On July 1st, Gelunhui reported that Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as 'Sino-American Huadong'), recently received a notification from the US Food and Drug Administration (FDA) that the clinical trial application for the HDM2005 injection drug submitted by Sino-American Huadong has been approved by the FDA and can conduct phase I clinical trials in the United States.
Injection HDM2005 is a type 1 new biological drug with global intellectual property rights developed and owned by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. It is an antibody-conjugated drug (ADC) that targets the receptor tyrosine kinase-like orphan receptor 1 (ROR1). Preclinical studies have shown that after entering the body, the antibody portion of HDM2005 specifically binds to target cells expressing tumor antigens. After being internalized by tumor cells, the cytotoxin is released intracellularly, thus completing the killing of tumor cells. Existing data show that HDM2005 has good drugability and safety.