Roche Trastuzumab Injection's marketing application was accepted by CDE

On April 21, Roche's application for the marketing of trastuzumab injection (subcutaneous injection) was accepted by CDE, which means that this subcutaneous preparation will soon be available in China.

The subcutaneously injected trastuzumab is a compound preparation composed of trastuzumab and recombinant human hyaluronidase.

The US FDA approved the marketing of Herceptin Hylecta® based on the results of the following clinical trials:

1) In a phase III HannaH study, neoadjuvant therapy and adjuvant therapy using Herceptin Hylecta® + chemotherapy were compared with intravenous Herceptin® + chemotherapy.

2) The second study, SafeHER, is a prospective, two-cohort, non-randomized, international, open-label trial.

3) The third study, PrefHER, is a patient preference trial.

As a ready-to-use preparation, Herceptin Hylecta can be administered within 2-5 minutes, while the time required for intravenous infusion of Herceptin is 30-90 minutes, which greatly shortens the administration process.