Medtide (03880.HK): Subsidiary Zhongtai Biochemical's Hangzhou Facility Successfully Passes FDA Pre-License Inspection, Paving Way for Commercial API Production of Hepcludex®

NewTimeSpace News: On July 31, 2026, Medtide (03880.HK) issued a voluntary announcement disclosing that the cGMP manufacturing facility of its wholly-owned subsidiary Zhongtai Biochemical Co., Ltd. in Hangzhou has successfully passed a Pre-License Inspection (PLI) conducted by the U.S. Food and Drug Administration (FDA).

The inspection, conducted from January 26 to February 3, 2026, comprehensively assessed the commercial manufacturing operational capabilities for the long-chain peptide active pharmaceutical ingredient (API) of Hepcludex® (bulevirtide-gmod) 8.5 mg for injection.

Hepcludex® received accelerated approval from the U.S. FDA on May 22, 2026, becoming the first and only approved treatment for chronic hepatitis D virus (HDV) infection in the United States. Zhongtai Biochemical serves as the commercial API supplier for this therapy. The Company noted that the approval of Hepcludex® fills a significant treatment gap where no FDA-approved therapy had previously existed, with the potential to fundamentally alter the clinical course for HDV patients in the United States. Founded in 2001, Zhongtai Biochemical possesses ton-scale GMP manufacturing capacity, and its manufacturing facilities have passed GMP inspections by multiple regulatory agencies including the FDA, NMPA, TGA, and EMA.

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