Roche trastuzumab subcutaneous injection application for listing

On April 22, the CDE official website showed that Roche's application for the listing of trastuzumab subcutaneous injection was officially accepted by the NMPA.

Trastuzumab subcutaneous injection is a compound preparation composed of Roche anti-Her2 monoclonal antibody trastuzumab and the recombinant human hyaluronidase PH20 (rHuPH20, a kind of endoglycosidase) developed by Halozyme based on the Enhanze technology platform.

The advantage of Herceptin Hylecta is that the hyaluronidase in the preparation can temporarily reduce the viscosity of the intercellular substance and promote the rapid diffusion and absorption of trastuzumab, making it a ready-to-use preparation that can be used in 2-5 The administration is completed within minutes, while intravenous infusion of trastuzumab takes 30-90 minutes.

The efficacy and safety of Herceptin Hylecta have been confirmed in 3 clinical studies on Her2-positive early breast cancer patients.

The Phase III clinical study code-named HannaH compared subcutaneous injection of Herceptin Hylecta combined with chemotherapy vs.

In the Phase III clinical study code-named SafeHER, the safety and tolerability of Herceptin Hylecta in the adjuvant treatment of Her2-positive breast cancer were consistent with the previous safety features of intravenous Herceptin, and no new safety signals were found.

The study code-named PrefHER investigated the medication preference of patients.

Trastuzumab subcutaneous injection provides a new treatment option for patients, and patients can choose treatment methods according to personal needs and preferences.