Heyuan Bio's Domestic CAR-T Therapy 'Najicelogene' Submits New Indication Application for Pediatric r/r B-ALL

(Source: Pharma Fortune Society)

Source|Beijing Pharmaceutical Research Conference

Acute Lymphoblastic Leukemia (ALL), commonly referred to as "acute lymphoblastic leukemia," is one of the four main types of leukemia. It is a malignant tumor disease characterized by abnormal proliferation of B- or T-lymphocyte precursor cells within the bone marrow.

B-cell Acute Lymphoblastic Leukemia (B-ALL) is an extremely aggressive hematological malignancy. Although the cure rate is relatively high for children and adolescents, the prognosis for adult B-ALL, especially relapsed or refractory (R/R) B-ALL, is very poor.

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On May 11, 2026, according to the latest information from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Juventas' new indication marketing application for Naciorlen Injection, submitted under Registration Category 2.2, has been accepted.

On May 7, 2026, the drug is proposed to be included in the priority review category, so the new indication for this application is predicted to be: pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

The injection of Naciorlumab, developed by Juventas, is a CD19 CAR-T cell therapy product with full independent intellectual property rights in China. It is an autologous T-cell immunotherapy product prepared by expressing chimeric antigen receptors (CAR) targeting CD19 on the surface of T cells through gene modification technology.

After infusion into the body, it binds to target cells expressing CD19, activates downstream signaling pathways, induces CAR-T cell activation and proliferation, and produces a cytotoxic effect on the target cells. The market approval of this product provides a new treatment option for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

On November 7, 2023, the injection of Naki Orel Cell was approved for the first time in China, for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

On November 28, 2025, a new indication was approved for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy.

999,000 yuan per injection, currently the lowest-priced CAR-T therapy in China. Data shows that CAR-T therapy is the abbreviation for Chimeric Antigen Receptor T-cell Immunotherapy, mainly used for leukemia, lymphoma, and multiple myeloma. In simple terms, it involves collecting immune cells from the patient’s body, genetically modifying them into "biological missiles" that precisely target cancer cells, and then reinfusing them into the body to specifically attack cancer cells. It has shown significant efficacy in some refractory hematologic tumors.

Due to the customized nature of "one person, one drug," the pricing of CAR-T is generally as high as millions of yuan per injection, making countless patients with hematological tumors hesitate.

It is reported that since the U.S. FDA approved the first CAR-T cell product for marketing in 2017, this anti-cancer drug, which once cost 1.2 million yuan per injection, has developed at a remarkable speed in China within just a few years.

So far, eight CAR-T products have been approved for marketing in China, such as Fosun Kite's Axicabtagene Ciloleucel Injection (Yikaida®), Wuxi Jw Therapeutics' Relmacabtagene Autoleucel Injection (Bennoda®), Legend Biotech's Ciltacabtagene Autoleucel Injection (Carvykti®), CARsgen Therapeutics' Zevor-cel (Saikaze®), Juventas’ Nabcabtagene Autoleucel Injection (Yuanruida®), and IASO Biotherapeutics' Ebcabtagene Autoleucel Injection (Fokusu®). These drugs mainly target relapsed or refractory hematologic malignancies, such as leukemia, lymphoma, and multiple myeloma.

CAR-T cell therapy is called a "living drug." Ordinary immune T cells are collected from cancer patients, and through genetic engineering technology, these T cells are equipped with "GPS navigation heads," enabling them to identify cancer cells.

These modified cells are then cultured in large quantities in vitro, and finally infused back into the patient's body, enabling the modified T cells to accurately identify and kill cancer cells.

To address the issue of CAR-T products being "astronomically expensive" and unaffordable for ordinary patients, the first edition of the **Commercial Health Insurance Innovative Drug List** will be implemented in 2025. Five CAR-T cell products have been included in the list, providing patients with a new payment option and potentially significantly reducing out-of-pocket costs for patients. As technology continues to mature, the price of CAR-T therapy is expected to decrease further.

At the same time, relevant clinical training is also advancing, and in the future, this therapy is expected to benefit more suitable patients.