SHENZHEN, CHINA – On 9 September, China Medical System Holdings Limited (867.HK/8A8.SG) (“CMS” or the “Group”) is pleased to announce that the initial prescriptions for the Class 1 innovative drug Silevimig Injection (the “Product”) have recently been issued in multiple hospitals across China, including Beijing Luhe Hospital of Capital Medical University, Wenzhou People’s Hospital, Kaiping Central Hospital, Dongguan Guangji Hospital and Huidong Jilong Ankang Hospital. This marks that the world’s first bispecific antibody for passive immunization against rabies has officially commenced its large-scale clinical application, offering a better solution for urgent post-exposure management against rabies in China.

Dual-Epitope Neutralization with Low Dosing, Addressing Clinical Pain Points

Silevimig Injection is the world’s first fully human bispecific antibody targeting dual epitopes (G protein epitopes I and III) of the rabies virus, which is consistent with the World Health Organization (“WHO”) recommendation for a “cocktail” therapeutic paradigm. It can effectively neutralize different viral strains or genotypes of the rabies virus, providing immediate protection before the establishment of full protection by active rabies vaccination, and building a critical line of defense against viral infection.

The Product is currently the passive immunization product with the smallest dose for rabies (0.05 mg/kg); compared with human rabies immune globulin (“HRIG”), it requires less injection volume and easier administration, which can effectively reduce pain and improve compliance for patient. Manufactured using recombinant technology, the Product is non-plasma-derived and carries no risk of blood-borne infections. It can be manufactured at scale through standardized and stable processes, with controllable production costs, while offering a single active ingredient, consistent quality and minimal batch-to-batch variability. These advantages open up new possibilities for improving the safety, standardized supply and patient accessibility of rabies passive immunization products, with the potential to further increase market penetration.

Initial Prescriptions Issued Within About Two Months After Approval, Academic-Driven Commercialization Platform Accelerating Value Realization

Silevimig Injection was approved for marketing in China in June 2026. Following the approval, CMS worked closely with its partner Genrix Bio to advance critical workstreams including drug supply, market access and academic promotion, while integrating expert networks and market resources. The inital prescriptions were issued in China within approximately two months, accelerating the translation of innovation outcomes into a clinically accessible new treatment option.

Currently, CMS has nine commercialized innovative drugs that are progressively achieving large-scale clinical application across China, accelerating the realization of the clinical value of each quality medicine. Going forward, CMS will remain focused on clinical unmet needs and continue to build a differentiated innovative product portfolio through a dual-track system of in-house R&D and collaborative R&D, accelerating accessibility of quality innovative drugs and taking concrete action to safeguard patients’ lives and health.

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, patients with confirmed Category II exposure involving severe immunodeficiency, and patients with Category II exposure involving wounds to the head or face while the health status of the offending animal cannot be determined 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 price, and restricted accessibility, only about 15% of Category III cases receive passive immunization^[1]. Currently, the primary passive immunization option in China is 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

In a Phase III clinical trial in adults in China, Silevimig Injection met its primary efficacy endpoint, demonstrating non-inferior protective efficacy compared with HRIG, the currently most used passive immunization product in China. 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 an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals. With a dual-engine approach of in-house R&D and collaborative R&D, and leveraging its core capability to build markets and brands from the ground up, the Group enables each medicine to fully realize both its clinical value and commercial value.

CMS has established an end-to-end capability loop across the full product lifecycle—precisely identifying quality innovation targets, matching them with optimal development pathways, and efficiently advancing clinical development and registration; developing medical strategies aligned with clinical needs, and driving scaled clinical adoption through a professional academic promotion system and network.

CMS focuses on advantaged specialties including cardiovascular-kidney-metabolic, central nervous system, gastroenterology, ophthalmology, and skin health. Through professional academic promotion and academic resources across multiple disease areas, CMS has built sustainable scale advantages in specialties, with its skin health business becoming a leading player in its segment. Meanwhile, CMS continues to strengthen its international replication capabilities, validating the transferability of its business model in emerging markets such as Southeast Asia and the Middle East, and injecting long-term momentum for the Group’s high-quality, sustainable development.

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/P02024090652542…

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. National Technical Guidelines 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.

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