China Approves New Derma Drug in Latest Dash to Finish

China’s National Medical Products Administration (NMPA) is accelerating its drug approval process, granting approval to several innovative drugs in a move aimed at bolstering its domestic biotech industry. Among the newly approved therapies is a pediatric version of Benvitimod, an arylhydrocarbon receptor agonist for atopic dermatitis (AD) developed by Thederma Shanghai Ltd. The adult version of this drug, marketed as Tapinarof, was already approved in 2019 for adult use and is available internationally.

In addition, Kelun Biotech's antibody-drug conjugate (ADC) targeting TROP2 has also been approved for triple-negative breast cancer (TNBC) patients, specifically for those with non-operable, metastatic disease. This drug, Sacituzumab tirintican (sac-TMT), has gained approval for its breakthrough therapy designation, reflecting its potential to significantly advance treatment options in a difficult-to-treat cancer area. Kelun Biotech has also licensed its ADC technology to Merck & Co. for further development in solid tumors.

This move reflects China’s push to foster homegrown biotech innovation. To streamline the approval process, on November 22, China’s regulatory agency announced that Ten provinces, including Beijing, Shanghai, and Guangdong, would expedite the review of innovative drugs. The streamlined review procedures are designed to ensure faster market entry for new drugs and reduce the approval timeline, which could be pivotal for biopharma companies seeking to introduce innovative therapies in China’s increasingly competitive market.

These measures signal China's ongoing efforts to not only strengthen its biotech capabilities but also position itself as a growing hub for innovative drug development.