LONDON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- TREOS Bio Ltd., a clinical-stage biotechnology company developing next-generation off-the-shelf peptide cancer immunotherapies, today announced the execution of clinical collaboration agreements with Charité – Universitätsmedizin Berlin and Junshi Biosciences for the initiation of OBERTO-202, a potentially registration-enabling Phase II clinical trial evaluating PolyPEPI1018 in combination with toripalimab (Junshi Biosciences' PD-1 inhibitor) and standard of care in ...

Core Viewpoint - Junshi Biosciences announced the acceptance of a supplemental new drug application for toripalimab in combination with disitamab vedotin for treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking toripalimab's 13th marketing application in mainland China [1] Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diversified R&D pipeline of over 50 drug candidates [11] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [11] - Toripalimab is China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in 40 countries and regions, including China, the US, and Europe [11][10] Group 2: Industry Context - Urothelial carcinoma (UC) is one of the ten most prevalent malignant tumors globally, with rising incidence and mortality rates in China; in 2022, there were 92,900 new cases and over 40,000 deaths [2] - The treatment landscape for advanced UC has been reshaped by the emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates (ADCs), offering significant improvements in survival benefits and tolerability compared to conventional chemotherapy [3] - The RC48-C016 study demonstrated that toripalimab combined with disitamab vedotin significantly improved progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy regimens [5][4]

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration (NMPA) for two supplemental new drug applications for ongericimab, marking it as China's first domestic PCSK9-targeted drug approved for statin-intolerant patients [1][10]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [13]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [13]. - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [13]. Product Details - Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody injection, approved for three indications in China: 1) adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia; 2) adult patients with heterozygous familial hypercholesterolemia (HeFH); 3) statin-intolerant patients with non-familial hypercholesterolemia and mixed dyslipidemia [11]. - The approved specifications for ongericimab are 150 mg (1 ml) in a single dose, available in pre-filled syringes and autosyringes [11]. Clinical Trials - The approval of ongericimab is based on two registered clinical trials: JS002-005 and JS002-007 [6]. - JS002-005 involved 135 patients with HeFH and demonstrated significant LDL-C reductions of 69.4% and 80.6% compared to placebo [8]. - JS002-007 is focused on statin-intolerant patients with primary hypercholesterolemia and mixed dyslipidemia, with results to be published soon [9]. Market Context - Cardiovascular disease is the leading cause of death in China, with atherosclerotic cardiovascular disease (ASCVD) being the predominant subtype [2]. - Lowering LDL-C levels is crucial for reducing the incidence of ASCVD and associated mortality [2]. - Approximately 9.1% of patients exhibit statin intolerance, which is more prevalent in Asian populations, leading to suboptimal LDL-C levels and increased cardiovascular risk [4].

Core Insights - Coherus BioSciences announced promising clinical data for CHS-114, a selective anti-CCR8 antibody, demonstrating efficacy in combination with toripalimab for treating head and neck squamous cell carcinoma (HNSCC) and gastric cancer [1][2][4] - A confirmed partial response was observed in a heavily pretreated PD-1 refractory patient, indicating potential for overcoming PD-1 resistance [2][13] - The ongoing Phase 1b trial aims to optimize dosing and evaluate safety and efficacy, with results expected in the first half of 2026 [1][8] Company Overview - Coherus BioSciences is focused on developing innovative oncology treatments, including the next-generation PD-1 inhibitor, LOQTORZI (toripalimab), and has a pipeline targeting various cancers [16][17] - The company is advancing CHS-114 in combination with toripalimab in two Phase 1b clinical trials for advanced solid tumors, including HNSCC and gastric cancer [15][17] Clinical Trial Details - The Phase 1b trial evaluated CHS-114 as a monotherapy and in combination with toripalimab in 21 patients, focusing on dose-limiting toxicities and treatment-emergent adverse events [5][12] - Key findings include a significant depletion of CCR8+ Treg cells (52-97%) and an increase in CD8+ T cells, supporting the mechanism of action for CHS-114 [6][13] Future Directions - The company plans to continue exploring CHS-114's potential in various solid tumors, with a strategic focus on HNSCC and gastric cancer [4][8] - Upcoming data presentations are expected to provide further insights into the efficacy and safety of CHS-114 in combination therapies [1][9]

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration for toripalimab as the first-line treatment for unresectable or metastatic melanoma, marking its 12th indication in mainland China [1][8]. Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [12]. - The company has achieved significant milestones, including the approval of toripalimab, China's first domestically developed anti-PD-1 monoclonal antibody, in over 35 countries and regions [12][9]. - The company aims to provide world-class, trustworthy, affordable, and innovative drugs, with a mission of "In China, For Global" [13]. Group 2: Product and Clinical Study Insights - Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-1 interactions, enhancing the immune system's ability to target tumor cells [6]. - The supplemental NDA approval for toripalimab was based on the MELATORCH study, a Phase 3 clinical trial that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to dacarbazine [3][4]. - The MELATORCH study showed a median PFS of 2.3 months for toripalimab versus 2.1 months for dacarbazine, with a 29.2% reduction in disease progression or mortality risk [4]. Group 3: Market Context and Clinical Need - Melanoma is a highly aggressive cancer with a rising incidence rate in China, where traditional treatments have limited effectiveness [2]. - The approval of toripalimab addresses an urgent clinical need for first-line immunotherapy options in advanced melanoma, as no domestic anti-PD-1 monoclonal antibody had been previously approved for this indication [2][5]. - The results from the MELATORCH study are particularly relevant to Chinese patients, as the trial exclusively enrolled participants from China [5].

Financial Data and Key Metrics Changes - UDENYCA net product sales for Q4 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023. For fiscal year 2024, UDENYCA net sales were $206 million, an increase of 62% compared to $127.1 million for fiscal year 2023 [24][10]. - Cost of goods sold (COGS) decreased to $118 million in 2024 from $159 million in 2023, primarily driven by lower COGS from divested products and reduced inventory write-offs [53]. - Total GAAP R&D and SG&A expenses for 2024 were $261 million, reflecting decreases in both R&D and SG&A due to lower headcount and cost savings from biosimilar divestitures [54]. Business Line Data and Key Metrics Changes - LOQTORZI net revenue was $7.5 million in Q4, a 29% increase quarter-over-quarter, with fiscal year 2024 revenue at $19.1 million [28]. - UDENYCA market share in Q4 was 15% with an exit share of 22%, with expectations for continued market share growth in 2025 [26]. Market Data and Key Metrics Changes - The company reported that nearly 80% of all NCCN institutions have used LOQTORZI for at least one patient, with a 37% increase in new accounts purchasing LOQTORZI in Q4 [30]. - The NCCN updated MPC guidelines in November 2024, placing LOQTORZI in a preferred position for metastatic and locally recurrent MPC patients [34]. Company Strategy and Development Direction - The company aims to maximize revenues with LOQTORZI, expand its indications, and advance its proprietary pipeline in innovative oncology [8]. - The divestiture of the UDENYCA franchise is a significant strategic change, expected to close in late Q1 or early Q2, which will enhance the company's focus on oncology [10][11]. - The company has divested at least $800 million in assets or commitments, paying off $480 million in debt, positioning itself with $250 million in cash post-transaction [17]. Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the divestiture process, stating there are no expected obstacles and that investor support is strong [64]. - The company is focused on enhancing investor appreciation of its value proposition post-transaction, with a strong balance sheet and promising data expected in the future [12]. Other Important Information - The company has made substantial progress in its strategic transformation, including the acquisition of Surface Oncology for $40 million, which adds promising oncology candidates to its pipeline [15]. - The company expects to reduce headcount by 30% post-transaction, with a significant portion of off-balance sheet commitments transitioning to the buyer [57]. Q&A Session Summary Question: Are there any hurdles expected with the UDENYCA divestiture? - Management sees no obstacles and believes the divestiture will proceed as planned, with all necessary reviews completed [64][65]. Question: Does the $250 million cash projection include cost savings from headcount reduction? - The $250 million represents expected cash after the transaction, net of payoffs and other cash flows, and does not specifically account for headcount reduction savings [67][68]. Question: Where is LOQTORZI currently being used now that it has both front line and second line in guidelines? - LOQTORZI is being used in a mix of recurrent locally advanced and metastatic first-line patients, with expectations for increased use due to updated guidelines [73][76]. Question: What is the FDA looking for regarding the second supplier's labeling and packaging? - The FDA requires validation runs and data review from the new contract manufacturer, which has been completed [81][82]. Question: What are the expectations for the head and neck cancer data in the first half of this year? - The company anticipates reporting data from around 30-35 patients, focusing on safety, early efficacy, and biomarker data [100]. Question: How much continued use is there of off-label IO agents in the MPC market? - There is ongoing off-label use, particularly in community settings, and the company is actively working to increase awareness of LOQTORZI and the NCCN guidelines [131][134].