Writer: Yingzi Shi
Editor: Justin Fischer
On June 22, NMPA green-lighted Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory large B cell lymphoma. This is the first drug approved for cell therapy in China.
The autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy was manufactured in China by Fosun Kite Biotechnology, a joint venture between Kite Pharma (now a subsidiary of Gilead Sciences) and its China market partner Fosun Pharmaceutical.
Fosun Kite Biotech was founded in 2017 in Shanghai, aiming to develop immune cell therapy products. Yescarta is its first commercialized product.
The FDA approved Yescarta for treating adults with certain types of large B-cell lymphoma in the US in October 2017，the first approval for this product globally. Nearly a year later in August 2018, the treatment also got a nod from the EMA.
Fosun, a major Chinese pharmaceutical company，seized the window of opportunity to sign the agreement. Kite's stock price subsequently soared upon publication of Yescarta's clinical trial results and FDA approval.
From in-licensing to approval, it only took four years and two months. Fosun Kite submitted a BLA to the NMPA in February 2020. The company conducted a single-arm, open-label, multi-center bridging trial (FKC876-2018-001) to evaluate the efficacy and safety of FKC876 in 24 Chinese patients with refractory intermediate invasive non-Hodgkin's lymphoma (NHL)/ large B-cell lymphoma (Details in Figure 1).
Figure 1. The history of FKC876 development
“This case will greatly boost the confidence in China's cell therapy industry,” Richard Wang, founder and former president of Fosun Kite said. “Based on this benchmark，the regulatory review of other cell therapies will be accelerated in the future.”
Since 2017, the CDE has been issuing technical guidelines for the research, evaluation and clinical trials of cell therapy products.
In this review, China’s CDE focused on how companies can ensure product quality from sample collection to transfusion. Some of the concerns are not common to other drugs, such as bacterial contamination, cross-contamination, production continuity and responsibility for monitoring the whole process from sampling to use.
The new challenge has become how cell therapies will be paid for. There are also WJ Therapeutics and other more than 20 CD19-directed CAR-T being developed in China. In addition, Legend’s BCMA-directed CAR-T therapy for myeloma is expected to be launched in America this year.
The cost of Yescarta, as reported by the manufacturer, is $373,000 per treatment regimen in America. And it has been estimated to reach 1 million RMB in China. Cost-sharing is an obvious barrier to such a product realizing successful commercialization
Huang Hai, the new CEO of Fosun Kite said, “ the company is dedicated to reducing payment burdens through patient assistance programs (PAPs), innovative payment models, and commercial insurance.
New technologies may also increase accessibility. After NMPA approval, Richard Wang started a new company, Neukio, to develop an allogeneic chimeric antigen receptor NK cell therapy (allogeneic CAR-NK) for solid tumors. He believes that within 5 years, cell therapy will no longer be limited to autologous CAR-T or two targets of CD19 and BCMA. There should be a variety of different types of cells in clinical studies and application.