- CEO
- Ting Xu
- Full Time Employees
- 498
- Sector
- Health technology
- Industry
- Biotechnology
- Address
- No. 175 Fangzhou Road Suzhou JS China 215127
- IPO Date
- Dec 12, 2019
- Business
- Alphamab Oncology, an innovative biopharmaceutical firm, focuses on the discovery, development, production, and commercialization of advanced oncology biologics. Established in 2015 and headquartered in Suzhou, People's Republic of China, the company leverages its proprietary platforms, including single-domain antibodies, bispecific antibodies, and antibody-drug conjugates, to address unmet needs in cancer treatment. Its robust clinical pipeline features several key candidates, notably KN046, a bispecific monoclonal antibody targeting PD-L1 and CTLA-4, currently undergoing pivotal Phase III studies for various solid tumors, including advanced pancreatic cancer and non-small cell lung cancer, and holds U.S. FDA Orphan Drug Designation for thymic epithelial tumors. KN026, an anti-HER2 bispecific antibody, recently had its New Drug Application accepted by China's NMPA for HER2-positive gastric or gastroesophageal junction cancer and is advancing through multiple pivotal Phase III trials for both gastric and breast cancers. This candidate also received Breakthrough Therapy Designation and U.S. FDA Orphan Drug Designation for gastric cancer in combination with KN046. KN035, known as Envafolimab, stands as the world's first subcutaneously injectable PD-L1 inhibitor and gained market approval in China in 2021 for MSI-H or dMMR advanced solid tumors, alongside an approval in Macau for similar indications in 2024. This innovative immunotherapy is also being evaluated in multiple pivotal Phase III trials globally and has secured U.S. FDA Orphan Drug Designation for biliary tract cancer and soft tissue sarcoma, with significant licensing partnerships established for international markets. Furthermore, KN019, a CTLA-4-based immunosuppressant fusion protein with completed Phase II studies, aims to address autoimmune conditions and oncology treatment-related immune disorders, with an IND approval for its subcutaneous formulation granted in late 2023. The company's pipeline also includes the promising antibody-drug conjugate JSKN003, which received U.S. FDA Fast Track Designation for platinum-resistant recurrent epithelial ovarian cancer and Breakthrough Therapy Designation for HER2+ advanced colorectal cancer. Newer bispecific ADC candidates such as JSKN016 (TROP2/HER3) and JSKN022 (PD-L1/αvβ6) are progressing into Phase I clinical trials.