Jinan Zhuocheng Bio-Tech Co., Ltd.

(Newswire Report) On June 30, Hybio Pharmaceutical Co., Ltd. announced that its Abbreviated New Drug Application (ANDA) for Tirzepatide Injection has been accepted for review by the U.S. Food and Drug Administration (FDA). The agency has preliminarily determined that the application is sufficiently complete and has formally initiated the review process.

Tirzepatide, developed by Eli Lilly and Company, is a dual GLP-1 receptor and GIP receptor agonist widely used in the treatment of type 2 diabetes and obesity. According to Eli Lilly’s 2025 financial report, global sales of tirzepatide reached approximately USD 36.5 billion in 2025, making it one of the world’s best-selling pharmaceutical products. Of this total, Mounjaro generated about USD 22.96 billion, while Zepbound contributed approximately USD 13.54 billion. The U.S. market accounted for roughly USD 32 billion, or about 88% of total global sales.

At present, no generic versions of tirzepatide have been approved worldwide, and the market remains in the early stage of patent protection and generic entry preparation.

According to the announcement, Hybio submitted two ANDA filings for tirzepatide injection on May 13, 2026, which is the earliest permissible submission date accepted by the FDA. The company also submitted Paragraph IV certification, formally challenging existing patents and initiating the generic litigation pathway.

Hybio stated that its vertically integrated capabilities in active pharmaceutical ingredients (API) and finished dosage forms provide strong support for the application. The company has established synthesis and scalable manufacturing capacity for tirzepatide API, and its Drug Master File (DMF) was the first to pass FDA completeness assessment in this category.

To date, Hybio has accumulated 20 U.S. DMF registrations and 6 European CEP certifications for its peptide API portfolio, strengthening its regulatory foundation for global expansion.

The tirzepatide injection represents another key GLP-1-related product for Hybio following its liraglutide injection, which previously received FDA approval as a first generic entrant. The latest ANDA acceptance further advances the company’s global strategy in peptide-based therapeutics.

Notably, one day prior to Hybio’s announcement, Swiss generic pharmaceutical company Sandoz also disclosed that the FDA had accepted its ANDA filings for tirzepatide autoinjector products. The proposed generics are intended to cover all indications of the reference products Mounjaro and Zepbound, including type 2 diabetes and weight management.

Industry observers note that the simultaneous entry of multiple companies into FDA review marks a transition of tirzepatide generics from development stage to regulatory review stage, potentially accelerating the restructuring of the global GLP-1 drug market landscape.