Hainan Poly Pharm Receives FDA Approval for PL002 in Primary Liver Cancer Surgery

China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received clinical trial approval from the US FDA for its novel injection candidate PL002. This innovative product is indicated for preoperative diagnosis and intraoperative navigation in patients with primary liver cancer.

PL002 is an in-house developed bimodal contrast agent that combines fluorescent and magnetic resonance imaging capabilities. This dual functionality represents a promising approach to enhancing the efficiency of primary liver cancer surgeries. The fluorescence imaging capability of PL002 allows for precise fluorescence navigation during surgical procedures, while its magnetic resonance enhancement can assess liver metabolism prior to surgery. This feature helps speculate on the uptake of contrast agents by both the tumor and liver, ultimately improving diagnostic accuracy and reducing the complexities of preoperative planning.

Notably, PL002 is primarily excreted through the liver, demonstrating good stability and safety profiles. By providing a more extended surgical window, this novel injection candidate has the potential to significantly improve outcomes for patients undergoing liver cancer surgery.-Fineline Info & Tech

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