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Innovent Announces NMPA Granted Marketing Approval for SULINNO® (Adalimumab Injection) in China

2020-09-03 17:50 3274

SAN FRANCISCO, U.S. and SUZHOU, China, Sept. 3, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that SULINNO® (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug, has been officially approved by the National Medical Products Administration (NMPA) of China for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis in China. SULINNO® is Innovent's third monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection). The approval of SULINNO® marks the expansion of Innovent's marketed products into the non-oncology field.

There are nearly 20 million patients suffering from rheumatoid arthritis, ankylosing spondylitis or psoriasis in China. Not only does this type of disease cause a decrease in these patients' physical function, life quality and social participation, but also brings heavy economic burden to their families and the society. Since the launch of adalimumab, it has been approved worldwide for the treatment of seventeen diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriasis arthritis, juvenile idiopathic arthritis, crohn's disease (including pediatric crohn's disease), ulcerative colitis, hidradenitis suppurativa, uveitis, etc. The efficacy and safety of adalimumab has been well recognized globally. Adalimumab injection is widely used in the North America and Europe. It has been consistently recommended in multiple diagnostic and therapeutic guidelines for the treatment of these diseases, and its significant efficacy has been universally recognized. However, as the cost of the injection still exceeds the affordability of many ordinary patients, the use of adalimumab remains limited in China. SULINNO®, a adalimumab biosimilar has similar clinical efficacy and safety to adalimumab, and its clinical results were published in the Inaugural Issue of The Lancet Rheumatology in 2019. The launch of SULINNO® will provide more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "As an example of our success with the National Major New Drug Innovation and Development Projects, SULINNO® is the third monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection), and the first drug marketed among Innovent's non-oncology pipeline. The launch of SULINNO® once again fulfilled our mission to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. We hope that this product will benefit more and more patients and families in need and improve their quality of life."

About SULINNO®

SULINNO® is an adalimumab (Humira®) biosimilar and a recombinant human anti-TNF-α monoclonal antibody independently developed by Innovent. TNF is a proinflammatory cytokine mainly produced by activated macrophages, natural killer cells and T lymphocytes, which is involved in inflammatory and immune responses. Anti-TNF-α antibody can bind to human TNF-α monomer or trimer, block TNF-α binding to the cellular surface receptor, p55 and p75, and neutralize the cytotoxic effect of TNF-α, thereby inhibiting the release of TNF-α mediated inflammatory factors and cytokines, the adhesion and infiltration of inflammatory cells, the proliferation of fibroblasts and the activation of osteoclasts. Since the launch of adalimumab, it has been approved globally for the treatment of seventeen diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriasis arthritis, juvenile idiopathic arthritis, crohn's disease (including pediatric crohn's disease), ulcerative colitis, hidradenitis suppurativa, uveitis, etc., and its efficacy and safety has been well recognized worldwide. The results of a complete pre-clinical comparison showed that SULINNO® has similar in vitro biological activity (binding activity to target antigen TNF-α and neutralizing activity), physicochemical property and pharmacokinetic characteristics to those of Humira®. The similarities were also demonstrated in pharmacological and toxicological studies. The head-to-head clinical study comparing SULINNO® and Humira® conducted in patients with ankylosing spondylitis demonstrated a clinical similarity. The study results were published at Inaugural Issue of The Lancet Rheumatology in 2019.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 3 products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and SULINNO® (adalimumab injection), on market, 1 asset under NDA review with priority review status, 4 assets in Phase III or pivotal clinical trials, and additional 15 molecules in or close to clinical trials. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com.

Source: Innovent Biologics, Inc.
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