Heyuan Biosciences' CAR-T Therapy YORWIDA Granted Breakthrough Medicine Designation by Saudi FDA

Jul 03, 2025 09:01 CST Updated 09:01

Juventas

Innovative Cell Therapy Drug Developer

Juventas Achieves Another Milestone in the Globalization of Cell Therapy: Its Self-Innovated CAR-T Therapy Receives Breakthrough Designation from Saudi Regulatory Authorities. We extend our warm congratulations to the Juventas team for their continuous efforts and achievements in advancing China's innovative medicines onto the global stage. This significant progress not only validates the international competitiveness of China-developed innovations but also brings new hope to more patients across the Middle East and the world.

Danlu Capital will continue to focus on and firmly support biopharmaceutical enterprises with international vision, clinical value, and proprietary technical barriers, looking forward to more "China Intelligent Manufacturing" reaching the global stage.

On June 23, 2025, Juventas Biotechnology (Tianjin) Co., Ltd. ("Juventas") announced that its self-developed CAR-T cell therapy product targeting CD19, Naciorlcel Injection (YORWIDA), has been granted Breakthrough Medicine Designation (BMD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This marks another significant milestone for Naciorlcel Injection in the Middle Eastern market following its Priority Review designation by the SFDA in February this year. It reflects growing international recognition of the high-quality clinical research data and advanced manufacturing processes and quality systems of China-developed CAR-T therapies. The registration and commercialization process for Naciorlcel Injection in Saudi Arabia is now entering an "accelerated track."

According to the guidelines issued by the Saudi Food and Drug Administration, the Breakthrough Therapy Drug Program aims to accelerate the development, review, and marketing of innovative new drugs to meet the urgent unmet clinical needs for treating serious or life-threatening diseases. Drugs applying for the Breakthrough Therapy Drug Program must meet several conditions, including targeting severely debilitating or life-threatening diseases with unmet clinical needs, demonstrating significant advantages over current treatment methods, and having a favorable benefit-risk ratio. Obtaining Breakthrough Therapy Drug designation will significantly shorten the marketing cycle of innovative drugs in Saudi Arabia, providing patients with faster treatment options.

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Professor Wang Jianxiang

Blood Disease Hospital, Chinese Academy of Medical Sciences(Institute of Hematology, Chinese Academy of Medical Sciences)Chief Clinical Expert and Director of the National Clinical Research Center for Hematological Diseases, Professor Wang Jianxiang：

Congratulations on the Chinese CAR-T product, Naciorl Injection, receiving Breakthrough Therapy Designation from the Saudi Food and Drug Authority! The high-quality multicenter clinical research conducted in China for Naciorl Injection and the resulting high-quality clinical data have been continuously showcased on international platforms, earning widespread global recognition. This has laid a solid foundation for its expansion from China to the rest of the world. It also represents the gradual alignment of China's innovative drug development with international standards and the globalization of research and registration. We look forward to the accelerated approval of Naciorl Injection in Saudi Arabia and more countries worldwide, allowing patients globally to benefit from Chinese-developed CAR-T therapy.

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Dr. Lulu Lyu

CEO of Juventas, Dr. Lulu Lv:

Receiving the Breakthrough Therapy Designation from the Saudi Food and Drug Authority, the clinical value and production quality of Nakiolumab Injection have gained increasing recognition from international regulatory authorities. This marks another significant milestone in Juventas' global strategic layout. Under the Breakthrough Therapy program, we are about to formally submit a new drug marketing application in Saudi Arabia, working closely with regulatory agencies, medical institutions, and partners to accelerate the availability of Nakiolumab Injection as a groundbreaking treatment.CAR-TTherapy Benefits Saudi Patients. The company actively responds to the "Belt and Road" initiative, driving China's original research with innovative strength.CAR-TGoing Global: Continuous Development of Innovative Cell Therapies with International Competitiveness to Create a "National Calling Card" for Cell Therapy!

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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 recognized biopharmaceutical enterprise driven by cutting-edge cell and gene technologies.

The Company's First Core Product: Yuanruida^®(Natuo Cell 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 China's leukemia treatment field and also the first fully self-innovated CD19 CAR-T drug in China. The company has deep cooperation with top national institutions, building an international new drug research and development system centered on the CAR technology platform, gene editing technology platform, etc., with more than 10 pipeline products under research covering hematological tumors, solid tumors, and autoimmune diseases. Juventas^®(Natiloleucel Injection, CNCT19, Inaticabtagene Autoleucel Injection) is a CAR-T cell therapy product targeting CD19 with independent intellectual property rights. It features a globally unique CD19 scFv (HI19a) structure and internationally leading production technology. It has successively obtained three Investigational New Drug (IND) clinical trial 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. It has also been granted the "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 approved by the U.S. Food and Drug Administration (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 strict production and quality system for cell therapy products. Juventas possesses 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.” It has also been awarded the title of "National Intellectual Property Advantage Enterprise" and received recognition as a "Specialized, Precise, Unique, and Innovative Small and Medium-sized Enterprise of Tianjin, China."

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