Four Domestic CAR-T Therapies Pass Preliminary Review for China's 2024 National Reimbursement Drug List

　　【Pharmaceutical Network Industry Dynamics] This year, the National Healthcare Security Administration conducted a preliminary formal review of the 2024 National Healthcare Security Drug Catalog. According to the public announcement, a total of 440 drugs passed the preliminary formal review, including four CAR-T products.
 

These four CAR-T products that passed the preliminary formal review are Fosun Kite's Axicabtagene Ciloleucel Injection, JW Therapeutics' Relmacabtagene Autoleucel Injection, Hekang Biotech's Naxicabtagene Autoleucel Injection, and Carsgen Therapeutics/Huadong Medicine's Zevorcabtagene Autoleucel Injection.
 

Among them, Axicabtagene Ciloleucel Injection is a CD19 CAR-T product developed by Fosun Kite Biotechnology Co., Ltd., a joint venture of Fosun Pharma. It was officially approved for marketing in China on June 22, 2021. On June 26, 2023, the indications for Fosun Kite's CAR-T drug Axicabtagene Ciloleucel Injection were expanded to include adult patients with large B-cell lymphoma who are ineffective with first-line immunochemotherapy or relapse within 12 months after first-line immunochemotherapy, marking the official launch of its second-line indications.
 

Data show that Axicabtagene Ciloleucel Injection is an autologous immune cell injection, prepared from autologous T cells genetically modified with a retroviral vector carrying the CD19 CAR gene to target human CD19 chimeric antigen receptor T cells (CAR-T). It is used to treat adult patients with relapsed or refractory large B-cell lymphoma who have received two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma. The product’s market launch has initiated a new journey for China's cell and gene therapy (CGT) industry and provided a new solution for certain cancer treatments.
 

JW Therapeutics' Relmacabtagene Autoleucel Injection has been approved for three indications. On August 27 this year, Relmacabtagene Autoleucel Injection received marketing approval for a new indication to treat adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) who have undergone second-line or later systemic treatments, including Bruton's Tyrosine Kinase Inhibitor (BTKi) therapy, becoming the first cell therapy product approved in China for treating r/r MCL patients. This drug also marks the third approved indication for JW Therapeutics' CAR-T therapy. It is reported that two indications were previously approved in China, priced at 1.29 million yuan per injection. Industry insiders stated that the future sales of JW Therapeutics' CAR-T products are expected to increase further.
 

Najiolun Injection is a CAR-T cell therapy product targeting CD19 independently developed by Hekang Bio, featuring the CD19 scFv(HI19a) structure and proprietary manufacturing process. In November 2023, Najiolun Injection was officially approved for marketing by the China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). In September this year, the second marketing application for this product was accepted by the Center for Drug Evaluation (CDE) for treating relapsed or refractory B-cell lymphoma after second-line or higher systemic therapies. Additionally, on October 11 this year, Hekang Bio's Najiolun Injection received tacit approval for clinical trials to treat refractory immune thrombocytopenia associated with systemic lupus erythematosus (SLE-ITP).
 

CARsgen Pharma's Zevor-cel Injection was approved for marketing on March 1, 2024, for the treatment of relapsed or refractory multiple myeloma. According to available information, this product is an autologous BCMA-targeted CAR-T cell therapy generated through lentiviral transduction of T cells. The lentivirus-encoded CAR includes a fully human BCMA-specific single-chain variable fragment (scFv), CD8α transmembrane domain, human CD8α hinge domain, CD3ζ activation domain, and 4-1BB co-stimulatory domain, demonstrating high binding affinity and stability. This product is mainly used to treat adult patients with relapsed or refractory multiple myeloma who have progressed after receiving at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
 

Experts in the industry indicate that CAR-T cell immunotherapy has been continuously gaining attention in recent years, becoming a hot topic in the field of oncology. Currently, CAR-T therapy is mainly focused on hematological malignancies such as leukemia, lymphoma, and myeloma, particularly showing good efficacy in patients with acute lymphoblastic leukemia.
 

However, the industry also pointed out that the high treatment costs have kept many patients who need CAR-T therapy out of reach. For instance, Fosun Kite's Axicabtagene Ciloleucel Injection is priced at 1.2 million yuan per dose, JW Therapeutics' Relmacabtagene Autoleucel Injection at 1.29 million yuan per dose, Innovent Biologics and IASO Biotherapeutics' co-developed Equecabtagene Autoleucel Injection at 1.166 million yuan per dose, CARsgen Therapeutics' Zevorcabtagene Autoleucel Injection at 1.15 million yuan per dose, and Hekang Biotech's Nacartcabtagene Autoleucel Injection at 999,000 yuan per dose.
 

In response, pharmaceutical companies are also attempting to promote the inclusion of CAR-T products in medical insurance. This year marks the first time that four CAR-T products have passed the medical insurance catalog review. However, the National Healthcare Security Administration pointed out in its announcement that passing the formal review only indicates that the drug meets the corresponding application criteria and has obtained the qualification to participate in the next stage of evaluation. Only drugs that pass all stages, including evaluation and negotiation, can be finally included in the catalog.
 

It is reported that the injections of Axicabtagene Ciloleucel and Relmacabtagene Autoleucel have passed the preliminary review for the third time, but both failed in previous medical insurance negotiations.
 

Data shows that currently, six domestically produced CAR-T cancer drugs have been approved for marketing in China. In addition to the four mentioned above, there are also Legend Biotech's Cilta-cel Injection and IASO Biotherapeutics' Equecabtagene Autoleucel Injection. On August 27 this year, Legend Biotech announced that its self-developed cell therapy product, Carvykti (generic name: Cilta-cel Injection), had been approved for marketing by the National Medical Products Administration (NMPA). It is used to treat adult patients with relapsed or refractory multiple myeloma who have progressed after receiving at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
 

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