Posted by Michael Wonder on 26 Jul 2022
Henlius Hanquyou received TGA approval in Australia
26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from the TGA for the approval of Henlius' self-developed and manufactured Hanquyou (trastuzumab, trade name in Europe: Zercepac) with the specification of 150 mg/vial in Australia under the trade names Tuzucip and Trastucip, covering all indications of the reference trastuzumab approved in Australia.
Henlius independently developed Hanquyou in accordance with the NMPA, the EMA, US FDA and other international biosimilar guidelines.
