SHANGHAI, CHINA, June 4, 2025 - JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that its new drugapplication (NDA) for the CAR-T cell immunotherapy product Carteyva® (relma-cel, targeting CD19) was approved by the Macao Special Administrative Region Government's Drug Regulatory Authority. This marks the first overseas market access for the product after its approval in mainland China, as well as a significant breakthrough in JW Therapeutics' global strategy.
The approval covers three major indications, including: Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy; Adult patients with refractory or relapsed within 24 months follicular lymphoma after two or more lines of systemic therapy; Adult patients with relapsed or refractory mantle cell lymphoma after second line or above systemic treatment, including treatment with Bruton tyrosine kinase inhibitors.As JW Therapeutics' first commercial product, the marketing approval of Carteyva® in Macao will further expand its accessibility in hematological oncology.
Mr. Min Liu
Chairman and CEO of JW Therapeutics
The approval of Carteyva® in Macao marks the official launch of JW Therapeutics' internationalization journey, demonstrating our technical strength and regulatory recognition in the field of cell therapy. As our first overseas market, Macao lays a solid foundation for our expansion into Asia-Pacific and global markets. In the future, we’ll speed up regional commercialization and strengthen global R&D and manufacturing collaboration to offer hope to more patients.
About JW Therapeutics
JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.
About Relmacabtagene Autoleucel Injection
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: 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, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, 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), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.
Forward-Looking Statements
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