According China’s National Medical Products Administration (NMPA), on September 3, it has approved the new drug application for Carteyva (relmacabtagene autoleucel injection), a CAR-T cell therapy developed indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Carteyva (relmacabtagene autoleucel) is an autologous CD19-targeted CAR-T cell immunotherapy developed by JW Therapeutics, based on the Breyanzi product platform from Juno Therapeutics. It is the first domestically approved Class 1 innovative CAR-T drug in China for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
This approval is supported by the results of a prospective, single-arm, multicenter pivotal study conducted by JW Therapeutics in China, which demonstrated the efficacy and safety of Carteyva® in Chinese patients with relapsed or refractory LBCL.
A New Therapy, A New Choice: China’s First Class 1 Innovative CAR-T Product Set to Lead the Industry
Professor Zhu Jun stated:
In recent years, China’s oncology landscape has entered a new era, marked by rapid advancements and the emergence of innovative therapies. However, the journey to approval for new anti-cancer drugs, especially domestically developed Class 1 innovative drugs, remains long and challenging. Dr. Zhu emphasizes that accelerating the approval and availability of these therapies is a shared mission for medical professionals, researchers, and pharmaceutical companies alike.
Dr. Zhu commends the achievement of Carteyva, a CAR-T cell therapy developed by JW Therapeutics, in becoming one of the few locally-developed anti-cancer drugs to secure regulatory approval. He highlights the immense effort, rigorous clinical trials, and collaboration across the medical community that led to this success. The product’s approval is not only a win for China’s biopharmaceutical innovation but also a contribution to global cancer care, reflecting China’s growing role and responsibility on the world stage.
The launch of Carteyva sets a new benchmark for the field, offering safer and more effective treatment options for lymphoma patients in China. Dr. Zhu expresses hope that this milestone will inspire the development of more cutting-edge therapies, helping more patients and fulfilling the shared aspirations of clinicians and the pharmaceutical industry. Ultimately, Carteyva® represents both a scientific breakthrough and a promise of better care for cancer patients.
Professor Huang Xiaojun stated:
“All five previously approved CAR-T products were developed by international pharmaceutical companies, including Yescarta and Tecartus by Gilead, Kymriah by Novartis, and Breyanzi and Abecma by Bristol Myers Squibb. Therefore, the approval of Carteyva, developed by JW Therapeutics, is of great significance. Carteyva is the sixth CAR-T product approved globally and the first domestically developed Class 1 innovative CAR-T product in China.”
