SourcePower, Renewing Lives | China's First Leukemia CAR-T Therapy Yuanruida Launches to Market
Juventas
Innovative Cell Therapy Drug Developer
B-cell Acute Lymphoblastic Leukemia (B-ALL) is one of the most common acute leukemias in adults, characterized by high malignancy. Most patients eventually progress to relapsed or refractory (R/R) status, with a poor prognosis. There is an urgent need for more effective new drugs to improve patient survival and break the treatment deadlock. Juventas has developed a CD19-targeted chimeric antigen receptor T-cell (CAR-T cell) therapy product — Yuan Ruida (Najiolumab Injection, CNCT19 Cell Injection, Inaticabtagene Autoleucel Injection), which has opened a new chapter in ALL treatment.
On November 8, 2023, the injection of Nakiolumab was approved for marketing by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. As the first and only CAR-T product in China for treating adult R/R B-ALL, it is also the first CD19-targeted CAR-T product with full independent intellectual property rights in China. Its successful launch not only marks a breakthrough in the field of ALL but also holds epoch-making significance. From research and development to clinical trials, from early exploration to commercial application, this journey has not been an overnight success and has been filled with challenges. However, it is the collective efforts of countless "believers" along the way that have contributed to this commercial success. On this occasion, Medlive specially invitedProfessor Wang Jianxiang from the Blood Disease Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), and Dr. Lü Lulu, CEO of JuventasThese two individuals, who have personally experienced the journey, discuss the initial intentions, explorations, and the path to market of this highly anticipated CAR-T cell product.
Thick Accumulation, Thin Emission, Finally Achieving Success: Touching the Brightest Star in the CAR-T Sky
"We must strengthen ourselves, aim high, and live up to the times and our youthful years! Based on the previous research of our predecessors, our R&D team successfully constructed a CAR-T structure targeting CD19 during 2013-2014. The antibody sequence used in this CAR-T construct came from earlier research achievements at our Hematology Research Institute," stated Professor Wang Jianxiang from the Hematology Hospital of the Chinese Academy of Medical Sciences. "Unlike the internationally common FMC63 single-chain antibody, the antibody used in Nalkiorensai Injection is HI19a, a self-developed single-chain antibody. These antibodies recognize different epitopes on CD19. Therefore, this is an entirely new CAR-T product with independent intellectual property rights!"
Only the tough grass can withstand the strong wind, and true gold fears no fire! In subsequent in vitro and mouse in vivo experiments, the efficacy and safety of Naciorlen were validated; based on this, investigator-initiated clinical research (IIT research) was also conducted afterward. This study further confirmed the excellent therapeutic effects of Naciorlen, with over 90% of patients achieving complete remission (CR) and reaching minimal residual disease (MRD) negativity. Thanks to the promising results obtained in the early stages, this CAR-T product, Naciorlen, has gained increasing recognition and is gradually moving from a scientific achievement toward commercialization.
Where there is a will, there is a way! Initiating a new drug clinical trial (IND) is an essential yet lengthy step toward product commercialization. Through Phase I clinical trials, the optimal clinical dosage of the product is determined, followed by Phase II clinical trials to confirm its efficacy and safety. Observations reveal that patients not only achieve high remission rates, but some also maintain them for extended periods. As research progresses, the pivotal Phase II clinical study of Narlagicel for adult R/R B-ALL has also reached its primary endpoint — the overall response rate (ORR) at 3 months.
Time flies, and the years pass like a shuttle! From the screening and establishment of hybridomas, to the cloning, sequencing, and validation of antibody sequences, and then to the construction of CAR-T products, after layer upon layer of testing through in vitro experiments, animal in vivo experiments, IIT, Phase I, and Phase II clinical trials, Juventas' Naciorlen Injection has been successfully approved for marketing by the National Medical Products Administration (NMPA). This also represents the best outcome of over thirty years of dedicated research in the field of hematological oncology by Chinese scholars and experts, who have relentlessly explored and fearlessly advanced.
Professor Wang Jianxiang commented, "As one of the members of the research and development team for China's first approved CAR-T product for leukemia indications, I sincerely congratulate the approval and market launch of Naji Orinase Injection. I also look forward to this product bringing new hope to patients with relapsed or refractory ALL!"
Unite Strengths, Source the Future, Draw the Most Brilliant Blueprint of the CAR-T Era
If you bloom, the breeze will come! From 2018 to 2023, through five years of relentless efforts, Juventas has finally ushered in the successful approval and market launch of its first core product, Naciaurel Injection! "This is Juventas' first major core product. Its development and market entry have carried the dreams, hard work, and hopes of so many people! I sincerely thank the scientists, researchers, patients, and medical institutions who have tirelessly worked on the development and market launch of Naciaurel!" said Dr. Lü Lulu emotionally.
When it comes to this product, she becomes effusive; as for the various experiences in the past, she enumerates them like cherished treasures—this is like a child she has painstakingly raised, and she has devoted all her efforts here. As China's first CAR-T drug in the field of leukemia treatment and also the first CD19 CAR-T product with full independent intellectual property rights in China, Nagegene Celurestem not only features a unique "warhead" and CAR structure design but also boasts internationally leading technology and a commercial production system. Currently, more than 200 patients in China have received treatment with Nagegene Celurestem.
"Resilient through countless trials, standing firm against winds from all directions!" Data from a multicenter registrational clinical study conducted in China on adult patients with R/R B-ALL shows that the overall response rate (ORR) of Naciorlenzumab reaches 82.1%, with better safety profiles. It demonstrates significant advantages over traditional chemotherapy, novel bispecific antibodies, and antibody-drug conjugates. Moreover, Naciorlenzumab truly makes the dream of "one treatment, lasting benefits" a reality for patients, providing sustained remission and long-term survival with a single infusion. Based on this breakthrough efficacy, Naciorlenzumab has been granted "Orphan Drug" designation by the U.S. Food and Drug Administration (FDA), and its overseas clinical research is about to commence. Additionally, clinical studies of Naciorlenzumab in pediatric ALL patients are already underway, and clinical research targeting earlier-line adult ALL patients will soon be initiated, bringing hope of a cure to more ALL patients. With the development of multiple indications such as lymphoma and autoimmune diseases, an increasing number of patients will benefit from Naciorlenzumab treatment in the future.
"And let us enjoy the full fragrance of fine wine, sharing the fleeting dream of life! Dr. Lü Lulu remarked, 'Over the past five years, we have witnessed together the development and successful launch of Naciorlenzene! In the future, we also want to work with all experts to build a patient-centered, end-to-end medical and quality control system for personalized cell therapy, ensuring that every ALL patient can receive the most effective medical treatment and high-quality cellular drug therapy, gaining long-term survival benefits from Naciorlenzene treatment. Let us join hands and create a bright future for Naciorlenzene in treating ALL!'"
Vast China, abundant with talents! As a novel type of cellular therapeutic drug, it not only breaks the limitations of traditional drug treatments but also successfully ushers in a new era of treatment for patients with hematologic malignancies! From an idea, an exploration, an application to the final implementation, it has undergone a long and arduous journey, filled with countless decisions at every crossroad. The successful launch of CAR-T cell therapy is not only a perfect representation of the hard work by experts, scholars, research institutes, and enterprises who have devoted day and night efforts, but also brings new hope to tens of thousands of patients with hematologic malignancies! It is believed that in the future, with everyone's joint efforts, patients with hematologic malignancies will eventually welcome a bright tomorrow!
Reviewed by: Vitalis
Typesetting: Gloria
Executor: Eve
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