Cinda Biopharmaceutical (Suzhou) Co., Ltd. announced that its self-developed fully human anti-PD-1 monoclonal antibody injection (sendril monoclonal antibody, research and development code IBI308) combined with recombinant anti-VEGF humanized monoclonal antibody injection (R&D code IBI305) treatment, has obtained the clinical trial approval of the drug issued by the State Drug Administration, and is intended to carry out clinical research in patients with non-small cell lung cancer and liver cancer.
Combined immunotherapy is the trend
Lung cancer is the first malignant tumor in China with the highest morbidity and mortality. The number of new cases is about 781,000 and the death is about 626,000. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancer cases, of which approximately 70% are non-squamous NSCLC with an EGFR mutation rate of approximately 40%. The tyrosine kinase inhibitor TKI (gefitinib, erlotinib or ectinib) is recommended for patients with advanced NSCLC who have EGFR mutations. Progression after TKI treatment, if there is a T790M mutation, can be treated with Ochinib. If the T790M mutation is negative or progresses after treatment with octatinib, the choice of systemic treatment is only platinum-containing dual-agent chemotherapy. For such patients, the treatment options are single, there is an urgent need for new treatment options in the clinic, and there is a huge unmet medical need.
Liver cancer is the second leading cause of cancer death in China. The number of newly diagnosed liver cancer cases is about 365,000 and the death rate is 319,000. It is estimated that in 2018, the number of new cases of liver cancer in the world reached 841,000, and the number of liver cancer deaths was 782,000. Most primary liver cancers (70%-90%) are hepatocellular carcinoma (HCC). Most HCC patients are already locally advanced or metastatic disease at the time of onset and are not suitable for radical treatment. In the case of supportive care, the median survival time was only 7.9 months. For patients with HCC in the Asia-Pacific region mainly caused by viral hepatitis, the median survival time was shortened to 4.2 months. Therefore, there is an urgent need for effective treatment to meet the needs of patients with advanced HCC in China and around the world.
Tumor combined immunotherapy is the future trend. Syndilumab is a fully humanized programmed cell death-1 (PD-1) monoclonal antibody that binds to the PD-1 receptor on the surface of T cells and blocks its ligand The binding between PD-L1 allows T cells and autoimmunity to function normally, thereby destroying tumor cells. Syndilumab is a PD-1 monoclonal antibody developed by Cinda Biotech and Eli Lilly and Pharmaceutical Group in China. On April 16, 2018, the State Drug Administration officially accepted the application for the listing of Cindalimumab submitted by Cinda Biotech, and on April 23, it was included in the priority review variety, the first application for the drug. One indication is relapsed/refractory classic Hodgkin's lymphoma. IBI305 is a biosimilar drug of the world's best-selling drug, bevacizumab, and has entered clinical phase III studies. IBI305 targets VEGF, and its mechanism of action is to specifically bind VEGF, block the binding of VEGF to VEGF receptor, inhibit VEGF-induced angiogenesis and permeability increase, and thus prevent malignant tumor growth. Clinical studies included bioequivalence studies in healthy populations and a multicenter, phase III study of randomized, double-blind, positive drug controls in patients with non-small cell lung cancer.
Deep-growing monoclonal antibody
Founded in 2011, Cinda Bio is committed to the development, production and sale of new monoclonal antibody drugs for the treatment of major diseases such as cancer. At present, the company has established a high-quality technology platform for the whole cycle of bio-innovative drug development, including research and development, pharmaceutical development and industrialization, clinical research and marketing, and has established a product chain including 17 new monoclonal antibody varieties. Covering four major disease areas: tumor, fundus disease, autoimmune disease, and metabolic disease, 4 varieties entered the clinical phase III study, and the application for the marketing of one product, salibizumab injection, was accepted by the State Food and Drug Administration and entered the priority. Review.
Dr. Yu Dechao, founder, chairman and president of Cinda Bio, said: “The number of malignant tumors in China ranks first in the world, among which lung cancer and liver cancer are among the highest in incidence. As a Chinese innovative biopharmaceutical company, Cinda Bio is eager to pass everyone. Efforts to let the people enjoy the healthy results brought about by scientific and technological advancement. IBI308 and IBI305 are the two products of Cinda Bio in the NDA and clinical phase III trials respectively, and the clinical study of the combination of two monoclonal antibodies We will provide more treatment options for patients. We will make full use of the company's product chain advantages, continue to explore in the direction of combined tumor immunotherapy, and strive to achieve more innovative breakthroughs as soon as possible."
Kerry L., chief scientist of Cinda Bio. Dr. Blanchard said: "The latest research literature shows that tumor cells stimulate the growth of new blood vessels by producing two proteins, VEGFA and ANGPT2, ensuring that tumors continue to develop while blocking T cell-through lesions to kill cancer cells, thereby limiting anti-PD-1. Therapeutic effect of immunotherapeutic drugs such as /PD-L1 antibody. Anti-PD-1 antibodies combined with anti-angiogenic antibodies can better eliminate tumor cells."
Vitamins are a type of trace organic substances that humans and animals must obtain from food in order to maintain normal physiological functions. In terms of physiological functions, vitamins are neither a raw material for tissues nor a substance for supplying energy, but they are an indispensable substance for the body. It has many types and different chemical structures. Most of them are the components of the coenzyme (or prosthetic group) of certain enzymes. They are the indispensable compounds for maintaining the normal growth (growth, health, reproduction and production function) of the body. It plays a catalytic role in the body to promote the synthesis and degradation of major nutrients (proteins, fats, carbohydrates, etc.), thereby controlling metabolism. Vitamins are essentially low-molecular organic compounds. They cannot be synthesized in the body, or the amount synthesized is difficult to meet the needs of the body, so they must be supplied from the outside. The daily requirement of vitamins is very small (usually measured in milligrams or micrograms). They are neither a raw material for body tissues nor a substance for energy supply in the body. However, they do not regulate material metabolism, promote growth and development, and maintain physiological functions.
Vitamin K2 MK-7, Vitamin C, Vitamin E, Vitamin K2, Vitamin H, Vitamin D3
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