We are a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 ("PD-1") inhibitor, LOQTORZI (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, head and neck, colorectal and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma ("NPC") and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners, driving sales multiples and synergies from proprietary combinations. On May 29, 2025, we changed our corporate name from "Coherus BioSciences, Inc." to "Coherus Oncology, Inc." to better align with our exclusive focus on proprietary innovative immuno-oncology medicines following the completion of the recent divestitures of our biosimilar businesses.
On October 27, 2023, we announced that LOQTORZI was approved by the U.S. Food and Drug Administration ("FDA") in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adults with recurrent unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is an anti-PD-1 antibody that we developed in collaboration with Junshi Biosciences Co., Ltd. ("Junshi Biosciences") that is currently the only immune checkpoint inhibitor approved by the FDA for the treatment of these indications that is commercially available in the United States. We announced the launch of LOQTORZI in the U.S. on January 2, 2024. Further evaluation of LOQTORZI is expected through multiple current and planned clinical studies by us, Junshi Biosciences and our biopharma partners.
Our pipeline comprises two mid-stage clinical candidates aimed at overcoming immune resistance in cancer. We plan to develop each of them in combination with LOQTORZI as well as in partnership with other companies with immune activating or cancer agents. Our clinical stage product candidate casdozokitug (CHS-388, formerly SRF388) is an investigational antagonist antibody targeting IL-27, an immune regulatory cytokine, that is overexpressed in certain cancers, including hepatocellular, lung and renal cell carcinoma. Casdozokitug received orphan drug designation from the FDA for the treatment of hepatocellular carcinoma ("HCC") in October 2020. The lead indication for casdozokitug is 1L HCC, and it is currently being studied in a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab (clinicaltrials.gov identifier# NCT06679985).
Our second clinical-stage product candidate, tagmokitug (CHS-114, formerly SRF114), is an investigational afucosylated IgG1 antibody targeting CCR8, a chemokine receptor highly expressed on regulatory T cells ("Treg cells") in the tumor microenvironment ("TME"). We are enrolling patients with head and neck squamous cell carcinoma ("HNSCC") in the U.S. in a clinical trial evaluating safety and pharmacokinetics of tagmokitug with and without LOQTORZI (clinicaltrials.gov identifier# NCT05635643). We have also initiated a multiregional Phase 1b clinical study of tagmokitug in combination with toripalimab and/or other treatments in participants with advanced solid tumors including several cohorts including 2L upper GI adenocarcinoma, 2L esophageal squamous cell carcinoma ("ESCC"), 1LESCC, and Phase 2a cohort evaluating 4L+ colorectal cancer (clinicaltrials.gov identifier# NCT06657144). We have planned a clinical study evaluating tagmokitug in combination with pasritamig (a T cell engaging bispecific antibody targeting KLK2) in metastatic castrate resistant prostate cancer.