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.
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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 Щорічна зустріч Американського товариства гематології (ASH) у грудні 2021 р. Результати когорти B показали, що Carteyva® продемонстрували дуже високі показники стійкої відповіді на захворювання (загальна частота відповіді (ORR)=100%, частота повної відповіді (CRR)=85.19% на 3-й місяць; ORR=92.58%, CRR=77.78% на 6-й місяць) і контрольований CAR-T асоційована токсичність у пацієнтів з р/р ФЛ. Враховуючи доступні на даний момент методи лікування в Китаї, Carteyva® може стати варіантом лікування з вищим співвідношенням користі та ризику для пацієнтів з r/r FL і має потенціал стати найкращим у своєму класі продуктом CAR-T.
Professor Yuqin Song, the principal investigator of RELIANCE study, Deputy Director of the Lymphoma Department, and Vice President of Ракова лікарня Пекінського університету, 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 Імунотерапія клітин CAR-T product for the treatment of the r/r FL in China.”
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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®, і подяка регуляторам за визнання 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 імунотерапія продуктів. "
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 лімфома (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 мантійноклітинна лімфома (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
Про Relmacabtagene Autoleucel Injection (торгова назва: Carteyva®)
Relmacabtagene autoleucel injection, which is also sold under the brand name Carteyva®. It is an autologous анти-CD19 CAR-T-клітинна імунотерапія 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 Продукт CAR-T в Китаї який одночасно був включений до Національної програми розробки нових значущих ліків, пріоритетного перегляду та призначення проривної терапії.
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Про 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.
