CSPC says China regulator grants breakthrough therapy designation for HER2-positive breast cancer combo

• CSPC won China NMPA breakthrough therapy designation for HB1801 albumin-bound docetaxel with KN026 anbenitamab in first-line advanced HER2-positive breast cancer.
• KN026 is co-developed by CSPC unit Shanghai JMT-BIO with Jiangsu Alphamab Biopharmaceuticals.
• Phase III Healer study met its primary PFS endpoint, beating the THP standard regimen; NDA filing planned soon.

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