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.
ನೀವು ಓದಲು ಇಷ್ಟಪಡಬಹುದು: ಚೀನಾದಲ್ಲಿ CAR T ಸೆಲ್ ಥೆರಪಿ
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 ಡಿಸೆಂಬರ್ 2021 ರಲ್ಲಿ ಅಮೇರಿಕನ್ ಸೊಸೈಟಿ ಆಫ್ ಹೆಮಟಾಲಜಿ (ASH) ವಾರ್ಷಿಕ ಸಭೆ® ಬಾಳಿಕೆ ಬರುವ ಕಾಯಿಲೆಯ ಪ್ರತಿಕ್ರಿಯೆಯ ಅತಿ ಹೆಚ್ಚಿನ ದರಗಳನ್ನು ಪ್ರದರ್ಶಿಸಿದೆ (ಒಟ್ಟಾರೆ ಪ್ರತಿಕ್ರಿಯೆ ದರ (ORR)=100%, ಸಂಪೂರ್ಣ ಪ್ರತಿಕ್ರಿಯೆ ದರ (CRR) = 85.19% ತಿಂಗಳಲ್ಲಿ 3; ORR=92.58%, CRR = 77.78% ತಿಂಗಳು 6) ಮತ್ತು ನಿಯಂತ್ರಿಸಬಹುದಾದ CAR-T r/r FL ರೋಗಿಗಳಲ್ಲಿ ಸಂಬಂಧಿಸಿದ ವಿಷತ್ವಗಳು. ಚೀನಾದಲ್ಲಿ ಪ್ರಸ್ತುತ ಲಭ್ಯವಿರುವ ಚಿಕಿತ್ಸೆಗಳನ್ನು ನೀಡಲಾಗಿದೆ, ಕಾರ್ಟೆವಾ® r/r FL ಹೊಂದಿರುವ ರೋಗಿಗಳಿಗೆ ಹೆಚ್ಚಿನ ಲಾಭ-ಅಪಾಯದ ಅನುಪಾತದೊಂದಿಗೆ ಚಿಕಿತ್ಸೆಯ ಆಯ್ಕೆಯಾಗಿ ಪರಿಣಮಿಸಬಹುದು ಮತ್ತು ಅತ್ಯುತ್ತಮ ದರ್ಜೆಯ CAR-T ಉತ್ಪನ್ನವಾಗುವ ಸಾಮರ್ಥ್ಯವನ್ನು ಹೊಂದಿದೆ.
Professor Yuqin Song, the principal investigator of RELIANCE study, Deputy Director of the Lymphoma Department, and Vice President of ಪೀಕಿಂಗ್ ವಿಶ್ವವಿದ್ಯಾಲಯದ ಕ್ಯಾನ್ಸರ್ ಆಸ್ಪತ್ರೆ, 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 ಸೆಲ್ ಇಮ್ಯುನೊಥೆರಪಿ product for the treatment of the r/r FL in China.”
ನೀವು ಓದಲು ಇಷ್ಟಪಡಬಹುದು: ಚೀನಾದಲ್ಲಿ ಬಹು ಮೈಲೋಮಾಕ್ಕೆ CAR T ಸೆಲ್ ಥೆರಪಿ
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®, ಮತ್ತು ಕಾರ್ಟೈವಾ ಗುರುತಿಸುವಿಕೆಗಾಗಿ ನಿಯಂತ್ರಕರಿಗೆ ಧನ್ಯವಾದಗಳು®. 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 ಇಮ್ಯುನೊ ಉತ್ಪನ್ನಗಳು."
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 ಲಿಂಫೋಮಾ (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 ನಿಲುವಂಗಿ ಕೋಶ ಲಿಂಫೋಮಾ (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
Relmacabtagene Autoleucel ಇಂಜೆಕ್ಷನ್ ಬಗ್ಗೆ (ವ್ಯಾಪಾರ ಹೆಸರು: Carteyva®)
Relmacabtagene autoleucel injection, which is also sold under the brand name Carteyva®. It is an autologous ವಿರೋಧಿ CD19 CAR-T ಸೆಲ್ ಇಮ್ಯುನೊಥೆರಪಿ 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 ಚೀನಾದಲ್ಲಿ CAR-T ಉತ್ಪನ್ನ ರಾಷ್ಟ್ರೀಯ ಮಹತ್ವದ ಹೊಸ ಔಷಧ ಅಭಿವೃದ್ಧಿ ಕಾರ್ಯಕ್ರಮ, ಆದ್ಯತೆಯ ಪರಿಶೀಲನೆ ಮತ್ತು ಪ್ರಗತಿಯ ಚಿಕಿತ್ಸಾ ಪದನಾಮಗಳಲ್ಲಿ ಏಕಕಾಲದಲ್ಲಿ ಸೇರಿಸಲಾಗಿದೆ.
ನೀವು ಓದಲು ಇಷ್ಟಪಡಬಹುದು: ಚೀನಾದಲ್ಲಿ CAR T ಸೆಲ್ ಚಿಕಿತ್ಸೆಯ ವೆಚ್ಚ
JW ಥೆರಪ್ಯೂಟಿಕ್ಸ್ ಬಗ್ಗೆ
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.
