PR91493

SHANGHAI, Sept. 6, 2021/PRNewswire=KYODO JBN/ --

- 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

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