Coherus BioSciences, Inc. is a commercial-stage biopharmaceutical company, which engages in the development and commercialization of biosimilar therapeutics. Its products include UDENYCA and Coherus COMPLETE. The company was founded by Dennis M. Lanfear, Stuart E. Builder, Dr. Alan Herman, Doug Farrar and Steve Glover in September 2010 and is headquartered in Redwood City, CA.
Clinical Trials
28
13 active
Approvals
8
Total approvals
Agencies
1
Regulatory bodies
Founded
2010
Active, not recruiting
12
42.9%
Completed
10
35.7%
Not yet recruiting
1
3.6%
Recruiting
2
7.1%
Terminated
2
7.1%
Unknown
1
3.6%
- Formycon AG announced a strategic partnership with ATHOS KG valued at approximately €650 million, marking one of the most significant developments in the German biotech company's history. - The collaboration grants Formycon participation rights in two biosimilar candidates, accelerating time-to-market while reducing clinical and regulatory risk compared to in-house development. - The deal structure includes upfront payments, milestone fees tied to regulatory approvals, and commercial royalties, representing a fundamental shift in Formycon's capital allocation strategy. - Biosimilars command higher margins than generic pharmaceuticals due to sophisticated manufacturing requirements and regulatory complexity, positioning Formycon in an attractive market segment driven by patent expirations and healthcare cost containment.
- Health Canada has granted approval for LOQTORZI (toripalimab), marking the first and only immunotherapy approved for patients with recurrent unresectable or metastatic nasopharyngeal carcinoma. - The therapy is indicated both as combination treatment with cisplatin and gemcitabine for metastatic or recurrent locally advanced disease, and as monotherapy for patients who have progressed following platinum-based chemotherapy. - This approval represents Apotex's first novel biologic therapy and addresses a critical unmet medical need for patients facing this ultra-rare and aggressive cancer. - The Canadian pharmaceutical company secured rights to LOQTORZI through an agreement with Coherus BioSciences, expanding access to innovative oncology treatments in Canada.
- Intas Pharmaceuticals and Accord BioPharma have completed the acquisition of UDENYCA (pegfilgrastim-cbqv), a biosimilar to Amgen's Neulasta, from Coherus BioSciences. - The acquisition positions the companies as one of the largest global suppliers of pegfilgrastim, significantly expanding their FDA-approved biosimilar portfolio. - UDENYCA is indicated to decrease infection incidence in cancer patients receiving myelosuppressive chemotherapy and offers three patient-friendly administration options. - Accord was the first company to commercialize a pegfilgrastim biosimilar in Europe and the only company to launch an autoinjector formulation.
- Coherus BioSciences has completed its strategic transformation to Coherus Oncology, reflecting its exclusive focus on proprietary innovative immuno-oncology medicines. - The company's pipeline centers on LOQTORZI (toripalimab-tpzi), the only FDA-approved PD-1 inhibitor indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma. - Two novel candidates are advancing through clinical trials: CHS-114, a selective CCR8 antibody targeting regulatory T cells, and casdozokitug, a first-in-class IL-27 antagonist showing activity across multiple cancer types. - A randomized Phase 2 study is evaluating casdozokitug combined with toripalimab and bevacizumab versus standard combination therapy in first-line advanced metastatic hepatocellular carcinoma.
- STORM Therapeutics has dosed the first patient in a Phase 1b/2 combination study evaluating STC-15, a METTL3 inhibitor, with LOQTORZI (toripalimab) for multiple cancer types. - The trial will enroll up to 188 patients with NSCLC, head and neck squamous cell carcinoma, melanoma, and endometrial cancer in the United States. - Previous Phase 1 data showed STC-15 achieved a 9% overall response rate and 67% disease control rate in patients with advanced malignancies. - The company appointed Atif Abbas, M.D. as Chief Medical Officer to lead the clinical development strategy for this first-in-class RNA modifying enzyme inhibitor.
- Coherus BioSciences has completed the divestiture of its UDENYCA pegfilgrastim franchise to Intas Pharmaceuticals in a deal valued at up to $558.4 million, receiving $483.4 million upfront with potential for $75 million in milestone payments. - The strategic transaction transforms Coherus into a focused oncology company with a $250 million post-close cash balance, extending its runway into 2027 and funding pipeline development through key data catalysts. - Coherus will now concentrate exclusively on its innovative oncology portfolio, including LOQTORZI (toripalimab-tpzi), a revenue-generating PD-1 inhibitor, and promising pipeline candidates casdozokitug (IL-27 antagonist) and CHS-114 (CCR8 antibody).
- Coherus BioSciences' selective anti-CCR8 antibody CHS-114 demonstrated clinical efficacy in combination with toripalimab in head and neck squamous cell carcinoma, achieving a confirmed partial response in a heavily pretreated PD-1 refractory patient. - The treatment showed proof of mechanism with >50% depletion of CCR8+ regulatory T cells and significant increases in CD8+ T cells in tumors, effectively remodeling the tumor microenvironment to favor anti-tumor activity. - Based on these promising results, Coherus is advancing a second-line Phase 1 dose optimization study of CHS-114 with toripalimab in both HNSCC and gastric cancer, with results expected in the first half of 2026.
- The FDA has not issued an action letter for toripalimab's Biologics License Application by the December 23, 2022 PDUFA date, pending required manufacturing facility inspection in China. - Toripalimab, developed by Junshi Biosciences and Coherus, has received priority review status for treating advanced recurrent or metastatic nasopharyngeal carcinoma in both first-line and second-line settings. - The drug represents a potential breakthrough for nasopharyngeal carcinoma patients, an aggressive head and neck cancer currently lacking FDA-approved treatment options.
- The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. - At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. - The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.
- Coherus BioSciences' novel triplet therapy combining casdozo, atezolizumab, and bevacizumab demonstrates significant efficacy in treating metastatic hepatocellular carcinoma during Phase 2 trials. - The company's unique anti-IL-27 therapy, casdozo, shows potential for enhancing anti-tumor effects when used in combination treatments, leading to a positive market outlook. - H.C. Wainwright analyst maintains a Buy rating with a $7.00 price target, citing promising clinical data and strategic valuation projections through 2035.
