First Approval of Synthetic Liraglutide in China: Hybio Achieves Full-Chain Breakthrough in Both API and FDF, Strengthening GLP-1 Core Barriers Across the Entire Industrial Chain

Recently, Hybio Pharmaceutical Co., Ltd. (Stock Code: 300199, hereinafter referred to as “Hybio”) has achieved two landmark milestones in its GLP-1 metabolic drug franchise:

1. Liraglutide (H) Injection Approved in China​ – On July 1, 2026, Hybio received the Drug Registration Certificate (Approval No.: H20260049) from China’s National Medical Products Administration (NMPA) for its Liraglutide (H) Injection. This is the first Category 2.2 modified new chemical drug approved in China for glycemic control in adult patients with type 2 diabetes mellitus (T2DM), and it also reduces the risk of major adverse cardiovascular events (MACE) in T2DM patients with established cardiovascular disease. With this approval, Hybio has achieved simultaneous commercial availability of Liraglutide in both China and the U.S., bringing a high-quality, internationally consistent treatment option to domestic patients.
2. Liraglutide (H) API Approved in China​ – On July 6, 2026, Hybio's wholly-owned subsidiary, Hybio Pharmaceutical (Wuhan) Co., Ltd., obtained the Chemical Bulk Drug Marketing Authorization Approval Notice from the NMPA for Liraglutide (H) Active Pharmaceutical Ingredient (API). This makes Hybio the first domestic pharmaceutical company to receive API approval using a full-chemical synthesis route. The approved API has a retest period of 48 months, with flexible packaging amount ranging from 1 g/bag to 50 g/bag, ensuring adaptability for various formulation scales. The approval qualification remains valid until June 29, 2031.

Full-Chemical Synthesis Technology – A Differentiated Competitive Advantage

Unlike traditional bio-fermentation processes used for biosimilars, Hybio's Liraglutide (H) API and injection employ a proprietary full-chemical synthesis route, leveraging over 20 years of deep expertise in peptide synthesis. This technology delivers four core advantages: controllable purity, high batch-to-batch consistency, superior impurity profile, and excellent product stability. It enables standardized and precise quality control from the raw material source, effectively resolving common issues such as impurity variability and batch inconsistency found in conventional processes.

Importantly, the approved injection formulation in China shares the exact same prescription, manufacturing process, and production site as the product marketed in the U.S. The manufacturing facility has passed on-site inspections by China NMPA and U.S. FDA, and other competitive authorities, demonstrating globally compliant quality management.

Integrated Pipeline and Global Commercialization

With the domestic approvals of both the API and the finished formulation, Hybio has completed a closed-loop, vertically integrated value chain from raw material production to finished drug marketing. This eliminates external dependency on API supply, significantly enhancing cost efficiency and commercial autonomy.

From global level, Hybio’s Liraglutide Injection got U.S. FDA first-generic approval in December 2024 and has already achieved commercial presence overseas. The domestic approvals mark the strategic implementation of our core strategy: one product, dual China-US launches, global standards. Domestic T2DM patients can now access the same high-quality, innovator-level medication available in regulated markets, greatly improving affordability and accessibility.

Expanding GLP-1 Product Matrix

Hybio has built a comprehensive, multi-layered, and differentiated GLP-1 metabolic drug portfolio, covering key targets including liraglutide, semaglutide, tirzepatide, and retatrutide, as well as novel multi-receptor agonists. Notably, the company’s chemically synthesized Semaglutide Injection (for weight management), jointly filed with Zhejiang Sunshine Mandi Pharmaceutical Co., Ltd., has been accepted for review by the CDE, positioning Hybio to potentially secure the first domestic approval for a chemically synthesized semaglutide injection.

These achievements underscore Hybio’s strong R&D capabilities in advanced peptide innovation, industrial-scale production, and global quality systems. Going forward, the company will continue to deepen its commitment to peptide drug innovation, leverage its full-industry-chain advantages, accelerate the development and adoption of high-quality domestic metabolic drugs, reduce clinical treatment costs, and enhance the global competitiveness of Chinese innovative pharmaceuticals.

About Hybio Pharmaceutical Co., Ltd.

Hybio Pharmaceutical Co., Ltd. (Stock Code: 300199) is a national high-tech enterprise with 28 years of dedicated focus on peptide innovation. The company specializes in the R&D, production, and global commercialization of peptide drugs. It has built a comprehensive pipeline covering major metabolic targets worldwide, including GLP-1 single-target agents, multi-target innovative drugs, and several globally blockbuster peptide products. Hybio has established a full-industry-chain layout spanning from APIs to finished formulations, from R&D to commercialization, and from China to global markets. Key products include but are not limited to novel GLP-1R/GIPR/GCGR triple receptor agonists, retatrutide, tirzepatide, semaglutide, and liraglutide.