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Tuesday, April 7, 2026

Coherus, Junshi Biosciences Get FDA Complete Response Letter (1) - Bloomberg Law

(Updates to add CHRS shares and context.)

Shanghai Junshi Biosciences and Coherus BioSciences received a complete response letter from the U.S. Food and Drug Administration for use of the PD-1 inhibitor toripalimab in head and neck cancers.

  • CHRS shares fall 2.7% in U.S. premarket trading
  • The Biologics License Application is for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy
  • Letter requests a quality process change that Coherus and Junshi Biosciences ...


Read Full Story: https://news.bloomberglaw.com/health-law-and-business/coherus-junshi-bioscien...