CMS (HKG: 00867) has announced that on July 15, 2026, its self-developed innovative drug, the complement factor B inhibitor CMS-D017 capsule, received a drug clinical trial approval notice from China's National Medical Products Administration (NMPA).
The NMPA has granted approval for the group to conduct clinical trials to evaluate the safety and efficacy of CMS-D017 for treating age-related macular degeneration (AMD).
CMS-D017 is a novel, oral, selective small-molecule inhibitor of complement factor B. The complement system is a crucial part of the innate immune system and can be activated via the classical, lectin, and alternative pathways to exert biological functions. Complement factor B, a specific serine protease primarily synthesized by the liver, acts as a "core switch" and "effector amplifier" in the complement alternative pathway, with its activity directly influencing the intensity of the complement response.
Research indicates that excessive activation of the complement system is closely associated with the pathogenesis of AMD. The alternative pathway serves as a powerful amplification loop within the complement system, and blocking its activation can effectively suppress complement system activity. CMS-D017 targets and inhibits complement factor B to prevent abnormal activation of the alternative pathway, thereby reducing damage to target tissues and organs by the membrane attack complex and alleviating the progression of complement dysregulation-related diseases like AMD.
Preclinical studies have shown CMS-D017 possesses favorable pharmacological activity and safety characteristics. It is intended for treating conditions such as age-related macular degeneration, complement-mediated kidney diseases, and paroxysmal nocturnal hemoglobinuria.
Age-related macular degeneration is a leading cause of low vision and blindness in the elderly. According to the "Chinese Clinical Diagnosis and Treatment Guidelines for Age-Related Macular Degeneration (2023)," the global number of AMD patients is projected to reach 288 million by 2040. In China, the prevalence of AMD among people over 70 is 20.2%, and patient numbers are rising with the aging population.
Current clinical AMD treatments primarily focus on anti-VEGF intravitreal injections for wet AMD, aimed at rapidly inhibiting choroidal neovascular leakage and growth to improve or stabilize vision. However, there remains a significant unmet need for long-term, disease-modifying therapies for early-to-mid-stage AMD and geographic atrophy patients, where abnormal complement activation and chronic inflammation are key features.
As an oral medication, CMS-D017 specifically blocks complement factor B upstream in the alternative pathway without affecting other complement pathways. It holds promise for slowing disease progression, potentially offering AMD patients a superior and more convenient treatment option.
If approved for market, CMS-D017 is expected to significantly enhance the overall competitiveness of the group's ophthalmology-focused subsidiary, CMS Vision. CMS Vision, with ophthalmology at its core, already covers disease areas including retinal diseases, asthenopia, and glaucoma, and has extended into the otolaryngology field.
CMS-D017 is anticipated to achieve high synergy and differentiated complementarity with existing products in terms of expert resources and distribution networks. These products include the marketed innovative drug Beiyoushi® (brolucizumab injection for conditions like diabetic macular edema), the marketed product Nuo Shide® (ranibizumab injection for wet AMD), and the exclusive marketed drug Shitulun Eye Drops (digoxin and scutellarin eye drops for macular degeneration and all types of asthenopia). Together, they aim to provide a multi-layered, precise, and comprehensive solution portfolio for ophthalmic diseases.
Previously, CMS-D017 received clinical trial approval notices for paroxysmal nocturnal hemoglobinuria on January 30, 2026, and for complement-mediated kidney diseases on February 3, 2026. Future development for the product is also planned for conditions like myasthenia gravis.
The group is actively preparing to commence the relevant clinical trial work, striving to bring this product to market as soon as possible.
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