Xinda Bio announced that Adamo single anti-injection sulyxin ® officially approved for listing in China.

READ MORE: Nationwide, Thynda Bio, Adamo Monoantitor, Suzhou, China, USA - Xinda Biopharmaceuticals (HKEx: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for major diseases such as cancer, metabolic diseases, autoimmunity, announced today that it is recombining human resistance Tumor necrosis factor-alpha (TNF-alpha) monoclonal antibody drug Su Lixin ® (Adamo monoantigen injection, English trademark: SULINNO®) has been officially approved by the State Drug Administration (NMPA) for the treatment of rheumatoid arthritis, strong spina bifida and psoriasis.
Three is the third monoclonal antibody drug to be approved by NMPA, following Dabershu ® (Syndili monoantigen injection) and Dabio ® (Beva Pearl monoantigen injection).
's approval ® the company marks the expansion of Xinda Bio's listed products into the non-tumor field.
There are nearly 20 million patients with rheumatoid arthritis, severe spina bifiditis and psoriasis in China, which not only causes the decline of physical fitness, quality of life and social participation, but also brings a huge financial burden to the families and society of patients.
Since its launch, the
original drug Adamo single anti-injection has been approved worldwide for the treatment of 17 diseases including rheumatoid arthritis, hyperthyroidized spina bifida, psoriasis arthritis, early idiopathic arthritis, Crohn's disease (including children's Crohn's disease), ulcerative colitis, septic sweating adenitis, and staphylococcitis.
the drug is widely used in North America and Europe, and several guidelines consistently recommend the use of Adamo monotherapy for the above-mentioned diseases, its remarkable efficacy has been widely recognized.
present, the treatment cost of Adamo monoantigen injection is still beyond the affordability of many ordinary Chinese patients, resulting in a low use rate of Adamo monoantigen in China.
Surisin® which was independently developed by Xinda Bio, is a adamo mono-biosynthetic drug with similar clinical efficacy and safety to Adama monoantigen, and its clinical findings were published in 2019 in the internationally renowned journal Lancet Rheumatology.
s launch of ®Surixin" will provide more Chinese patients with high-quality and relatively affordable Adamo monoantigen injections, giving more patients hope and opportunities.
"As a special achievement of the country's major new drug creation, Sully-Reliance ® is the third monoclonal antibody drug approved for sale after Xinda Biojourshu ® (Syndili single anti-injection) and Dabio ® (Beva Zhu monoantigen anti-injection) and the first drug to be marketed on the Xinda Bio-Non-Tumor Product Line," said Dr.
's ® has enabled Xinda Bio to once again fulfill its mission of 'developing high-quality biological drugs that people can afford'.
hope that this product will benefit more and more patients and families and improve their quality of life.
"about Surixin ®Surixin® biosynthetic drug for Adami monoantigen injection (Shumeile ®), is the recombinant human anti-TNF-alpha monoclonal antibody independently developed by Xinda Bio.
TNF is an inflammatory cytokine produced mainly by active macrophages, natural killer cells and T lymphocytes, involved in inflammatory and immune responses.
anti-TNF-alpha antibodies can bind to human TNF-alpha monomers or tripolymers, blocking their binding to cell surface subjects p55 and p75, neutralizing the cytotoxic effects of TNF-alpha, thereby inhibiting the release of inflammatory and cytokines mediated by TNF-alpha, the adhesion and immersion of inflammatory cells, and the proliferation and biopulation of fibroblasts.
Since its launch, the original drug Adamo monoantigen anti-injection has been approved worldwide for the treatment of 17 diseases including rheumatoid arthritis, hyperthyroidized spina bifida, psoriasis, psoriasis arthritis, early idiopathic arthritis, Crohn's disease (including crohn's disease in children), ulcerative colitis, septic sweating adenitis, staphylococcitis and other 17 diseases, its remarkable efficacy and safety has been widely recognized.
The complete preclinical matching test results show that Su Lixin ® and Shumeile® are similar in in-body biological activity (binding activity and melising activity of target antigen TNF-alpha), physical and chemical properties and drug metabolic dynamics characteristics are similar to Shumeile ® and pharmacological toxicology studies have confirmed that Su Lixin ® is similar to Shumeile ®.
's head-to-head control study with Shumeile ® in patients with strong straight spina bryssis showed that Su Lixin ® and Shumeile® had similar clinical efficacy and safety. Published in 2019 in the internationally renowned journal The Lancet Rheumatology, the first clinical study of a biosynthetic drug developed in China was published in the world's leading medical journal, proving the high quality of ®.
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