Ranikioelunsa Injection (HR001, trade name: Hengkailai®) is a CD19-targeted CAR-T cell therapy developed by Shanghai Hengrun Dasheng Biotechnology Co., Ltd. It was approved for marketing by the National Medical Products Administration (NMPA) on July 30, 2025. Its indications areAdult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy——This is the most common subtype in non-Hodgkin lymphoma, specifically including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified. This drug is alsoThe Fourth CD19 CAR-T Cell Therapy Approved in China。

▲Screenshot source“NMPA”

As early as the 2024 American Association for Cancer Research (AACR) conference, Shanghai Hengrun Dasheng Biotechnology Co., Ltd. announced the inspiring data from the Phase 2 clinical trial (HRAIN01-NHL01-II) of this drug for the treatment of relapsed/refractory non-Hodgkin lymphoma (R/R NHL).

Results showed: patientThe median progression-free survival (PFS) was 176 days.（95%CI：91-NE），Overall Survival (OS) Not Yet Reached; Median Duration of Response (DOR) is 339 Days（95%CI：149-NE），The median time to best response was 30 days.(Range: 28-358 days).The Objective Response Rate (ORR) at 3 months, 6 months, and the best time point were 53.1%, respectively.（95%CI：41.7～64.3）、45.7%（95%CI：34.6～57.1）、74.1%（95%CI：63.1～83.2）；The complete response rate (CRR) at the aforementioned three time points was 32.1%, respectively.（95%CI：22.2～43.4）、29.6%（95%CI：20.0～40.8）、49.4%（95%CI：38.1～60.7）。

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Natieolumab Injection (Trade Name: Yuanruida®, Generic Name: Inaticabtagene Autoleucel Injection, Former Name: CNCT19 Cell Injection) is the first China-developed CD19-targeted CAR-T cell therapy product independently researched and developed by Hecan Biotech. On November 28, 2025, it received formal approval from the National Medical Products Administration (NMPA) of China for a new indication to treat relapsed or refractory large B-cell lymphoma (r/rLBCL) after two or more lines of systemic therapy. This is the product'sThe Second Marketing Approval in China, alsoThe only CAR-T product in China that currently covers both leukemia and lymphoma in the field of hematological tumors。

▲Screenshot source“HeYuan Biotechnology Official Website”

The Journal of Cancer Immunotherapy reported the exciting data from the Phase I/II clinical trial of "Nakiloleucel (CNCT19) combined with high-dose chemotherapy/autologous stem cell transplantation (HDT/ASCT) for the treatment of r/rLBCL." The results showed:The Best Objective Response Rate (ORR) Reached 92.0%（95%CI：74.0%-99.0%），The optimal complete remission rate (CR) was 72.0%.（95%CI：50.6%-87.9%）。

It is worth mentioning that, on May 30, 2025, the First Affiliated Hospital of Sun Yat-sen University, Guizhou Hospital / Affiliated Hospital of Guizhou Medical University has carried out the first case of Nabo Olensai CAR-T therapy treatment in Guizhou Province. A 23-year-old patient with relapsed/refractory acute lymphoblastic leukemia (r/r B-ALL) who was in a "no available medication" predicament completed cell infusion, filling the gap in precise immunotherapy for this type of disease within the province.Read the original article for more details: The first case of CAR-T therapy "Nagioluocai" in Guizhou Province successfully implemented at the Blood·Lymphoma Center of Guian Campus, The First Affiliated Hospital of Sun Yat-sen University, Guizhou Hospital / The Affiliated Hospital of Guizhou Medical University.

Lisocabtagene maraleucel (brand name: Breyanzi, generic name: lisocabtagene maraleucel, abbreviated as liso-cel) is an autologous CD19-targeted CAR-T cell therapy developed by Bristol-Myers Squibb.

On November 25, 2025, the drug was approved by the European Commission for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy (including a BTK inhibitor). Just ten days later (December 4, 2025), Liso-cel was granted a new indication approval by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. This approval makes it the...The world's first and currently only CAR-T cell therapy for this indication, successfully filling the gap in the MZL treatment field.

The approval of the new FDA indication is mainly based on the inspiring data from the MZL cohort in the TRANSCEND FL II trial (NCT04245839). The results showed that, in the intent-to-treat population, patientsOverall Response Rate (ORR) Reached 84.4%（95%CI：74.4%-91.7%），The complete response rate (CR) was 55.8%.（95%CI：44.1%-67.2%），Median Duration of Response (DOR) Not Yet Reached（NR；95%CI：25.59-NR），Significant and lasting efficacy。

▲Screenshot source“FDA”

Relmacabtagene Autoleucel Injection (Generic Name: relmacabtagene autoleucel, abbreviated as relma-cel; Trade Names: Benuo® and Carteyva®) is a CD19-targeted CAR-T cell therapy product developed by WuXi Jumo. It is not only the first CAR-T therapy approved in China for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL), but also...China's First CAR-T Product with Three Indications, even moreChina's First CAR-T Benchmark Product Covering Three Major Cancer Indications。

On May 24, 2025, the drug officially submitted its fourth indication for marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It is intended for the treatment of adult patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (r/r B-NHL) who are not suitable for high-dose chemotherapy and autologous stem cell transplantation after first-line treatment failure, marking its push towards the fourth indication.

The globally renowned journal *Nature*'s subsidiary publication, *Bone Marrow Transplantation*, published the two-year follow-up data of a Phase I clinical trial on "Relmacabtagene Autoleucel Injection for the Treatment of Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL)." The results showed that, among 20 evaluable patients,The objective response rate (ORR) was as high as 85.0%, the best complete response rate (CRR) reached 75.0%, the 2-year progression-free survival rate (PFS rate) was 60.0%, and the 2-year overall survival rate (OS rate) reached 70.0%.。

▲Screenshot source“NMPA”

Brexucabtagene Autoleucel Injection (generic name: Brexucabtagene autoleucel, abbreviated as Brexu-cel, trade name: Tecartus, KTE-X19) is an autologous anti-CD19 CAR-T cell therapy developed by Fosun Kite. On September 24, 2025, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration showed that the drug has been submitted for marketing approval and is proposed for the treatment of adult relapsed/refractory precursor B-cell acute lymphoblastic leukemia.

It is worth mentioning that the drug has been previously approved in the United States, the European Union, Canada, and other countries and regions, with indications covering mantle cell lymphoma and B-cell acute lymphoblastic leukemia (B-ALL). This submission progress in China means that Chinese patients with relevant types of leukemia are expected to access cutting-edge international treatment options more quickly, bringing hope to many families awaiting new beginnings.

▲Screenshot source“NMPA”

In June 2025, the latest data from the Phase II bridging registration clinical study (ChiCTR2300073872) of Brexucabtagene Autoleucel in Chinese patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) was announced. The results showed:The overall complete response (CR)/complete response with incomplete hematologic recovery (CRi) rate reached 78.6%.(90% CI: 62.0%, 90.2%) (see figure below);Median recurrence-free survival (RFS) and median duration of response (DOR) cannot be estimated at this time.；All responders were negative for minimal residual disease (MRD) (100%).。

Pucioluen Injection (R&D code: pCAR-19B, trade name: Pulidekai®) is an autologous CAR-T cell product. Its core advantage lies in the optimized humanized CD19-specific single-chain variable fragment (scFv), designed specifically to enhance treatment safety.

On November 7, 2025, the National Medical Products Administration (NMPA) conditionally approved the marketing of Pucibio Cell Injection, submitted by Chongqing Precision Biotech, through the priority review and approval process. The drug is indicated for the treatment of refractory or relapsed CD19-positive acute B lymphoblastic leukemia (patients who relapse after 12 months of first remission require salvage chemotherapy) in patients aged 3 to 21 years. This marks "the first breakthrough" in the CAR-T field for pediatric and adolescent r/rB-ALL indications in China.

The internationally renowned journal *Blood* published exciting data from the "Pivotal Phase II Clinical Trial (NCT05334823) of Pucibio Cell Therapy for Chinese Pediatric and Adolescent Patients with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL)," which is also the first pivotal clinical trial focusing on an Asian population with pediatric B-ALL.

Results:The best objective response rate (ORR) reached 90.63% (58/64), with 78.13% (50/64) achieving complete response (CR).，12.5% (8/64) achieved complete remission with incomplete hematologic recovery (CRi)., demonstrating superior efficacy compared to other marketed anti-CD19 CAR-T therapies;98.27% (57/58) of the relieved patients achieved minimal residual disease (MRD) negativity.. In addition, the patientThe ORR at 3 months was 76.56% (49/64), with a median duration of response (DOR) reaching 10.61 months.（95%CI：7.66-20.96），Median overall survival (OS) was 23.92 months(95% CI: 9.86 - not reached).

▲Screenshot source“NMPA”

Raniky Orencel Injection (trade name: Hengkailai®, HICARA®) is a CD19-targeted CAR-T cell product independently developed by Shanghai Hengrun Dasheng Biotechnology Co., Ltd, holding two major significant identities—it is not onlyThe First CAR-T Drug Produced in China for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (r/rLBCL), alsoThe First Approved Chinese CAR-T Product Using a Stable Cell Line Virus Process。

On July 30, 2025, the drug was officially approved for marketing by the China National Medical Products Administration. The indication is for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, specifically including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified.

▲Screenshot source“NMPA”

The approval was based on the inspiring data from the pivotal Phase II clinical trial (HRAIN01-NHL01-II): This study enrolled 81 patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL) having a baseline ECOG score of 0-1, who were treated with the infusion of Ranikyorensai (code name HR001). The median follow-up time reached 160 days (range 7-454 days).

Results showed that: the patientAt 3 months, 6 months, and the best overall response rate (ORR) was 53.1%, respectively.（95%CI：41.7-64.3）、45.7%（95%CI：34.6-57.1）、74.1%（95%CI：63.1-83.2）；The 3-month, 6-month, and optimal complete remission rates (CRR) were 32.1%, respectively.（95%CI：22.2-43.4）、29.6%（95%CI：20.0-40.8）、49.4%（95%CI：38.1-60.7）；The median duration of response (DOR) was 339 days.（95%CI：149-NE），The median progression-free survival (PFS) was 176 days.（95%CI：91-NE）。

Notably, Ranikyelocel has successfully transitioned from clinical trials to prescription availability. The Department of Hematology at Zhongshan Hospital, Fudan University, as the leading unit of its registration clinical trial, has been fully responsible for and deeply involved in the research, witnessing every key milestone of the drug from clinical research to commercialization.

On December 12, 2025, HD CD19 CAR-T cell drug independently developed by Huadao Bio officially submitted its marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This is the company's...The First CAR-T Therapy for Relapsed or Refractory Non-Hodgkin LymphomaTo date, the drug has been approved for two clinical indications, namely the treatment of refractory or relapsed non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia.

More excitingly, this "Made-in-China" cell drug, which has complete independent intellectual property rights, is expected to significantly reduce the previous CAR-T treatment costs of millions of yuan to around 200,000 yuan. This will not only substantially lower the threshold for patients to access medication but also make once "unattainably expensive" precision treatments truly accessible to ordinary patients.

▲Screenshot source“NMPA”

Satri-cel Injection (satri-cel, Satricabtagene autoleucel, CT041) is an autologous CLDN18.2 CAR-T cell therapy developed by CARsgen Therapeutics. On May 20, 2025, the drug was granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of advanced gastric/esophagogastric junction adenocarcinoma that is CLDN18.2-positive and has failed at least two prior lines of therapy. This progress makes it...Is expected to becomeThe world's first marketed solid tumor CAR-T product, bringing a historic breakthrough in overcoming the challenges of solid tumor treatment.

▲Screenshot source“NMPA”

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting presented multiple key data on Surugiolecet Injection, with the results of the randomized controlled trial simultaneously published in The Lancet.

Results Show: According to the assessment by the Independent Review Committee, the satri-cel group demonstrated significant benefits over the standard treatment group (TPC) in terms of progression-free survival and overall survival:Median progression-free survival (PFS) was 3.25 months.（95%CI：2.86–4.53），Significantly higher than the 1.77 months in the TPC group（95%CI：1.61–2.04）。Median Overall Survival (OS) Reached 7.92 Months（95%CI：5.78–10.02），Compared with 5.49 months in the TPC group（95%CI：3.94–6.93）Increase by over 30%. In addition,The confirmed objective response rate in the satri-cel group was 22%.（23/104，95%CI：15–31）、The disease control rate was 63%.(95% CI: 52–72), whileThese two data points in the TPC group are only 4%.(2/52, 95% CI: 0–13) and25%(95% CI: 14–39), demonstrating a very significant therapeutic advantage.

One of the typical cases has attracted widespread attention: although the liver lesions increased from the baseline during the second week after the patient was infused with satri-cel, they continued to shrink in subsequent follow-ups.By the 26th weekBelow baseline levels, visually confirming the sustained anti-tumor activity of the therapy.。

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ESO-T01 is a key vector for achieving in vivo CAR-T therapy preparation. It is an immune-shielded lentiviral vector targeting nanobodies, containing a humanized anti-B cell maturation antigen (BCMA) single-domain antibody chimeric antigen receptor (CAR), specifically designed for in vivo T-cell engineering. It has demonstrated good safety and efficacy in preclinical studies.

On July 2, 2025, the Hematology Department team of Wuhan Union Hospital published a groundbreaking study in the prestigious international medical journal *The Lancet*, becoming the world's first to report clinical success in "in vivo preparation of CAR-T cell therapy for relapsed/refractory multiple myeloma." This study is based on an in vivo CAR-T therapy using the ESO-T01 vector and involves the first-in-human trial (NCT06691685) conducted on patients with relapsed or refractory multiple myeloma.

Results showed that: after receiving ESO-T01 treatment, the patient's efficacy was significant. Patient 1 experienced marked improvement during the treatment.Complete remission (CR) in the strict sense was achieved in the 2nd month, with all intra-medullary and extra-medullary lesions regressed.(See Figure B below); Patient 2Achieved stringent complete remission on Day 28, with complete resolution of lesions.Withdrawal (see Figure D below); Patients 3 and 4 achievedPartial Response (PR), with tumor lesion reduction by Day 28 and negative minimal residual disease in bone marrow.。

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On October 30, 2025, the eighth National Medical Insurance Drug Catalog negotiation (referred to as "National Negotiation") officially began. The biggest breakthrough in this adjustment lies inFirst Addition of Commercial Insurance Innovative Drug Directory。

It is reported that among the seven CAR-T products approved for marketing in China, five have participated in the commercial insurance innovative drug list application (three of which also applied for basic medical insurance). These are Fosun Kite's Axicabtagene Ciloleucel, Wuxi Jumo's Relmacabtagene Autoleucel, IASO Biotherapeutics' Equecabtagene Autoleucel, Kexing Life’s Zevocabtagene Autoleucel, and Hekang Bio's Nacibartgene Autoleucel. The price range per injection for these five products is 990,000 to 1.29 million yuan, and they have all passed the expert review before the national negotiation (see the table below for details).

▲Data source: "National Healthcare Security Administration (NHSA) Official Website", Global OncologyDoctor NetworkMedical Department Summary

CAR-T Cell Therapy Achieves Breakthrough Progress in the Treatment of Hematologic Malignancies, Benefiting Numerous Patients. Encouragingly, Researchers Worldwide Have Continued to Explore Relentlessly in Recent Years, Studying Various Novel Strategies to Reduce Tumor Antigen Heterogeneity, Overcome Immunosuppressive Challenges, and Have Made Groundbreaking Progress in Solid Tumors Such as Gastric Cancer, Brain Tumors, Pancreatic Cancer, Liver Cancer, and Colorectal Cancer!

The good news is that China has successfully developed several CAR-T therapies targeting various hematological malignancies and solid tumors, which have been initiated in clinical trials at multiple well-known cancer centers in China. Patients who wish to identify their own targets or seek help from novel therapies such as CAR-T can submit complete pathology reports, treatment histories, and other relevant materials toGlobal Cancer Doctors Network Medical Department (400-666-7998), conduct a preliminary assessment or understand the detailed inclusion and exclusion criteria.