Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316) with SHR-A1811 plus chemotherapy for the treatment of HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ). Additionally, the company will assess the drug candidate SHR-1139 for the treatment of psoriasis.
Adebrelimab, a programmed death-ligand 1 (PD-L1) monoclonal antibody, was approved in China in March last year for the first-line treatment of extensive stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. SHR-A1811 is a HER2-targeted antibody-drug conjugate (ADC), and the combination therapy is anticipated to enhance anti-tumor effects, offering a potential new treatment option for patients with HER2-expressing tumors.
SHR-1139, a Category 1 therapeutic biologic product with an undisclosed target, has demonstrated significant therapeutic effects in preclinical data. It has shown the ability to effectively improve skin psoriasis scores in a mouse model of the disease. Hengrui describes SHR-1139 as the first of its kind globally to enter clinical development, highlighting the innovation and potential impact of this drug candidate in the treatment of psoriasis.
These IND approvals follow Hengrui’s commitment to advancing therapies in high-demand areas such as cardio-renal-metabolic, immunology, neuroscience, and oncology, reinforcing the company’s position at the forefront of pharmaceutical innovation in China and beyond.- Flcube.com
