SimbayPark Tenant Hepalink Bio's Najirolunse Injection (Yuanruida®) Approved for Lymphoma, Marking a New Era for China-Originated CAR-T with Dual Indications

Dec 01, 2025 10:02 CST Updated 10:02

Juventas

Innovative Cell Therapy Drug Developer

November 28, 2025SimbayPark FTIH Park EnterpriseJuventasAnnounced that itsJuventas' Self-Developed CAR-T Cell Therapy Product: Nalkio Race Injection(Product Name：Yuan Ruida^®）The new drug has been approved by the National Medical Products Administration of China for marketing.Used forTreatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or above systemic therapy. This is Najio Lun InjectionFollowing its approval in November 2023 for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), this marks the second new drug marketing approval received in China. It represents the first drug of its kind in China with...A CD19 CAR-T product with fully independent intellectual property rights, becomingThe Only CAR-T Cell Therapy Product in China That Covers Two Major Hematological Tumor Indications: Leukemia and Lymphoma。

Clinical Value Upgrade: A New Chapter in the Treatment of Large B-Cell Lymphoma

Lymphoma is one of the most common malignant tumors of the hematologic system, and large B-cell lymphoma (LBCL) is the most common type of adult non-Hodgkin lymphoma (NHL). After first-line treatment, approximately 40% of patients experience progression or relapse. These patients have a poor prognosis, posing significant clinical challenges. The approval of the new drug Naciorlen Injection for lymphoma brings accessible hope of a cure to LBCL patients.

Naciorl Injection (Yuan Ruida^®) is a China-developed CD19-targeted CAR-T cell therapy product, originating from the long-term technological innovation accumulation of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. It features a globally unique CD19 scFv (HI19a) structure and internationally leading production and manufacturing processes. As China's first fully independently intellectual property-owned CD19 CAR-T cell therapy product, the successive approvals for its two major indications—adult leukemia and lymphoma—have provided more treatment options for patients with hematological malignancies. This milestone achievement not only strongly validates its clinical value, further solidifying its leading position in China’s CAR-T therapy field, but also highlights the original innovative strength and high-quality industrial development level of China's cell therapy sector.

This new indication approval is based on the positive results of a single-arm, open-label, multi-center pivotal Phase II clinical study (NCT04586478) of Naciorl Injection for the treatment of r/r LBCL. The study, jointly led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Ruijin Hospital affiliated with Shanghai Jiao Tong University, was conducted across more than ten clinical centers in China. Key clinical research data demonstrated that Naciorl Injection provided durable remission and long-term survival benefits for lymphoma patients, while also showing excellent safety.

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Dehui Zou, ProfessorGrant

Blood Disease Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

Congratulations on the Nakiolumab Injection for the Treatment of Relapsed or Refractory LargeBFineNew Drug for Lymphoma Approved for Market Launch in China, Offering Patients a New Breakthrough Treatment Option.BOnce patients with lymphoma experience recurrence or become refractory, the efficacy of traditional treatment methods is limited, and the prognosis is extremely poor. In pivotal registration clinical studiesIn China, the injection of Naciorlens has demonstrated excellent efficacy, lasting relief, and long-term survival benefits. While showing superior efficacy, the safety performance of Naciorlens injection is outstanding, with no cases of ≥3Grade Cytokine Release Syndrome, Only1Example: Patients experience ≥3Grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), significantly superior to similar products abroad. We look forward to the approval and market launch of Nalkio Cell Injection, which will further accumulate evidence in real-world settings, promote the advancement of treatment lines, explore combination strategies, and benefit more patients.BPatients with lymphoma benefit.

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Professor Weili Zhao

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Nakiolec Injection TreatmentBNew Cellular LymphomaDrug LaunchApproved, is China's self-developedCAR-TAnother significant milestone for cell therapy products, and a typical representation of China's independent innovation in the cell drug industry. The unique features of the Naciorlen Injection have contributed to its success.CD19 scFvStructure, advanced production and manufacturing technology, strict quality control system, and outstanding clinical data demonstrated in multiple clinical studies will become recurrent or refractory largeBHigh-quality and effective treatment options for patients with lymphoma. Looking forward to the treatment of largeBReal-world performance of cell lymphoma, also looking forward to the injection of Naciorlen from China to the global market, and expecting more "Chinese power" in cell therapy innovative drugs.

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Professor Qiulu Gui

Clinical Chief Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Nakio Cell Therapy Liberates Patients from Long-Term Hospitalization. Developed in ChinaCAR-T, with definite efficacy, good safety, and combined with NarlakotamabASCTInnovation can lead to better treatment outcomes for patients, optimalORRAs high as92%`, Optimal`CRRate72%, after the infusion of Nakiolumab3Months and6months, respectively80%And72% Patients continue to achieve relief,24At ... months, there is still64.9%Patients achieve lasting relief, allowing more patients to return to their lives and be with their families. This is a dual breakthrough in medical technology and humanistic care — cancer treatment can be warmer and more dignified!

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Professor Wang Jianxiang

Clinical Chief Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; Director of the National Clinical Research Center for Hematological Diseases

Nakio Cell Injection is a self-developed product in China.CD19 CAR-TProduct, which has included adult acute lymphoblastic leukemia, largeBCellular lymphoma, blood tumor diseases such as pediatric acute lymphoblastic leukemia, and multiple types of autoimmune diseases, including systemic lupus erythematosus and hemolytic anemia, have demonstrated excellent efficacy and safety, with over500For example, patients, corresponding clinical research data have been continuously published in international academic journals and conferences, receiving widespread attention.2023Year11Months after the approval and market launch of Juventas' Nakiorun Cell Injection for the first indication in treating adult acute lymphoblastic leukemia, the real-world effectiveness rate has reached a high of92.8%, included in authoritative treatment guidelines in China, gradually becoming a standard treatment option. Congratulations on the inclusion of Jilin Oronis Injection in the treatment of largeBThe approval and market launch of the cell lymphoma indication is anticipated, with expectations for subsequent approvals of pediatric acute lymphoblastic leukemia and autoimmune disease indications, benefiting more patients.

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Dr. Lü Lulu

CEO of Juventas

The approval and market launch of the new drug, Naciorl Injection, for the treatment of lymphoma marks another significant achievement by Juventas in its commitment to independent innovation and focus on clinical needs. Naciorl Injection has also become the only drug in China approved for dual indications, covering both leukemia and lymphoma.CAR-TProduct. Naciorl Injection is a self-developed product in China.CD19 CAR-TProducts. Next, the company will also accelerate the development and market launch of Naciorlen Injection for treating childhood acute lymphoblastic leukemia and various types of autoimmune diseases. It will actively promote the inclusion of this innovative drug in the National Medical Insurance Drug List to continuously improve drug accessibility. In parallel, Juventas will advance the global registration of Naciorlen Injection, enabling more patients in China and worldwide to benefit from a product made in China.CAR-TCellular Innovation Drugs.

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About Juventas

Juventas, founded in June 2018, has grown into a leading innovator in China's cell therapy industry, striving to become a globally leading biopharmaceutical enterprise driven by cutting-edge cell and gene technologies.

The Company's First Core Product: Yuan Ruida^®(Natiloleucel Injection, CNCT19) was officially approved for marketing by the National Medical Products Administration in November 2023. This product is the first CAR-T drug in the field of leukemia treatment in China and also the first fully self-innovated CD19 CAR-T drug in China. Juventas has deeply cooperated with top national institutes to build an international new drug research and development system centered on technology platforms such as the CAR technology platform and gene editing technology platform, with more than 10 pipeline products under research covering diseases such as hematological tumors, solid tumors, and autoimmune diseases. Yuan Ruida^®(Natiloleucel Injection, CNCT19, Inaticabtagene Autoleucel Injection) is a CAR-T cell therapy product targeting CD19 with proprietary intellectual property rights. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. It has successively obtained three Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for the treatment of adult relapsed or refractory acute lymphoblastic leukemia (r/r B-ALL), relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it has been granted "Breakthrough Therapy Designation" by the Center for Drug Evaluation of the NMPA and Orphan Drug Designation (ODD) by the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Natiloleucel Injection for the treatment of adult r/r B-ALL and included it in the priority review process. In March 2023, the IND application for Natiloleucel Injection for the treatment of adult r/r B-ALL was also approved by the U.S. FDA. In November 2023, Juventas...^®(Najio Longcell Injection) Officially Approved for Marketing by China's National Medical Products Administration (NMPA).

Guided by clinical needs, the company is committed to creating safe, efficient, and accessible immune cell therapy products for patients through a stringent production and quality system for cell therapy products. Juventas boasts world-class R&D technology platforms, process development platforms, quality control systems, and commercial-scale production bases. In June 2021, it obtained the first-ever "Drug Production License" for cell-based drugs in Tianjin, China. The company holds multiple invention patents and has been selected for the National Key Research and Development Program of the Ministry of Science and Technology of China under the “Technology Supporting the Economy 2020 Key Special Projects.” Additionally, Juventas has received titles such as “National Intellectual Property Advantage Enterprise” and “Tianjin City’s Specialized, Precise, Unique, and Innovative Small and Medium Enterprises Recognition.”

About SimbayPark

Shanghai FT1 Life Science Park (Abbreviation"Simbay Park, Star North · Free Trade No.1") is located in the Waigaoqiao Bonded Area, the core of Shanghai's Pudong New Area Free Trade Zone. It is an innovative service-oriented characteristic industrial park under the Star North Group, focusing on the incubation, cultivation, and transformation of medical enterprises.The park relies on the unique advantages of an outward-oriented economic zone with "Free Trade + Bonded" characteristics. By gathering the entire industry chain service resources of CRO+CDMO+CSO+EHS in the biopharmaceutical field, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with deep technical incubation in the medical industry. It serves as a steward for the transformation of corporate technological achievements, striving to build an international biopharmaceutical industry innovation and entrepreneurship base.