China's top drug regulatory body has granted approval to the country's inaugural stem cell therapy aimed at addressing complications related to bone marrow transplants and a new HIV medication that needs just two injections per year. The National Medical Products Administration revealed on Thursday that it has conditionally approved an injection developed by Platinum Life, intended for individuals aged 14 and above suffering from acute graft-versus-host disease (aGVHD), particularly those who do not respond to conventional steroid treatments.

Acute graft-versus-host disease is a serious condition that generally affects patients post-stem cell transplant due to significant blood disorders and is a leading cause of mortality associated with such procedures. The recently sanctioned therapy is noteworthy as it is the first mesenchymal stromal cell treatment to receive official approval in mainland China, and it was approved through an expedited registration pathway meant for essential innovative medicines.

Stem cell therapy harnesses the unique properties of stem cells, such as their ability to differentiate and self-renew, enabling them to repair tissues and treat various diseases. This field of research is rapidly expanding globally, with applications being explored for conditions like diabetes, Parkinson's disease, and cancer. Earlier this year in May, Platinum Life received the first drug manufacturing license for a stem cell treatment from the Beijing Municipal Medical Products Administration, representing a significant step towards formal clinical applications and the establishment of a robust regulatory framework for these therapies.

At an academic conference held in early December in Guangzhou, researcher Chen Jiekai from the Chinese Academy of Sciences emphasized the substantial progress in the field, noting that there are numerous clinical research initiatives on stem cell treatments throughout the nation. He reported that 141 hospitals have registered with a national medical research platform to prepare for conducting clinical studies involving stem cells.

On the same day, China also approved lenacapavir, a long-acting HIV medication produced by Gilead Sciences, which is specifically designed for HIV patients with multidrug resistance and those who struggle to manage their viral load with existing treatments. This medication received prior approval in Europe and the United States in 2022, and there are ongoing studies investigating its potential for preventing HIV infection.