Heyuan Bio's Yuoruida® (Inaticabtagene Autoleucel Injection) Approved in Macao to Mark the 25th Anniversary of Macao’s Return to China
Juventas
Innovative Cell Therapy Drug Developer
Preface
Preface
2024 marks the 25th anniversary of Macao's return to China!Daotong Family Enterprise——Committed to becoming a global leading biopharmaceutical company driven by cutting-edge innovative cell and gene technologies - JuventasAnnounced that its first core productYuan Ruida® (Natrium Allogeneic CAR-T Injection) has been approved for marketing by the Drug Administration of the Macao Special Administrative Region.. This not only means that the first domestically developed leukemia cell therapy drug in China - Yuan Ruida® (Najiolun Race Injection) will be successfully introduced into Macao, but more importantly, itWill Provide New Breakthrough Treatment Options and Survival Hope for Hematological Tumor Patients in Macao and Even Southeast Asia。
Yuanruida® (Najiolumab Injection) is the first CD19 CAR-T cell therapy product with full independent intellectual property rights in China, and also the first CAR-T product in the field of leukemia treatment in China. It was approved for marketing by the National Medical Products Administration in November 2023. Yuanruida® has a wide range of indications. In addition to the already approved indication for adult relapsed or refractory B-cell acute lymphoblastic leukemia,September 2024Juventas' new drug application for the treatment of relapsed or refractory large B-cell lymphoma, Source Ruida®, has been accepted by the National Medical Products Administration.OctoberJuventas' new drug clinical trial application for the treatment of autoimmune diseases (refractory systemic lupus erythematosus-related immune thrombocytopenia) has received implied permission. Meanwhile, the clinical research for Juventas' treatment of pediatric relapsed or refractory B-cell acute lymphoblastic leukemia and various types of autoimmune diseases is also proceeding steadily.
As the first CAR-T cell therapy product in China's leukemia treatment field, Yuanruida® has been recommended by multiple diagnosis and treatment guidelines, including those from CSCO (Chinese Society of Clinical Oncology) and the Chinese Medical Association. It has been adopted by nearly 90 top hematology hospitals in China, with its real-world efficacy and safety highly recognized by doctors and patients.
Recently, the 2-year follow-up results of 48 patients published in Blood Advances indicated that Yuanruida® (Natriolone Injection) demonstrated encouraging and durable responses in treating adult relapsed or refractory B-cell acute lymphoblastic leukemia, with manageable safety.
Professor Wang Jianxiang, Chief Clinical Expert of the Blood Diseases Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology of the Chinese Academy of Medical Sciences) and Director of the National Clinical Research Center for Hematological Diseases:
"Congratulations on the approval and market launch of Naciorl Injection in Macao! As China's first self-developed CD19-targeted CAR-T drug, Naciorl Injection has demonstrated significant clinical benefits and manageable safety in clinical studies and real-world clinical practices, including adult relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, and pediatric and adolescent relapsed/refractory B-cell acute lymphoblastic leukemia. It has also achieved positive clinical data in exploratory clinical research for autoimmune diseases. We look forward to Naciorl Injection being approved in more regions and countries in the future, allowing more patients worldwide to benefit from China's cutting-edge CAR-T therapy."
Dr. Lulu Lv, CEO of Juventas:
"Coinciding with the significant moment of the 25th anniversary of Macao's return to China, the approval of Yuanruida® in Macao marks an exciting milestone. We are committed to maximizing the clinical value of Yuanruida®, not only through comprehensive deployment across multiple disease areas such as leukemia, lymphoma, and autoimmune diseases, but also by continuously expanding its approved use in numerous countries and regions worldwide. This approval in Macao lays a solid foundation for its further global expansion. Juventas will partner with local hospitals in Macao to provide high-quality CAR-T treatment options, filling the gap in the field of CAR-T cell therapy for leukemia in Macao with remarkable clinical outcomes and stringent drug quality control. This will bring hope to patients and extend these premium medical resources to broader regions, benefiting even more patients."
END
ID：daltonventure
Long press to follow
R E C O M M E N D E D R E A D I N G
