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CSPC Pharma's Breast Cancer Drug Combination Granted China Breakthrough Designation

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CSPC Pharmaceutical's (HKG:1093) albumin-bound docetaxel and anbenitamab combination received breakthrough therapy designation in China for the first-line treatment of unresectable or metastatic HER2-positive breast cancer, according to a Tuesday filing with the Hong Kong bourse.

The designation follows positive phase 3 results announced in June, when the combination significantly improved progression-free survival compared with the current standard-of-care regimen.

The therapy also demonstrated a favorable safety profile, the company said.

CSPC plans to submit a new drug application for the indication in the near term.

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