CFDA Policies Won't Affect Fosun Pharma's Plan to Bring Overseas CAR-T Therapies to China, CEO Says
(Yicai Global) Sept. 12 -- Shanghai Fosun Pharmaceutical Group Co. [SHA:600196] does not expect government policy to hinder its introduction of foreign biological cellular immune (CAR-T) therapies to China, online media outlet The Paper reported, quoting Wu Yifang, chief executive.>
"The China Food and Drug Admintration gradually formulating and perfecting policies on approval for cellular immune therapies, and I think it well prepared," he said in a press briefing.
Companies bringing in CAR-T therapy from abroad will not be obstructed by regulation, Wu added. "We have had at least two dcussions with the CFDA, who has given clear replies to our questions on many key points regarding approval," he said.
Fosun has already been working with Kite Pharma [NASDAQ:KITE], a leading company in the CAR-T sector, and will focus on bringing the latter's KET-C19 products and technologies to China.
The US FDA approved the sales of KTE-C19 in March th year, for use in the treatment of lymphoma.
Fosun Pharma and Kite Pharma set up a joint venture in April 2017 named Fosun Kite Biotechnology Co., which committed to bringing biological cellular immune therapies to China.