斯乐韦米单抗(GR1801)注射液
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康哲药业与智翔金泰就两款创新生物制剂签订独家合作协议
Zheng Quan Ri Bao Wang· 2025-09-23 06:13
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]