CAR-T Multiple Myeloma,Carsgen Therapeutics’ Zevorcabtagene Autoleucel (CT053) Approved for Marketing in China for the Treatment of Relapsed or Refractory Multiple Myeloma
CAR-T Multiple Myeloma,Carsgen Therapeutics’ Zevorcabtagene Autoleucel (CT053) Approved for Marketing in China for the Treatment of Relapsed or Refractory Multiple Myeloma
Zevorcabtagene Autoleucel Approved in China for Marketing
On March 1, 2024, CARsgen Therapeutics announced that its CAR-T product candidate Zevorcabtagene Autoleucel (CT053) has received formal approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory multiple myeloma. This approval marks a significant breakthrough for CARsgen in the field of cell therapy and provides a new treatment option for patients with multiple myeloma.
Multiple myeloma is a malignant blood cancer for which there is currently no definitive cure. Traditional treatments such as chemotherapy and radiation therapy have limited efficacy for relapsed or refractory patients, so the development of new therapeutic drugs is crucial for improving patient survival and quality of life.
Introduction to Zevorcabtagene Autoleucel
Zevorcabtagene Autoleucel is an autologous BCMA-targeted CAR-T product candidate that has demonstrated significant therapeutic effects in clinical trials for adult patients with relapsed or refractory multiple myeloma. In patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, Zevorcabtagene Autoleucel can effectively prolong survival and significantly improve treatment outcomes, bringing new hope to this patient population.
Zevorcabtagene Autoleucel is an autologous BCMA-targeted CAR-T cell product generated by lentiviral transduction of T cells. The lentivirus encodes a CAR comprising a fully human BCMA-specific single-chain variable fragment (scFv), a human CD8α hinge and transmembrane domain, a 4-1BB costimulatory domain, and a CD3ζ activation domain. The proprietary fully human scFv exhibits high binding affinity and stability. As an autologous CAR-T product, Zevorcabtagene Autoleucel works by modifying a patient’s own T cells to enable them to more effectively recognize and attack tumor cells. This personalized, targeted approach offers improved treatment outcomes for patients with relapsed or refractory multiple myeloma.
Notably, the approval of Zevorcabtagene Autoleucel is based on its demonstrated efficacy and safety in a series of clinical trials. The results showed that the drug can significantly prolong patient survival and improve quality of life, while adverse reactions remain manageable. Therefore, the NMPA’s approval is a well-informed decision based on a rigorous, scientific, and regulatory review process.
Remarks from CARsgen Therapeutics
The approval of Zevorcabtagene Autoleucel marks a major breakthrough for CARsgen in the field of CAR-T therapy and provides more treatment options for patients with multiple myeloma. As a malignant cancer with limited response to traditional therapies, the availability of Zevorcabtagene Autoleucel brings new hope to these patients. This NDA approval also signifies that Zevorcabtagene Autoleucel will become the first approved autologous CAR-T product in China, offering a new treatment hope for domestic multiple myeloma patients. As CAR-T therapy continues to evolve and improve, the launch of Zevorcabtagene Autoleucel is expected to bring new breakthroughs and transformations to cancer treatment in China.
“On the 10th anniversary of CARsgen’s founding, I am thrilled to announce the successful approval of Zevorcabtagene Autoleucel, a significant milestone in the company’s development journey and the best reward for our team’s unwavering efforts,” said Dr. Zonghai Li, Founder, Chairman, CEO, and Chief Scientific Officer of CARsgen Therapeutics. “I sincerely thank our team members, researchers, patients, and all sectors of society for their support and trust. We look forward to Zevorcabtagene Autoleucel bringing more hope to adult patients with relapsed or refractory multiple myeloma and improving their survival. Upholding our vision of ‘Innovation for Human Health,’ we will continue to explore new technologies, expand our product pipeline with global rights, address key challenges in CAR-T cell therapy, and bring innovative and differentiated cell therapies to cancer patients worldwide.”
Mr. Liang Lv, Chairman and General Manager of Huadong Medicine, said, “CARsgen Therapeutics is a leader in cell therapy for cancer. Zevorcabtagene Autoleucel is a differentiated fully human BCMA CAR-T product that has demonstrated outstanding safety and efficacy in clinical trials. We are pleased to collaborate with CARsgen Therapeutics and be responsible for the commercialization of Zevorcabtagene Autoleucel in mainland China, enabling more Chinese multiple myeloma patients to benefit from this treatment. In the future, we will continue to accelerate our presence in the oncology field, upholding the corporate philosophy of ‘science-based and patient-centered,’ actively promoting the research and industrialization of our pipeline and in-licensed new drugs, and ultimately achieving Huadong Medicine’s international presence and leading market competitiveness in the field of oncology.”
The approval of CARsgen Therapeutics’ Zevorcabtagene Autoleucel will provide a new treatment option for patients with relapsed or refractory multiple myeloma. This breakthrough not only showcases the potential of cell therapy in the field of malignant tumors but also injects new momentum into the development of innovative companies like CARsgen Therapeutics. We look forward to seeing more innovative drugs come to market in the future, bringing hope and vitality to more patients.