JW Therapeutics Announces NMPA Acceptance of the Supplemental New Drug Application for Carteyva® in Patients with Relapsed or Refractory Follicular Lymphoma

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Feb 27, 2022, 05:30 ET

SHANGHAI, Feb. 27, 2022 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva^® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL). This is the second marketing application on Carteyva^® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva^® was granted Breakthrough Therapy Designation by NMPA in September 2020.

The sNDA was supported by the 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 study results were presented at the 63^rd American Society of Hematology (ASH) Annual Meeting in December 2021. The cohort B results showed that Carteyva^®demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).

Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63^rd American Society of Hematology (ASH) Annual Meeting: "The RELIANCE study results show that Carteyva^®demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China."

About Relmacabtagene Autoleucel Injection (trade name: Carteyva^®)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva^®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of Carteyva^® in adult patients with relapsed or refractory B cell non-hodgkin lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) in China.

RELIANCE cohort B study enrolled 28 patients with r/r FL who had failed the second-line (or above) therapy, including an anti-CD20 agent and anthracycline. Patients received 100*10⁶ CAR-T or 150*10⁶ CAR-T cell of Carteyva^®infusion, and followed up until 2 years or above for long term outcomes. As of the cut-off date of September 10, 2021, of 27 evaluable patients, the Complete Response Rate (CRR) and Overall Response Rate (ORR) at 3 months were 85.19% and 100%, and the Best Complete Response Rate and Overall Response Rate was 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), Among these AEs, no CRS of Grade 3 or above occurred, and only 3.6% of the patients experienced NT of Grade 3 or above.

About JW Therapeutics

JW Therapeutics (HKEx: 2126) is an independent, innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and WuXi AppTec in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-Looking Statements

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

SOURCE JW Therapeutics