By Fineline Cube 
American pharmaceutical giant AbbVie (NYSE: ABBV) disclosed that its bispecific T‑cell engager, epcoritamab, has been granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The approval is targeted at adult patients with relapsed or refractory follicular lymphoma (FL), a high‑need subset of B‑cell malignancies.
Why Epcoritamab Matters
- Dual‑Target Mechanism – Epcoritamab simultaneously engages CD3 on T‑cells and CD20 on malignant B‑cells, directing cytotoxic T‑cell activity precisely to lymphoma cells.
- Regulatory Track Record – The drug received FDA and European Commission approvals in 2023, underscoring its safety and efficacy profile.
- Co‑Development Synergy – The partnership with Genmab (NASDAQ: GMAB) began in 2020, encompassing three bispecific antibodies, with epcoritamab emerging as the flagship product.
Commercial Strategy
- Joint Responsibility in US & Japan – AbbVie and Genmab currently share commercialization duties in these key markets.
- Global Roll‑Out – AbbVie will take the lead on worldwide commercialization, leveraging its global oncology portfolio and distribution network.
Impact on the Chinese Oncology Landscape
The NMPA’s priority review signals a rapid approval pathway, potentially shortening the time to market for a highly effective therapy in China. For patients with relapsed or refractory FL, epcoritamab offers a novel mechanism of action that may improve response rates and durability compared to existing salvage regimens.
Future Outlook
AbbVie plans to submit the full NDA to the NMPA by Q2 2026, with a potential market launch in China by late 2027. The company is also exploring combination strategies with checkpoint inhibitors to further enhance efficacy.-Fineline Info & Tech