Hengrui Medicine’s Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531.

SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has been approved to proceed to clinical trials for the treatment of vitiligo, a condition for which Jakavi (ruxolitinib) is currently the only globally available treatment. Additionally, the NMPA has accepted marketing approval filings for SHR0302 for the treatment of ankylosing spondylitis, atopic dermatitis, and rheumatoid arthritis, indicating a broadening scope of applications for this drug candidate.

In parallel, HRS9531, a peptide GLP-1/GIP dual receptor agonist, is moving into clinical development with the aim to treat type 2 diabetes and manage weight. Currently, there is no similar oral product available on the global market. Hengrui has recently entered into a significant licensing agreement worth USD 6 billion with Hercules CM Newco Inc., which grants the US firm the worldwide rights, excluding Greater China, to HRS9531 and at least two other obesity candidates from Hengrui’s pipeline.- Flcube.com

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