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华东医药(000963.SZ):HDM2006片药品临床试验申请获得美国FDA批准

Huadong Medicine (000963.SZ): The clinical trial application for the HDM2006 pharmaceutical has received approval from the USA FDA.

Gelonghui Finance ·  Jan 13 09:33

On January 13, Glonghui reported that Huadong Medicine (000963.SZ) announced that on January 10, 2025, its wholly-owned subsidiary, Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd., received a notice from the US Food and Drug Administration that the clinical trial application for the HDM2006 tablet submitted by Sino-US Huadong has been approved by the FDA, allowing it to conduct Phase I clinical trials in the USA, with the indication being advanced malignant tumors.

The HDM2006 tablet is a new, highly effective, and selective orally bioavailable protein degradation targeted chimeric compound (PROTAC) type 1 chemical drug independently developed by Sino-US Huadong, which owns global intellectual property rights. Preclinical research results show that HDM2006 has good drug-like properties, safety, and efficacy; it specifically binds to human HPK1 (Hematopoietic Progenitor Kinase-1), E3 ligase to form a ternary complex, which is further ubiquitinated and degraded, thus relieving HPK1's negative regulation on human T lymphocytes, B lymphocytes, and DC cells, activating immune cells, reversing immune suppression and T cell exhaustion in the tumor microenvironment, and exerting anti-tumor effects; HDM2006 has shown significant anti-tumor effects in multiple tumor models and has a synergistic anti-tumor effect when used in combination with PD-1/PDL1 antibodies.

In November 2024, Sino-US Huadong completed the submission of the clinical trial application for HDM2006 tablets to the FDA and recently received FDA approval. In addition, the clinical trial for HDM2006 tablets in China was approved by the National Medical Products Administration in October 2024, with the indication being advanced solid tumors. In December 2024, the Phase I clinical study on the safety, tolerability, efficacy, and pharmacokinetics of HDM2006 in advanced solid tumor patients completed the first subject enrollment and administration at Fudan University Shanghai Cancer Center.

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