China's First Human Anti-PD-L1 mAb from CStone Pharmaceuticals Was Approved for Clinical Trials
Last year, CStone Pharmaceuticals raised the biggest funds in Series A financing among domestic bio-medicine companies. The recombinant anti-PD-L1 humanized monoclonal antibody injection CS1001 received the clinical trial approval documents issued by China Food and Drug Administration (CFDA), marking China's first human anti-PD-L1 monoclonal antibody successfully entered the clinical research and development stage.
After more than 8 months of examining and appraising, CS1001 received clinical trial approval documents issued by CFDA. CS1001 is independently developed by CStone Pharmaceuticals with completely independent intellectual property rights and is the world's first PD-L1 monoclonal antibody (mAb) drugs screened by the international leading OMT transgenic animal platform. CS1001 can get the whole sequence of human body by one step and belongs to Category I biological products with a new molecular structure for treatment purpose. Human antibody is closest to the body's G-type immunoglobulin (IgG) and can reduce immunogenicity and related risks of toxicity, so as to ensure drug exposure and clinical efficacy. Recently, CStone Pharmaceuticals has started Phase 1 clinical trials of CS1001 in advanced cancer patients. Proposed clinical indications include common cancers and cancers with high incidence in China.
"I am delighted that the first IND application from CStone Pharmaceuticals was successfully reviewed by CFDA and was allowed to conduct clinical studies. This is an important milestone in the development of the company.”Dr. Jiang Ningjun, chief executive officer of CStone Pharmaceuticals, said the progress has laid a solid foundation for the follow-up a variety of groundbreaking joint treatments with PD-L1 as the framework. CStone Pharmaceuticals will bring hope for cancer patients in China as soon as possible by virtue of its unique advantages in clinical research and development as well as its various product lines of tumor drugs.
Immunotherapy, represented by PD-1 / PD-L1 and other checkpoint inhibitors, has indicated the direction of global cancer therapy and has achieved definite and breakthrough therapeutic effects in a variety of tumors, thus creating a new era of human treatment of tumors. At present, the world has five PD-1 / PD-L1 new drugs which are approved for listing, involving more than 10 kinds of indications, but China has no similar products successfully approved for listing.
About CStone Pharmaceuticals
CStone Pharmaceuticals, with its headquarter in Suzhou, China, is a biopharmaceutical company driven by the research and development of innovative drugs. The company is committed to the development of tumor immune drugs and has a variety of product lines. CStone Pharmaceuticals has closed its Series A round of 150 million dollars financing (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. The company's leadership team, from the well-known international pharmaceutical business management, has successfully built a team regarding clinical research and development and translational medicine as the core competitiveness and will carry out high-quality clinical research with international standards, especially the development of cancer immunotherapy to speed up the registration of products and to bring benefits to Chinese patients as soon as possible.
CS1001 (formerly known as WBP3155) is independently developed by CStone Pharmaceuticals with completely independent intellectual property rights and is China’s first human anti-PD-L1 monoclonal antibody (mAb). CS1001 is also the world's first monoclonal antibody (mAb) drugs screened by the international leading OMT transgenic animal platform and can get the whole sequence of human body by one step. OMT technology, authorized and introduced by Ligand company in United States, has a humanized monoclonal antibody production and screening platform with the world's leading level.
About PD-L1PD-L1, with the full name of programmed cell death-ligand 1 and the English name of programmed cell death-ligand 1 (PD-L1), is a type of transmembrane protein with a size of 40 kDa. Under normal physiological conditions, the immune system reacts to antigens that accumulate in lymph nodes or spleen, promoting antigen-specific T cell proliferation. PD-1 binds to PD-L1, which can induce inhibitory signals and reduce the proliferation of T cells to control the overreaction of the immune system, so that the body can restore the natural immune balance after clearing the pathogen. In the tumor microenvironment, cancer cells will directly improve PD-L1 expression levels, strongly inhibit the body's natural anti-tumor immune response, thus making the tumor "escape" the identification and attack of body's immune system. At present, monoclonal antibody drugs regarding PD-1 and PD-L1 as the target spot are developed and approved in the world, while the domestic development of monoclonal drugs for PD-1 is relatively more. CS1001, as the first human anti-PD-L1 monoclonal antibody, is of great value in academic research and clinical treatment.