Subsidiary of Yantai Dongcheng Biochemicals (002675.SZ) receives drug clinical trial approval notice.
Dongcheng Pharmaceutical Co., Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary company LNC ...
Yantai Dongcheng Biochemicals (002675.SZ) issued an announcement on August 22, 2025. The company's subsidiary, LNC PHARMA PTE. LTD. (referred to as "LNC Pharma"), received a drug clinical trial approval notice for 225Ac-LNC1011 injection from the Food and Drug Administration (FDA) of the United States (referred to as "FDA"), and will soon conduct a Phase I clinical trial.
The FDA has completed the safety review of the 225Ac-LNC1011 injection application and believes that the proposed prostate cancer clinical study can proceed. According to the requirements of US drug registration laws and regulations, after obtaining the Study May Proceed Letter (SMP) for the 225Ac-LNC1011 injection, clinical trials must be conducted and approved by the FDA before it can be marketed and sold in the United States.
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