Investment Rating - The industry investment rating is Attractive [7] Core Insights - The report highlights several promising clinical trial results for various biotech companies, indicating potential best-in-class therapies in oncology and other therapeutic areas [2][3][4][5][6] - The report emphasizes the competitive landscape in the biotech sector, particularly in the context of EGFRm+ NSCLC, where DB-1310 faces significant competition [3] - The report provides a detailed analysis of multiple abstracts presented at ASCO, showcasing the efficacy and safety of various drug candidates [6][10] Summary by Relevant Sections Clinical Trial Results - DB-1311 in 3L CRPC shows a median rPFS of 8.3 months, indicating best-in-class potential [2] - DB-1310 in pre-treated EGFRm+ NSCLC demonstrates a uORR of 35.7% and mPFS of 7.0 months, competitive against peer HER3-ADCs [3] - Surufatinib + KN046 in 1L PDAC shows better response and safety, with mPFS competitive against SoC [4] - IBI363 in MSS/pMMR CRC shows consistent ORR and potential best-in-class mDoR of 7.5 months [4] Abstract Reactions - The report includes reactions to select abstracts from ASCO, indicating meaningful upside for DB-1311 and modest upside for DB-1310 [6][10] - IBI363 shows consistent results in immunotherapy-treated acral/mucosal melanoma with a DoR of 14 months [5] - ZL-1310 in r/r ES-SCLC shows an ORR of 68%, demonstrating best-in-class potential [5] Company Ratings - The report provides ratings for various companies in the healthcare sector, with notable mentions including: - 3SBio rated as ++ - Adicon Holdings rated as Overweight - Alibaba Health rated as Overweight [61]

Core Insights - Zenas BioPharma is advancing its obexelimab program through multiple clinical trials, with topline results expected in late 2025 for Immunoglobulin G4-Related Disease and early Q4 2025 for Relapsing Multiple Sclerosis [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease is the largest clinical trial conducted for this condition, with topline results anticipated around year-end 2025 [1][4] - The Phase 2 MoonStone trial for Relapsing Multiple Sclerosis is concluding enrollment, with topline results expected early in Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus is expected to complete enrollment by year-end 2025, with topline results anticipated in mid-2026 [1][4] Leadership Changes - The company has strengthened its leadership team with the appointments of Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., as Chief Scientific Officer [1][4] Financial Position - As of March 31, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $314.2 million, which is expected to fund operations into Q4 2026 [1][11] - License and collaboration revenue for Q1 2025 was $10 million, attributed to a sublicense agreement with Zai Lab [11] - Research and development expenses increased to $34.9 million in Q1 2025 from $22.6 million in Q1 2024, primarily due to clinical development costs for obexelimab [11] - General and administrative expenses rose to $12.4 million in Q1 2025 from $4.9 million in Q1 2024, driven by increased personnel costs and pre-commercialization activities [11] Product Overview - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function without depleting them, targeting autoimmune diseases [3][7][9] - The drug has shown clinical activity in five completed trials involving 198 patients, providing initial proof of concept for its efficacy [8]

Financial Performance & Guidance - Zai Lab reported total revenue of $399.0 million for FY'24, a 50% year-over-year increase, and $109.1 million for 4Q'24, a 66% year-over-year increase[33, 34] - Adjusted loss from operations improved by 28% year-over-year for FY'24 and 53% year-over-year for 4Q'24[8] - The company's cash position was strong at $879.7 million as of December 31, 2024, compared to $806.5 million as of December 31, 2023[8, 46] - Zai Lab projects total revenue guidance of $560~$590 million for 2025 and targets profitability by 4Q'25[45] Product Performance & Pipeline - VYVGART/VYVGART Hytrulo revenue reached $93.6 million in FY'24, an 835% increase year-over-year, and $30.0 million in 4Q'24, a 492% increase year-over-year[33] - ZEJULA revenue was $187.1 million in FY'24, an 11% increase year-over-year, and $48.4 million in 4Q'24, a 16% increase year-over-year[33] - NUZYRA revenue was $43.2 million in FY'24, a 99% increase year-over-year, and $11.0 million in 4Q'24, an 81% increase year-over-year[33] - The company anticipates launching three new potential blockbuster drugs in China in 2025-26: Bemarituzumab, KarXT, and TTFields[13, 15, 17] Clinical Development & Regulatory Milestones - KarXT's NDA was accepted by the NMPA in January 2025 for schizophrenia[7, 16, 99] - ZL-1310 (DLL3 ADC) showed a 74% ORR in 2L+ SCLC patients in Phase 1 trials and was granted Orphan Drug Designation by the FDA for SCLC in Jan'25[8, 21, 22, 150] - The company plans to initiate a pivotal study for ZL-1310 in SCLC and a Phase 1 study in other DLL3-expressing tumors in 2025[26]