Chiesi Pharma's self-developed innovative drug, the INHBE small nucleic acid drug CMS-D008, has received clinical trial approval for the indication of overweight or obesity

- CMS-D008 is a subcutaneously injectable siRNA drug that targets and inhibits INHBE. It can reduce lipid accumulation by downregulating the level of the INHBE gene and its encoded protein Activin E, thereby decreasing the activation of the fat metabolism pathway Activin E-ALK7. In the future, it can be developed to treat overweight/obesity, abdominal obesity, and related metabolic diseases.

- Preclinical studies suggest that CMS-D008 effectively and continuously suppresses INHBE expression. In obese animal models, significant weight loss and fat reduction were achieved without affecting muscle, and safety was good; indicating a promising prospect of fat reduction without muscle loss and long-term high-quality weight loss.

- CMS-D008 will synergize with the self-developed innovative drug GLP-1R/GCGR dual agonist CMS-D005 currently in clinical development, achieving efficient weight loss benefits and long-term result maintenance, providing patients with a more comprehensive and innovative treatment solution.

Chiesi Pharmaceuticals Holdings Limited ('Chiesi Pharma' or 'the Group') is pleased to announce that CMS-D008 Injection, the Group’s self-developed innovative INHBE small nucleic acid drug ('CMS-D008'), received clinical trial approval from the National Medical Products Administration ('NMPA') on March 4, 2026. The NMPA agreed to initiate clinical trials for CMS-D008 Injection for the treatment of overweight or obesity.

About CMS-D008

CMS-D008 is a subcutaneously injectable siRNA drug that targets and inhibits the expression of the INHBE gene in the liver, reducing the levels of Activin E (Activin E) encoded by INHBE, thereby decreasing the activation of the Activin E-ALK7 pathway in fat metabolism and effectively reducing lipid accumulation. Preclinical studies suggest that CMS-D008 efficiently and continuously suppresses INHBE expression. In obese animal models, it achieves significant weight loss and fat reduction without affecting muscle mass, showing good safety. This indicates its promising potential for high-quality long-term weight management without muscle loss. It can be developed in the future to treat overweight/obesity, abdominal obesity, and related metabolic diseases.

Fat reduction without muscle loss: A potentially superior treatment for overweight/obesity

Overweight or obesity is a chronic, progressive, and recurrent disease characterized by excessive accumulation or abnormal distribution and function of adipose tissue [1]. According to the 'World Obesity Report 2025,' it is projected that by 2030, the proportion of overweight and obese adults globally will rise to 50%, with nearly 3 billion adults affected by high body mass index (BMI), and the number of overweight/obese adults in our country reaching 515 million [2]. Existing GLP-1RA drugs have demonstrated excellent weight loss effects, primarily by acting on the central nervous system to suppress appetite and delay gastric emptying to reduce weight [3]. However, INHBE differs from GLP-1 drugs in its mechanism of action, as it was identified through genome-wide association analysis. Populations with INHBE loss-of-function exhibit favorable fat distribution and advantageous metabolic characteristics [4]. Targeted inhibition of INHBE allows precise reduction of visceral fat at the genetic level and improves metabolic status, making it more conducive to long-term weight management.

CMS-D008 partners with CMS-D005: Combining efficient weight loss and long-term maintenance to build a more comprehensive weight management solution

CMS-D008 will synergize with CMS-D005, an innovative drug currently in clinical development. CMS-D008 precisely inhibits INHBE gene expression to reduce fat without muscle loss, while CMS-D005, as a dual GLP-1R/GCGR agonist, effectively reduces liver fat during weight loss. Together, they achieve efficient weight loss benefits and long-term results, enhancing the group’s R&D strength and product competitiveness in the obesity/metabolic treatment field. Leveraging the group’s well-established network in cardiovascular and metabolic diseases, the development and commercialization process of these drugs will be accelerated to provide patients with more comprehensive and innovative treatment options.

The group is actively preparing for related clinical trial work, striving to bring this product to market as soon as possible.

About China Medical System Holdings

Cisen Pharmaceutical is an open platform enterprise that links pharmaceutical innovation with commercialization, managing the entire lifecycle of products. It is committed to providing competitive products and services to meet unmet medical needs.

Cisen Pharmaceutical focuses on First-in-Class (FIC) and Best-in-Class (BIC) innovative products and efficiently advances clinical research, development, and commercialization processes for innovative products. By empowering the continuous transformation of research achievements into clinical practice, it benefits patients.

Pharmaceutical Company A focuses on specialized fields, possessing proven commercialization capabilities, extensive channel coverage, and expert resources across multiple disease areas. Its core products already hold leading academic and market positions. The company continues to deepen its presence in key specialized areas such as cardio-renal metabolism, gastroenterology, ophthalmology, and skin health, strengthening its competitive edge. Its skin health business (Company B) has become a leader in its niche and is preparing for an independent listing on the stock exchange. Meanwhile, Pharmaceutical Company A actively promotes the entire industry chain, including R&D, production, and sales, expanding into Southeast Asia and the Middle East to capture incremental growth in emerging markets and support the group’s high-quality sustainable development.

References/Resources

1. Chinese Society of Endocrinology. Guidelines for Long-Term Weight Management and Clinical Application of Drugs for Obese Patients (2024 Edition). Chinese Journal of Endocrinology and Metabolism, 2024, 40(7): 545-564.

2. World Obesity Federation. 'World Obesity Report 2025' [EB/OL]. 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.

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