35% [7] Group 2: Product and Market Insights - BeiGene's product revenue reached $1.3 billion in Q2 2025, with US sales at $685 million, up from $479 million year-on-year, and European sales of Brukinsa® increased by 85% to $150 million [1] - Hengrui's orphan drug designation will facilitate clinical trials and market registration, providing tax credits for trial costs and waiving new drug application fees [2] - Dizh's Fast Track Designation allows for expedited drug development processes, addressing unmet medical needs in chronic lymphocytic leukemia [3] - Novo Nordisk's GLP-1 diabetes treatment sales increased by 8%, contributing to the overall growth in the diabetes and obesity treatment sectors [4] - Gan Li's self-developed insulin product GZR4 is in global Phase III clinical trials, indicating a strong position in the insulin market [5][6] - Innovent's product lines, including Xinbile® and Xinbimin®, are experiencing significant market growth, driven by effective marketing and channel access [7]

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： 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 三、本次获得美国FDA孤儿药认定的影响 本次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孤 儿药资格认定后，能够加快推进临床试验及上市注册的进度。同时，可享受一定的政策支持，包括但不 限于临床试验费用的税收抵免、免除新药申请费、产品获批后将享受7年的市场独占权。 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 ...

证券日报网讯 8月6日晚间，恒瑞医药发布公告称，近日，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（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。 （编辑 任世碧） ...

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]

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) has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Qutuzumab combined with Adebeli monoclonal antibody and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization in the U.S. [1] Group 1 - The product received orphan drug designation from the U.S. FDA [1] - The indication is for gastric cancer or gastroesophageal junction adenocarcinoma [1] - The designation allows for potential policy support in research, registration, and commercialization [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase of nearly 6%, with a cumulative rise of over 65% in the month, currently trading at 10.12 HKD with a transaction volume of 51.2966 million HKD [1] Group 1: Company Developments - Corning Jereh Pharmaceutical announced that its drug JSKN003 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ) [1] - JSKN003 is developed using Corning Jereh's proprietary glycosylation site-specific conjugation platform and is a HER2 dual-targeted antibody-drug conjugate (ADC) [1] Group 2: Regulatory and Market Implications - The ODD designation encourages the development of innovative drugs for diseases affecting fewer than 200,000 patients in the U.S. and provides various policy supports for research, development, registration, and commercialization [1] - Following the ODD recognition, JSKN003 is expected to benefit from funding for research expenses, tax reductions for clinical research costs, waivers for prescription drug user fees, and expedited review processes for market approval [1] - Upon approval, the drug is anticipated to receive a seven-year exclusivity in the U.S. market [1]