SHANGHAI, CHINA, October 10, 2022 – JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing, and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, trade name: Carteyva®) for the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). This is the second approved indication for relma-cel following its initial approval and launch in September last year, and it makes it the first cell immunotherapy product approved in China for the treatment of r/r FL patients.
Maaari mong basahin ang: CAR T Cell therapy sa Tsina
This approval is based on the 6-month clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva® in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma in China. The 3-month data were presented at the 63rd Taunang Pagpupulong ng American Society of Hematology (ASH) noong Disyembre 2021. Ang mga resulta ng cohort B ay nagpakita na ang Carteyva® nagpakita ng napakataas na rate ng matibay na pagtugon sa sakit (kabuuang rate ng pagtugon (ORR)=100%, kumpletong rate ng pagtugon (CRR)=85.19% sa ika-3 buwan; ORR=92.58%, CRR=77.78% sa ika-6 na buwan) at nakokontrol na CAR-T nauugnay na mga toxicity sa mga pasyente na may r/r FL. Dahil sa kasalukuyang magagamit na mga paggamot sa China, ang Carteyva® ay maaaring maging opsyon sa paggamot na may mas mataas na ratio ng benepisyo-panganib para sa mga pasyenteng may r/r FL, at may potensyal na maging pinakamahusay sa klase na produkto ng CAR-T.
Professor Yuqin Song, the principal investigator of RELIANCE study, Deputy Director of the Lymphoma Department, and Vice President of Ospital ng Kanser sa Pamantasan ng Peking, commented, “The overall response rate (ORR) of the efficacy endpoint was over 90%, and the overall safety profile was manageable. Remal-cel has become the first CAR-T cell immunotherapy product for the treatment of the r/r FL in China.”
Maaari mong basahin ang: CAR T Cell therapy para sa maramihang myeloma sa China
James Li, co-founder, chairman, and CEO of JW Therapeutics, said, “Thanks to the patients and investigators who contributed to the clinical studies of Carteyva®, at salamat sa mga regulator para sa pagkilala sa Carteyva®. We are pleased with the second approved indication, which provides a new and breakthrough treatment option for r/r FL patients. JW Therapeutics is committed to maximizing the value of Carteyva®, continuously advancing technology innovation and pipeline development, and improving the accessibility of cell immunotherapy mga produkto. "
As the first product of JW Therapeutics and the first CAR-T product approved as a Category 1 biologics product in China, relma-cel has been approved for two indications in China, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). JW Therapeutics is currently doing or plans to do more clinical studies on hematologic malignancies and autoimmune diseases to fully explore the clinical potential of Carteyva®. These include third-line mantel cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
Tungkol sa Relmacabtagene Autoleucel Injection (pangalan ng kalakalan: Carteyva®)
Relmacabtagene autoleucel injection, which is also sold under the brand name Carteyva®. It is an autologous anti-CD19 CAR-T cell immunotherapy product that was built on a CAR-T cell process platform from Juno Therapeutics, a Bristol Myers Squibb company. Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only Produktong CAR-T sa China na sabay-sabay na isinama sa National Significant New Drug Development Program, priority review, at breakthrough therapy designations.
Maaari mong basahin ang: Gastos ng CAR T Cell therapy sa China
Tungkol sa JW Therapeutics
JW Therapeutics (HKEX: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing, and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering both hematologic malignancies and solid tumors. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China’s cell immunotherapy industry.
