Shanghai Henlius Biotech's (HKG:2696) new drug application (NDA) for HLX11 has been accepted by China's National Medical Products Administration, a Wednesday bourse filing said.
Of the two indications included in the NDA, the first is the use of the drug in combination with trastuzumab and chemotherapy as adjuvant treatment for patients with HER2-positive early breast cancer at high risk of recurrence.
The second indication is the use of HLX11 in combination with trastuzumab and docetaxel to treat patients with HER2-positive, metastatic, or unresectable local recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
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