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VISEN Wins China Approval for Once-Weekly Growth Hormone Drug SKYTROFA

Story Highlights
  • VISEN secured Chinese approval for SKYTROFA, a once-weekly pediatric growth hormone therapy.
  • Backed by strong trial data, VISEN readies broad commercialization via supply and distribution alliances.
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VISEN Wins China Approval for Once-Weekly Growth Hormone Drug SKYTROFA

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VISEN Pharmaceuticals ( (HK:2561) ) has shared an announcement.

VISEN Pharmaceuticals has received approval from China’s National Medical Products Administration for its biologics license application for lonapegsomatropin (SKYTROFA), a once-weekly growth hormone replacement therapy for children and adolescents aged three and above with growth hormone deficiency. The decision, supported by positive Phase 3 trial data in China showing superior efficacy and comparable safety versus daily human growth hormone, positions lonapegsomatropin as the only long-acting growth hormone in China that delivers unmodified human growth hormone and may improve treatment compliance; VISEN is moving quickly to commercialize the drug through supply agreements with Ascendis Pharma and distribution and promotional partnerships with Shanghai Pharmaceutical, United Family Healthcare and Anke Biotechnology, signalling a major expansion of its presence in the pediatric endocrine market.

The most recent analyst rating on (HK:2561) stock is a Hold with a HK$34.00 price target. To see the full list of analyst forecasts on VISEN Pharmaceuticals stock, see the HK:2561 Stock Forecast page.

More about VISEN Pharmaceuticals

VISEN Pharmaceuticals is a Cayman Islands–incorporated biopharmaceutical company listed in Hong Kong that focuses on endocrine and rare disease therapies in China, particularly pediatric growth disorders. The group works with international partners such as Ascendis Pharma and leverages specialized commercialization teams and strategic distribution alliances to bring innovative biologic treatments to the Chinese market.

Average Trading Volume: 35,090

Technical Sentiment Signal: Strong Sell

Current Market Cap: HK$4.3B

Find detailed analytics on 2561 stock on TipRanks’ Stock Analysis page.

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