Innovent Announces First Patient Dosed in a Phase 2 Clinical study of IBI112 (IL-23p19 Monoclonal Antibody) in Patients with Moderate-to-Severe Active Ulcerative Colitis

SAN FRANCISCO and SUZHOU, China  , July 3, 2022 /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, autoimmune, metabolic, ophthalmology and other major diseases, announced that the first patient with moderate-to-severe active ulcerative colitis has been successfully dosed in a Phase 2 clinical study (clinicaltrials.gov, NCT05377580) of its innovative recombinant anti-interleukin 23p19 subunit antibody injection (R & D code: IBI112) in China.

The study is a multi-center, randomized, double-blind, parallel, placebo-controlled Phase 2 clinical study, evaluating the efficacy and safety of IBI112 in the treatment of moderate-to-severe active ulcerative colitis. The primary objective of the study is to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of IBI112 induction and maintenance therapy in Chinese patients with moderate-to-severe active ulcerative colitis. This is also the first Phase 2 clinical study of domestic innovative drugs targeting IL-23p19 for UC patients in China, which marks a significant milestone. Innovent will continue to leverage its fast execution capabilities in the clinical development and research and strive to provide better treatment options for UC patients.

Professor Minhu Chen from The First Affiliated Hospital of Sun Yat Sen University, the principal investigator of the study, stated, "The pathogenesis of ulcerative colitis is complex, which is related to genetic, immune, environmental and other factors. Currently, the quality of life and mental health of patients with ulcerative colitis in China, especially those with refractory ulcerative colitis, are greatly affected, and new treatments are urgently needed. IBI112, a novel anti-IL-23p19 monoclonal antibody developed by innovative Chinese biopharmaceutical company, belongs to National Class 1 New Drug Category and has shown favorable safety and tolerability in Phase 1 clinical studys. We hope that IBI112 will be successful in the Phase 2 clinical study, and provide an alternative treatment option for Chinese patients with ulcerative colitis."

Dr. Qian Lei, Vice President of Clinical Development of Innovent, stated: "Ulcerative colitis is a kind of inflammatory bowel disease characterized by persistent and recurrent diarrhea, mucus pus and bloody stool, abdominal pain, and severe internal emergency. The number of patients has increased rapidly in the past 20 years. With the increase in incidence rate, ulcerative colitis has become a common digestive system disease in China. As a chronic inflammatory disease, in addition to the damage to physical health, it also seriously interferes with patients' daily life and has a huge negative impact on patients' psychological health. In recent years, a new generation of drugs targeting IL-23 has attracted special interests due to its excellent efficacy and favorable safety profile. IL-23 plays a key role in T cell-mediated response and is regarded as a pivotal initiator of immune-mediated diseases. IBI112 plays an anti-inflammatory role by blocking IL-23-mediated signaling pathway and has the potential to treat autoimmune diseases such as inflammatory bowel disease including ulcerative colitis and psoriasis. Currently, there is no self-developed IL-23p19 inhibitors on the market in China. Results from the first-in-human Phase 1 clinical study of IBI112 has confirmed its favorable safety and tolerability profiles, and has preliminarily demonstrated its potential to serve a longer dosing interval and more patient-friendly treatment regimen. We are greatly encouraged that it can provide strong foundation for the subsequent clinical development. Based on this, we are confident in collaborating with our study sites to advance the clinical development of IBI112 in moderate to severe active ulcerative colitis as well as other indications to fulfill our mission of providing high-quality innovative biopharmaceutical products that are affordable to ordinary people."

About IBI112
IBI112 is a monoclonal antibody independently developed by Innovent, with proprietary intellectual property rights. This product specifically binds to IL-23p19 subunit, thereby preventing IL-23 from binding to cell surface receptors, resulting in the inhibition of IL-23 receptor-mediated signaling pathway. Preclinical data of IBI112 demonstrated that it has a clear target and well-elucidated mechanism of action, and significant anti-inflammatory effect. It has been verified to be safe and well tolerated in phase 1 clinical study. IBI112 may provide a more effective treatment option for patients with inflammatory bowel disease including ulcerative colitis and other autoimmune diseases.

About Ulcerative Colitis  Ulcerative colitis is a chronic inflammatory disease characterized by mucosal inflammation of the colon and rectum, with typical symptoms such as recurrent diarrhea, mucus, pus and blood stool with abdominal pain, and urgency. UC is a serious threat to physical health and has an impact on daily life and mental health for patients. UC is common in Europe and North America. And in China, the prevalence rate has been increasing gradually in the past 20 years with a prevalence rate of 11.6/100000. UC is more common diagnosed in young and middle-aged people. The clinical treatment of UC is mainly medication and surgical treatment. Thiopurine is the most traditional immunosuppressant, however the incidence of adverse reactions is high. In terms of biologics, anti-TNF-α Monoclonal antibodies have problems such as loss of response caused by immunogenicity. In recent years, drugs targeting IL12 and IL 23 have shown advantages in efficacy and safety in the treatment of UC. At present, there is no self-developed IL-23p19 inhibitors for the treatment of ulcerative colitis in China, and there is still a huge unmet clinical need.

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 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) , 3 asset under NMPA NDA review, 3 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:

Sintilimab is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab 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), 1 asset under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect.

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