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.
Use by subcutaneous injection.
The product has been approved by the FDA in February 2019 for the treatment of Her2-positive early breast cancer, under the trade name Herceptin Hylecta.
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.
rHuPH20 takes effect locally, the half-life of the tissue is less than 15 minutes, and the hyaluronic acid in the local tissue can rebuild its normal density within a few days.
Therefore, the effect of rHuPH20 on the structure of the subcutaneous tissue is temporary.
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.
intravenous Herceptin (trastuzumab) combined with chemotherapy neoadjuvant therapy (preoperative) or adjuvant therapy (postoperative) for patients with Her2-positive breast cancer.
The results showed that the blood levels of trastuzumab (pharmacokinetic characteristics) and clinical efficacy (pathological complete remission rate, pCR (45.
7%)) in the blood of patients receiving subcutaneous Herceptin Hylecta were not inferior to Jing.
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.
The results of the study showed that most patients (86%) prefer Hercep Hylecta, and only 13% of patients prefer to receive intravenous Herceptin treatment.
Trastuzumab subcutaneous injection provides a new treatment option for patients, and patients can choose treatment methods according to personal needs and preferences.