CStone Receives US FDA IND Approval for Recombinant PD-1 mAb CS1003

SUZHOU, China, Oct. 23, 2018 /PRNewswire/ — CStone Pharmaceuticals (“CStone”) today announced that the United States Food and Drug Administration (FDA) has recently granted approval to the company’s Investigational New Drug (IND) application for the independently developed recombinant humanized anti-programmed death-1 (PD-1) monoclonal antibody (mAb) CS1003. This represents CStone’s second drug candidate to receive IND approval from the FDA less than one month after US clinical trial approval for CS1001 (PD-L1), and demonstrates CStone’s global clinical development capability.

“Since May this year, CS1003 has now quickly received clinical trial approvals in Australia, China, and the United States, indicating that there are high expectations behind the product itself,” said Dr. Frank Jiang, Chairman and CEO of CStone. “I hope that in the future CS1003 can play a key role within combination cancer drug therapies.”

CS1003 is a full-length, humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody that has shown a good tolerability and efficacy profile in preclinical in vivo studies. The forthcoming clinical trial in the United States extends the Phase I study that began in Australia in May this year to US research centers, and will determine the recommended Phase II dose (RP2D) for CS1003 in solid tumor patients.

Dr. Jason Yang, CStone’s Chief Medical Officer commented: “PD-1 and PD-L1 immunotherapy have been shown to produce strong therapeutic effects in various cancers both as single agents or in combination with multiple cancer therapeutics. CS1003 is a key pipeline candidate for CStone and is currently progressing smoothly through Phase I trial in Australia. We will continue to push forward CS1003’s development in China and around the world to provide patients with a new treatment option at the earliest opportunity.”

About CS1003 and the PD-1/PD-L1 pathway

PD-1, or programmed death-1, is an inhibitory checkpoint receptor expressed on T cells. Under normal circumstances, it binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2), inhibiting T cell and cytokine activation, serving to dampen the immune response in order to prevent damage to healthy tissues. However, studies have shown that PD-L1 can be abundantly expressed on the surface of many solid tumors as well as hematological malignancies. Cancer cells can therefore make use of the PD-1/PD-L1 pathway to successfully avoid immune system recognition. Targeting of the PD-1/PD-L1 checkpoint by anti-tumor drugs can block the “tumor immune evasion mechanism” and restore anti-cancer immune ability in patients.

Unlike other anti-PD-1 mAbs, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models particularly for development of effective combination therapies.


CStone Pharmaceuticals is a China-based innovative biopharmaceutical company devoted to meeting patient needs, focused on development of innovative tumor drugs and immunotherapies. Established at the end of 2015, CStone has built a world-class management team with experience ranging across the drug development life cycle from clinical development to commercialization. Our international-standard clinical research and development team gained experience developing some of the world’s best-selling anti-tumor drugs. In terms of business model, CStone’s approach combines independent research, clinical development capabilities, and commercial partnering. The company has built one of the largest anti-cancer drug pipelines in China, with 14 anti-tumor drugs under research including independently developed and internationally partnered products. Exclusive cooperation and licensing agreements have been reached with Blueprint Medicine and Agios. CStone’s business model have been recognized by partners and investors in Series A and B financing rounds that were record-breaking within the biopharmaceutical field at that time, raising a combined total of USD 410 million. CStone aims to become a leading Chinese biopharmaceutical company with international prestige and serve as the cornerstone for the future health of patients.

For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

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