IND Approval for Self-developed Product: CMS’s Innovative Drug Complement Factor B Inhibitor CMS-D017 is approved for Drug Clinical Trials for Complement – mediated Kidney Disease Indication

Date:
2026-02-03
Category:
Company News
  • CMS-D017 is a novel selective small-molecule inhibitor of complement factor B（CFB）.By targeting and inhibiting CFB, it blocks abnormal activation of the alternative complement pathway, which reduces damage to target tissues and organs caused by the membrane attack complex, and effectively slows the progression of a range of complement dysregulation-related inflammatory responses and autoimmune diseases.
  • CMS-D017 has demonstrated excellent efficacy and safety in preclinical studies. Besides paroxysmal nocturnal hemoglobinuria(which has been approved for drug clinical trials), it is also being developed for clinical use in the treatment of complement-mediated kidney diseases, including IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, C3 glomerulopathy, etc.; providing a potentially better therapeutic alternative for patients.
  • Upon approval for marketing, CMS-D017 will synergize with the marketed innovative drug Velphoro (hyperphosphatemia of Chronic Kidney Disease) and the new drug currently under NDA review, Desidustat Tablets(renal anemia), in expert networks and market resources, collectively elevating the Group’s capabilities in the field of nephrology.

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that innovative drug CMS-D017 capsules (“CMS-D017” or the “Product”) self-developed by the Group, has obtained the Drug Clinical Trial Approval Notice issued by National Medical Products Administration (“NMPA”) on 3 February 2026. The NMPA has approved the Group to conduct clinical trials in healthy participants in China to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of CMS-D017.

About CMS-D017

CMS-D017 is a novel 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, or alternative pathways[1]. Complement factor B, a specific serine protease primarily synthesized in the liver, acts as the “core switch” and “amplifier” of the alternative complement pathway, with its activity directly determining the intensity of complement responses. Excessive activation of the complement system can attack the body’s own cells and tissues, leading to a range of inflammatory responses and autoimmune diseases.

By targeting and inhibiting complement factor B, CMS-D017 blocks abnormal activation of the alternative complement pathway, which reduces damage to target tissues and organs caused by the membrane attack complex, and effectively slows the progression of complement dysregulation-related diseases[2]. CMS-D017 has demonstrated excellent efficacy and safety in preclinical studies. It is being developed for clinical use in the treatment of complement-mediated kidney diseases, including but not limited to IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy. Previously, CMS-D017, intended for the treatment of paroxysmal nocturnal hemoglobinuria, was approved by NMPA of drug clinical trials on 30 January 2026. Future development plans for CMS-D017 also include the treatment of age-related macular degeneration, myasthenia gravis and other complement – mediated conditions.

A potentially better therapeutic option for complement – mediated kidney disease (CMKD)

The kidney serves as the primary target organ of abnormal complement system activation, with the onset and progression of numerous kidney diseases being closely associated with excessive complement activation. In recent years, researchers both in China and internationally have increasingly explored the role of complement in renal pathologies, leading to the proposal of the concept of CMKD. CMKD refers to a spectrum of renal disorders directly or indirectly mediated by abnormal activation of the complement system, encompassing various primary and secondary glomerular diseases[3]. Based on pathogenesis, CMKD can be divided into two major groups: (1) Diseases directly mediated by abnormal complement activation, including C3 glomerulopathy (C3G), atypical hemolytic uremic syndrome, and immune complex–mediated membranoproliferative glomerulonephritis; (2) Nephropathies involving complement system participation, such as IgA nephropathy (IgAN), idiopathic membranous nephropathy (IMN), and lupus nephritis (LN)[4]. Among these, IgAN and IMN are primary glomerular diseases with a relatively high incidence in China[5], while LN is a common secondary immune-mediated glomerular disease[6]. According to data from 2023, China has an estimated 5 million patients with IgA nephropathy, of whom about 1.3 million are receiving treatment, with a compound annual growth rate of approximately 8%. Additionally, there are roughly 2.6 million patients with membranous nephropathy (MN)[7,8], and approximately 240,000 patients with lupus nephritis (LN)[9].

Current clinical treatments for these conditions—such as corticosteroids and immunosuppressants—have limitations, including suboptimal efficacy, considerable side effects, and unfavorable prognosis, which result in multiple unmet clinical needs. With the deepening understanding of CMKD pathogenesis, targeted inhibition of complement factor B has emerged as an effective therapeutic strategy for the treatment of CMKD. Given its favorable clinical profile, CMS-D017 may offer patients an improved treatment option.

Upon approval for marketing, CMS-D017 will significantly enhance the Group’s capabilities in the field of nephrology. It will synergize with the marketed innovative drug Velphoro (Sucroferric Oxyhydroxide Chewable Tablets, indicated for hyperphosphatemia of Chronic Kidney Disease) and the new drug Desidustat Tablets (indicated for renal anemia, currently undergoing regulatory review for market approval) in expert networks and market resources, collectively elevating the Group’s competitiveness and market position in this field.

 

The Group is actively preparing to initiate relevant clinical trials and strives to launch the Product as soon as possible.

Reference:

  1. McMurray JC., et al. Immunodeficiency: Complement disorders. Allergy Asthma Proc. 2024;45(5):305-309.
  2. Zhu Min, He Chenglu, Li Ya. Research Progress of Complement Factor B [J]. Journal of Qiqihar Medical University, 2025, 46(10): 979-984.
  3. The expert group of Nephrology Department of Peking University Medical School. Expert Consensus on Diagnosis and Treatment of Complement-Associated Nephropathy [J]. Chinese Journal of Internal Medicine, 2024, 63(3): 258-271.
  4. Tan Ying, Zhao Minghui. Key Points Interpretation of Expert Consensus on Diagnosis and Treatment of Complement-Associated Nephropathy [J]. Chinese Journal of Practical Internal Medicine, 2025, 45(03): 237-240.
  5. Li, J., et al. Primary glomerular nephropathy among hospitalized patients in a national database in China. Nephrol Dial Transplant, 2018. 33(12): p. 2173-2181.
  6. Liu Zhihong. Diagnosis and Treatment Guidelines for Lupus Nephritis in China. Chinese Medical Journal, 2019. 99(44): p. 3441-3455.
  7. IQVIA. White Paper on Chronic Kidney Disease in China, 2023.
  8. Yang Y, Zhang Z, Zhuo L, Chen DP, Li WG. The Spectrum of Biopsy-Proven Glomerular Disease in China: A Systematic Review. Chin Med J (Engl). 2018;131(6):731-735.
  9. Roveta A, Parodi EL, Brezzi B, et al. Lupus Nephritis from Pathogenesis to New Therapies: An Update. Int J Mol Sci. 2024;25(16):8981.

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