HUTCHMED Initiates Phase I Study of its novel SHP2 inhibitor HMPL-415 for Advanced Malignant Solid Tumors in China

HONG KONG and SHANGHAI, China and FLORHAM PARK, NJ, USA I July 09, 2023 I HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 (“SHP2”). The first patient received their first dose on July 6, 2023.

The clinical trial is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-415 as a single agent in patients with advanced malignant solid tumors. This study is expected to enroll up to approximately 80 patients, including patients as part of the dose escalation stage, and further patients at the determined recommended Ph II dose (RP2D). The leading principal investigators are Dr. Tianshu Liu of Zhongshan Hospital Fudan University and Dr. Nong Yang of Hunan Cancer Hospital. Additional details may be found at, using identifier NCT05886374.

About HMPL-415

HMPL-415 is a novel, highly potent and selective allosteric inhibitor targeting SHP2. SHP2 is a non-receptor protein tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm of several tissues. SHP2 modulates diverse cell signaling events that control metabolism, cell growth, differentiation, cell migration, transcription and oncogenic transformation. It interacts with diverse molecules in the cell and regulates key signaling events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines. Dysregulation of SHP2 expression or activity causes many developmental diseases, and hematological and solid tumors.1

HUTCHMED currently retains all rights to HMPL-415 worldwide.


HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: or follow us on LinkedIn.

1 Asmamaw, M.D., Shi, XJ., Zhang, LR. et al. A comprehensive review of SHP2 and its role in cancer. Cell Oncol. 45, 729–753 (2022). 

SOURCE: Hutchmed

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