VISEN Announces Acceptance of a Biologics License Application for Lonapegsomatropin in China

2024-03-08

上市批准临床3期临床结果申请上市

SHANGHAI, March 7, 2024 /PRNewswire/ -- VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, today 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."

Lonapegsomatropin is a prodrug of somatropin administered once weekly. By leveraging the innovative technology platform TransConTM (transient conjugation), it is designed to provide sustained release of active, unmodified somatropin, the same growth hormone used in daily pediatric GHD treatments. The unmodified, unbound somatropin released from lonapegsomatropin has the identical 191 amino-acid sequence and size (22 kDa) as endogenous growth hormone.

Lonapegsomatropin and TransCon technology are owned and developed by Ascendis Pharma A/S. VISEN Pharmaceuticals holds exclusive rights to develop, manufacture and commercialize lonapegsomatropin in the Greater China.

Approval No.: COMU2024029/EN/PR

About VISEN Pharmaceuticals

VISEN is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' need first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier.

For more information, please visit our website:

http://www.visenpharma.com/

[email protected]

SOURCE VISEN Pharmaceuticals (VISEN)

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