Livzon Pharmaceutical has secured NMPA marketing approval for LiYouBao®, its self-developed recombinant human follicle-stimulating hormone injection. The approval marks a key milestone for Livzon’s fertility pipeline, expanding its market-leading urinary FSH (u-FSH) product portfolio to build a dual u-FSH and recombinant FSH (r-FSH) technology platform.
As Livzon’s trusted preclinical CRO partner, Medicilon provided integrated pharmacokinetic, safety and bioanalytical testing services for LiYouBao®. Drawing on mature GLP quality systems and extensive biologic development experience, Medicilon generated robust, thoroughly analyzed datasets with strict quality oversight to support the product’s smooth path to approval.
High Unmet Clinical Demand for Fertility Treatments
FSH products fall into two technical categories: urinary-derived u-FSH and recombinant r-FSH. Livzon’s LiShenBao® already holds more than 95% of China’s u-FSH market share. With LiYouBao® now launched, Livzon stands as the only Chinese biotech with full dual-technology coverage, creating a complete product portfolio for all stages of assisted reproduction.
Industry-Leading Technology Engineered for Global Markets
Livzon refined genetic engineering, cell culture and chromatographic purification processes to achieve consistent, high-yield production of r-FSH, with end-to-end controls over critical manufacturing steps to guarantee uniform batch quality. A head-to-head clinical comparison against Merck’s Gonal-f® showed positive equivalence outcomes: Phase I pharmacokinetic profiles met predefined bioequivalence criteria, Phase III primary efficacy endpoints reached equivalence thresholds, and the two products demonstrated comparable safety and immunogenicity profiles, establishing solid clinical validation for LiYouBao®.
Full-Cycle Fertility Portfolio Supports Global Expansion
Medicilon has partnered with Livzon for years, witnessing its growth from an early reproductive medicine pioneer to a fully integrated leader with full-cycle, multi-mechanism, globally competitive assets.
