VISEN Announces China's Approval to Submit Lonapegsomatropin Biologic License

VISEN Pharmaceuticals, a pioneering biotherapeutics enterprise with a concentration on hormonal disorders, declared that the China National Medical Products Administration has given the green light to the company's submission of a Biologics License Application for Lonapegsomatropin.

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The groundbreaking growth hormone known as Lonapegsomatropin has received approval for use on a once-weekly basis for the management of Pediatric Growth Hormone Deficiency, with the endorsement coming from both the U.S. Food & Drug Administration and the European Medicines Agency.

VISEN Pharmaceuticals' Chief Executive Officer, Mr. Pony Lu, remarked, "Receiving the Biologics License Application approval is a pivotal moment in the journey towards bringing this product to the market. We are committed to focusing on the delivery of top-tier or pioneering medications, aiming to enhance the therapy available to Chinese patients suffering from endocrine disorders, which in turn should lead to improved management and health outcomes."

As a precursor to somatropin, Lonapegsomatropin is introduced into the body on a weekly basis. With the assistance of the cutting-edge TransConTM technology, this therapy has been tailored to ensure the consistent release of somatropin in its pure form - a therapy aligning with the somatropin currently employed in day-to-day treatments of pediatric GHD. The somatropin released from Lonapegsomatropin maintains its natural state, mirroring the 191 amino-acid make-up and dimensions of the body's own growth hormone.

Ownership and development of Lonapegsomatropin and the transformative TransCon technology belong to Ascendis Pharma A/S. Meanwhile, VISEN Pharmaceuticals possesses the exclusive authorization to further develop and market Lonapegsomatropin across the extensive Chinese market.

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According to the data provided by the Synapse Database, As of March 11, 2024, there are 358 investigational drugs for the GR target, including 498 indications, 489 R&D institutions involved, with related clinical trials reaching 12368, and as many as 21501 patents.

Lonapegsomatropin-tcgd targets the GR and is indicated for growth hormone deficiency, hormone deficiency, and Turner Syndrome. With its recent approval in the United States and orphan drug status, Lonapegsomatropin-tcgd holds promise in addressing various diseases within the nervous system, endocrinology, cardiovascular, congenital, and urogenital domains.