China's Drug Regulator Approves First Stem Cell Therapy and Novel HIV Treatment

China has made significant strides in medical advancements by approving its first stem cell therapy designed to address acute graft-versus-host disease (aGVHD). This therapy is intended for patients aged 14 and older who have not responded to traditional steroid treatments. aGVHD is a severe condition that can affect individuals following a stem cell transplant, often leading to high mortality rates in such patients.

The stem cell therapy, developed by a domestic company called Platinum Life, represents a major breakthrough as it is the first approved mesenchymal stromal cell treatment in mainland China. The National Medical Products Administration expedited its approval through a special market registration process meant for urgently needed and innovative medicines. Stem cell therapy leverages the unique self-renewing and differentiating capabilities of stem cells to aid in tissue repair and disease management, with ongoing global research exploring its potential for treating a range of ailments, such as diabetes and cancer.

In a related announcement, the drug regulator has also given the green light to lenacapavir, a novel HIV treatment by Gilead Sciences. This long-acting medication is particularly designed for individuals with multidrug-resistant HIV who have struggled to control their viral load using existing treatment options. Originally sanctioned in Europe and the United States in 2022, lenacapavir is currently being evaluated for its potential role in HIV prevention.