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Xinda Biopharmaceutical Co., Ltd. announced that the company developed injection recombinant all-human source anti-OX40 monoclonal antibody (research and development code IBI101) and recombinant all-human source anti-RANKL monoclonal antibody injection (research and development code IBI307) at the same time obtained the National Drug Administration issued clinical trial approval. Since its inception in 2011, 9 research and development products have been approved by the National Drug Administration clinical trials.
IBI101 is currently the first OX40 monoclonal antibody to be approved for clinical trials in China. As one of the important targets in the field of anti-tumor immunotherapy, the development progress of OX40 monoclonal antibody has been paid close attention. The IBI101 approved clinical trial gives Thyme Bio a place in one of the few companies in the world that pushes OX40 astrations into clinical practice.
IBI307 is a recombinant all-human anti-RANKL monoclonal antibody injection, is an all-human monoclonal antibody developed by Xinda Bio, which will be used to treat osteoporosis and soluble bone damage associated with cancer metastasis. At present, there is no RANKL antibody drugs approved for market.
Sinda Bio, a biopharmaceutical company dedicated to the development, production and sale of new monoclonal antibody drugs for major diseases such as tumors, said Dr. Dechao Yu, founder, chairman and president of the company: "We are encouraged that the two monoclonal antibodies developed by the company have received clinical approval from the National Drug Administration at the same time." At present, the company has built a full cycle of bio-innovative drug development of high-quality technology platform, we will continue to deeply cultivate the field of single resistance, accelerate the pace of research and development, develop more people can afford high-quality biological drugs, for China's biopharmaceutical industry development contribution. " on IBI101
injection recombinant all-human source antiOX40 (tumor necrotic cause sub-member super family member 4) monoclonal antibody (research and development code IBI101) is Xinda Biopharmaceuticals developed with independent intellectual property rights ox40 astrologist, intended to be used to treat a variety of tumor diseases.
preclinical study data confirmed that IBI101 has a clear mechanism of action, which can significantly enhance the active effect of T cells, and mediate the removal of regulatory T cells, thus playing a role in inhibiting tumor cell growth. Compared with the disclosed similar target antibodies, IBI101 has a stronger active T-cell capability and anti-tumor effect, and has obvious advantages in safety and effectiveness. Ox40 astrologists are expected to expand into more unsoponsed oncology treatments with the company's existing drug ranges, including PD-1 monoantigen (IBI308) and other drugs in the development pipeline. There is currently no single anti-drug market approved for the same target worldwide.about IBI307
recombinant all-human source anti-RANKL monoclonal antibody (developed code-named IBI307) is an all-human monoclonal antibody developed by Xinda Biopharmaceuticals for the treatment of osteoporosis and soluble bone damage associated with cancer metastasis. The mechanism of action of the drug is to block the interaction between RANKL and its only receptor, RANKK, thereby delaying the differentiation of bone-breaking cell pregenitors, inhibiting the differentiation and maturation of bone-breaking cells, and accelerating the apoptosis of mature bone-breaking cells, and ultimately affecting bone density and bone strength, to prevent bone mass reduction. There is currently no single anti-drug market for the same target. (U.S. News Agency)