China Medical System: Self-developed Innovative Drug Complement Factor B Inhibitor CMS-D017 is Approved for Drug Clinical Trials for Age-related Macular Degeneration

• CMS-D017 is a novel selective small-molecule inhibitor of complement factor B (CFB). Through administered orally, targeting and inhibiting complement factor B,it blocks abnormal activation of the alternative complement pathway, and thereby slows the progression of complement dysregulation-related diseases such as age-related macular degeneration (“AMD”), offering a potentially superior and more convenient treatment option^[1]. CMS-D017 has demonstrated favourable efficacy and safety profiles in preclinical studies.
• Upon approval for marketing, CMS-D017 will synergise with the marketed innovative drug Beovu^®(diabetic macular oedema, etc.), the branded drug Lucentis^® (neovascular age-related macular degeneration, etc.), and the exclusive drug Augentropfen Stulln Mono Eye Drops (senile macular degeneration and all forms of asthenopia), building a multi-layered, precise and comprehensive solution for ophthalmic diseases.

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 15 July 2026, the Group’s self-developed innovative drug, Complement Factor B inhibitor CMS-D017 capsules (“CMS-D017” or the “Product”), obtained the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (“NMPA”). The NMPA has approved the Group to conduct clinical trials to evaluate the safety and efficacy of CMS-D017 in the treatment of age-related macular degeneration.

About CMS-D017

CMS-D017 is a novel oral selective small-molecule inhibitor of complement factor B. The complement system, a vital component of the innate immune system, exerts its biological functions through activation via the classical, lectin, and alternative pathways^[2]. Complement factor B, a specific serine protease primarily synthesized in the liver, serves as the “core switch” and “amplifier” of the alternative complement pathway, with its activity directly influencing the intensity of complement responses. Studies have shown that overactivation of the complement system is closely associated with the pathogenesis of AMD. As the alternative pathway serves as a powerful amplification mechanism in the complement system, blocking its activation can effectively inhibit complement activation.

By targeting and inhibiting complement factor B, CMS-D017 blocks abnormal activation of the alternative complement pathway, reduces damage to target tissues and organs caused by the membrane attack complex, and slows the progression of complement dysregulation-related diseases such as AMD^[3]. CMS-D017 has demonstrated favourable efficacy and safety profiles in preclinical studies. It is being developed for the treatment of age-related macular degeneration, complement-mediated kidney diseases, paroxysmal nocturnal hemoglobinuria, and other conditions.

A Potentially Superior and More Convenient Treatment Option for AMD

AMD is one of the leading causes of visual impairment and blindness in the elderly. According to the Chinese Clinical Practice Guidelines for Age-related Macular Degeneration (2023), the global number of AMD patients is projected to reach 288 million by 2040^[4]. In China, the prevalence of AMD among people aged 70 and above is 20.2%^[4]. With the acceleration of population aging in China, the number of AMD patients continues to rise.

Current clinical treatments for AMD mainly focus on intravitreal anti-VEGF therapies for neovascular AMD, which rapidly inhibit the leakage and growth of choroidal neovascularization, thereby improving or stabilising patients’ vision^[5]. However, for patients with early-to-intermediate-stage AMD and geographic atrophy, where abnormal complement activation and chronic inflammation are important features, there remains an urgent need for long-term, disease-modifying therapies^[6]. CMS-D017, administered orally, specifically blocks the upstream complement factor B in the alternative pathway without affecting other complement pathways, and is expected to delay disease progression and provide AMD patients with a potentially superior and more convenient treatment option^[1].

Enriching the Innovation Pipeline, Building a Multi-Layered, Precise and Comprehensive Solution for Ophthalmic Diseases

Upon approval for marketing, CMS-D017 will significantly enhance the overall competitiveness of the Group’s ophthalmology business company—CMS Vision, which focuses on ophthalmology and covers fundus diseases, asthenopia, glaucoma, and has extended into the ear, nose and throat (ENT) field, committed to becoming a “leading ophthalmology pharmaceutical company in China”. CMS-D017 will synergise with the marketed innovative drug Beovu^® (Brolucizumab Injection, indicated for diabetic macular oedema, etc.), the marketed branded drug Lucentis^® (Ranibizumab Injection, indicated for neovascular age-related macular degeneration, etc.), and the marketed exclusive product Augentropfen Stulln Mono Eye Drops (Esculin and Digitalisglycoside Eye Drops, indicated for senile macular degeneration and all forms of asthenopia) in expert resources and channel networks, while forming differentiated complementary products, providing a multi-layered, precise and comprehensive solution for ophthalmic diseases.

Previously, CMS-D017 obtained Drug Clinical Trial Approval Notices for the indications of paroxysmal nocturnal hemoglobinuria and complement-mediated kidney diseases on 30 January 2026 and 3 February 2026, respectively. Future development plans for the Product also include the treatment of myasthenia gravis and other conditions.

In-house R&D is positioned as the core driver of the Group’s long-term development. Currently, including CMS-D017, 6 self-developed products have entered the clinical development stage, while over 20 in-house R&D projects are steadily advancing through preclinical research. Going forward, the Group will continue to focus on unmet clinical needs in specialty therapeutic areas, efficiently advance the R&D and commercialisation processes, and bring more comprehensive and innovative treatment solutions to patients.

Reference:
1.Desai D., et al. Complement cascade inhibition in geographic atrophy: a review. Eye (Lond). 2022 Feb;36(2):294-302

2.McMurray JC., et al. Immunodeficiency: Complement disorders. Allergy Asthma Proc. 2024;45(5):305-309.

3.Zhu Min, He Chenglu, Li Ya. Advances in the Study of Complement Factor B [J]. Journal of Qiqihar Medical University, 2025, 46(10): 979-984.

4.Xu Xun. Chinese Clinical Diagnosis and Treatment Guidelines for Age-related Macular Degeneration (2023 Edition). Chinese Journal of Ophthalmology, 2023, 59(5): 347-366.

5.Fleckenstein, Monika et al. “Age-Related Macular Degeneration: A Review.” JAMA vol. 331,2 (2024): 147-157.

6.Mettu, Priyatham S et al. “Incomplete response to Anti-VEGF therapy in neovascular AMD: Exploring disease mechanisms and therapeutic opportunities.” Progress in retinal and eye research vol. 82 (2021): 100906.

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