Huayu Pharmaceutical (688553.SH): Injection HY05350 has obtained the drug clinical trial approval notice.

Huayu Pharmaceutical (688553.SH) has announced that its wholly-owned subsidiary, Sichuan Huayu Haiyue Medical Technology Co., Ltd. ("Huayu Haiyue"), has received the Approval Notice for Drug Clinical Trial issued by the National Medical Products Administration. The clinical trial for the injectable drug HY05350 (research and development project code "HY-0005") for the treatment of advanced solid tumors has been approved. Research has shown that HY05350 can recruit T cells by recognizing CD3 antibodies, target tumor cells by recognizing MSLN and/or PD-L1 antibodies, and reactivate immune cells by releasing the immune suppression of tumor cells on T cells through PD-L1 antibodies. MSLN is highly expressed in various solid tumors such as gastric cancer, lung cancer, and pancreatic cancer compared to normal tissues. Early preclinical studies have shown that HY05350 has shown promising anti-tumor effects and safety, indicating high clinical development value. Injectable HY05350 is an innovative therapeutic biologic product not yet marketed domestically or internationally, and it holds significant clinical development value.