China Approves First Stem Cell Therapy And Long-Acting HIV Drug To Address Critical Patient Needs

China's top drug regulator has given the green light to the country's first stem cell therapy for treating complications related to bone marrow transplants, alongside approving a groundbreaking HIV drug that requires just two injections per year. The National Medical Products Administration announced that it had conditionally approved an injection developed by the domestic pharmaceutical company Platinum Life. This new treatment is aimed at patients aged 14 and older who suffer from acute graft-versus-host disease (aGVHD) – a rare condition that arises after stem cell transplants and does not respond to standard steroid treatments.

Acute graft-versus-host disease is a serious and often fatal complication for patients who undergo stem cell transplants to address severe blood disorders. The condition is one of the leading causes of death following transplantation. Platinum Life’s therapy is the first mesenchymal stromal cell-based treatment to receive approval on the Chinese mainland. The approval process was expedited through a unique market registration pathway designed to fast-track innovative or urgently needed drugs.

Stem cell therapy, which harnesses the regenerative and repair abilities of stem cells, is a rapidly growing area of research worldwide, with potential applications in treating diseases such as diabetes, Parkinson's, and cancer. In May, Platinum Life also became the first company in China to receive a drug manufacturing license for stem cell therapy, granted by the Beijing Municipal Medical Products Administration.

Chen Jiekai, a researcher at the Guangzhou Institutes of Biomedicine and Health under the Chinese Academy of Sciences, described this development as a significant milestone in advancing stem cell treatments toward clinical use. He emphasised that the license marks the beginning of a comprehensive regulatory framework for stem cell therapies. Speaking at an academic conference in Guangzhou in December, Chen noted that hundreds of stem cell research projects are underway in China, with 141 hospitals registered nationally to prepare for future clinical studies, according to local media reports.

Additionally, the regulator approved lenacapavir, a long-acting HIV treatment is developed by global biopharmaceutical company Gilead Sciences. This innovative drug is designed for patients with multidrug-resistant HIV who are unable to control their viral load with existing treatments. Lenacapavir was first approved in Europe and the United States in 2022. Ongoing research is also exploring its potential in preventing HIV infections.