Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the US FDA for its product, injection of Rikan Trastuzumab combined with Adebali monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1][3] Group 1: Orphan Drug Designation - The orphan drug designation allows the company to benefit from US policy support in product development, registration, and commercialization [1][3] - Orphan drugs are defined as medications used for the prevention, treatment, or diagnosis of rare diseases [1] Group 2: Gastric Cancer Statistics - In 2022, gastric cancer ranked 5th in global cancer incidence and mortality, with 968,400 new cases and 659,900 deaths worldwide [1] - In China, there were 358,700 new cases and 260,400 deaths, ranking 5th in incidence and 3rd in mortality [1] Group 3: Product Details - Injection of Rikan Trastuzumab targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release [2] - The product is set to be approved for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received at least one systemic treatment [2] - Competing products include Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), with combined global sales projected at approximately $6.557 billion in 2024 [2] Group 4: Clinical Trial and Market Exclusivity - The orphan drug designation will expedite clinical trials and market registration processes [3] - The company will enjoy various policy supports, including tax credits for clinical trial costs, waiver of new drug application fees, and 7 years of market exclusivity post-approval [3]

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]