VISEN Announces Acceptance of a Biologics License Application for Lonapegsomatropin in China [Yahoo! Finance]
Ascendis Pharma A/S - American Depositary Shares (ASND)
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Source: Yahoo! Finance
announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA). Lonapegsomatropin is the first once-weekly administrated growth hormone approved by both the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of Pediatric Growth Hormone Deficiency (PGHD). Mr. Pony LU, CEO of VISEN Pharmaceuticals, said, "As the first upcoming commercial product of VISEN Pharmaceuticals, lonapegsomatropin has demonstrated statistically significantly greater efficacy than the daily hGH in the Chinese Phase 3 clinical results. The BLA acceptance represents a significant step towards the product commercialization. We believe that by continuously focusing on providing first-in-class or best-in-class products and treatments, we could provide Chinese endocrine patients with innovative therapies and achieving better treatment processes and outcomes." Lonapegsomatro
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