JW Therapeutics Announces NMPA Approval of Relmacabtagene Autoleucel Injection in China

The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally

Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation

May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated toxicities

JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, R&D code JWCAR029) for 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 has released the drug registration certificate. Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally.

Relma-cel, JW Therapeutics' first CAR-T product, was independently developed based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company) to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review (in r/r LBCL) and breakthrough therapy designations (in follicular lymphoma). To date, over 100 patients have been dosed with relma-cel in clinical studies, marking relma-cel a most studied anti-CD19 CAR-T product in China.

This approval is based on the results of a single-arm, multi-center, pivotal study (RELIANCE study) to evaluate the efficacy and safety of relma-cel in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. RELIANCE study results show that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities, and may provide a best-in-class CAR-T therapy profile.

Professor Zhu Jun, the lead investigator of RELIANCE study, Chief of Internal Medicine Department and Lymphoma Department at Peking University Cancer Hospital, said, "The RELIANCE study is a registrational clinical study completed with high quality, and I'm very proud of that. Based on the outstanding efficacy and safety profiles it demonstrated in RELIANCE study, I believe that relma-cel will provide healthcare professionals in China with an additional treatment option and bring hope for long-term remission and even cure for lymphoma patients."

Edward Hu, Vice Chairman and Global Chief Investment Officer at WuXi AppTec, said, "Congratulations to JW Therapeutics for the approval of its first product. WuXi AppTec will continue to enable more companies to deliver advanced therapies for patients globally. Cell and gene therapy is one of the most promising therapies for curing cancer. As the co-founder and investor of JW Therapeutics, we are very pleased to witness its development over the past five years and are fully confident that JW Therapeutics will continue to lead the development of cell immunotherapy in China, and to bring us closer to a cure for cancer."

Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb, said, "As a long-standing strategic partner of JW Therapeutics, we are pleased by our work together to advance the important science of cell therapy. Today's news, building from our CAR T cell process platform from Juno Therapeutics, marks an important milestone for patients in China and in achieving our shared goal of innovating breakthroughs for patients with cancer."

James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, "We sincerely thank all the patients and investigators who have participated and contributed in the clinical studies of relma-cel. We're also encouraged by the Chinese regulators for taking the lead in following the science and approving the NDA of the sixth CAR-T therapy on a global scale. JW is committed to serving every Chinese patient through continued technology innovation."

Sources:

Zhu J, et al. Clinical Response of CD19 CAR-T Cells (relma-cel) in Adults with Heavily-Pre-Treated Relapsed/Refractory (r/r) Large B-Cell Lymphoma in China. ASH 2020. Abstracts 1186.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)

Relmacabtagene autoleucel injection (trade name: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). 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 a 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 relmacabtagene autoleucel injection (relma-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. At the time it was conducted, this study was the largest clinical study of CAR-T cell therapy in China under the Investigational New Drug (IND) pathway.

RELIANCE study enrolled 59 patients with r/r LBCL who had failed at least two lines of therapy, including a CD20 agent and anthracycline, and patients continue to be monitored for up to 2 years and beyond for long term outcomes. As of the June 17, 2020 data cut-off, the Best Overall Response Rate was 75.9% with a Best Complete Response Rate of 51.7% in 58 evaluable patients; of 59 treated patients, 5.1% and 3.4% of the patients experienced CRS and NT of Grade 3 or above, respectively. Rates for any severity grade CRS and NT were 47.5% and 20.3%, respectively.

About JW Therapeutics

JW Therapeutics (HKEx: 2126) is an 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

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Source: JW Therapeutics

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