CASI Pharmaceuticals shares fall 18.00% premarket after NMPA rejects FOLOTYN license renewal, halting China sales.

CASI Pharmaceuticals fell 17.99% in premarket trading following the National Medical Products Administration (NMPA) of China formally rejecting the company’s renewal application for the FOLOTYN import drug registration license. The denial, announced after a May 2025 submission and prior regulatory warnings, forced the company to halt FOLOTYN sales in China, a key market and its only commercialized product. The loss of this revenue stream, coupled with ongoing legal disputes over other assets like EVOMELA and CNCT-19, has narrowed the firm’s commercial focus to its CID-103 clinical program. The regulatory setback and halted sales in China, a primary geographic market, directly contributed to the sharp premarket decline.