China-based Alphamab Oncology (HKG: 9966) reported RMB 53.57 million (USD 7.7 million) in H1 2022 revenue, primarily from commercialization and licensing of envafolimab, its PD-L1 inhibitor co-developed with Simcere Pharma and 3D Medicines. The firm also posted RMB 38.75 million (USD 5.6 million) in gross profits.
Envafolimab Commercialization
Envafolimab, China’s first homegrown PD-L1 inhibitor, received approval in November 2022 for advanced solid tumors with MSI-H/dMMR. Priced at RMB 5,980 (USD 866) per dose, it gained a new regimen (300 mg every two weeks) in July 2023, enhancing patient convenience. Ascletis holds rights to develop the drug for viral diseases under a 2019 deal.
Pipeline Updates
- KN046/KN026 NDAs: Alphamab plans to file for KN046 (PD-1/CTLA-4 bispecific antibody) in 2023 and KN026 (HER2-targeted therapy) in 2024. KN046 is in ~20 trials across NSCLC, TNBC, and other cancers. CSPC’s JMT Biotech licensed KN026 in 2022, gaining exclusive China rights.
- JSKN003 (HER2 ADC): China’s first bispecific ADC, JSKN003, received NMPA IND approval in July 2023 for solid tumors, following Phase I trials in Australia.
Manufacturing Expansion
Alphamab is scaling production to support commercial growth. A 4,000L facility in Jiangsu was approved in 2020 (Phase I), with a 2,000L expansion set for late 2023. Phase II plans will raise total capacity to 40,000L.-Fineline Info & Tech
