Huiyu Pharmaceutical (688553.SH) announced that its subsidiary, Seacross (Europe) Pharma Ltd., recently received marketing authorization from the French National Agency for Medicines and Health Products Safety for the company's Paclitaxel Injection (Albumin-Bound).
The product's primary monotherapy indication is for the treatment of adult patients with metastatic breast cancer who have not responded to first-line treatment for metastatic disease and for whom standard anthracycline-containing regimens are not suitable; in combination with gemcitabine, it is indicated for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma; and in combination with carboplatin, it is indicated for the initial treatment of adult patients with non-small cell lung cancer who are not eligible for potentially curative surgery and/or radiotherapy.
Following the successful development of the company's Paclitaxel Injection (Albumin-Bound), registration applications have been filed in multiple countries. To date, marketing authorization has been obtained in 15 countries, including the United Kingdom and France. As of now, the company has submitted a registration application in Serbia.