Empowering Peptide Innovation for Global Expansion | The Evolution of Regulatory Frameworks for Global GLP?1 Peptide Generics

15 October 2026, Xi’an — The 5th China Peptide Industry Conference, hosted by China Biochemical Pharmaceutical Industry Association, was held in Xi’an. As a supporting organization of this conference, Hybio Pharmaceutical (300199) participated in the event.

Mr. Yangming Tang, Executive Director & CEO of Hybio, delivered a keynote speech at the main forum, titled Evolution of Regulatory Requirements for Certain Highly Purified Synthetic Peptides ANDA Pathway.
In his presentation, Mr. Tang shared Hybio’s practical experience in global peptide registration and commercialization. He illustrated global main authority’s evolving regulatory requirements for synthetic peptide generics, the differentiated evaluation logic compared with small molecules, critical points including RLD comparative studies, impurity profiling, structural elucidation, regulatory pathway strategy, patent risk assessment and market access strategy. The talk provided actionable insights for Chinese peptide manufacturers pursuing oversea market access.
Hybio is a fully integrated peptide enterprise in China with end-to-end capabilities covering API, finished dosage forms, auto-injector delivery system, quality control and international regulatory affairs. The company is advancing multiple peptide pipelines for registration in the global stringent authority and emerging markets.
Hybio will continue to collaborate with industry partners, drive technological upgrading and compliant global development of Chinese peptide therapeutics, to bring high-quality peptide medicines to patients worldwide.
About Hybio Pharmaceutical
Hybio Pharmaceutical Co., Ltd. (Stock Code: 300199) is a national high-tech enterprise focusing on the R&D, production, and sales of innovative drugs. Deeply engaged in peptide drugs for 28 years, the company boasts a comprehensive formulation pipeline covering mainstream global peptide targets. This includes, but is not limited to, original new drugs like GLP-1R/GIPR/GCGR triple receptor agonists, as well as global blockbuster peptide ANDA formulations such as Retatrutide, Tirzepatide, Semaglutide, and Liraglutide. With nearly 500 domestic and international patents authorized, it is the first company globally to receive FDA approval for a daily GLP-1 preparation (Liraglutide ANDA), with its products successfully entering regulated markets in Europe and the United States.

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