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On September 13, 2024, Fosun Pharmaceutical announced that its holding subsidiary, Fosun Pharmaceutical IndustryProposed cash investment of US$27 million to acquire 50% equity interest in Fosun Kite held by Kite PharmaUpon the completion of this transfer, Fosun Pharmaceutical will hold 100% of the equity in Fosun Kite and plans to make a cash contribution of US$10 million or an equivalent amount in RMB as the sole shareholder to increase the capital of Fosun Kite.
Revised License AgreementOn the same day as the signing of the "Equity Transfer Agreement," Fosun Kite and Kite Pharma comprehensively amended and restated the original license agreement, resulting in the "Amended and Restated License Agreement." Accordingly,Fosun Kite has obtained the exclusive rights from Kite Pharma to develop, manufacture, and commercialize Yikaida and Brexu-Cel (FKC889, a research project by Fosun Kite) within the region (mainland China, Hong Kong, and Macao) and the field (cancer treatment).。The announcement shows that Fosun Kite should pay Kite Pharma a total of US$10 million in milestone payments for this license. Depending on the achievement of annual net sales of the licensed products, Fosun Kite should pay Kite Pharma up to US$25 million in sales milestones as agreed. Fosun Kite should pay Kite Pharma royalties at varying rates ranging from 7% to 13% on the annual net sales of all licensed products within the licensed territory.In addition, Fosun Pharmaceutical's wholly-owned subsidiary, Fosun KiteProposed name change to Fosun Kite, and will serve as the core platform for Fosun Pharmaceutical's cell therapy technology, continuing to focus on the field of tumor immunotherapy. It aims to promote CAR-T cell therapy products to benefit more patients and meet unmet clinical needs. In the future, Fosun Pharmaceutical and Kite Pharma will maintain a long-term strategic partnership through a licensing cooperation model.Wu Yifang, Chairman of Fosun Pharmaceutical, stated："Since establishing a strategic partnership with Kite Pharma in 2017, the two parties have worked closely together to promote the rapid development of CAR-T technology and the cell therapy product Yikaida in China. Fosun Pharmaceutical remains firmly optimistic about the future of cell therapy and continues to advance the construction of world-leading technology platforms.In the future, we will further expand the application of cell therapy in fields such as oncology and autoimmune diseases, focusing on unmet clinical needs, fulfilling our commitment to patients, and allowing the fruits of technological innovation to benefit more patients.”Main Products of Fosun KiteFosun Kite is mainly engaged in the research and development, production, and commercialization of cell therapy products.Its first CAR-T cell therapy productYikaida (Axicabtagene Ciloleucel Injection)A CAR-T cell therapy product that Fosun Kite has localized for production and sales in China, based on the technology transfer of Yescarta, which was introduced from Kite Pharma.Yescarta, a CD19-targeted CAR-T cell therapy product independently developed by Kite Pharma, was approved for marketing by the U.S. FDA in October 2017.Yikaida was approved for marketing in China (excluding Hong Kong, Macao, and Taiwan regions, hereinafter the same) in June 2021.Becoming the first CAR-T cell therapy product approved for marketing in ChinaAs of the date of this announcement, the approved indications include: (1) the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who have received two or more lines of systemic therapy; (2) the treatment of adult patients with r/r LBCL that is either refractory to first-line immunochemotherapy or relapses within 12 months after first-line immunochemotherapy; its third indication (for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL), including adult patients with follicular lymphoma and marginal zone lymphoma) is currently in the bridging clinical trial phase in China and has been included in the breakthrough therapy drug program.In addition, Fosun Kite'sThe Second CAR-T Cell Therapy Product FKC889It is based on the technology transfer and development of Brexu-Cel. Brexu-Cel is a CAR-T cell therapy product targeting CD19 independently developed by Kite Pharma. It was approved for marketing by the U.S. FDA in July 2020 and by the European EMA in December 2020, under the trade name "Tecartus".FKC889The first indication (for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have received at least two prior lines of therapy) and the second indication (relapsed or refractory adult precursor B-cell acute lymphoblastic leukemia, adult r/r ALL) were approved to conduct clinical trials in China in 2022, respectively; as of the date of this announcement, these indications are in the bridging clinical trial stage in China.
Financial Status of Fosun KiteAccording to the management report of Fosun Kite (unaudited), as of July 31, 2024, Fosun Kite's total assets amounted to RMB 931 million, owner's equity was RMB 369 million, and total liabilities were RMB 562 million.From January to July 2024, Fosun Kite Biotechnology Co., Ltd. achieved operating revenue of RMB 189 million and a net profit of RMB -193 million.As audited by the Shanghai branch of Ernst & Young Hua Ming LLP (Special General Partnership), as of December 31, 2023, Fosun Kite's total assets amounted to RMB 987 million, owner's equity was RMB 161 million, and total liabilities were RMB 826 million. In 2023, Fosun Kite achieved operating revenue of RMB 242 million and a net profit of RMB -353 million.CAR-T Products in China and AbroadAs of the date of this announcement, except for Yikai Da (Axicabtagene Ciloleucel Injection) from Fosun Kite, the other CAR-T cell therapy products approved for marketing in China are as follows:
As of the date of this announcement, in addition to the aforementioned products, the CAR-T cell therapy products approved for marketing worldwide also include:
Reference: Company Announcement
