On September 12, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has been accepted by the National Medical Products Administration (NMPA). KN026 has been applied for as a Class 1 therapeutic biological product and the indication is for use in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).
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This NDA for KN026 is primarily based on a pivotal Phase II/III clinical trial (Study ID: KN026-001). Results from the first interim analysis of the Phase III clinical study demonstrated that, compared to the current standard of care, KN026 combined with chemotherapy significantly improved clinical efficacy, by prolonging progression-free survival (PFS) and overall survival (OS). Furthermore, the combination showed no new safety signals, with a low incidence of cardiotoxicity and low immunogenicity in terms of safety profile. Previously, results from the Phase II clinical study, presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, showed that KN026 in combination with chemotherapy achieved an objective response rate (ORR) of 40.0%, with a median PFS of 8.6 months as assessed by the independent review committee (IRC). KN026 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA on November 4, 2023, and received Priority Review status on August 28, 2025.
Currently, there are no approved anti-HER2 therapies for the second-line treatment of HER2-positive gastric cancer. KN026 is the first HER2 bispecific antibody to demonstrate positive results in the second-line treatment of gastric cancer in China. Meanwhile, multiple pivotal Phase III clinical studies of KN026 in gastric cancer and breast cancer are undergoing smoothly, with the aim of benefiting more patients.
About KN026
KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with trastuzumab and pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with trastuzumab-resistant cell lines.
The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. Currently, several pivotal clinical trials of KN026 for the second-line or above treatment of HER2-positive GC/gastroesophageal junction cancer (GEJ), the first-line treatment of HER2-positive BC, neoadjuvant treatment for HER2-positive BC are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).
In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).
(Press release, Alphamab, SEP 12, 2025, View Source [SID1234656998])