Novartis has paid $40 million for a 9% stake in Cellular Biomedicine Group (CBMG), a Shanghai-based firm which will manufacture CAR-T cell therapy Kymriah for the China market.
Under terms of the deal, CBMG will take responsibility for the manufacture of the chimeric antigen receptor (CAR) T-cell therapy Kymriah (tisagenlecleucel) from its facility in Shanghai, China, on behalf of Novartis entity Beijing Novartis Pharma for supply in China.
“Aligned with our global supply and regulatory strategy, Novartis actively has been pursuing options for additional manufacturing capacity to help meet global demand for Kymriah,” Julie Masow, a spokesperson from the Swiss pharma giant told BioProcess Insider.
“CBMG came to our attention as we were looking for a collaborator that would be capable of helping us to manufacture and supply Kymriah to patients in China, as local regulations require that the product be manufactured in China.”
Previously, Chinese drug firms were not allowed to resort to contract manufacturing organizations (CMOs), so relied almost entirely on overseas manufacturers. But in 2015, the Chinese government implemented the marketing authorization holder (MAH) system completely rewriting regulations governing the way that pharmaceuticals, are manufactured, researched, clinically developed, and reviewed. While these continue to evolve, they demand biopharmaceutical CMOs to operate locally.
“This partnership is essential to addressing the needs of patients in China as part of our mission to progressively implement access to Kymriah to patients around the world,” said Masow.
Novartis has invested $40 million (€35 million) in CBMG, gaining approximately a 9% stake of the company, she added.
‘More than a Chinese manufacturing company’
According to Tony Liu, CEO of CBMG, his firm has its own in-house developed and in-licensed technologies with robust operations in China, and “is more than a Chinese manufacturing company.”
He told us: “CBMG has ample production capacity to support Kymriah and simultaneous clinical trials for our own cell therapy products. Our Shanghai facility, built in 2017, will be the one making Kymriah in China.
The Shanghai facility includes a ‘Joint Laboratory of Cell Therapy’ with GE Healthcare and a ‘Joint Cell Therapy Technology Innovation and Application Center’ with Thermo Fisher Scientific,” he continued, adding the “partnerships focus on improving manufacturing processes for cell therapies.”
Novartis Kymriah network
The Shanghai facility is the latest part of Novartis’ global CAR T manufacturing network.
The Swiss firm makes Kymriah inhouse from its Morris Plain, New Jersey facility, a 16,000m2 plant acquired from Dendreon Corporation for $43 million in December 2012.
But since Kymriah’s approval in August 2016, the firm has looked to secure supply of the product across the globe.
Novartis inked a deal in July with French contract development and manufacturing organization (CDMOs) CELLforCURE, has manufacturing capacity at the Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) facility in Leipzig, Germany, and has procured the services of a CDMO in Japan.
And in August, the firm laid down plans for a new cell and gene therapy production facility in Stein, Switzerland at a cost of approximately CHF 90 million (US$92 million).