Hualan Biological investee gets nod for cancer drug clinical trial

Hualan Biological Engineering Co., Ltd. announced that its investee, Hualan Genetic Engineering Co., Ltd., has received an acceptance notice from the National Medical Products Administration for its clinical trial application for the domestic production of Pembrolizumab Injection. The application pertains to a treatment for various cancers including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma.

The drug, a biosimilar of Pembrolizumab Injection (Keytruda®), is classified as a Class 3.3 therapeutic biological product. Pembrolizumab, developed by Merck, is a humanized monoclonal antibody targeting the PD-1 pathway, which restores T-cell immune function against tumors. The company notes this acceptance will not impact its recent financial performance, but the timing and outcome of further clinical registration are uncertain.

Hualan Biological Engineering will actively advance the project and fulfill its information disclosure obligations. Investors are advised to exercise caution due to the inherent investment risks. The company highlighted that no similar drugs from domestic manufacturers, apart from the original research product, have yet been approved for market entry.