Shanghai’s Pudong skyline, June 2012
A Shanghai-based cell therapy manufacturer will produce Swiss drugmaker Novartis’ CAR-T therapy for the Chinese market.
Cellular Biomedicine Group, also known as CBMG, said Thursday that it had entered a licensing and collaboration deal with Novartis to manufacture Kymriah (tisagenlecleucel) in China, with Novartis acting as exclusive holder of the marketing license.
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In exchange, Novartis will make a $40 million equity investment in CBMG, which also has operations in Cupertino, California, for more than 1.45 million shares, while licensing some of the Chinese company’s technology for global use. The equity investment equals about 9 percent of the company.
“This collaboration with Novartis reflects our shared commitment to bringing the first marketed CAR-T cell therapy, Kymriah, a transformative treatment option currently approved in the United States, European Union and Canada for two difficult-to-treat cancers, to China, where the number of patients in need remains the highest in the world,” CBMG CEO Tony Liu said in a statement.
Kymriah became the first-ever CAR-T therapy to win regulatory approval last August, when the Food and Drug Administration approved it for treating relapsed and refractory acute lymphoblastic leukemia in pediatric patients. Earlier this year, it also won approval for diffuse large B-cell lymphoma in adults. Another CAR-T therapy, Gilead Sciences’ Yescarta (axicabtagene ciloleucel), was approved for DLBCL last October, shortly before Gilead announced its acquisition of the product’s original developer, Kite Pharma, for $11.9 billion.
Kite Pharma formed a joint venture in January 2017 with Shanghai-based Fosun Pharma to manufacture Yescarta there, and Fosun announced initiation of manufacturing in December.
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However, neither Kymriah nor Yescarta is approved in China. Meanwhile, both CAR-Ts face significant competition in the Chinese market, as numerous companies around the country have been developing products of their own. Searches for currently recruiting or active “CAR-T” or “chimeric antigen receptor” trials in China turned up 159 and 121 results, respectively. When “CD19” – the cell-surface antigen that Kymriah and Yescarta target – was added to the search terms, the respectively 77 and 61 trials came up.
Still, shortly after the announcement of the Kite-Fosun joint venture last year, a series of articles in BioPharm Insight reported that Western CAR-T manufacturers eyeing the Chinese market would likely face pressures around pricing and see their therapies – with their complex logistics and administration – restricted to wealthier, urban regions. At the same time, it was reported, Western CAR-Ts would likely carry a cachet among Chinese consumers that their homegrown products would not. Kymriah’s list price in the US is $475,000 for pediatric ALL and $373,000 for DLBCL, the latter of which is the same as Yescarta’s DLBCL list price.
Photo: Alaric DeArment, MedCity News
