On October 18, 2016 CStone Pharmaceuticals announced reported that, following the successful site inspection by the Jiangsu FDA for its recombinant anti PD-L1 monoclonal antibody (WBP3155), the CFDA has recently accepted the submission of WBP3155’s IND (acceptance number CXSL1600075) (Press release, CStone Pharmaceauticals, OCT 18, 2016, View Source [SID1234517821]). Wholly owned and independently developed by CStone Pharmaceuticals, WBP3155 is China’s first innovative, fully humanized, full length original format IgG (most similar to human’s naturally produced IgG) monoclonal antibody drug candidate. WBP3155 is also the world’s first OMT platform produced antibody, which could mean safer and less immunogenic. WBP3155 has hopes of becoming one of the first China developed PD-L1 therapies. Schedule your 30 min Free 1stOncology Demo! The inhibition of key checkpoints, such as PD-1/PD-L1, is currently the major development focus for immuno-oncology both in China and abroad. These drugs are designed to use our own immune system to treat cancer and have shown significant effects in the treatment of melanoma, lung cancer, renal cell carcinoma, bladder cancer, as well as other tumors. There are a number of related monoclonal antibody drugs approved internationally, and a few domestic companies also have related drug candidates in both pre-clinical and clinical trial phases. The acceptance of WBP3155’s IND by the CFDA signifies that the CStone has made significant progress with the development of this molecule.
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Dr. Frank Jiang, CEO of CStone Pharmaceuticals, stated that China has the highest number of newly diagnosed cancer patients and deaths from cancer in the world. As such, CStone is committed to meeting this pressing need by developing innovative, effective, and safe therapies for Chinese patients.