CMS: Class 1 Innovative Drug Silevimig Injection Approved in China, Becoming the World’s First Bispecific Antibody for Passive Immunization Against Rabies
SHENZHEN, CHINA, June 22, 2026 (GLOBE NEWSWIRE) -- China Medical System Holdings Limited (867.HK/8A8.SG) (“CMS”, or the “Group”) is pleased to announce that, the New Drug Application for Silevimig Injection (GR1801, the “Product”), a Class 1 therapeutic biological product has been approved by the National Medical Products Administration of the People’s Republic of China (“NMPA”) and the drug registration certificate was obtained on 22 June 2026. The Product is indicated for passive immunization in adults following rabies virus exposure.
Silevimig Injection is the world’s first fully human bispecific antibody targeting dual epitopes of the rabies virus (“RABV”), which is consistent with the recommendations of the World Health Organization (“WHO”) for a “cocktail” therapeutic paradigm. It demonstrates broad neutralization, which can effectively neutralize different viral strains or genotypes of RABV, providing immediate protection. Moreover, it is the passive immunization product with the smallest dose for rabies, resulting in less injection volume and easier administration, which can effectively reduce patient pain and improve compliance. In addition, the Product can be manufactured at scale with standardized processes and controlled production cost, and also carries no risks of blood-borne infections, low immunogenicity, and minimal interference with vaccine-induced active immunization. The market for rabies passive immunization is substantial, yet existing passive immunization products are constrained by low market penetration and limitations in safety and accessibility. The approval of the Product will provide a new treatment option for patients requiring urgent post-exposure management against rabies in China.
The approval of Silevimig Injection expands the Group’s commercialized innovative drug portfolio to 8 products, with 6 more innovative drugs under marketing review and approximately 20 projects advancing clinical development, further strengthening a tiered innovation pipeline. As of now, CMS’s innovation transformation strategy has fully entered the value-harvesting phase. Leveraging the Group’s existing expert network and market resources, the commercialization rollout of Silevimig Injection is expected to proceed steadily providing sustained momentum to the Group’s performance growth.
About Rabies
Rabies is an acute zoonotic disease caused by RABV, clinically characterized by aerophobia, hydrophobia, pharyngeal muscle spasms, and progressive paralysis[1], with a case-fatality rate approaching 100%. At present, there is no proven treatment for rabies once clinical symptoms appear. Standardized post-exposure management, comprising wound care, vaccination, and passive immunization administered as needed, remains the most effective strategy[2]. As vaccine-induced antibodies require 1-2 weeks after the first dose of vaccine injection to reach protective levels, passive immunization provides immediate coverage[1]. According to the National Technical Guidelines for the Rabies Exposure Prophylaxis (2023 Edition), patients with Category III exposure and those with Category II exposure involving severe immunodeficiency should receive passive immunization at the same time as the first dose of rabies vaccine[3]. In China, more than 40 million people are exposed to rabies annually, of whom approximately 40% fall under Category III exposure[1]. However, due to factors such as limited awareness, high cost, and restricted accessibility, only about 15% of Category III cases receive passive immunization[1]. Currently, the primary approved passive immunization option in China is human rabies immune globulin (“HRIG”). However, HRIG must be sourced from healthy donors, making it difficult and costly to obtain. Furthermore, it carries potential risks of blood-borne infections. This has led to a low penetration rate of passive immunization products in China.
More information about Silevimig Injection
Silevimig Injection is a recombinant, fully human bispecific antibody against rabies virus. It targets the viral envelope glycoprotein (G protein) of RABV and blocks its interaction with host receptors by binding to epitopes I and III. Through this mechanism, Silevimig Injection specifically neutralizes the RABV prior to the establishment of full protection by active rabies vaccination.
In a Phase III clinical trial in adults, the Product met its primary efficacy endpoint, demonstrating non-inferior protective efficacy compared with HRIG, the currently most used passive immunization product in China. The study confirmed that the Product provides immediate protection during the early stages of rabies virus exposure without compromising the active immune response induced by vaccination. In addition, a Phase III clinical trial in children and adolescents aged 2 to <18 years is currently ongoing in China. The Product has been granted a patent in China.
In September 2025, the Group through subsidiaries of the Company entered into an Exclusive Collaboration Agreement (the “Agreement”) with Chongqing Genrix Biopharmaceutical Co., Ltd.. In accordance with the Agreement, the Group has obtained exclusive commercialization rights for the Product in mainland China and exclusive licensing rights for the rest of the Asia-Pacific region, the Middle East and North Africa. The collaboration term extends until ten years after the Product receives the marketing approval in Mainland China (the “Initial Term for the Product”). Unless terminated or dissolved under the terms set forth in the Agreement, the Agreement will automatically renew for successive ten-year periods upon expiration of the Initial Term for the Product.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.
CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.
CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardiovascular-kidney-metabolic/gastroenterology/ophthalmology/skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.
Reference:
1. Chinese Center for Disease Control and Prevention. Technical Guidelines for Human Rabies Prevention and Control (2016). https://www.chinacdc.cn/jkyj/crb2/yl/kqb/jswj_kqb/202409/P020240906525420231910.pdf
2. Yin Wenwu, Wang Chuanlin, et al. Expert consensus on rabies exposure prophylaxis[J]. Chinese Journal of Preventive Medicine, 2019,53(7): 668-679. DOI:10.3760/cma.j.issn.0253-9624.2019.07.004
3. Chinese Center for Disease Control and Prevention. The National Regulation for the Rabies Exposure Prophylaxis (2023 Edition). https://www.chinacdc.cn/jkyj/crb2/yl/kqb/jswj_kqb/202409/P020240906525421817465.pdf
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.
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