Core Insights - Kangzheng Pharmaceutical has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. to obtain exclusive commercialization rights for two Class 1 therapeutic biological products in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1][2] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a passive immunization agent for tetanus that offers rapid and long-lasting protection, outperforming human tetanus immunoglobulin (HTIG). The product has met its primary efficacy endpoint in Phase III clinical trials and is included in the NMPA's list of breakthrough therapeutic varieties as of May 2024, with its New Drug Application (NDA) accepted in May 2025, potentially becoming China's second approved passive immunization monoclonal antibody for tetanus [1] - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human dual-specific antibody targeting rabies virus glycoprotein epitopes I and/or III. It aligns with WHO recommendations for developing "cocktail" therapies targeting different antigen sites, allowing for large-scale standardized production. Its NDA for passive immunization in adults exposed to suspected rabies virus was accepted by CDE on January 14, 2025, and clinical trial applications for children aged 2 to 18 have been approved, with Phase III trials currently underway [2] Group 2: Market Potential and Strategic Positioning - The passive immunization market for tetanus and rabies is vast, with existing passive immunization agents facing limitations in safety and accessibility. The approval and market entry of Weikangduta and Sileweimi monoclonal antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, enhancing the synergy with Kangzheng Pharmaceutical's existing products in expert networks and market resources [2]

Core Insights - Kangzheng Pharmaceutical Holdings Limited has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. for two innovative biological agents aimed at infectious disease prevention, obtaining exclusive commercialization rights in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a recombinant humanized monoclonal antibody that provides rapid and long-lasting protection against tetanus, outperforming human tetanus immunoglobulin (HTIG) [2] - The product targets the C-terminal heavy chain of tetanus toxin (TeNT-Hc), blocking its entry into neuronal cells, and has achieved primary efficacy endpoints in Phase III clinical trials [2] - The NDA for Weikangduta Monoclonal Antibody was accepted by the National Medical Products Administration (NMPA) on May 22, 2025, and it was included in the list of breakthrough therapies by the NMPA in May 2024 [2] Group 2: Market Potential - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human bispecific antibody for passive immunity against rabies, designed to block the rabies virus from infecting neurons before the rabies vaccine can take effect [3] - The product can be produced in a standardized and stable manner, with broad neutralization spectrum, low immunogenicity, minimal interference with vaccine-induced immunity, and controllable costs [3] - The NDA for Sileweimi Monoclonal Antibody for adults was accepted by the NMPA on January 14, 2025, and clinical trial applications for children aged 2 to 18 were approved in July 2025, with ongoing Phase III clinical trials [3] Group 3: Strategic Focus - Kangzheng Pharmaceutical is committed to developing innovative products with clinical value and differentiated advantages, addressing the limitations of existing passive immunization agents in terms of safety and accessibility [3] - The approval and market launch of Weikangduta and Sileweimi Monoclonal Antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, leveraging the company's existing market resources and expert networks [3]