Sunho Biologics, Inc. is a clinical-stage biopharmaceutical company founded in 2018 and headquartered in Nanjing, China, engaged in the discovery, development, and commercialization of biologics that regulate the immune microenvironment by modulating both the innate and adaptive immune systems. Its main products include IAH0968, an antibody-dependent cell-mediated cytotoxicity (ADCC) enhanced monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2) in Phase II clinical trials for biliary tract carcinoma and colorectal cancer; immunocytokines IAP0971 and IAE0972, which have completed Phase I trials for advanced solid tumors such as non-small cell lung cancer and colorectal cancer; and several preclinical candidates including IBB0979 (immunocytokine for solid tumors), IBC0966 (anti-PD-L1 and SIRP fusion protein for tumor-specific immune responses), IBD0333, IAN0982 (multi-specific innate effector activator for advanced solid tumors), ISH0988 (bifunctional antibody for systemic lupus erythematosus), and ISH0613 (bifunctional antibody for inflammatory bowel disease). The company leverages proprietary technology platforms including the AIC™ Platform for antibody-cytokine fusion proteins, the AEA™ Platform for ADCC-enhanced antibodies using FUT8 knock-out cell lines, and the AIM™ Platform for innate immunity stimulator-based bispecific/multispecific antibodies. Recent major developments include a successful initial public offering in Hong Kong in 2024, completing a significant ¥210 million financing round in 2023, advancing multiple clinical-stage candidates, and filing an investigational new drug (IND) application to the U.S. FDA for ISH0613 to start Phase I clinical trials in mid-2025, reflecting its strategic focus on expanding biologic immunotherapies for oncology and autoimmune diseases. Its operations are focused primarily in China with an expanding clinical pipeline targeting global markets. Sunho Biologics maintains a fully integrated biological therapeutic platform that covers discovery, development, clinical trial management, and manufacturing through customized cell line technology to optimize product safety, efficacy, and cost efficiency.
This comprehensive product portfolio and pipeline, advanced technology platforms, recent fundraise, clinical progress, and public listing position Sunho Biologics as a growing player in the biopharmaceutical industry specializing in innovative immunotherapies for cancer and autoimmune conditions.