Ten New Drugs Approved, Changing Medical History

According to the official announcement from the National Medical Products Administration (NMPA), Platinum Biotechnology (Beijing) Co., Ltd. has received conditional approval for its stem cell therapy "Aimi Mitosai," which is used to treat acute graft-versus-host disease (GVHD) in patients aged 14 and older, primarily affecting the digestive tract and resistant to hormone therapy. This therapy has become the first approved stem cell therapy in China.

In addition, AstraZeneca's new indication application for Osimertinib has also been officially approved. This drug will be used to treat adult patients with locally advanced unresectable (stage III) non-small cell lung cancer (NSCLC) who have not shown disease progression after receiving platinum-based radical chemoradiotherapy and have epidermal growth factor receptor (EGFR) exon 19 deletion (Ex19del) or exon 21 (L858R) substitution mutations.

The NMPA also announced the approval of the marketing applications for Lanapavir tablets and injections submitted by Gilead Sciences. Lanapavir is an HIV-1 capsid inhibitor that will provide a new treatment option for HIV-infected individuals who do not respond effectively to existing therapies, requiring administration only twice a year. This drug has previously been approved in the EU, the U.S., and other regions.

Johnson & Johnson's innovative compound drug "Maxiten" has been submitted for marketing approval in China for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare progressive and life-threatening vascular disease characterized by the constriction of small pulmonary arteries and increased pulmonary circulation pressure, which may eventually lead to right heart failure. Multiple drugs have been approved for the treatment of PAH.

GlaxoSmithKline (GSK)'s depemokimab has also been submitted for marketing approval in China. Based on the progress of clinical trials, the expected indication is for severe eosinophilic asthma (SEA). Depemokimab is a new generation anti-IL-5 monoclonal antibody developed by GSK, featuring a longer half-life, high binding affinity, and potency, requiring only one injection every six months.

Innovent Biologics' next-generation ROS1 tyrosine kinase inhibitor (TKI) Dabrutinib's second New Drug Application (NDA) has also been approved by the NMPA for the treatment of adult patients with ROS1-positive locally advanced or metastatic NSCLC. This approval is based on positive results from the Phase II clinical study TRUST-I (NCT04395677).