By Fineline Cube 
JW (Cayman) Therapeutics Co. Ltd (HKG: 2126) announced today that the National Medical Products Administration (NMPA) of China has formally accepted its post‑marketing supplementary application for Carteyva (relmacabtagene autoleucel injection) based on an in‑house produced lentiviral vector. The approval marks a pivotal step in expanding Carteyva’s commercial availability and addresses long‑standing supply‑chain constraints that have limited the product’s global rollout.
Key Highlights
- NMPA Acceptance – The supplementary application confirms that Carteyva, an autologous anti‑CD19 CAR‑T cell therapy, can be manufactured using JW’s newly developed lentiviral vector JWLV011.
- First‑in‑China Category 1 Biologic – Carteyva is the first CAR‑T product approved as a Category 1 biologics therapy in China, covering relapsed or refractory large B‑cell lymphoma (r/r LBCL), follicular lymphoma (r/r FL), and mantle cell lymphoma (r/r MCL).
- Supply‑Chain Stabilization – By shifting from overseas lentiviral vector suppliers to the in‑house JWLV011 platform, JW Therapeutics aims to reduce raw‑material costs, enhance production scalability, and improve quality control.
Clinical Evidence
A Phase 2 single‑arm study demonstrated that Carteyva produced with JWLV011 is clinically comparable to products manufactured with traditional lentiviral vectors, supporting the safety and efficacy profile that underpins the NMPA’s acceptance.
Strategic Impact
- Commercial Expansion – The new manufacturing route positions JW Therapeutics to meet growing demand for CAR‑T therapies in China and abroad.
- Cost Optimization – In‑house vector production is projected to lower per‑dose costs, potentially expanding patient access.
- Innovation Leadership – The successful integration of a proprietary lentiviral vector platform reinforces JW’s reputation as a pioneer in next‑generation immunotherapies.-Fineline Info & Tech