Zisheng® is the commercial brand name of Paclitaxel Polymeric Micelles for Injection, an innovative solvent-free paclitaxel formulation developed by Shanghai Yizhong Pharmaceutical. It exerts anti-tumor activity by promoting microtubule polymerization and inhibiting tumor cell mitosis. The polymeric micelle carrier removes the need for conventional solvent and routine premedication against hypersensitivity.
Main Indications
In combination with platinum agents, first-line treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with negative EGFR mutation and negative ALK rearrangement.
Clinical Research
A multicenter, randomized, positive-controlled Phase III clinical trial was conducted in China, comparing paclitaxel polymeric micelles plus cisplatin versus conventional solvent-based paclitaxel plus cisplatin for first-line NSCLC;
The trial met its primary endpoint, achieving a higher objective response rate, with a lower incidence of severe hypersensitivity reactions compared with conventional paclitaxel;
Long-term follow-up confirmed a manageable safety profile, and no routine premedication was required before infusion.
Common Side Effects
Severe but important risks: Severe neutropenia, febrile neutropenia, peripheral neuropathy;
Common mild adverse reactions: Alopecia, nausea, vomiting, diarrhea, fatigue, myalgia, arthralgia, decreased appetite and abnormal liver function.
Approval Status in China
Original drug Zisheng® (Paclitaxel Polymeric Micelles for Injection, specification: 30mg) was officially approved for marketing in China in October 2021. It is currently a prescription anti-tumor innovative drug included in China’s category B medical insurance catalogue.
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