Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study

Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment of advanced solid tumors.

SHR-A1811: An In-House Antibody-Drug Conjugate (ADC) Targeting HER2
SHR-A1811 is an in-house developed antibody drug conjugate (ADC) that targets human epidermal growth factor receptor 2 (HER2). This molecule is designed to bind to HER2-expressing tumor cells, release toxins through protease cleavage within tumor lysosomes, and induce cell cycle arrest, leading to the apoptosis of tumor cells. Hengrui has initiated multiple clinical trials for SHR-A1811, with targeted indications including advanced breast cancer and other solid tumors that express or have mutations in HER2.

Pyrotinib: A Small-Molecule HER Inhibitor
Pyrotinib, another in-house discovery by Hengrui, is an oral tyrosine kinase inhibitor (TKI) that targets HER1, HER2, and HER4. The drug received its first conditional approval in 2018 and was converted to full approval in 2020 for the treatment of patients with metastatic, recurrent breast cancer.-Fineline Info & Tech

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