(Yicai Global) Jan. 3 -- China's food and drug regulator, the China Food and Drug Administration, has accepted an application by Anhui-based biopharmaceutical company Anke Biotechnology (Group) Co. [SHE:300009] to conduct clinical trials of chimeric antigen receptor-T (CAR-T) therapies. Five Chinese firms applied to test CAR-T therapies last month as China edges ahead of Europe in the field.
CAR-T is a type of advanced cellular immunotherapy that is very effective in treating diseases such as leukemia, lymphoma and myeloma. Chinese companies lead the world in CAR-T clinical research and have carried out 135 relevant research projects, surpassing Europe and behind only the US in terms of the number of CAR-T projects registered, the Shanghai Securities News reported today.
The US approved the use of two CAR-T products in August and October last year, which are the only available CAR-T products in the world. China has accelerated its approval of clinical trials of such therapies. From Dec. 8, 2017, until now, five companies including Anhui Anke Biotechnology, Galaxy Biomedical Investment Co. [SHE:000806] and Shanghai Runda Medical Technology Co. [SHA:603108] have had their applications accepted.
Many more Chinese firms are carrying out research on CAR-T therapies and are on course to apply to conduct trials this year. Leading drugmaker Shanghai Fosun Pharmaceutical (Group) [SHA:600196] has set up a joint venture with Kite Pharma Inc. [NASDAQ:KITE], which develops one of the two US-approved CAR-T products.
A course of treatment with CAR-T therapies costs CNY400,000 (USD61,528) to CNY500,000, meaning China's CAR-T therapy market is worth about CNY18.5 billion, insiders said.