SHENZHEN, CHINA – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that self-developed innovative drug INHBE-targeting small nucleic acid drug CMS-D008 injection (“CMS-D008”) received the Drug Clinical Trial Approval Notice issued by National Medical Products Administration (“NMPA”) on 4 March 2026. The NMPA has approved the conduct of clinical trials of CMS-D008 injection for overweight or obese individuals.

About CMS-D008

CMS-D008 is a novel siRNA therapy administered by subcutaneous injection. CMS-D008 targets and reduces the hepatic expression of the inhibin subunit beta E (INHBE) gene and lowers the level of Activin E protein encoded by INHBE, which blocks Activin E-ALK7 signaling and reduces fat accumulation effectively. Preclinical studies suggested that CMS-D008 efficiently and sustainably suppressed INHBE expression. In the diet-induced obesity model, CMS-D008 enhanced weight loss by reducing fat mass while retaining lean mass with a good safety profile. It demonstrates potentially better prospects for high-quality, long-term weight loss that boosts fat-specific loss while preserving muscle mass. In the future, it may be developed for the treatment of overweight/obesity, abdominal obesity, and related metabolic diseases.

Fat Loss, muscle preserved: a potentially better therapeutic option for overweight/obesity

Overweight or obesity is a chronic, progressive, relapsing disease characterized by excessive accumulation or abnormal distribution or function of body fat^[1]. World Obesity Atlas 2025 Report projected that the global proportion of overweight and obese adults will rise to 50%, with nearly 3 billion adults impacted by high body mass index (BMI), and the population of adults who are overweight or obese in China is projected to reach 515 million by 2030^[2]. Existing GLP-1RAs have been proven to be effective for the treatment of overweight and obesity. The main actions of GLP-1RAs are to suppress appetite by acting on the central nervous system and to delay gastric emptying^[3]. INHBE’s novel mechanism of action differs from GLP-1RAs. INHBE is identified through genome-wide association studies. Populations with loss of function in INHBE are associated with favorable fat distribution and beneficial metabolic characteristics^[4]. Targeted inhibition of INHBE might be more conducive for long-term weight management at the genetic level with precisely lower visceral fat and favorable metabolic profiles.

CMS-D008 teams up with CMS-D005: highly effective weight loss plus long-term maintenance, building a more comprehensive weight-loss solution

CMS-D008 will synergize with CMS-D005, a self-developed innovative drug currently in clinical development. CMS-D008 reduces fat without sacrificing muscle mass by precisely inhibiting INHBE gene expression; while CMS-D005, as a GLP-1R/GCGR dual agonist, can effectively reduce liver fat while losing weight. The synergy between these two drugs will achieve highly effective weight loss benefits and long-term maintenance of results, jointly enhancing the Group’s R&D capabilities and product competitiveness in the field of obesity/metabolic treatment. Furthermore, leveraging the Group’s mature network resources in the field of cardiovascular and metabolic diseases, the drug’s R&D and commercialization process will be accelerated, providing patients with more comprehensive and innovative treatment options.

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

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardiovascular-kidney-metabolic/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.

Reference:

1. Chinese Society of Endocrinology. Guideline for chronic weight management and clinical practice of anti-obesity medications(2024 version). Chinese Journal of Endocrinology and Metabolism. 2024,40(7):545-564.
2. World Obesity Federation. World Obesity Atlas 2025. London: World Obesity Federation, 2025. https://data.worldobesity.org/publications/?cat=23
3. Zhikai Zheng, Yao Zong, Yiyang Ma, Yucheng Tian, Yidan Pang, Changqing Zhang, Junjie Gao. Glucagon-like peptide-1 receptor: mechanisms and advances in therapy. Sig Transduct Target Ther 9, 234 (2024). doi: 10.1038/s41392-024-01931-z
4. Parsa Akbari, Olukayode A Sosina, Jonas Bovijn, et al. Multiancestry exome sequencing reveals INHBE mutations associated with favorable fat distribution and protection from diabetes. Nat Commun.2022 Aug 23;13(1):4844. doi: 10.1038/s41467-022-32398-7.

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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