Heyuan Bio's Inaticabtagene Autoleucel (YORWIDA) Granted Breakthrough Medicine Designation by Saudi FDA for r/r B-ALL, Accelerating Access for Middle Eastern Hematologic Cancer Patients
Juventas
Innovative Cell Therapy Drug Developer
June 23, 2025Daotong Family Enterprise——Juventas (Tianjin) Biotechnology Co., Ltd. (referred to as "Juventas")Announced recently that its self-developed CD19-targetedCAR-T Cell Therapy Product Nalkiorensai Injection (YORWIDA) 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 is another significant milestone for Nakiolumab Injection in the Middle Eastern market following its Priority Review designation by the Saudi Food and Drug Authority in February this year. It indicates that the high-quality clinical research data, advanced production techniques, and quality systems of China-originated CAR-T therapy are gaining increasing international recognition, with its registration and commercialization process in Saudi Arabia entering an "accelerated pathway."
Professor Wang Jianxiang, Chief Clinical Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS) and Director of the National Clinical Research Center for Hematological Diseases:
Congratulations on the Chinese Original CAR-T Product, Naciorl Injection, Being Granted Breakthrough Therapy Designation by the Saudi Food and Drug Authority! The high-quality multicenter clinical research conducted in China for Naciorl Injection and the high-quality clinical research data obtained have been continuously showcased on the international stage, receiving widespread international recognition. This has laid a solid foundation for its expansion from China to the global market. It also serves as a microcosm and representation of 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 China’s original CAR-T therapy.
CEO of Juventas, Dr. Lulu Lv:
Awarded Breakthrough Therapy Designation by the Saudi Food and Drug Authority, the clinical value and production quality of Nakiolumab Injection have gained increasing recognition from international regulatory agencies, marking another significant milestone in Juventas' global strategic layout. Under the Breakthrough Therapy program, we are preparing to formally submit a new drug application in Saudi Arabia. Collaborating closely with regulatory authorities, medical institutions, and partners, we aim to expedite the availability of Nakiolumab Injection, a groundbreaking CAR-T therapy, for patients in Saudi Arabia. The company actively responds to the "Belt and Road" initiative, leveraging innovative strength to promote China-originated CAR-T drugs globally. We continue to develop cell therapies with international competitiveness, building a "national calling card" for cell therapy!
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