Challenges in Commercialization and Market Leadership of CAR-T Cell Therapy in China

Pharnex Cloud Data (www.pharnexcloud.com)Display：As of now, the CAR-T cell therapy products approved in the Chinese market include Fosun Kite's Axicabtagene Ciloleucel Injection, Wuxi Jono's Relmacabtagene Autoleucel Injection, IASO Bio's Equecabtagene Autoleucel Injection (Innovent Biologics has become an 18% shareholder of IASO Bio, which holds all rights to this product), Hekang Bio's Nacibartagene Autoleucel Injection, CARsgen Therapeutics' Zevorcabtagene Autoleucel Injection (in collaboration with Huadong Medicine), and the most recently approved Legend Biotech’s Ciltacabtagene Autoleucel. (Three target CD19, three target BCMA)

Due to the high cost of drugs and limitations in indications, despite their significant efficacy, the vast majority of patients find them out of reach; currently, it mainly relies onPartial Commercial InsuranceAndInnovative PaymentImprove accessibility.

Pharnex Cloud Data (www.pharnexcloud.com)DisplayOn the evening of July 20, 2024, Fosun Pharmaceutical disclosed that its holding subsidiary, Fosun Pharmaceutical Industry, and Kite Pharma, the other shareholder of Fosun Kite, intend to convert their respective $28.5 million ongoing creditor's rights into equivalent new registered capital for a proportional increase in investment in Fosun Kite. After the completion of this capital increase, the shareholding percentages of Fosun Pharmaceutical Industry and Kite Pharma in Fosun Kite will remain unchanged (both still at 50%), and Fosun Kite will remain a joint venture of the Group. Fosun Kite is mainly engaged in the research and development, production, and commercialization of tumor immunotherapy cell treatment products. The proceeds from this capital increase will be mainly used for the commercialization of Fosun Kite’s products and investment in its R&D pipeline.

Fosun Kite Biotechnology Co., Ltd. is mainly engaged in the research and development, production, and commercialization of tumor immunotherapy cell treatment products. Its first CAT-T cell therapy product, Yikaida (Axicabtagene Ciloleucel Injection), 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 to be approved for marketing in China.

Two indications have been approved: - For the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after receiving two or more lines of systemic therapy; - For the treatment of adult patients with large B-cell lymphoma (r/r LBCL) who are ineffective with first-line immunochemotherapy or relapse 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) has been approved for clinical trials in China and included in the breakthrough therapy drug program. This indication is currently in the bridging clinical trial stage in China.

In addition, the first indication (for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/rMCL) who have received two or more prior lines of therapy) and the second indication (relapsed or refractory adult precursor B-cell acute lymphoblastic leukemia, adult r/r ALL) of FKC889, the second CAR-T cell therapy product developed by Fosun Kite, were approved to conduct clinical trials in China in 2022. As of the date of this announcement, both indications for FKC889 are currently in the bridging clinical trial phase in China.

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 987.28 million, owner's equity was RMB 161.16 million, and total liabilities were RMB 826.12 million.In 2023, Fosun Kite Biotechnology Co., Ltd. achieved operating revenue of RMB 242.54 million., Net profit RMB -353.25 million. (It is reported that,Fosun Kite is currently the largest CAR-T commercial product in China's pharmaceutical market.）

Kite Pharma, Inc. was established in June 2009 as a corporation formed under the laws of the State of Delaware, USA, with its registered address in Delaware, USA. As of the date of this announcement, Gilead Sciences, Inc. (hereinafter referred to as "Gilead Sciences") holds 100% of its equity. Gilead Sciences was founded in 1987, with its registered address in the United States, and was listed on NASDAQ in 1992. Gilead Sciences is a research-based biopharmaceutical company whose products and investigational drugs address therapeutic areas including HIV/AIDS, liver diseases, cancer, inflammation and respiratory diseases, as well as cardiovascular conditions. According to Gilead Sciences' published financial reports (on a consolidated basis), audited by Ernst & Young LLP, as of December 31, 2023, Gilead Sciences had total assets of $62,125 million, shareholders' equity of $22,749 million, and total liabilities of $39,376 million. In 2023, Gilead Sciences achieved total revenue of $27,116 million and net profit of $5,665 million.

Relevant company public disclosure;

Fosun Pharmaceutical;

https://www.fosunpharma.com/；

https://www.fosunpharma.com/investor/materials.html；

https://data.eastmoney.com/notices/detail/600196/AN202407191638102008.html；

Globocan 2022 World Fact Sheet:

https://cn.iasobio.com/info.php?id=302；

https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf. Accessed March 2024.

Etc.

This article is intended to provide scientific information to healthcare professionals only, and does not represent the platform's position or any medication recommendations.