Business
Coherus BioSciences Reports Fourth Quarter and Full Year 2021 Results
– YUSIMRY™ (adalimumab-aqvh), Coherus’ second product, approved by FDA on December 17, 2021 –– BLAs under FDA review for PD-1 inhibitor toripalimab and
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– YUSIMRY™ (adalimumab-aqvh), Coherus’ second product, approved by FDA on December 17, 2021 –– BLAs under FDA review for PD-1 inhibitor toripalimab and CIMERLI™ (ranibizumab-ranq) –– New FDA filings expected in 2022 for UDENYCA® on-body injector and additional toripalimab indications –– UDENYCA® delivered net sales of $73 million in 4Q 2021; $327 million in FY 2021 –– Conference call and webcast today at 5:00 p.m. ET – REDWOOD CITY, Calif., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for the quarter and full year ended December 31, 2021 and highlighted recent achievement of important milestones toward the Company’s key strategic initiatives: RECENT EXECUTION ON KEY STRATEGIC INITIATIVESBuilding an innovative immuno-oncology company: U.S. Food and Drug Administration (“FDA”) granted toripalimab BLA priority review for nasopharyngeal carcinoma (“NPC”) and assigned a target action date of April 30, 2022.Toripalimab in combination with chemotherapy demonstrated a statistically significant overall survival benefit in prespecified interim analysis of Phase 3 clinical trial in patients with non-small cell lung cancer.Initiated process to exercise option to license JS006, a TIGIT targeted antibody being evaluated in combination with toripalimab in an ongoing Phase 1/2 clinical trial.Advancing internal immuno-oncology antibody into IND enabling studies. Diversifying and growing the commercial product portfolio: FDA approved YUSIMRY™ (adalimumab-aqvh), a Humira® biosimilar, on December 17, 2021.FDA accepted for review the BLA for CIMERLI™ (ranibizumab-ranq), a Lucentis® biosimilar, and assigned a target action date in August 2022.UDENYCA® (pegfilgrastim-cbqv) on-body injector (“OBI”) achieved both pharmacokinetic and pharmacodynamic bioequivalence in randomized clinical trial, enabling prior approval supplement filing with FDA in 2022; if approved, a UDENYCA OBI would compete directly with Neulasta® Onpro® which retains approximately 50% share of the overall pegfilgrastim market. “We have made rapid progress transforming Coherus into an innovative immuno-oncology company supported by income from a diversified portfolio of FDA-approved products. In 2022, we expect to launch two new products, if approved, including our first immuno-oncology antibody...