Sihuan Pharmaceutical Unit's New Drug Application for Breast Cancer Drug Gets China Nod

MT Newswires Live

2025/05/16

Sihuan Pharmaceutical (HKG:0460) said the new drug application of the Bireociclib tablets, developed by unit Xuanzhu Biopharmaceutical, has been approved by China's National Medical Products Administration for two indications, a Thursday Hong Kong bourse filing said.

The first indication is as monotherapy for adult patients with local advanced or metastatic breast cancer, while the second involves the drug in combination with Fulvestrant for the treatment of adult patients with HER2-advanced or metastatic breast cancer.

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