Core Viewpoint - Kangfang Biopharma (09926) received Orphan Drug Designation from the FDA for its novel anti-CD47 humanized IgG4 monoclonal antibody, Lefacitinib (AK117), for the treatment of acute myeloid leukemia (AML) [1][2] Group 1: Company Developments - Kangfang Biopharma's stock rose nearly 3% in early trading, currently up 1.98% at HKD 133.5, with a trading volume of HKD 150 million [1] - The FDA's Orphan Drug Designation provides various incentives for the development and commercialization of Lefacitinib, including tax credits for clinical trial costs, waiver of BLA application fees, and potential seven years of market exclusivity upon approval [1] Group 2: Product Information - Lefacitinib specifically binds to CD47 expressed on tumor cells, blocking its interaction with the SIRPα receptor, thereby enhancing macrophage phagocytosis of tumor cells and inhibiting tumor growth [2] - The unique design of Lefacitinib prevents red blood cell aggregation, significantly improving the drug's safety and efficacy compared to other drugs targeting the same pathway, enhancing therapeutic effectiveness and convenience [2]

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]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Trastuzumab combined with Atezolizumab injection 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 [1][4]. Group 1: Drug Information - Drug Name: Injection of Rukang Trastuzumab - Indication: Combined with Atezolizumab injection and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma - Application Number: DRU-2025-10850 - Approval Conclusion: Granted orphan drug designation under Section 526 of the U.S. Federal Food, Drug, and Cosmetic Act [1]. Group 2: Market Context - In 2022, gastric cancer ranked 5th in global cancer incidence and mortality, with 968,400 new cases and 659,900 deaths worldwide. In China, there were 358,700 new cases and 260,400 deaths, ranking 5th in incidence and 3rd in mortality [2]. - Current first-line treatment standards have shown some clinical effectiveness, but unmet clinical needs remain due to short survival periods and poor prognosis [2]. Group 3: Competitive Landscape - Injection of Rukang Trastuzumab binds to HER2-expressing tumor cells, inducing apoptosis. It was approved in China in May 2025 for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with HER2 mutations [3]. - Competing products include Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), with combined global sales projected at approximately $6.557 billion in 2024 [3]. Group 4: Impact of Orphan Drug Designation - The orphan drug designation will expedite clinical trials and registration processes. The company will benefit from policy support, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [4].

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]

智通财经APP获悉，康宁杰瑞制药-B(09966)再涨近6%，月内累涨逾65%。截至发稿，涨5.86%，报10.12 港元，成交额5129.66万港元。 据悉，ODD是FDA鼓励开发用于治疗在美国患病人数低于20万的疾病的创新药措施。JSKN003获得该 认定后将有利于后续在美国的研究及开发、注册与商业化等方面获得相关政策支持，包括研发费用资 助、临床研究费用税收减免、处方药用户费用豁免、加速上市审评审批等，以及药物获批后有望获得美 国市场的7年独占权。 消息面上，康宁杰瑞制药发布公告，JSKN003已获美国食品药品监督管理局(FDA)授予孤儿药资格认定 (ODD)，用于治疗胃癌及胃食管结合部癌(GC/GEJ)。JSKN003是康宁杰瑞利用特有的糖基定点偶联平台 自主研发的HER2双抗ADC。 ...