-Coherus Oncology formally introduces non-proprietary name: tagmokitug- -Publication shows picomolar affinity for CCR8 with no off-target binding and proof-of- mechanism in preclinical and clinical studies- -Data show CCR8 target is present with high prevalence and density in many solid tumors- REDWOOD CITY, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced the publication of preclinical and clinical biomarker research in Molecular Cancer Therapeutics describing ...

Core Insights - Junshi Biosciences announced promising long-term survival results for toripalimab from the JUPITER-02 and JUPITER-06 trials at the ESMO ASIA Congress 2025, highlighting its potential as a leading immunotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC) and advanced esophageal squamous cell carcinoma (ESCC) [1][2] Group 1: JUPITER-02 Trial - JUPITER-02 is the first global multicenter, double-blind, randomized Phase 3 trial in immunotherapy for NPC, demonstrating significant long-term survival benefits with toripalimab plus chemotherapy [3][6] - The trial enrolled 289 chemotherapy-naïve patients with R/M NPC, showing a median overall survival (mOS) of 64.8 months for the toripalimab group compared to 33.7 months for the placebo group, representing a 39% reduction in death risk [5][8] - Toripalimab plus chemotherapy is now approved in over 40 countries and endorsed by major international guidelines, establishing a new standard of care for first-line treatment of R/M NPC [6][8] Group 2: JUPITER-06 Trial - JUPITER-06 is a Phase 3 trial evaluating toripalimab combined with paclitaxel and cisplatin (TP) chemotherapy for advanced or metastatic ESCC, showing a mOS of 17.7 months compared to 12.9 months for the placebo group, with a 28% reduction in death risk [11][12] - The trial included 514 systemic treatment-naïve patients, confirming consistent overall survival benefits across subgroups, regardless of PD-L1 expression status [12][14] - Toripalimab has gained approval for first-line treatment of advanced ESCC in multiple regions, including Europe, marking a significant milestone in immunotherapy [14][19] Group 3: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on developing novel therapies, with a diverse R&D pipeline of over 50 drug candidates across various therapeutic areas [20][21] - The company has successfully developed toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody, which has been approved in over 40 countries [20][21] - Junshi Biosciences aims to provide world-class, affordable, and innovative drugs, with a commitment to global health [21]

Core Viewpoint - Junshi Biosciences has received acceptance for the new drug application (NDA) of roconkibart injection, a treatment for moderate to severe plaque psoriasis, by the National Medical Products Administration (NMPA) in China [1][5]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of innovative therapeutics [8]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8]. - Junshi Biosciences has achieved significant milestones, including the approval of five products in China and international markets, notably toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [8]. Product Details - Roconkibart (JS005) is a recombinant humanized anti-IL-17A monoclonal antibody injection designed to treat adult patients with moderate to severe plaque psoriasis [1][6]. - The drug works by selectively blocking IL-17A, a cytokine involved in the inflammatory pathway of psoriasis, thereby alleviating symptoms of autoimmune diseases [6]. Clinical Study Insights - The NDA is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy in improving psoriasis severity scores compared to placebo [3][4]. - Results indicated that treatment with roconkibart for 12 weeks led to substantial improvements in the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) scores, with a favorable safety profile maintained over 52 weeks [4]. Future Prospects - The acceptance of the NDA is seen as a critical step in transitioning roconkibart from clinical research to real-world application, with expectations for early approval to enhance treatment options for patients in China [5].

Coherus Oncology Conference Call Summary Company Overview - Coherus Oncology transitioned to being solely an innovative oncology company after divesting its biosimilar business in Q2 2025, marking Q3 2025 as its first quarter focused exclusively on oncology [6][13] - The company reported $198 million in cash on its balance sheet at the end of Q3 2025, indicating strong financial management [13] Pipeline Programs Toripalimab (LOQTORZI) - Toripalimab is a next-generation PD-1 inhibitor with unique binding sites, demonstrating activity in low PD-L1 states [7] - Approved for front-line and second-line nasopharyngeal carcinoma in 2023, generating $11 million in revenue in Q3 2025, a 12% increase from Q2 2025 [17][19] - The drug has shown a strong hazard ratio, extending survival from 22 months to over 48 months in nasopharyngeal cancer patients [18] - The company aims for 10-15% revenue growth, targeting $150-$200 million by 2028 [20] - Adoption is strong among academic physicians, but community physicians require more education about the drug [21][22] - Combination strategies with other therapeutics are being explored to enhance treatment efficacy [15][16] CHS-114 (CCR8 Targeting) - CHS-114 is a highly selective molecule targeting CCR8, which plays a significant role in Treg cells within the tumor microenvironment [26][28] - The drug is designed to deplete Tregs, potentially allowing CD8 positive T cells to infiltrate tumors, which is crucial for effective immunotherapy [30][34] - The clinical program is strategically designed to evaluate efficacy across various cancers, including head and neck, gastric, and colorectal cancers [32][35] - The company is optimistic about the potential for CHS-114 to show significant activity in underserved tumor types [32] Casdozokitug - Casdozokitug is an anti-IL-27 molecule showing promising efficacy in liver cancer, with a focus on improving overall response rates and progression-free survival [50][51] - The company anticipates data from ongoing studies in the first half of 2026, which will inform the design of future phase two and three trials [47][48] Strategic Partnerships and Deals - Coherus has global rights to its products, allowing for flexibility in forming partnerships, particularly in Asian markets for liver cancer treatments [12][53] - The company is open to collaborations with other biotech firms to enhance the development of its products [40][41] - Upcoming deals are expected to validate the value of its assets and provide upfront funding to offset clinical costs [53][54] Key Catalysts and Future Outlook - The company is focused on delivering data in 2026 that will support the advancement of its pipeline products [34][46] - Coherus is positioned to leverage its scientific leadership and partnerships to enhance patient outcomes and drive growth [45][46] - The next 12-18 months are expected to be pivotal for the company, with significant updates anticipated from ongoing studies and potential partnerships [52][55]

Core Insights - Coherus Oncology's CHS-114 shows promising results in selectively depleting CCR8+ Tregs and enhancing immune response in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] Clinical Trial Results - The Phase 1b clinical trial of CHS-114 demonstrated a greater than 50% increase in intratumoral CD8 T cells, indicating a shift towards a "hot" tumor microenvironment [1][2] - CHS-114 treatment resulted in a 74% reduction in CCR8+ Treg density and a 73% increase in CD8+ T cell density, showcasing effective immune remodeling [5][6] Safety and Efficacy - The combination of CHS-114 with toripalimab has shown a manageable safety profile and early signs of antitumor activity in HNSCC patients [2][3] - A partial response was observed in a refractory head and neck cancer patient during initial safety testing of the combination therapy [3] Development Strategy - The data supports advancing CHS-114 in combination with toripalimab or other immune activators, aligning with the company's development plan [3][4] - Ongoing enrollment in the dose optimization arm aims to address the FDA's Project Optimus and define a phase 2 dose for CHS-114 [3][7] Company Overview - Coherus Oncology is focused on developing innovative oncology therapies, including the next-generation PD-1 inhibitor LOQTORZI and CHS-114, targeting various cancers [9][10]

Core Insights - Coherus Oncology announced new multiomic tumor and blood-based biomarker data from the Phase 1b clinical trial of CHS-114, a selective anti-CCR8 antibody, presented at the SITC Annual Meeting [1][2] - The data indicate that CHS-114, both as a monotherapy and in combination with toripalimab, shows promising early antitumor activity and a manageable safety profile in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] Clinical Trial Findings - The interim analysis shows significant immune activation enhancement with CHS-114 and toripalimab, including selective depletion of CCR8+ Tregs and increased CD8+ T cells in the tumor microenvironment [2][5] - CHS-114 treatment resulted in a 74% decrease in CCR8+ Treg density and a 73% increase in CD8+ T cell density, indicating effective tumor microenvironment remodeling [6][5] - A partial response was observed in a refractory HNSCC patient during initial safety testing of the combination therapy [3] Development Strategy - The data support advancing CHS-114 in combination with toripalimab or other immune activators, with ongoing enrollment in the dose optimization arm of the study [3][8] - The study aims to define a phase 2 dose and address the FDA's Project Optimus [3] About CHS-114 - CHS-114 is designed to selectively target and deplete CCR8+ Tregs while preserving CD8+ effector T cells, showing potential for enhanced antitumor activity [9][10] - The drug is currently being evaluated in multiple Phase 1b clinical trials for various advanced solid tumors, including HNSCC, colorectal cancer, gastric cancer, and esophageal cancer [9][11] Company Overview - Coherus Oncology is a commercial-stage oncology company with an approved PD-1 inhibitor, LOQTORZI, and a promising pipeline targeting various cancers [10][11] - The company's strategy focuses on growing sales of LOQTORZI and advancing new indications in combination with its pipeline candidates [10]

Core Viewpoint - Junshi Biosciences has received FDA approval for its investigational new drug application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable non-small cell lung cancer (NSCLC) in a phase 2/3 clinical study [1][3][4] Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [2] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis; however, 30%-55% of these patients experience recurrence post-surgery [2] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies, with over 50 drug candidates in its R&D pipeline [8][9] - The company has five therapeutic focus areas, including cancer, and has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8] Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences, currently approved for phase 2/3 clinical studies and being explored in various cancers [5][6] - The drug can bind to PD-1 and VEGFA, blocking their interactions and improving the tumor microenvironment, which enhances anti-tumor activity [6][7] Clinical Study Insights - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing JS207 to nivolumab for neoadjuvant treatment in patients with stage II/III, resectable, AGA-negative NSCLC [3][4] - Professor Yilong WU from Guangdong Provincial People's Hospital will lead the study as the principal investigator [3]

Core Viewpoint - Junshi Biosciences has received FDA approval for the IND application of JS207, a bispecific antibody targeting PD-1 and VEGF, for a phase 2/3 clinical study in patients with resectable NSCLC [1][4]. Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022. NSCLC accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis. Despite surgical treatment, 30%-55% of patients experience recurrence and death [2]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies. The company has over 50 drug candidates in its R&D pipeline, with five products approved in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8][9]. Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences for advanced malignant tumors. It is currently approved for phase 2/3 clinical studies and is being explored in combination with other therapies for various cancers, including NSCLC and triple-negative breast cancer [5][6]. Clinical Study Design - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing the efficacy and safety of JS207 to nivolumab for neoadjuvant treatment in stage II/III, resectable, AGA-negative NSCLC. This study is significant as JS207 is the first PD-1/VEGF dual-target drug approved for such a study [3][4]. Mechanism of Action - JS207 binds simultaneously to PD-1 and VEGFA, blocking their interactions and enhancing anti-tumor activity. It combines the effects of immunotherapeutic and anti-angiogenic drugs, improving the tumor microenvironment and increasing cytotoxic T lymphocyte infiltration [6][7].

Core Insights - HUTCHMED will present new and updated data from several studies at the ESMO Congress 2025, scheduled for October 17-21, 2025, in Berlin, Germany [1][2] Group 1: Study Presentations - Results from the FRUSICA-2 study on the combination of fruquintinib and sintilimab for second-line treatment of advanced renal cell carcinoma will be presented in a Mini Oral session [2] - Additional analyses from the FRUSICA-1 study in endometrial cancer and the SACHI and SAVANNAH studies in non-small cell lung cancer will be showcased during poster sessions [2] - Specific presentations include a phase 3 study comparing fruquintinib plus sintilimab against axitinib or everolimus for renal cell carcinoma [2] Group 2: Drug Information - Fruquintinib is a selective oral inhibitor of VEGFRs and is co-developed by HUTCHMED and Eli Lilly, marketed as ELUNATE® in China [4] - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, commercialized as ORPATHYS® [5] - Surufatinib is an oral angio-immuno kinase inhibitor marketed in China as SULANDA® and retains all rights with HUTCHMED [8]

Company Overview - Junshi Biosciences is a leading innovation-driven biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies [1][8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, the first domestically produced anti-PD-1 monoclonal antibody in China [8] Product Development - The recombinant humanized anti-IL-17A monoclonal antibody, JS005, has shown positive results in a Phase 3 clinical study for treating moderate to severe plaque psoriasis [1][3] - The study met both co-primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements compared to the placebo group [1][4] - JS005 is designed to block IL-17A, a cytokine involved in autoimmune diseases, thereby alleviating symptoms of conditions like psoriasis [6] Clinical Study Insights - The Phase 3 study was conducted at 60 clinical sites across China, led by Professor Jianzhong ZHANG from Peking University People's Hospital [3] - Results indicated that a higher proportion of participants achieved a sPGA score of 0 or 1 with JS005 compared to the placebo, along with good safety profiles [4][5] - The study results will be presented at future international academic conferences, highlighting the significance of JS005 in psoriasis treatment [4] Market Context - Psoriasis affects approximately 125 million people globally, with a prevalence of 2.0% to 3.0% worldwide and 0.47% in China [2] - Patients with moderate to severe psoriasis face increased risks of metabolic syndrome, cardiovascular disease, and mental health issues, underscoring the need for effective treatments [2] - The successful Phase 3 study of JS005 represents a significant milestone in addressing the treatment gap for patients suffering from this chronic condition [5]