Novo Nordisk Submits NDA for Long-Acting Growth Hormone Sogroya in China

▎Armstrong

On September 5, 2024, the marketing application for Novo Nordisk's long-acting growth hormone, Pasireotide Injection, was accepted by the NMPA.

The FDA has cumulatively approved 3 long-acting growth hormones, including Novo Nordisk's Sogroya (somapacitan), Ascendis' Skytrofa (lonapegsomatropin), and Pfizer/OPKO.Ngenla (somatrogon). Novo Nordisk holds a 19% share of the global growth hormone market, with sales reaching $570 million in 2023. In terms of domestically produced varieties, only Jin Sai Zeng from Changchun High-Tech has been approved for marketing.

Pasitropin is non-inferior to short-acting growth hormone in Phase III clinical trials.

Summary

In 2023, the市场规模 of growth hormone in China exceeded 13 billion RMB. Changchun High-Tech holds a leading position, followed by Anke Bio. The long-acting growth hormone has been on the market for a relatively short time and currently holds a market share of around 30%, but it is in a stage of rapid growth. It is expected that in the future, long-acting growth hormone will become mainstream.