Through more than ten years efforts, HaiKang Pharm formed independent intellectual property of DK-001 project. It is a globally innovative project. The company has reported it to the State Intellectual Property Office for patent application.and also started PCT application.DK-001 Project was granted by SIPO as an invention patent.
Colorectal cancer is chosen to be the preferred indication for DK-001. We have completed all the preclinical study of it, including pharmacodynamics, pharmacokinetics, long-term toxicity, acute toxicity, drug safety, immune toxicity, and local irritation test. According to the test reports given by the national authoritative institutes, DK-001 antibody could significantly suppress the tumor growth in more than 81.8%-86.2% of colorectal cancer patients. Since the monoclonal antibody is highly tumor specific, it has no cross react with 15 kinds of normal human organs, 11 kinds of embryonic tissues, normal lymphocytes and bone marrow cells. At the same time, we also accomplished the pilot plant production of it, established the quality control methods, and domesticated the serum-free production cells with high-yield expression ability. Also IND application has been submitted to the State Food and Drug Administration last year.