MEDTIDE's HEPCLUDEX® Active Ingredient Passes FDA Pre-License Inspection

Stock News07-31

MEDTIDE (03880) has announced that its wholly-owned subsidiary, Zhongtai Shenghua Co., Ltd. ("Zhongtai Shenghua"), has successfully completed a Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA) at its current Good Manufacturing Practice (cGMP) facility in Hangzhou, China.

This rigorous on-site review, conducted from January 26 to February 3, 2026, comprehensively evaluated the facility's operations for the commercial production of the complex fully chemically synthesized long-chain peptide active pharmaceutical ingredient (API) for 8.5 mg Hepcludex® (bulevirtide-gmod) injection. The drug received accelerated approval from the U.S. FDA on May 22, 2026, becoming the first and only approved treatment in the United States for chronic Hepatitis D virus (HDV) infection.

Dr. Li Xiang, Chairman of Zhongtai Shenghua, commented: "With the landmark accelerated approval of Hepcludex® by the U.S. FDA, Zhongtai Shenghua extends its warmest and most sincere congratulations to our strategic partner, Gilead Sciences. As the commercial API supplier for this groundbreaking therapy, we are deeply proud to witness and support this historic medical advancement that has the potential to fundamentally transform the treatment landscape for patients with chronic HDV."

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