Shanghai Fosun Pharmaceutical (Group) Co Ltd (Fosun Pharma) did a joint venture with US-based Kite Pharma Inc to develop and commercialize autologous T-cell therapies to treat cancer.
Dubbed “Fosun Pharma Kite Biotechnology Co Ltd”, the 50/50 owned joint venture will be Based in Shanghai to develop, manufacture and commercialize axicabtagene ciloleucel (KTE-C19) in China with the option to include additional products, such as two T cell receptor (TCR) product candidates from Kite.
KTE-C19 is Kite’s lead product candidate, an investigational chimeric antigen receptor (CAR) T-cell therapy under development for the treatment of B-cell lymphomas and leukemias.
Kite Pharma will receive upfront payment of $40 million, milestone payments, profit share and sales royalties upon commercialization of KTE-C19 in China, and will provide certain technical transfer services to the joint venture.
Fosun Pharma, for its part, will provide $20 million in initial funding to support clinical development and manufacturing activities of the new entity.
Each party will share in any profits from the joint venture with Kite Pharma receiving 40 per cent and Fosun Pharma receiving 60 per cent.
Fosun Pharma chairman Qiyu Chen said the partnership with a global industry leader in CAR-T and TCR therapy such as Kite, is an important and strategic step to build a long-term foundation for T cell therapy in China.
“This partnership, which leverages each company’s respective strengths, will help us bring novel cancer treatments to patients in need,” Qiyu said.
Kite Pharma chairman and president Arie Belldegrun, M.D., said the joint venture will allow them to access a critically important market and meet a major objective of expanding global reach.
“We are committed to bring engineered T-cell therapy to patients in China who are suffering from cancer,” Belldegrun said. “Fosun Pharma is an innovator and market-maker, which makes them an ideal partner to develop and commercialize axicabtagene ciloleucel in China. Together, we look forward to addressing significant unmet need in China.”
The joint venture will also have the option to license additional product candidates including KITE-439, a TCR therapy directed against the human papillomavirus type 16 E7 oncoprotein and KITE-718, a TCR therapy directed against MAGE A3 and MAGE A6, antigens frequently found in solid tumors including bladder, esophageal, head and neck, lung and ovarian cancers. Opt-in and milestone payments for KITE-439 and KITE-718 could total $140 million plus profit sharing and mid-single digit sales royalties.
Kite Pharma noted China is the second largest pharmaceutical market in the world after the US. With increasing incidence and mortality, cancer is the leading cause of death in China with over four million new cases per year.
According to recent estimates, there are approximately 73,000 newly diagnosed cases of non-Hodgkin lymphoma (NHL) in China each year.
Kite announced in December 2016 that it has initiated the rolling submission to the US Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with refractory aggressive B-cell NHL.