China Market Approval Tracker: Feb 2021

Writer: Minhua Chu

Editor: Justin Fischer

Six new molecular entities (NME) received market approval in China in Feburary 2021, including three COVID-19 vaccines developed by Chinese companies.

Gilteritinib, a new oral drug for acute myelod leukemia (AML) therapy, was granted conditional market authorization by China’s National Medical Products Administration (NMPA). It was developed by Japanese pharmaceutical company Astellas and was approved as a therapy for relapsed or refractory AML adult patients carrying FLT3 mutations.

AML patients with FLT3 mutation often have a very poor prognosis, with the median survival of less than six months after salvage chemotherapy. Moreover, the status of FLT3 mutations may change during AML treatment or even after relapse. As FMS-like tyrosine kinase 3 (FLT3), gilteritinib has shown significant inhibition of two common FLT3 mutations - FLT3-ITD and FLT3-TKD, which is found in approximately one third of AML patients.

Before the new leukemia drug was launched in China on December 16, Astellas had already reached a cooperation agreement with Chinese company Baheal on the import and distribution of the drug. In the near future, the drug can enter China directly from Japan via air or sea through the port of Qingdao.

Bristol-Myers Squibb's (BMS) subsidiary Celegene submitted a marketing application for Luspatercept for Injection in China. It was accepted by the Center for Drug Evaluation (CDE) under NMPA. The drug is a red blood cell maturation agent for beta-thalassemia adult patients who require regular red blood cell (RBC) infusions.

According to BMS, Luspatercept is the company's first innovative hematology drug to be granted a priority review designation following the submission of offshore clinical trial data to the China CDE.

Also, Junshi Biosciences (HK: 1877; SH: 688180) submitted an application to extend the labels of its only marketed product, anti-PD-1 antibody toripalimab, to first-line NSCLC and stage III nasopharyngeal carcinoma (NPC). This is the first application of PD-1 antibodies for NPC indication.