CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment

China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug tildrakizumab, which will be used to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy.

Tildrakizumab: A Humanized Monoclonal Antibody for Psoriasis
Tildrakizumab is a humanized lgG1/κ Monoclonal antibody (mAb) designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with IL-23 receptors. This mechanism of action results in the inhibition of the release of pro-inflammatory cytokines and chemokines, offering a targeted approach to managing plaque psoriasis. India-based Sun Pharmaceutical Industries obtained global rights to the drug from Merck & Co., Inc.’s subsidiary in 2014 and later partnered with CMS for its development in China.

Global Approvals and Availability
Tildrakizumab was approved in the US in 2018 to treat plaque psoriasis based on its efficacy and clinical sustainability results. The drug was also approved in Hong Kong in April 2022. Additionally, tildrakizumab is commercially available in the European Union, Japan, the UK, Switzerland, Canada, and Australia, highlighting its broad acceptance and use in treating plaque psoriasis globally.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry