Green signal for first stem cell therapy, novel HIV drug

China's top drug regulator has recently approved the nation's first stem cell therapy to treat a type of complication associated with bone marrow transplant, as well as a novel HIV drug that only requires two shots yearly.

The National Medical Products Administration said on Thursday that it granted conditional approval to an injection from the domestic drugmaker Platinum Life to treat patients aged 14 and above who suffer a rare disease called acute graft-versus-host disease and do not respond to regular steroid therapy.

Acute graft-versus-host disease, or aGVHD, typically hits patients who have just undergone a stem cell transplant due to severe blood condition. The disease is one of the primary reasons of death following transplantation.

The homegrown therapy is the first mesenchymal stromal cell treatment that has gained the greenlight on the Chinese mainland. The approval was issued through an accelerated market registration track designed for novel or urgently needed medicines.

Stem cell therapy utilizes the differentiation and self-renewal capacity of stem cells to repair tissues and treat diseases. It represents a booming research field being studied worldwide to treat a variety of illnesses, including diabetes, Parkinson's disease and cancer.

In China, the nation's first drug manufacturing license for stem cell treatment was issued in late May by the Beijing Municipal Medical Products Administration to Platinum Life.

Chen Jiekai, a researcher at Chinese Academy of Sciences' Guangzhou Institutes of Biomedicine and Health, said that the issue of the license constitutes a key step toward clinical applications of stem cell treatment and signals the establishment of a complete supervision procedure for this kind of novel therapy.

During an academic conference held in Guangzhou, Guangdong province in early December, he said that there are hundreds of clinical research projects on stem cell treatment across the nation, and a total of 141 hospitals have registered with a national medical research platform in preparation for carrying out stem cell clinical studies, local media reported.

Also on Thursday, China approved lenacapavir, a long-acting HIV drug made by global biopharmaceutical company Gilead Sciences, according to the administration and the company.

The treatment is approved to treat HIV patients who have multidrug resistance and cannot have their viral load effectively suppressed under available drug regimens.

It was first approved in Europe and the United States in 2022, and research is underway to test its potential in preventing infection.