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Kexing Pharmaceutical: The application for marketing authorization of the drug in cooperation with Haichang Bio has been accepted by the EMA

 Last Update: 2022-03-09
 Source: Internet
 Author: User

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On January 23, Kexing Pharma announced that its partner Zhejiang Haichang Biomedical Technology Co.
, Ltd.
(referred to as "Haichang Bio") received the "Notice of Acceptance" issued by the European Medicines Agency (referred to as "EMA").
EMA Officially confirmed and accepted the Marketing Authorization Application (MAA) of the drug paclitaxel for injection (albumin-bound) jointly developed by it and Haichang Bio, and entered the technical review process
.

Abraxane, the original drug of paclitaxel for injection (albumin-bound), was founded and developed by Abraxis BioScience and later acquired by Celgene, and is now a wholly-owned subsidiary of Bristol-Myers Squibb
.

The European Medicines Agency has approved the drug for the first-line treatment of breast cancer, metastatic pancreatic adenocarcinoma, and non-small cell lung cancer

At present, the only manufacturers of paclitaxel for injection (albumin-bound) sold in the EU are the original drug manufacturer Bristol-Myers Squibb and Ratiopharm Gmbh (a subsidiary of Teva Pharmaceutical Industries Limited)
.

The relevant research is carried out for the target drug in accordance with the quality requirements of complex injections in the United States, the European Union and China

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