SHANGHAI, June 4, 2025 /PRNewswire/ — 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 LiuChairman 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."
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