Novartis and CBMG Announce Strategic Collaboration for In-Country Manufacturing and Supply of Kymriah® in China
Sep 27, 2018 23:46
CST Updated
23:46
AbelZeta
Developer of Immune Cell and Stem Cell Therapy Products
September 27, 2018NovartisThe Company and Cellular Biomedicine Group (CBMG) announced today a strategic licensing and collaboration agreement to manufacture CAR-T cell therapy drugs in China for Chinese patients.
⊕NovartisAcquired 1,458,257 shares of CBMG for $40 million, making an equity investment in the company at a share price of $27.43 per share.
⊕CBMG will authorizeNovartisThe Company utilizes its specific proprietary technologies on a global scale.
⊕CBMG to Manufacture and Supply Kymriah® (tisagenlecleucel) in China
CBMG will be responsible for the production and supply of the CAR-T cell therapy drug Kymriah® (tisagenlecleucel) in China.NovartisThe Company holds the exclusive rights to the marketing authorization for Kymriah® (tisagenlecleucel).
Following the execution of the licensing and collaboration agreement, CBMG—a company engaged in cancer immunotherapy and degenerative diseasesStem Cells/">Stem Cellsa biopharmaceutical company engaged in the clinical development of therapies—will sell approximately 9% of its equity to Novartis at a price of $27.43 per share, receiving $40 million in equity acquisition proceeds.NovartisThe Company will obtain royalty-free licenses for certain CBMG CAR-T-related technologies on a global basis.Intellectual Property. CBMG will receive tiered, single-digit percentage collaboration payments based on the net sales of the products, while CBMG will also receive fromNovartisThe company receives a markup on manufacturing costs. In the future, CBMG will be primarily responsible for the manufacturing process,NovartisThe Company holds the exclusive rights to the marketing authorization for Kymriah® and will be primarily responsible for distribution, product registration, and commercialization in China.
Cellular Biomedicine Group’s Liu Bizuo, “WithNovartis“This collaboration reflects our shared commitment to bringing Kymriah®, the marketed CAR-T cell therapy, to China, which has the largest patient population in need globally. Kymriah® is currently an innovative treatment approved in the United States, the European Union, and Canada for two hard-to-treat cancers,” said Liu Bizuo, CEO of CBMG. “We hope to work withNovartistogether with the company, we brought the first CAR-T cell therapy to Chinese patients. In addition, we continue to focus on developing CBMG’s series of immunotherapiesTumorassets."
NovartisTumorPascal Touchon, Senior Vice President of the Cell and Gene Therapy Division and Head of Global Business, “NovartisCommitted to serving patients with malignant hematologicTumor, bringing new treatment options and hope to pediatric and adult patients who currently have limited therapeutic alternatives. We are honored to collaborate with CBMG in China to enhance our Kymriah® manufacturing capabilities, with the aim of ensuring that more patients in need can smoothly access this innovative one-time therapy.”
About Kymriah
Kymriah is a CAR-T immune cell therapy developed by the University of Pennsylvania andNovartisa revolutionary immune cell therapy co-developed by the company. In August 2017, Kymriah was approved by the U.S. Food and Drug Administration (FDA) for official market approval.
May 2, 2018, United StatesFDAApprovedNovartisThe second indication for the CAR-T cell therapy drug Kymriah (tisagenlecleucel, CTL019) is for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who have received two or more prior lines of systemic therapy. This includes diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma, as well as high-grade B-cell lymphomas and DLBCL arising from follicular lymphoma (FL).
About Cellular Biomedicine Group
Cellular Biomedicine Group is primarily engaged in cancer immunotherapy and degenerative diseasesStem CellsA clinical-stage biopharmaceutical company focused on the development of stem cell therapies, its GMP-compliant facilities in China consist of 12 independent cell production lines, designed and managed in accordance with both Chinese and U.S. GMP standards. Currently, Cellular Biomedicine Group has collaborated with multiple enterprises in Shanghai, such as establishing the “Joint Laboratory for Cell Therapy” with GE Healthcare and the “Joint Center for Innovation and Application of Cell Therapy Technologies” with Thermo Fisher Scientific. Meanwhile, Cellular Biomedicine Group’s product pipeline includes preclinical candidates targeting CD20-, CD22-, and B-cell maturation antigen-specific CAR-T compounds, as well as T-cell receptor andTumorTumor-Infiltrating Lymphocyte Technology.
Editor's RecommendationMeeting2018 (4th) Next-Generation CAR & TCR-T Symposium
http://meeting.bioon.com/2018CAR-T/
⊕NovartisAcquired 1,458,257 shares of CBMG for $40 million, making an equity investment in the company at a share price of $27.43 per share.
⊕CBMG will authorizeNovartisThe Company utilizes its specific proprietary technologies on a global scale.
⊕CBMG to Manufacture and Supply Kymriah® (tisagenlecleucel) in China
CBMG will be responsible for the production and supply of the CAR-T cell therapy drug Kymriah® (tisagenlecleucel) in China.NovartisThe Company holds the exclusive rights to the marketing authorization for Kymriah® (tisagenlecleucel).
Following the execution of the licensing and collaboration agreement, CBMG—a company engaged in cancer immunotherapy and degenerative diseasesStem Cells/">Stem Cellsa biopharmaceutical company engaged in the clinical development of therapies—will sell approximately 9% of its equity to Novartis at a price of $27.43 per share, receiving $40 million in equity acquisition proceeds.NovartisThe Company will obtain royalty-free licenses for certain CBMG CAR-T-related technologies on a global basis.Intellectual Property. CBMG will receive tiered, single-digit percentage collaboration payments based on the net sales of the products, while CBMG will also receive fromNovartisThe company receives a markup on manufacturing costs. In the future, CBMG will be primarily responsible for the manufacturing process,NovartisThe Company holds the exclusive rights to the marketing authorization for Kymriah® and will be primarily responsible for distribution, product registration, and commercialization in China.
Cellular Biomedicine Group’s Liu Bizuo, “WithNovartis“This collaboration reflects our shared commitment to bringing Kymriah®, the marketed CAR-T cell therapy, to China, which has the largest patient population in need globally. Kymriah® is currently an innovative treatment approved in the United States, the European Union, and Canada for two hard-to-treat cancers,” said Liu Bizuo, CEO of CBMG. “We hope to work withNovartistogether with the company, we brought the first CAR-T cell therapy to Chinese patients. In addition, we continue to focus on developing CBMG’s series of immunotherapiesTumorassets."
NovartisTumorPascal Touchon, Senior Vice President of the Cell and Gene Therapy Division and Head of Global Business, “NovartisCommitted to serving patients with malignant hematologicTumor, bringing new treatment options and hope to pediatric and adult patients who currently have limited therapeutic alternatives. We are honored to collaborate with CBMG in China to enhance our Kymriah® manufacturing capabilities, with the aim of ensuring that more patients in need can smoothly access this innovative one-time therapy.”
About Kymriah
Kymriah is a CAR-T immune cell therapy developed by the University of Pennsylvania andNovartisa revolutionary immune cell therapy co-developed by the company. In August 2017, Kymriah was approved by the U.S. Food and Drug Administration (FDA) for official market approval.
May 2, 2018, United StatesFDAApprovedNovartisThe second indication for the CAR-T cell therapy drug Kymriah (tisagenlecleucel, CTL019) is for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who have received two or more prior lines of systemic therapy. This includes diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma, as well as high-grade B-cell lymphomas and DLBCL arising from follicular lymphoma (FL).
About Cellular Biomedicine Group
Cellular Biomedicine Group is primarily engaged in cancer immunotherapy and degenerative diseasesStem CellsA clinical-stage biopharmaceutical company focused on the development of stem cell therapies, its GMP-compliant facilities in China consist of 12 independent cell production lines, designed and managed in accordance with both Chinese and U.S. GMP standards. Currently, Cellular Biomedicine Group has collaborated with multiple enterprises in Shanghai, such as establishing the “Joint Laboratory for Cell Therapy” with GE Healthcare and the “Joint Center for Innovation and Application of Cell Therapy Technologies” with Thermo Fisher Scientific. Meanwhile, Cellular Biomedicine Group’s product pipeline includes preclinical candidates targeting CD20-, CD22-, and B-cell maturation antigen-specific CAR-T compounds, as well as T-cell receptor andTumorTumor-Infiltrating Lymphocyte Technology.
Editor's RecommendationMeeting2018 (4th) Next-Generation CAR & TCR-T Symposium
http://meeting.bioon.com/2018CAR-T/