CStone Pharma' PD-L1 Monoclonal Antibody IND Has Been Formally Accepted By The CFDA
Published: Oct 18, 2016
SUZHOU, China, Oct. 18, 2016 /PRNewswire/ -- CStone Pharmaceuticals announced today 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). 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.
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.
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.
CStone Pharmaceuticals is an innovative, research-based, biopharmaceutical company committed to the development of a new generation of therapeutic drugs. Based in both Shanghai and Suzhou, the company's leadership team consists of seasoned executives from top pharmaceutical MNCs. In July 2016, CStone announced the completion of its Series A financing, raising a total of US$150 million (about 975 million RMB). Three prestigious investment companies in the industry, Oriza Seed Venture Capital (Oriza Seed), Boyu Capital, and WuXi Healthcare Ventures (WXHV), jointly invested in the round. With an overarching commitment to meeting the most pressing needs of Chinese patients, the company's pipeline covers five therapeutic areas, including oncology, cardiovascular diseases, rheumatoid arthritis, hematology and autoimmune diseases. With immuno-oncology as CStone's core therapeutic focus, the company strives to lead Chinese research to the global market through its world class R&D team, its innovative portfolio, and an open innovation strategy.
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SOURCE CStone Pharmaceuticals