Zhitong Finance App News, Kangzhe Pharmaceutical (00867) announced that on July 15, 2026, the innovative drug complement factor B inhibitor CMS-D017 capsules (CMS-D017 or product) independently developed by the Group obtained a drug clinical trial approval notice issued by the China National Drug Administration (NMPA). The NMPA agreed that the Group will conduct clinical trials to evaluate the safety and efficacy of CMS-D017 in treating age-related macular degeneration (AMD) indications.
CMS-D017 is a novel oral selective complement factor B small molecule inhibitor. The complement system is an important component of the innate immune system. It can be activated through classical pathways, lectin pathways, and bypass pathways to perform biological functions. Complement factor B is a specific serine protease mainly synthesized by the liver. It is a “core switch” and “effect amplifier” in the complement bypass pathway, and its activity directly affects the intensity of the complement response. Studies have shown that excessive activation of the complement system is closely related to the onset of AMD, and that the complement bypass pathway acts as a powerful amplification pathway in the complement system, and blocking its activation can effectively inhibit activation of the complement system. By targeting and inhibiting complement factor B, CMS-D017 blocks abnormal activation of complement bypass pathways, reduces damage to target tissues and organs by membrane attack complexes, and mitigates the progression of diseases related to complement disorders such as AMD. CMS-D017 has shown good pharmacodynamic activity and safety characteristics in preclinical studies, and is intended to treat diseases such as age-related macular degeneration, complement-mediated kidney disease, and paroxysmal nocturnal hemoglobinuria.
Age-related macular degeneration is one of the main causes of poor eyesight or even blindness in the elderly. According to the “Guidelines for the Clinical Diagnosis and Treatment of Age-Related Macular Degeneration in China (2023)”, the number of AMD patients worldwide is expected to reach 288 million in 2040. The prevalence of AMD among people aged 70 and over in China is 20.2%. As the aging of our population intensifies, the number of patients with AMD continues to rise. Currently, clinical AMD treatment methods are mainly intraocular injections of anti-VEGF drugs centered around wet AMD treatment. They are mainly used to rapidly inhibit the leakage and growth of choroidal neovascularization and improve or stabilize patients' eyesight. However, for patients with early to middle AMD and map like atrophy, which are important features of abnormal complement activation and chronic inflammation, there is still an urgent need for treatments that can be implemented over a long period of time and have the potential to modify the disease. Through oral administration, CMS-D017 specifically blocks complement factor B upstream of the complement bypass pathway without affecting other complement pathways. It is expected to mitigate disease progression and provide potentially better and more convenient treatment options for AMD patients.
If approved for listing, CMS-D017 will effectively enhance the Group's ophthalmology business company, Kangzhe Weisheng's overall competitiveness in the field of ophthalmology. Kangzhe Weisheng focuses on ophthalmology, and has covered ophthalmologic diseases such as fundus disease, visual fatigue, glaucoma, etc., and extends to the otolaryngology field. CMS-D017 will create a high degree of collaboration with products such as the innovative drug Beyusizumab® (bucizumab injection, suitable for diabetic macular edema, etc.), the currently sold product Novartizumab® (Ranibizumab injection, suitable for wet age-related macular degeneration, etc.), and the exclusive drug Sturen eye drops (seven-leaf digitalis diside eye drops, suitable for macular degeneration under the eye and all types of visual fatigue), and at the same time form differentiated complementarity to provide multiple levels of precision and precision for ophthalmology diseases A comprehensive solution.
Previously, CMS-D017 had obtained drug clinical trial approval notices for paroxysmal nocturnal hemoglobinuria and renal disease indications mediated by complement participation on January 30 and February 3, 2026, respectively. The product will also be developed in the future to treat diseases such as myasthenia gravis.
The Group is actively preparing to carry out relevant clinical trials and strive to launch this product as soon as possible.