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Bio-Dyutton® and Surixin® Approved for New Indications!
Bio-Dyutton® and Surixin® Approved for New Indications!. Bio-Dyutton® (bevacizumab) and Surixin® (adalimumab) developed by Chinese company:Innovent Biologics have been approved for new indications!
China Innovent Biologics recently announced that its self-developed recombinant humanized anti-VEGF humanized monoclonal antibody drug Dayoto® (bevacizumab, international trademark: BYVASDA®) has officially obtained the approval of China State Drug Administration ( NMPA) approved for the treatment of adult recurrent glioblastoma (GBM), which is one of the most common primary brain malignancies.
GBM is the third indication approved by Dayoto®. On June 17, 2020, Danoton® received NMPA marketing approval for the first time for the treatment of advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).
In recent years, the burden of cancer has continued to increase. According to the 2018 World Health Organization (WHO) Global Oncology Research Agency Cancer Today report, the number of new cancer cases in China in 2018 was 4.285 million and the number of deaths was 2.865 million. Among them, glioblastoma is the most common and most malignant primary intracranial tumor in adults. It has the characteristics of high morbidity, high recurrence, high mortality and low cure rate.
The current main treatment options for glioblastoma include surgical resection, radiotherapy, and chemotherapy. The median survival time is about 12-15 months, and there has been no significant change in the past ten years. Therefore, patients urgently need more treatment options.
Dayton® is a biosimilar of Roche’s original drug Bevacizumab injection (Avastin, Chinese trade name: Avastin), also known as recombinant anti-VEGF humanized monoclonal antibody injection. VEGF is an important factor in the process of angiogenesis and is over-expressed pathologically in most human tumor endothelial cells.
Anti-VEGF antibodies can selectively bind to VEGF with high affinity. By blocking the binding of VEGF to receptors on the surface of vascular endothelial cells, it blocks the conduction of PI3K-Akt/PKB and Ras-Raf-MEK-ERK signaling pathways, thereby Inhibit the growth, proliferation, migration and angiogenesis of vascular endothelial cells, reduce vascular permeability, block the blood supply of tumor tissues, inhibit tumor cell proliferation and metastasis, and induce tumor cell apoptosis, thereby achieving anti-tumor therapeutic effects.
The original research drug Bevacizumab injection (Avastin, Avastin) has been approved worldwide for the treatment of non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, and cervical cancer. Cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer and other solid tumors. The indications approved in China are advanced non-small cell lung cancer, metastatic colorectal cancer and adult recurrent glioblastoma. Its remarkable curative effect and Good safety has been generally recognized.
However, the treatment cost of the original drug of bevacizumab injection is still beyond the affordability of many ordinary patients, and there is a huge unmet clinical demand in China. Dayoutong® is a recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody injection independently developed by Cinda Biopharmaceuticals. It is a biological analogue of bevacizumab. The launch of Dayton® provides more Chinese patients with high-quality and affordable bevacizumab injections.
It is worth mentioning that last week, Cinda Bio’s recombinant human anti-tumor necrosis factor-α (TNF-α) monoclonal antibody drug Sulixin® (adalimumab injection, English trademark: SULINNO®) also officially won the national The Drug Administration (NMPA) approved 2 new indications for the treatment of plaque psoriasis in children and adults with inadequate response to glucocorticoids, need to use glucocorticoids sparingly, or unsuitable for glucocorticoid therapy Non-infectious intermediate uveitis, posterior uveitis and pan uveitis.
This is the fifth and sixth indication approved by Su Lixin®. On September 2, 2020, Su Lixin® received NMPA marketing approval for the first time. The previously approved indications are rheumatoid arthritis, ankylosing spondylitis, psoriasis and polyarticular juvenile idiopathic arthritis.
The original research drug adalimumab injection (Humira, Chinese trade name: Xiu Mei Le) has been approved globally for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis (including plaque in children) since its launch. Psoriasis), psoriatic arthritis, juvenile idiopathic arthritis, Crohn’s disease (including Crohn’s disease in children), ulcerative colitis, hidradenitis suppurativa, uveitis and other 17 diseases.
As a biosimilar of Adalimumab injection, Cinda Bio’s independent research and development of Su Lixin®, clinical research results were published in the first issue of the internationally renowned journal “Lancet Rheumatology” in 2019. The launch of Su Lixin® provides more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and treatment opportunities to more patients.
(source:internet, reference only)