Healthcare Industry News:  Humira 

Biopharmaceuticals Regulatory

 News Release - November 23, 2020

Innovent Announces NMPA Granted New Indication Approval for SULINNO(R) (Adalimumab Injection) in China for the Treatment of Polyarticular Juvenile Idiopathic Arthritis

SAN FRANCISCO and SUZHOU, China, Nov. 23, 2020 -- (Healthcare Sales & Marketing Network) -- 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 polyarticular juvenile idiopathic arthritis (pJIA), which is the fourth approved indication of SULINNO® in China. On September 2, 2020, SULINNO® was approved by NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

Juvenile idiopathic arthritis (JIA) is defined as arthritis with an unknown cause lasting at least 6 weeks in children aged 16 years or younger. Arthritis is divided into oligarthritis (<5 joints)and polyarthritis. Polyarthritis can be further divided into rheumatoid factor (RF)-negative polyarthritis and RF-positive polyarthritis. It is estimated RF-negative polyarticular JIA affects 1 to 4 per 100,000 children annually. Less commonly, RF-positive polyarticular JIA occurs in an estimated 0.3 to 0.7 per 100,000 children each year. JIA occurs in children at a young age, and is often accompanied by many complications that will lead to high rates of defects, disability and mortality when left untreated, deeply impacting the quality of life in children. Early aggressive therapy leads to improved outcomes and prevents potential disease complications.

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, and 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. SULINNO® is adalimumab biosimilar developed by Innovent, and its clinical results were published in the Inaugural Issue of The Lancet Rheumatology in 2019. The launch of SULINNO® has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients.

Dr. Qian Lei, Senior Director of Medical Sciences and Strategies of Special Diseases of Innovent, stated: "Not only does Juvenile idiopathic arthritic lead to functional impairment and decrease in quality of life and social participation in children, but also places a huge economic burden on their families. The approval of SULINNO® will provide a high-quality and accessible treatment option for children with polyarticular idiopathic arthritis in China. We hope that this product will benefit more children with polyarticular idiopathic arthritis and their families, allowing them to receive early treatment with high-quality biological drugs.''

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.

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 4 products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar) , SULINNO® (adalimumab biosomilar) and HALPRYZA®(rituximab biosimilar)on market, 4 assets in Phase III or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.


Source: Innovent Biologics

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