Jiangsu Hengrui Medicine Advances Clinical Trials for Cancer Therapies with NMPA Clearance

Jiangsu Hengrui Medicine Advances Clinical Trials for Cancer Therapies with NMPA Clearance

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability, and efficacy of SHR-1826 in combination with other anti-tumor therapies for solid tumors.

HRS-4642, a liposome formulation and a self-developed KRAS G12D inhibitor, can specifically bind to KRAS G12D, inhibiting the phosphorylation of MEK and ERK proteins to exert anti-tumor effects.

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-1826, a treatment with no similar products approved for marketing domestically or internationally, can bind to target antigens on tumor cells, leading to internalization and tumor cell death.

SHR-9839, an in-house developed humanized antibody drug for advanced malignant tumors, blocks two key signaling pathways related to tumor occurrence and development. No drugs with the same target are currently approved in China.

SHR-8068, a fully human anti-CTLA-4 monoclonal antibody, enhances anti-tumor immune effects. Globally, two similar products, ipilimumab and tremelimumab, are approved for marketing.

The bevacizumab biosimilar was approved for marketing in China in June 2021, following the original drug, co-developed by Chugai Pharmaceutical and Roche/Genetech, which has received approval in multiple global markets, including China.- Flcube.com

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