Two Million-Dollar CAR-T Therapies Make Third Attempt to Enter China's National Reimbursement Drug List

　　【Pharmaceutical Network Product InformationCAR-T therapy is a novel precision-targeted treatment for tumors. In recent years, through optimization and improvement, it has achieved excellent results in clinical tumor treatment. It is a very promising new tumor immunotherapy method that can precisely, quickly, and efficiently treat cancer, and potentially cure it. So far, six CAR-T cell therapies have been approved for marketing in China: Cilta-cel Injection by Legend Biotech, Axicabtagene Ciloleucel Injection by Fosun Kite Biotechnology Co., Ltd., Relma-cel Injection by JW Therapeutics, Idecabtagene Vicleucel Injection by IASO Biotherapeutics, Nacibotamab Autoleucel Injection by Hekang Bio, and Zevor-cel Injection by CARsgen Therapeutics, Ltd. These products offer new treatment options for cancer patients, but their prices are generally in the millions of yuan, making them unaffordable for most patient families. How to improve accessibility and affordability remains a challenge that both companies and patients are concerned about.
 

CAR-T Therapy Entering National Medical Insurance Catalogue Highly Anticipated. According to the announcement published by the National Healthcare Security Administration on August 27 regarding the list of drugs that passed the formal review for the adjustment of the 2024 National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalogue, four CAR-T products passed the preliminary formal review this year: Axicabtagene Ciloleucel Injection from Fosun Kite Biotechnology Co., Ltd., Relmacabtagene Autoleucel Injection from JW Therapeutics, Naxibcabtagene Autoleucel Injection from Hekang Biotech, and Zevocabtagene Autoleucel Injection from CARsgen Therapeutics, Ltd. The prices of these four products are 1.2 million RMB per injection, 1.29 million RMB per injection, 1.166 million RMB per injection, and 999,000 RMB per injection, respectively.
 

It is worth mentioning that the Axicabtagene Ciloleucel Injection from Fosun Kite Biotechnology Co., Ltd. and the Relmacabtagene Autoleucel Injection from WuXi Jumo have passed the preliminary review for the third time, indicating the significant challenge faced by the million-dollar-per-dose CAR-T products in their bid to be included in China's medical insurance system.
 

Staff members of Fosun Kite have also admitted that the company actively prepares for negotiations every year. However, due to the significant difficulty in reducing the price of CAR-T drugs, it remains challenging to include them in medical insurance.
 

From the sales situation of the six domestically produced CAR-T therapies approved in China, Fosun Kite's Axicabtagene Ciloleucel Injection (brand name: Yikaida), a joint venture of Fosun Pharma, is the first CAR-T cell therapy product to be approved for marketing in China and has already received approval for two indications. In its 2023 annual report, Fosun Pharma mentioned that by the end of the reporting period, Axicabtagene Ciloleucel Injection (brand name: Yikaida) had benefited more than 600 lymphoma patients, been included in over 100 municipal惠民insurance plans and more than 75 commercial insurance programs, with registered treatment centers covering more than 25 provinces and cities across China, totaling over 160 institutions. In its 2024 half-year report, it disclosed that by the end of June this year, the drug had been incorporated into more than 110 municipal惠民insurance plans and over 80 commercial insurance programs, with registered treatment centers covering more than 28 provinces and cities across China, totaling over 170 institutions.
 

CARsgen Therapeutics' Zevor-cel Injection is the fifth CAR-T therapy approved in China. In terms of commercialization, CARsgen Therapeutics has chosen Huadong Medicine as its partner. According to CARsgen Therapeutics' semi-annual report, as of July 31, 2024, the drug has been included in nearly 20 provincial or municipal惠民保 (inclusive insurance) and commercial insurance plans. Medical institutions that have completed certification and registration cover 19 provinces and cities in China, with over 100 institutions in total. A total of 52 orders have been received from Huadong Medicine.
 

Moreover, Legend Biotech's CAR-T therapy has not yet been sold in China, but its performance overseas is remarkable. According to the 2024 half-year report of Legend Biotech's partner Johnson & Johnson, the drug's sales reached $343 million, approximately 2.5 billion yuan RMB, representing an 81.5% year-on-year increase. In 2023, the drug's total sales reached $500 million.
 

The industry is paying close attention to whether CAR-T therapy can be included in medical insurance this year. If the payment issue for such drugs can be resolved, it is believed to greatly boost the product's market expansion.
 

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