A historic approval for Fosun-Kite’s CAR-T therapy Yescarta in China looks set to pave the way for further developments in the Chinese cell and gene therapy space, as multinationals look to bring their new therapies to the rapidly expanding China market


Yescarta, originally approved in the US in 2017 and in Europe in 2018, is indicated for patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of prior treatment, represents a historic first approval. There were an estimated 88,090 newly diagnosed non-Hodkin lymphoma patients in China in 2018, around one third of which may be eligible for treatment with Yescarta if original lines of treatment have failed.


CAR-T therapies like Yescarta and Novartis’ Kymriah work by taking a sample of a patient’s T cells from their blood, then modifying them to produce chimeric antigen receptors (CARs) on their surface. When these CAR-T cells are reinfused into the patient, the new receptors enable them to latch onto a specific antigen on the patient’s tumour cells and kill them.


While these drugs may represent a one-time ‘cure’ for certain cancers, their pricing has been controversial and has run into the hundreds of thousands in some geographies. Analysts will be watching carefully to see how Yescarta is priced in China; a decision that could have wide-ranging ramifications for the entire field in the country.


The existence of the Fosun-Kite joint venture predates even Yescarta’s US FDA nod, highlighting that this first approval was a long time coming. Representatives from the two firms were keen to play up the historic significance of this recent development.


MEI Jingping, chairwoman of Fosun-Kite, said that “this approval brings a revolutionary treatment option to cancer patients in China,” while Terence O’Sullivan, Kite’s international region VP added that, “In relapsed or refractory LBCL, current standard-of-care is associated with poor long-term outcomes, so we are pleased to offer this new hope of survival for patients in China who are in need of new therapeutic options.”


Dr MA Jun, of the Harbin Institute of Hematology & Oncology and Chinese Society of Clinical Oncology, noted that “this approval shows China’s innovation to establish new review guidelines and standards for cell therapies, and determination to bring in world-leading technologies and medicines to benefit cancer patients in China.”


While a China approval spells good news for Kite’s parent company Gilead in terms of sales potential, the firm still has a long way to go to recoup the USD 12 billion it spent on acquiring the drug in the first place. Gilead’s cell therapy product sales, including both Yescarta and Tecartus (for mantle cell lymphoma) increased 33 percent to USD 607 million for the full year 2020, compared to the same period in 2019, driven primarily by the continued uptake of Yescarta in Europe and the third quarter 2020 product launch of Tecartus in the United States.