Huiyu Pharmaceuticals (688553.SH): Paclitaxel Injection (Albumin-bound) Obtains Overseas Marketing Authorization.
Huiyu Pharmaceuticals (688553.SH) issued an announcement, the company's subsidiary Seacross (Europe)...
Huiyu Pharmaceuticals (688553.SH) announced that its subsidiaries, Seacross (Europe) Pharma Ltd. and Seacross Pharmaceuticals Ltd., have recently received approval from the Portuguese Medicines and Health Products Regulatory Authority and the UK Medicines and Healthcare products Regulatory Agency for the market authorization of the company's product Paclitaxel for injection (albumin-bound).
Paclitaxel for injection (albumin-bound) is mainly used as a single-agent therapy for treating adult patients with metastatic breast cancer who have not responded to first-line treatment for metastatic disease and are not suitable for standard anthracycline-based chemotherapy; as a combination therapy with gemcitabine for adult patients with metastatic pancreatic adenocarcinoma for first-line treatment; and as a combination therapy with carboplatin for the initial treatment of adult patients with non-small cell lung cancer who are not suitable for potentially curative surgery and/or radiotherapy.
After the successful development of Paclitaxel for injection (albumin-bound), the company has applied for registration in multiple countries and has already obtained market authorization in the UK, Portugal, Denmark, the Netherlands, Ireland, Finland, and Sweden. As of now, the company has submitted registration applications in 7 countries including Italy, France, and Spain.
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