Innovent Announces NMPA Granted New Indication Approvals for SULINNO® (Adalimumab Injection) for the Treatment of Pediatric Plaque Psoriasis and Non-infectious Uveitis

Innovent Biologics, Inc., 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 announces 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 two new indications, including the treatment of pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults who do not respond adequately to corticosteroids, require restraint of corticosteroids, or are not suitable for corticosteroid therapies. These are the fifth and sixth approved indications of SULINNO® in China. SULINNO® was firstly approved by China NMPA on September 2, 2020. Previous approved indications of SULINNO® include rheumatoid arthritis, ankylosing spondylitis, psoriasis, and polyarticular juvenile idiopathic arthritis.

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, "There remains huge unmet medical need for the treatment of psoriasis and uveitis in China. Psoriasis can bring tremendous pain and physiological burden that seriously affect patients' quality of life and mental health. Psoriasis in children is a particular challenge. However, early diagnosis and adequate management will have the opportunity to avoid complications that may result from chronic inflammation in adulthood. Uveitis can cause severe eye discomfort and directly affect vision. Meanwhile, patients with uveitis are at high risk for ocular complications, including glaucoma, macular edema, and cataracts, and recurrent episodes may result in cumulative ocular damage, increasing the risk of visual impairment or blindness. Up to 35% of patients with uveitis may have impaired vision, imposing a heavy economic burden on patients and society. Early diagnosis and standardization of effective treatment are important to maintain visual acuity. We hope the approval of SULINNO® for new indications will provide psoriasis and uveitis patients with a high quality, effective and more affordable treatment option."

About Psoriasis and Pediatric Plaque Psoriasis

Psoriasis is a chronic inflammatory skin disease affecting approximately 2% of the population worldwide. The skin disorder begins in childhood in about one-third of the cases. The prevalence of psoriasis in the population aged 0-19 is about 0.18% in China. Thus it is estimated that psoriasis affects about 600,000 children in China. The most common type of psoriasis in children is chronic plaque psoriasis (74%), followed by guttate psoriasis (14%), seborrheic dermatitis-like psoriasis (8%), and the least common is pustular psoriasis (1%). The treatment of plaque psoriasis in children is complex and difficult due to the lack of adequate clinical data, effective systemic therapy, and standardized treatment guidelines. Psoriasis not only brings serious psychosocial burden to children, but also may increase the risk of complications such as hypertension and diabetes mellitus. Thus, timely and effective treatment is particularly important. Adalimumab injection was approved by FDA for the treatment of psoriasis (including pediatric plaque psoriasis), and is widely used in the North America and Europe for this disease. 

About Uveitis and Non-infectious Uveitis

Uveitis is a group of ocular diseases characterized by inflammation of the uveal tract and neighboring structures. Uveitis is mainly grouped into infectious uveitis and non-infectious uveitis, in which non-infectious uveitis accounts for about 20% to 40% of uveitis cases. The prevalence of uveitis in China is 152 / 100,000, of which the prevalence of non-infectious uveitis is 62.6-83.3/100,000. Thus it is estimated that there are about 800,000-1,150,000 patients with non-infectious uveitis in China. Non-infectious uveitis is an ocular immune disorder caused by an inappropriate inflammatory response of the immune system to antigens in the uveal tract and retina, some of which may be associated with systemic autoimmune diseases, but some may affect the eyes only. Since uveitis typically affects the working age group (20-60 years old), not only does it affect patients' quality of life, but also has profound socioeconomic impact on the affected patients. Topical corticosteroid eye drops can be used for non-infectious anterior uveitis, but non-infectious intermediate, posterior, and panuveitis often requires long-term topical or even systemic corticosteroids or other immunomodulators. Some patients do not respond well to corticosteroid therapy, and the side effects of corticosteroids limit their long-term use. Adalimumab injection was approved by FDA on June 30, 2016 for the treatment of non-infectious intermediate, posterior and panuveitis. In 2018, international committee on uveitis issued a guideline on nonsteroidal systemic immunomodulatory treatment in uveitis, which made detailed recommendations on the use of TNF-α monoclonal antibody, represented by adalimumab, in non-infectious uveitis.

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, S.A.R., China 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.