Cinda Biological's two monoclonal antibodies are simultaneously approved for clinical approval

Medical Network August 1st, Xinda Bio-Pharmaceutical Co., Ltd. released the company's recombinant human anti-OX40 monoclonal antibody for injection (R&D code IBI101) and recombinant human-derived anti-RANKL monoclonal antibody injection (R&D) Codename IBI307) also obtained the clinical trial approval issued by the State Drug Administration. Since the founding of Cinda Bio in 2011, nine R&D products have been approved by the State Drug Administration for clinical trials.

IBI101 is currently the first OX40 monoclonal antibody approved for clinical trials in China. As one of the important targets in the field of anti-tumor immunotherapy, the development of OX40 monoclonal antibody has been receiving much attention. The IBI101 approved clinical trials have made Cinda Biotech one of the few companies in the world to advance OX40 agonists into the clinic.

IBI307 is a recombinant full-human anti-RANKL monoclonal antibody injection, a fully human monoclonal antibody developed by Cinda Bio, which will be used to treat osteoporosis and lytic bone damage associated with cancer metastasis. At present, there are no RANKL antibody drugs approved for marketing in China.

Cinda Bio is a biopharmaceutical company dedicated to the development, production and sale of new monoclonal antibody drugs for the treatment of major diseases such as cancer. Dr. Yu Dechao, founder, chairman and president of the company, said: "The two companies developed by the company We are encouraged by the cloning of antibodies and the clinical approval of the State Food and Drug Administration. At present, the company has built a high-quality technology platform that runs through the entire cycle of bio-innovative drug development. We will continue to deepen the field of monoclonal antibody, accelerate the pace of research and development, and develop more The high-quality biopharmaceuticals that many people can afford to contribute to the development of China's biopharmaceutical industry."

About IBI101

Monoclonal antibody (research code IBI101) of recombinant human-derived anti-OX40 (tumor necrosis factor receptor superfamily member 4) for injection is an OX40 agonist with independent intellectual property rights developed by Cinda Biopharmaceutical, which is intended to treat a variety of tumors. Disease .

Preclinical studies have confirmed that IBI101 has a clear mechanism of action, which can significantly enhance the activation of effector T cells and mediate the clearance of regulatory T cells, thereby inhibiting the growth of tumor cells. Compared with the published antibodies of the same kind, the IBI101 has stronger ability to activate T cells and anti-tumor effect, and has obvious advantages in safety and effectiveness. OX40 agonists are expected to expand into more unmet cancer treatment areas with the company's existing drug classes, including PD-1 monoclonal antibody (IBI308) and other drugs in the R&D pipeline. There are currently no monoclonal antibodies against the same target in the world.

About IBI307

The recombinant human-derived anti-RANKL monoclonal antibody (R&D code IBI307) is a fully human monoclonal antibody developed by Cinda Biopharmaceuticals for the treatment of osteoporosis and lytic bone damage associated with cancer metastasis. The drug's mechanism of action is to block the interaction of RANKL with its unique receptor RANK, thereby delaying the differentiation of osteoclast precursors, inhibiting the differentiation and maturation of osteoclasts, and accelerating the apoptosis of mature osteoclasts, and ultimately affecting bone. Density and bone strength prevent bone loss. There is currently no monoclonal antibody against the same target in China.