Deepening Commitment to Metabolic Health – Hybio and Sunshine Mandi Jointly Filed Semaglutide Injection (Weight Management) NDA Accepted by CDE

Hybio Pharmaceutical Co., Ltd. (hereinafter referred to as “Hybio”) announced that the New Drug Application (NDA) for its independently developed Semaglutide Injection for long-term weight management has been formally accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The application was jointly submitted by Hybio and Zhejiang Sunshine Mandi Pharmaceutical Co., Ltd. (referred to as "Sunshine Mandi"), and is intended for long-term weight management in adult patients based on dietary control and increased physical activity.

Overweight and obesity have become major public health challenges affecting the well-being of Chinese residents. According to the Report on Nutrition and Chronic Disease Status of Chinese Residents (2020), the prevalence rates of overweight and obesity among Chinese adults stand at 34.3% and 16.4%, respectively. Obesity significantly elevates the risk of type 2 diabetes, stroke, coronary heart disease, hypertension, and various malignancies. In 2019, approximately 549,500 cardiovascular deaths were attributed to high body mass index (BMI). Currently, the only GLP-1 receptor agonists approved for weight management in China are imported originator products, leaving extremely limited therapeutic options and creating an urgent clinical demand for high-quality domestic alternatives. The acceptance of Hybio’s Semaglutide Injection NDA signals that the first domestically produced chemically synthesized semaglutide injection may soon be available, effectively addressing this unmet need. As a GLP-1 receptor agonist, semaglutide selectively activates GLP-1 receptors in appetite-regulating brain regions such as the hypothalamus and brainstem, reducing hunger, increasing satiety, improving eating control, and modulating energy intake across multiple dimensions to support long-term weight management.

Full-Chemical Synthesis Technology Builds Core Product Competitiveness

Leveraging 28 years of accumulated expertise in peptide synthesis, Hybio employs a full-chemical synthesis route. Compared with traditional bio-fermentation pathways, the full-chemical synthesis approach offers differentiated advantages including controllable purity, high batch-to-batch consistency, superior product stability, and an optimized impurity profile—enabling precise quality control at source. This fully demonstrates Hybio’s robust R&D strength in advanced peptide innovation and process optimization. Under this collaboration, Hybio serves as the developer and manufacturer, drawing on its technical strengths in peptide drug synthesis, large-scale production, and quality management to ensure product quality and supply. Meanwhile, Sunshine Mandi brings its commercialization capabilities in metabolic diseases, with both parties working together to drive the product from development to market.

Deepening GLP-1 Metabolic Pipeline with a Global Vision

The acceptance of this NDA represents a significant milestone for Hybio in the independent R&D and industrial transformation of innovative peptide drugs, further enriching the company’s heavyweight GLP-1 product portfolio. Previously, Hybio’s Liraglutide Injection achieved simultaneous commercial availability in both China and the U.S., making it the first domestic liraglutide formulation approved via a full-chemical synthesis route. The current acceptance of the Semaglutide Injection filing complements and synergizes with the company’s pipeline under development or already launched, including multi-receptor agonists, tirzepatide, and retatrutide, continuously strengthening Hybio’s leading position in the global peptide metabolism space. At present, only Novo Nordisk’s original semaglutide injection is marketed for both glycemic control and weight loss indications, with no generic versions yet available. The acceptance of this NDA paves the way for timely approval, offering new treatment options for overweight and obese patients in China and advancing the accessibility of high-quality domestic drugs in the metabolic disease field.

About Hybio Pharmaceutical Co., Ltd.

Shenzhen Hybio Pharmaceutical Co., Ltd. (Stock Code: 300199) is a national high-tech enterprise with 28 years of deep specialization in the peptide innovation field, focusing on the R&D, production, and global commercialization of peptide drugs. The company has built a comprehensive pipeline covering mainstream metabolic targets worldwide, encompassing single-target GLP-1 agents, multi-target innovative drugs, and several globally blockbuster peptide varieties. It has established a full-industry-chain layout spanning from active pharmaceutical ingredients (APIs) to finished formulations, from R&D to commercialization, and from the Chinese market to global markets. These include but are not limited to novel GLP-1R/GIPR/GCGR triple receptor agonists, retatrutide, tirzepatide, semaglutide, and liraglutide.