CMS(00867): Approval granted for the application for the Chinese market of a type 1 new drug, the recombinant human anti-rabies virus bispecific antibody Semlerweiming monoclonal injection.

CMS (00867) announced that the marketing authorization application for the first class therapeutic biological product Slewavemab monoclonal antibody (GR1801) injection (referred to as "Slewavemab monoclonal antibody injection" or "product," trade name: Jinsuxi) has been approved by the National Medical Products Administration (NMPA) of China and received a drug registration certificate on June 22, 2026. The product is used for passive immunity in adults exposed to rabies virus. Slewavemab monoclonal antibody injection is a recombinant fully human anti-rabies virus (RABV) bispecific antibody that targets epitopes I and III of the envelope glycoprotein (G protein) of RABV, blocking its binding to receptors and specifically neutralizing the rabies virus before the active immunity of rabies vaccine fully protects. The product is the world's first bispecific antibody for passive immunity to rabies, designed in accordance with the World Health Organization's (WHO) recommended "cocktail" combination formulation to ensure effectiveness against different virus strains or genotypes. The product has demonstrated non-inferior protection compared to the main passive immunity product for rabies currently used in China, Human Rabies Immune Globulin (HRIG), providing immediate protection in the early stages of rabies virus exposure without adverse effects on vaccine-induced active immunity. In addition, the product is undergoing phase III clinical trials in China for children and adolescents aged 2 to 18. The product has been granted authorized patents in China. Rabies is an acute zoonotic disease caused by RABV infection, mainly characterized by symptoms such as hydrophobia, aerophobia, muscle spasms, and progressive paralysis, with an almost 100% mortality rate. Currently, there is no recognized effective treatment for rabies once symptoms appear, and the standard post-exposure management is the most effective strategy, including wound care, vaccination, and passive immune therapy as needed. Vaccine-induced antibody production takes 1-2 weeks, and passive immune therapy can provide immediate protection until the body produces enough antibodies after the first vaccine injection. According to the "Guidelines for Rabies Exposure Prevention and Management (2023 Edition)," cases of rabies level III exposure and severe immunodeficiency level II exposure should receive passive immune therapy simultaneously with the first dose of vaccine immunization. Each year in China, there are over 40 million people exposed to rabies virus, with 40% experiencing level III exposure. However, due to patient awareness, price, accessibility, and other factors, only about 15% of level III exposure cases in China receive passive immune therapy injections. The main passive immunity product for rabies in China currently is HRIG. However, HRIG is sourced from healthy individuals, has limited availability, is expensive, and carries a potential risk of bloodborne infections, resulting in a low penetration rate of passive immune therapies in China. The group continues to develop and commercialize differentiated innovative products. The passive immunity market for rabies is broad, with low penetration of existing passive immune therapeutics, and certain limitations in safety and accessibility. Slewavemab monoclonal antibody injection is the world's first fully human bispecific antibody targeting two epitopes of rabies virus, in line with WHO development recommendations. It can be mass-produced in a standardized and stable manner, has a broad neutralization spectrum, low immunogenicity, minimal interference with vaccine-induced active immunity, and cost-effectiveness. Additionally, it is currently the lowest dose passive immunity product for rabies, with minimal dosage and ease of administration, effectively reducing patient pain and improving compliance. The marketing approval of this product will provide a new treatment choice for patients in China who urgently require post-exposure management for rabies, and working together with the group's existing network of experts and market resources is expected to have a positive impact on the group's performance. In September 2025, the group signed an exclusive cooperation agreement (agreement) with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. through its subsidiary for the product. According to the agreement, the group has obtained the exclusive commercialization rights for the product in mainland China and the exclusive licensing rights for the Asia-Pacific region, the Middle East, and North Africa, excluding mainland China. The cooperation period extends to ten years after the product is marketed in mainland China (initial period of the product), and unless there is a termination or dissolution as stipulated in the agreement, the agreement automatically extends every ten years after the initial period. The group will methodically advance the commercialization of the product to offer new choices for patients in need of passive immunity to rabies as soon as possible.