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华东医药(000963.SZ):中美华东申报的HDM1005注射液药品临床试验申请已获得美国FDA批准

Huadong Pharmaceutical (000963.SZ): The HDM1005 injectable drug clinical trial application declared by China and the US East China has been approved by the US FDA

Gelonghui Finance ·  Apr 22 16:08

Gelonghui, April 22丨Huadong Pharmaceutical (000963.SZ) announced that recently, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“China-US Huadong”), a wholly-owned subsidiary of Huadong Pharmaceutical Co., Ltd., received a notice from the US Food and Drug Administration (“US FDA”) that the HDM1005 injectable drug clinical trial application declared by China and US East China has been approved by the US FDA to conduct phase I clinical trials in the US.

HDM1005 injection is a new class 1 chemical drug developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. and has global intellectual property rights. It is a long-acting agonist with dual targets for the polypeptide human GLP-1 (glucagon-like peptide 1) receptor and GIP (glucose-dependent insulin-promoting polypeptide) receptor. Preclinical studies have shown that HDM1005 can activate GLP-1 receptors and GIP receptors to promote insulin release, suppress appetite, and exert significant effects in improving glucose tolerance, lowering sugar and weight loss; at the same time, existing data shows that HDM1005 has good pharmacogenicity and safety.

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