China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that innovative drug CMS-D003 capsules (“CMS-D003”) self-developed by the Group has been granted approval for drug clinical trials by National Medical Products Administration of the People’s Republic of China (“NMPA”) on 11 March 2025. The approval was obtained on 12 March 2025. The NMPA grants the Group consent to conduct a clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of CMS-D003 in both healthy adults and adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in China.
CMS-D003
CMS-D003 is a small molecule cardiac myosin inhibitor, which is a targeted therapy for hypertrophic cardiomyopathy. By targeting inhibition of cardiac myosin adenosine triphosphate (ATP) enzymes, it inhibits myosin-actin interactions, reduces myofilament sliding, inhibits myocardial over-contraction, and improves diastolic dysfunction of the heart, thereby alleviating the patient’s clinical symptoms[1]. CMS-D003 demonstrates a short half-life, minimal risk for drug interactions, and improved safety profiles. CMS-D003 can also be developed for the treatment of heart failure with preserved ejection fraction in the future.
Hypertrophic cardiomyopathy (HCM) is a myocardial disease characterized by myocardial hypertrophy caused by mutations in genes encoding sarcomere-associated proteins or unknown genetic variants. Obstructive hypertrophic cardiomyopathy, a subtype of HCM, manifests symptoms such as syncope, palpitations, and fatigue, and may lead to sudden cardiac death or severe cardiovascular complications including progressive heart failure, atrial fibrillation, and thromboembolism. According to the 2023 Guideline for Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy, echocardiographic screening of over 8,000 individuals in the general population in China during the early 21st century revealed the HCM prevalence of approximately 0.08%[2]. However, due to limitations in early screening methods, this prevalence is likely underestimated. As clinical and molecular genetic research advances, the prevalence of HCM is estimated to be at least 0.5%[2], with oHCM accounting for approximately 70% of cases[3]. Cardiac myosin inhibitor represents a clinically validated, targeted therapeutic approach specifically designed for oHCM. Traditional therapies, such as β-blockers and calcium channel blockers, serve merely as symptomatic treatments and are limited to provide partial relief of symptoms. Preclinical study data suggests that it is expected to become an oral drug with superior efficacy, providing patients with better treatment options. If approved for marketing, CMS-D003 will synergize with the marketed exclusive drug XinHuoSu (Recombinant Human Brain Natriuretic Peptide for Injection).
Reference:
- Suman Nag, Sampath K Gollapudi, Carlos L Del Rio, et al. Mavacamten, a precision medicine for hypertrophic cardiomyopathy: From a motor protein to patients. Sci Adv, 2023 Jul 28;9(30):eabo7622.
- 2023 Guideline for Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy. Molecular Cardiology of China, 2023, 23 (01): 5115-5149.
- Tian Z, et al. JAMA Cardiol. 2023 Oct 1; 8(10): 957-965.
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