Coherus Oncology Conference Summary Company Overview - **Company**: Coherus Oncology (NasdaqGM:CHRS) - **Focus**: Transitioned from a biosimilar company to a commercial-stage innovative oncology company with a focus on immuno-oncology pipeline, particularly PD-1 inhibitors and novel therapies [3][4][5] Key Products and Pipeline - **Toripalimab**: FDA-approved next-generation PD-1 inhibitor, cornerstone of the oncology pipeline [4][5] - **Casdozokitug**: First-in-class anti-IL27 therapy showing promise in liver cancer and other tumor types [11][12] - **Tagmukitug**: Cytolytic antibody targeting CCR8, showing potential in various solid tumors [53][54] Clinical Data and Efficacy - **Casdozokitug**: - Phase 1 trial showed manageable safety profile with no dose-limiting toxicities (DLTs) [16] - Monotherapy activity observed in squamous non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) [17] - In combination with Atizo and Bev for hepatocellular carcinoma (HCC), showed an overall response rate (ORR) of 38% and a complete response (CR) rate of 17%, compared to historical controls of 30% and 8% respectively [20][21] - Responses observed irrespective of viral etiology, indicating broad applicability [22] - **Tagmukitug**: - Demonstrated ability to deplete CCR8-positive T regulatory cells in tumors, leading to increased CD8 T cell activity [56] - Early data from head and neck cancer patients showed promising responses in heavily pre-treated individuals [62] Safety and Tolerability - **Casdozokitug**: Safety profile encouraging, with no significant increase in immune-related adverse events compared to standard treatments [26][27] - **Tagmukitug**: Selective targeting of CCR8 with a favorable safety profile, avoiding off-target toxicity seen in other CCR8 programs [58][59] Market Position and Future Outlook - **Market Strategy**: Coherus aims to leverage its innovative pipeline to establish a strong position in the oncology market, focusing on underserved patient populations [5][9] - **Upcoming Milestones**: - Initial data for the Casdozokitug triplet combination expected in mid-2026 [47] - Continued development of Tagmukitug across multiple tumor types with data anticipated throughout 2026 [65] Conclusion - Coherus Oncology is positioned for a data-rich 2026 with promising clinical trials and innovative therapies that could significantly impact cancer treatment, particularly in HCC and other solid tumors [71]

Core Viewpoint - Junshi Biosciences announced the acceptance of the new drug application (NDA) for 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 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 designed to treat moderate to severe plaque psoriasis by targeting the inflammatory pathway associated with the disease [1][6]. - The NDA submission is based on a pivotal phase 3 clinical study involving 747 patients across 60 clinical sites in China, demonstrating significant efficacy and a favorable safety profile [3][4]. Clinical Study Insights - The phase 3 clinical study showed that treatment with roconkibart for 12 weeks resulted in significant improvements in the Psoriasis Area and Severity Index (PASI) scores and static Physician Global Assessment (sPGA) scores compared to the placebo group [4]. - The efficacy of roconkibart was maintained throughout a 52-week treatment period, indicating its potential as a long-term treatment option for patients [4]. Market Implications - 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]. - The company aims to collaborate closely with regulatory authorities to expedite the product's market approval process [5].

Summary of Shanghai Junshi Biosciences Conference Call Company Overview - **Company**: Shanghai Junshi Biosciences - **Established**: 2012 - **Focus**: Commercialization-stage biotech company specializing in oncology and autoimmune indications with over 15 clinical-stage assets [11][29] Key Industry Insights - **Market Performance**: Junshi's share price increased by 167% year-to-date, outperforming HSBIO's 100% increase [2] - **Valuation**: The price target is set at HK$34.70, reflecting a risk-adjusted P/peak sales of 2.4x, in line with peer median [5][7] Core Product Insights - **Toripalimab (PD-1)**: - Remains the primary revenue driver, with sales of Rmb954 million in H125, up 42% YoY [4][29] - Expected to exceed Rmb2 billion in 2025 due to new indications included in the National Reimbursement Drug List (NRDL) [29] - Anticipated sales growth driven by additional indications such as perioperative NSCLC and 1L TNBC [9][29] Clinical Development Highlights - **JS207 (PD-1/VEGF)**: - Key candidate with eight phase-2 trials initiated, covering various cancers [3][12] - Early-stage data expected by late 2025/early 2026, crucial for demonstrating its potential [3][15] - Positioned as a strong competitor in the PD-1/VEGF field [3][12] - **Other Candidates**: - **JS015 (DKK1)**: First-in-class DKK1 in phase-2, showing promising early data in colorectal and gastric cancers [19][20] - **JS203 (CD20/CD3)**: Early efficacy signals with 80% ORR in phase-1 trials, pivotal trials expected to start in 2026 [22][23] - **Tifcemalimab (BTLA)**: Global first-in-class candidate in phase-3 for limited-stage small cell lung cancer, with data read-out expected in late 2026 [16][17] Financial Projections - **Revenue Growth**: Projected sales CAGR of 20% from 2025 to 2027, primarily driven by toripalimab and new NRDL inclusions [4][9] - **Profitability Timeline**: Expected to reach breakeven by 2027, with net earnings improving from losses in the coming years [6][29] Risks and Considerations - **Clinical Data Dependency**: The success of multiple candidates, especially JS207, hinges on upcoming clinical data readouts [15][28] - **Market Sentiment**: Positive market sentiment exists for Junshi's potential business development (BD) opportunities, but actual performance will depend on clinical outcomes [15][28] Conclusion - Junshi is positioned for growth with a strong pipeline and key revenue drivers, particularly toripalimab. However, the company must navigate the challenges of clinical data validation and market competition to realize its full potential.

Coherus BioSciences FY Conference Summary Company Overview - Coherus BioSciences has transitioned from a biosimilar company to a full immuno-oncology (IO) company, divesting its biosimilar business over the past year and acquiring Surface Oncology in 2023, which added key assets CHS-114 and Casdozokitug to its pipeline [4][6] Core Strategies and Differentiation - The company focuses on combining its PD-1 agent, Toripalimab, with other agents like CHS-114 and Casdozokitug to enhance patient outcomes in various cancers [5][6] - Coherus emphasizes partnerships and collaborations, aiming to validate its platform, generate income, and share costs for pivotal trials [6][7] - The company plans to focus on ex-U.S. partnerships and licensing, with global rights to its assets acquired through recent acquisitions [6][8] Product Performance and Market Position - LOQTORZI, the company's product, has been positioned at the top of NCCN guidelines, leading to a 36% increase in utilization from Q1 to Q2 2025 [12] - The company anticipates reaching $150 to $200 million in revenue by mid-2028, although early adoption may be uneven due to the nature of the patient population [12][13] - 90% of NCCN institutions have ordered LOQTORZI, indicating strong performance in academic centers, while community settings require more educational efforts [14][15] Pipeline Developments - Casdozokitug, an IL-27 antagonist, is in a phase 2 study for first-line HCC, showing promising early responses and safety profiles [16][18] - CHS-114, a CCR8 antibody, is in several phase 1 studies, targeting T-regs in solid tumors, with early data showing immune activation and robust T-reg depletion [22][23] Competitive Landscape and Market Dynamics - The company does not foresee significant impact from the potential loss of exclusivity for Keytruda, as its products are differentiated and will not be directly affected by biosimilars [25][26] - Coherus is positioned to collaborate with other biotechs, especially in underserved tumor types, enhancing its development capabilities [28] Future Milestones - Upcoming milestones include top-line results from the HCC study on Casdozokitug and further progression of CHS-114 in head and neck and gastric cancers [33] - The company expects to pursue transactions to offset development costs and anticipates earnout payments from its partner Accord Healthcare, which has gained significant market share [34]