On February 24, Fosun Pharmaceutical issued an announcement stating that the marketing application (CXSS2000006) for Yikaililunsai Injection, a CAR-T product of Fosun Kite, has been accepted by the National Medical Products Administration. The product is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), not otherwise specified; primary mediastinal B-cell lymphoma (PMBCL); high-grade B-cell lymphoma; and DLBCL transformed from follicular lymphoma.
Product Name: Yijililunsai Injection (proposed) (Code FKC876, Anti-human CD19 CAR-T Cell Injection)
Acceptance No.: CXSS2000006 (National)
Application Items: New Drug Application: Special Approval Procedure; Additional Application Items: Others
Applicant: Fosun Kite
Conclusion: Accepted
Yikaililunsai Injection is the anti-human CD19 CAR-T cell injection (brand name Yescarta) from Kite Pharma, a subsidiary of Gilead Sciences. In October 2017, Yescarta received FDA approval for marketing, becoming the first CAR-T cell therapy approved by the FDA for specific types of non-Hodgkin lymphoma. In August 2018, Yescarta was approved for marketing in the European Union.
Fosun Kite Biotechnology Co., Ltd. licensed Yescarta from Kite Pharma, obtaining the technology and commercialization rights for mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region, and plans to localize production within China (excluding Hong Kong, Macao, and Taiwan, hereinafter referred to as "mainland China"). In August 2018, the product received approval for clinical trials from the National Medical Products Administration. As of the date of this announcement, the product has completed the bridging clinical trials in mainland China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.
Another globally approved CAR-T cell immunotherapy product is Novartis’s Kymriah, which also targets CD19. It is primarily indicated for the treatment of acute lymphoblastic leukemia in children and young adults (aged 2 to 25 years) and relapsed/refractory large B-cell lymphoma in adults (including diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma). In 2019, the global sales of Yescarta and Kymriah were approximately USD 456 million and USD 278 million, respectively.
As of January 2020, Fosun Kite’s cumulative R&D investment in this product at the current stage amounted to approximately RMB 474 million (including patent and technology licensing fees, unaudited).