Innovent Announces the China NMPA Approvals for SULINNO® (adalimumab injection) for the Treatment of Adult and Pediatric Crohn's Diseases

SAN FRANCISCO, U.S. and SUZHOU, China, June 1, 2022 – Innovent Biologics, Inc. (“Innovnet”)(HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announces that SULINNO® (adalimumab injection) , a fully humanized recombinant human anti-tumor necrosis factor-α (TNF-α) monoclonal antibody, has been officially approved by the National Medical Products Administration (NMPA) for two new indications for the treatment of adult Crohn's disease and pediatric Crohn's disease, which are the seventh and the eighth approved indications of SULINNO® in China. In September 2020, SULINNO® was initially approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis, becoming the third approved antibody drug of Innovent. In the same year, the NMPA approved three additional indications including polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and non-infectious intermediate uveitis, posterior uveitis, and panuveitis in adults who have had an inadequate response to glucocorticoids, require corticosteroid sparing, or are not eligible for glucocorticoid therapy. The pre-filled syringe of SULINNO® was launched to market in August 2021, which can be used directly for self-injection after proper instruction, ensuring the safety and efficacy, improving the stability and convenience, and significantly enhancing the treatment experience of patients. The prevalence of Crohn's disease in China is about 2.29 cases per 100,000 people, and the incidence is 0.848 cases per 100,000 people with a rapid increase in recent years. The number of patients increased from 81,000 to 134,000 between 2015 and 2019, with a compound annual growth rate of 13.3%, based on which, it is estimated that the patient population will exceed 280,000 in 2030. Crohn's disease is a type of inflammatory bowel disease, which belongs to chronic non-specific intestinal inflammatory disorders. It is prone to relapses and rapid progression. Complications are commonly seen in patients with Crohn's disease. If the symptoms are not well controlled, it will seriously affect the quality-of-life of patients. Treatment options are limited for patients with poor response, intolerance, or contraindications to traditional treatments, thus, more treatment options are urgently needed. Adalimumab injection was approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease and pediatric Crohn's disease in 2007 and 2014, respectively. The original drug Humira® (adalimumab injection) has been approved for 19 indications globally and domestically, and its robust efficacy and good safety profile have been well-recognized. However, the treatment cost still exceeds the affordability of many Chinese patients, and there is a huge unmet medical need in China. The launch and new indication approvals of SULINNO® will provide more Chinese patients with high-quality and affordable adalimumab injection. "The treatment of Crohn's disease and pediatric patients with Crohn's disease are the seventh and eighth indications for SULINNO® respectively, following ankylosing spondylitis, psoriasis, rheumatoid arthritis, uveitis, pediatric plaque psoriasis, and polyarticular juvenile idiopathic arthritis. There is a large number of unmet medical needs in the treatment of Crohn's disease in China, and its long-term and recurring symptoms seriously affect patient's quality-of-life and mental health. We sincerely hope that the high quality and accessibility of the treatment options provided by SULINNO® will benefit an increasing number of Chinese patients with Crohn's disease." Said Dr. Lei Qian, Vice President of Clinical Development of Innovent. About Adult and Pediatric Crohn's Diseases Crohn's disease, also known as segmental enteritis, localized enteritis, or granulomatous enterocolitis, is an inflammatory bowel disease whose pathogenesis has not been fully elucidated. Its main pathological features are intestinal inflammation accompanied by granuloma formation, and the lesions can involve any part of the gastrointestinal tract. The typical symptoms are abdominal pain, diarrhea, fatigue, loss of appetite, weight loss and hematochezia, which seriously affect the quality-of-life of patients. For children, chronic diarrhea, loss of appetite and insufficient nutrient intake caused by Crohn's disease can seriously affect their growth and development, causing heavy physical and psychological burden to children and their families. There is currently no cure for Crohn's disease, and the goals of management are to induce and maintain remission, prevent and treat complications, and improve quality of life. Conventional treatment mainly includes aminosalicylic acid, glucocorticoids, and thiopurine immunosuppressive agents. Antibiotics are also used in the adjuvant setting of this disease. New therapeutic agents are urgently needed for patients with poor response, intolerance, or contraindications to conventional treatments. About SULINNO® (adalimumab biosimilar) SULINNO®, an adalimumab (Humira®) biosimilar, is a fully humanized recombinant human anti-TNF-α monoclonal antibody independently developed by Innovent. TNF, a proinflammatory cytokine mainly produced by activated macrophages, natural killer cells and T lymphocytes, is involved in inflammatory and immune responses. Anti-TNF-α antibody can bind to human TNF-α monomer or trimer, subsequently block the binding of TNF-α to the cellular surface receptor, p55 and p75, and neutralize the cytotoxic effect of TNF-α, ultimately resulting in the inhibition of 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. Current authoritative guidelines have unanimously recommended adalimumab for the first-line treatment of moderately to severely active Crohn's disease. The results of a comprehensive 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. In China, SULINNO® had been approved for the treatment of ankylosing spondylitis, psoriasis, rheumatoid arthritis, uveitis, pediatric plaque psoriasis and polyarticular juvenile idiopathic arthritis, all of which have been covered in the National Reimbursement Drug List (NRDL). As the first-line treatment recommended by authoritative guidelines, it is believed that the approval of SULINNO® for the treatment of Crohn's disease and pediatric patients with Crohn's disease can benefit more patients in China. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture 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, autoimmune, metabolic, ophthalmology 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 1 asset under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. (“Innovent” or “Company”) , are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. 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