Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has announced that the National Medical Products Administration (NMPA) has accepted for review a marketing approval filing for its lonapegsomatropin, TransCon hGH, a once-weekly long-acting growth hormone. This drug, which is the first long-acting growth hormone approved in the US and Europe, is utilized for the treatment of childhood growth hormone deficiency.
Visen holds exclusive rights to develop, manufacture, and commercialize lonapegsomatropin in Greater China, a drug globally developed by Ascendis Pharma A/S. The human growth hormone prodrug is designed using the innovative TransCon (Temporary Connection) patented technology platform, which is recognized as a leading method worldwide. The drug’s mechanism of action differs from other long-acting growth hormone analogues due to its technology. After weekly administration, it can gradually release unmodified human growth hormone in a controlled manner within the body. The released growth hormone is structurally identical to the endogenous growth hormone secreted by the human body, and its biological activity, mechanism of action, and physiological distribution are the same as those of widely used daily growth hormone preparations, ensuring its safety and effectiveness. A Phase III China study has demonstrated that the molecule is currently the only long-acting growth hormone that is superior to daily growth hormone preparations.- Flcube.com
