First Domestic HER2 Bispecific Antibody Anitumomab (KN026) Nominated for Breakthrough Therapy Designation in First-Line Metastatic HER2-Positive Breast Cancer

On July 6, the CDE website showed that the joint application submitted by CSPC and Alphamab OncologyRecombinant Humanized Anti-HER2 Bispecific Antibody Injection（Anitocabtagene Autoleucel）Proposed for inclusion in the Breakthrough Therapy designation,Combined with Docetaxel(Albumin-bound)For use inFirst-line Unresectable or Metastatic Epidermal Growth Factor Receptor 2（HER2）Positive Adult Breast Cancer。

Source: CDE Official Website

Anitocabtagene autoleucel(Development Code:KN026）YesAlphamab Oncology R&D Announcementa type ofHER2 Bispecific AntibodySimultaneously binds to two non-overlapping epitopes of HER2, resulting in the blockade of HER2 signaling. In August 2021,CSPCSubsidiary Jinmant Bio reached an agreement with Alphamab OncologyRMB 1 billionExclusive licensing agreement, obtaining the drug in mainland ChinaBreast Cancer, Gastric CancerExclusive development and exclusive commercialization licensing rights for the indication.

Previously,Anitocabtagene autoleucelGranted Breakthrough Therapy Designation by the CDE on November 4, 2023,and was approved for marketing by the NMPA through the priority review program in May 2026，Combination chemotherapy is indicated for the treatment of locally advanced or metastatic disease in patients who have previously received at least one trastuzumab-containing regimen.HER2-Positive Adult Gastric or Gastroesophageal Junction Adenocarcinomacancer patients, becomingFirstApproved Domestic HER2 Bispecific Antibody.

If this public notice is successfully passed, it will becomeof AnitumabItem 2Breakthrough Therapy Designation.

InHER2-Positive Breast CancerCSPC and Alphamab Oncology have initiated three Phase III clinical trials for first-line, neoadjuvant, and adjuvant therapies.Full-Course Disease Management Strategy。

Screenshot source: Insight database

In June 2026, CSPC and Alphamab Oncology announced thatAnitocabtagene Autoleucel in Combination withDocetaxel(Albumin-bound) (HB1801)First-line Treatment for Breast CancerPhase III Clinical Study Meets Primary Endpoint of PFS, with a trend toward OS benefit.

The results showed that,Anitocabtagene autoleucelHB1801 Combination TherapyCompared with existing standard therapies, it can significantly prolong progression-free survival in such patients, demonstrating more pronounced efficacy.It demonstrates a favorable safety profile, making it more suitable for long-term treatment, particularly during the maintenance phase following combination chemotherapy, where it offers superior safety advantages. Furthermore, the first-line use of non-toxic antibody-based regimens preserves subsequent treatment opportunities with antibody-drug conjugates (ADCs), enabling a sequential strategy of “first-line bispecific antibodies, second-line ADCs.” This approach aims to extend patients’ overall survival with high quality of life and enhance the benefits of comprehensive treatment.

According to the Insight database, there are currently two HER2 bispecific antibodies approved for marketing globally, namely Zymeworks/BeiGene'sZenidatamab, and CSPC/Alphamab Oncology'sAnitumab.

In addition, TQB2930 from Chia Tai Tianqing is also advancing rapidly, with a Phase III clinical trial currently underway for HER2-positive breast cancer.

Screenshot source: Insight Database

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Cover Source: Zcool Hualuo

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