*ST Shuangcheng (002693.SZ): Paclitaxel for injection (albumin binding) ANDA has obtained marketing approval from the US FDA

Zhitong Finance App News, *ST Shuangcheng (002693.SZ) announced that the company recently received a notice from the US Food and Drug Administration (“FDA”) that the company submitted a simplified new drug application for injectable paclitaxel (albumin binding) to the US FDA (“ANDA” for short) has been approved for marketing by the US FDA. The US FDA conducted a comprehensive technical review of the ANDA application data for injectable paclitaxel (albumin binding type) submitted by the company and determined that the company's products were bioequivalent and curative equivalent to the original drug.

According to the announcement, paclitaxel for injection (albumin binding type) is a nanoparticle preparation formed by wrapping paclitaxel in albumin. When paclitaxel is combined with albumin to form nanoparticles, compared with other paclitaxel drugs, the cytotoxic side effects of injectable paclitaxel (albumin binding type) are significantly reduced, the dose is increased, and the anti-tumor effect is enhanced. Furthermore, injectable paclitaxel (albumin binding type) can generate savings in tumors and be targeted to tumor cells. It is targeted and further enhances the efficacy of the drug.