中文

Haichang Biotech’s Nanoparticle Albumin-bound Paclitaxel for Biological Injection Received Approval, Pioneering Complex Injectable Commercialization in China

Publisher: Time:2023-10-31

Hangzhou, China, October 31st, 2023 – Zhejiang Haichang Biotech Co., Ltd. (Haichang Biotech) is pleased to announce that it has achieved a significant millstone with the authorization of its Nanoparticle Albumin-bound (nab) Paclitaxel for Injection by the National Medical Products Administration of China (National Drug Approval H20234299).

 

Paclitaxel, a cytoskeletal drug that target tubulin, is a classical plant type of tubulin can inhibit division of tumor cells. As an important chemotherapy medication, Paclitaxel has been applied extensively for treating a myriad of cancers including ovarian, esophageal, breast, lung, Kaposi’s sarcoma, cervical, and pancreatic.

 

The transformative power of Haichang’s nab Paclitaxel lies in its unique formulation. Through a special process that builds nanoparticles out of paclitaxel and serum albumin, this nab Paclitaxel enjoys heightened safety, reduced toxicity, and superior biocompatibility. Moreover, it can be more user-friendly as patients with prior mild to moderate hypersensitivity reactions may not need premedication. This formulation also enjoys an enhanced efficacy profile, attributed to an optimized pharmacokinetic profile and increased tumor uptake compared to its traditional counterpart.

 

Haichang’s vision transcends borders. In collaboration with Kexing Pharmaceuticals, a prominent figure in the biotech landscape, Haichang aims to manufacture its nab Paclitaxel commercially for global markets outside of the United States. Additionally, with an application already underway to the European Medicines Administration (EMA) since 2021, market approval for European shores is anticipated by 2024.

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