On September 27, 2018, Cellular Biomedicine Group Inc. (NASDAQ: CBMG) announced it entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® in China.
Kymriah’s Approval History and Geographic Spread
CAR-T is a type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the power to easily recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as living drugs.
Last year, Novartis made history by becoming the first company to bring a CAR-T cell therapy (Kymriah) to market in the United States. Kymriah was approved by U.S. FDA in August 2017 for use in children and adults with ALL. The second CAR-T product, Yescarta by Kite Pharmaceuticals, was approved by FDA in October 2017 for patients with lymphoma.
On May 1, 2018, FDA approved Kymriah for a second indication, diffuse large B-cell lymphoma. In August 2018, both Kymriah (and Yescarta) secured approval in Europe, indicating the willingness of European regulators to usher in a new class of cellular immunotherapies.
In September 2018, Health Canada approved Kymriah as the first CAR-T therapy to receive regulatory approval in Canada. Clearly, there is regulatory momentum supporting the global spread of novel CAR-T cell therapies.
Novartis and Cellular Biomedicine Group (CBMG)
Cellular Biomedicine Group (CBMG) is a leading immuno-oncology company that is conducting immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Its lab is designed and managed according to both China and U.S. GMP standards.
This latest strategic licensing and collaboration agreement between the Novartis and Cellular Biomedicine Group is significant, because it is extending Novartis’ reach into a massive new healthcare market. With China’s current population of 1.39 billion, the country contains almost one-fifth (18.2%) of the total global population of 7.65 billion.
It also allows Novartis to outsource its manufacturing of Kymriah within China.
As stated by Tony Liu, Chief Executive Officer, CBMG:
“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. Together with Novartis, we hope to bring the first CAR-T cell therapy to patients in China. In addition, we continue to focus on developing CBMG’s pipeline of immuno-oncology assets.”
As stated by Pascal Touchon, Senior VP and Global Head, Cell & Gene, Novartis Oncology:
“Novartis is committed to bringing new hope to children and adults who are suffering from aggressive forms of blood cancer and currently have limited therapeutic options. We are proud to collaborate with CBMG in China to expand our Kymriah manufacturing capabilities and the potential to facilitate safe and seamless delivery of this innovative, one-time treatment to patients in need.”
Previously, on July 10, 2018, Novartis had signed an agreement to have CELLforCURE manufacture CAR-T products for it in Europe. CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne).
Learn More Novartis and CBMG
To learn more about the strategic licensing and collaboration agreement between the Novartis and CBMG, see the press announcement here.
What impact do you think this partnership will have on the companies involved and global CAR-T market at large? Share your thoughts in the comments.