CSPC Holdings: HER2 Bispecific antibody submitted for marketing approval

On September 12, 2025, the marketing application for Cspc Holdings' HER2 bispecific antibody Anitumab Injection was accepted by the NMPA.

Yesterday, Cspc Holdings Company Limited announced that the indication applied for this listing is for use in combination with chemotherapy in HER2-positive locally advanced, recurrent or metastatic gastric cancer patients who have failed at least one systemic treatment (must include trastuzumab combined with chemotherapy). On August 28, Anitumab has been granted priority review status.

KN026 was developed by Jiangsu Alphamab Biopharmaceuticals Co., LTD. In August 2021, Cspc Holdings Company Limited acquired the China rights to KN026 for a total amount of 1 billion yuan. Additionally, in September 2024, Cspc Holdings Company Limited acquired the China rights to the HER2 bispecific antibody ADC new drug JSKN003 for a total amount of 3.08 billion yuan (with an upfront payment of 400 million yuan).

In addition to the second-line and above gastric cancer indications for which KN026 is currently under regulatory review, it is also being explored for first-line treatment of breast cancer, neoadjuvant therapy for breast cancer, and first-line treatment of gastric cancer.

At last year's ESMO conference, KN026 announced its phase II clinical data: among 35 evaluable patients, the ORR was 40.5%, the DCR was 80.0%, the mPFS was 8.6 months, and the mOS was 13.2 months.

JSKN003 has also demonstrated excellent therapeutic potential in clinical settings.

Summary

In May this year, BeiGene's HER2 bispecific antibody, licensed from Zymeworks, was approved for marketing to treat HER2-positive biliary tract cancer. Cspc Holdings' Anitumab is the first HER2 bispecific antibody to deliver positive results in second-line gastric cancer indications.