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

SHANGHAI,Feb.27,2022 -- 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 63rd 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 63rd 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,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.

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