On May 28, the NMPA announced that it had approved the marketing of Anituzumab Injection (trade name: Enituzumab) submitted by Shanghai Jinmante Biotechnology through the priority review and approval procedure. This product, in combination with chemotherapy, is indicated for the treatment of locally advanced or metastatic HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing therapy .
Anitumumab (KN026) was originally developed by KNJ Biopharma as a HER2 bispecific antibody that binds to two non-overlapping epitopes of HER2, blocking HER2 signaling. It enhances ADCC and CDC effects through antibody-induced receptor aggregation while downregulating cell surface HER2 receptors. In August 2021, KN026 was licensed to CSPC Pharmaceutical Group for a total transaction value of RMB 1 billion. Its wholly-owned subsidiary, Shanghai Jinmante Biotechnology, obtained exclusive rights to develop and commercialize KN026 in mainland China for breast cancer and gastric cancer indications. In November 2023, it received Breakthrough Therapy Designation from the CDE (Center for Drug Evaluation). In August 2025, it received Priority Review designation for second-line treatment of HER2-positive gastric cancer. Multiple registration clinical trials of Anitumumab for first-line HER2-positive breast cancer, neoadjuvant therapy, and adjuvant therapy in HER2-positive breast cancer are currently underway.

This approval is based on a pivotal Phase II/III clinical trial called KN026-001 . The first interim analysis of the Phase III clinical trial showed that, compared with the current standard of care, KN026 in combination with chemotherapy significantly improved clinical efficacy, prolonged progression-free survival and overall survival, and had no new safety risks, low incidence of cardiotoxicity and low immunogenicity.

As of April 3, 2025, the median follow-up time in the anitumumab group was 9.7 months (95% CI: 7.2 to 11.9 months), and the median follow-up time in the control group was 9.8 months (95% CI: 7.4 to 12.9 months).
Validity assessed by the Independent Review Committee (IRC):
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The median progression-free survival (PFS) in the anitumumab group was 7.1 months, compared to 2.7 months in the control group. The hazard ratio (HR) was 0.25, corresponding to a 75% reduction in the risk of disease progression or death.
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The median overall survival (OS) in the anitumumab group was 19.6 months (premature) and in the control group was 11.5 months. The HR was 0.29, which corresponds to a 71% reduction in the risk of death. The P value was far below the pre-set alpha threshold (0.00001).
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The objective response rate (ORR) in the anitumumab group was 55.8%, compared to 10.8% in the control group. The disease control rate (DCR) was 80.0% and 41.9%, respectively. The median duration of response (DoR) was 8.2 months and 2.9 months, respectively.
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The median duration of treatment in the anitumumab group was 6.5 cycles, compared to 3.0 cycles in the control group.
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The incidence of grade 3 or higher treatment-related adverse events (TEAEs) in the anitumumab group was 60.6%, compared to 51.6% in the control group. The incidence of serious adverse events (SAEs) was 31.9% and 33.3%, respectively.

Currently, in the HER2 bispecific antibody field, only Zymeworks' zanitumumab (introduced by BeiGene) has been approved for marketing globally. The recent approval of zanitumumab makes it the first domestically produced HER2 bispecific antibody to receive such approval. In the same field, domestically, Chia Tai Tianqing's TQB2930 is progressing rapidly and is in Phase III clinical trials; Shanghai Baoji Pharmaceutical's KJ015, Sihuan Pharmaceutical's KM257, and Beijing Tianguangshi Biosciences' MBS301 are all in Phase I clinical trials.

https://mp.weixin.qq.com/s/EFiE3Z_fWtDUhU2aGsPrcw