Hybio Pharmaceutical (300199) said its Pingshan site completed a joint US FDA inspection of drug-device combination products with a No Action Indicated (NAI) classification. It was the site’s third successful FDA inspection. The inspection covered drug cGMP and device quality systems, including manufacturing and assembly validation, design and development, risk management, traceability and data integrity. The company said its Longhua R&D laboratory, Wuhan peptide API site and Pingshan finished dosage site had all received NAI outcomes.
Hybio also reported that HY3003 injection received US clearance for its first clinical trial, while China accepted a clinical trial application for HY3003 tablets. The oral candidate is a GLP-1R, GIPR and GCGR triple agonist under development for indications including weight management, type 2 diabetes and metabolic dysfunction-associated steatohepatitis. R&D expenses rose 117.11% year on year to RMB 161 million in the first nine months of 2026, equivalent to 12.95% of revenue. Third-quarter revenue rose 314.48% to RMB 554 million, and attributable net profit rose 369.76% to nearly RMB 200 million.

Source: http://finance.eastmoney.com/a/202611133930579679.html