CSPC Pharmaceutical Group Limited (1093) Announces U.S. FDA Approval for Clinical Trials

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CSPC Pharmaceutical Group Limited (1093) announced that its Paclitaxel Protein-Bound Particles for Injectable Suspension, Rapid Suspension (Albumin-Bound) (SYHX2011G1) received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States.

According to the announcement dated 2 March 2026, the product is a new-generation innovative nano-preparation developed using patented technology. It has the potential to become the world’s first rapidly dissolving albumin-bound paclitaxel formulation. The approved indication targets the treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within six months of adjuvant chemotherapy.

The announcement indicates that this milestone will diversify the company’s international product pipeline and reinforce its competitiveness in the global pharmaceutical market.

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