Innovent Announces First Patient to Receive One Dose in 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 markets high-quality drugs for the treatment of cancer, autoimmune diseases, metabolic, ophthalmological and other 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 antibody injection anti-interleukin 23p19 (R&D code: IBI112) in China.

The study is a multicenter, 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 induction and maintenance treatment with IBI112 in Chinese patients with moderate to severe active ulcerative colitis. It is also the first phase 2 clinical study of domestic innovative drugs targeting IL-23p19 for patients with UC in China, which marks an important step. Innovent will continue to leverage its rapid turnaround capabilities in clinical development and research and strive to provide better treatment options for UC patients.

Teacher Minhu Chen of The First Affiliated Hospital of Sun Yat Sen University, the study’s principal investigator, said: “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 severely affected and new treatments are urgently needed. IBI112, a novel anti-The IL-23p19 monoclonal antibody developed by an innovative Chinese biopharmaceutical company belongs to the national class 1 new drug category and has shown favorable safety and tolerability in phase 1 clinical studies. We hope that IBI112 will pass the phase 2 clinical study and will provide an alternative treatment option for Chinese patients with ulcerative colitis. »

dr. Qian Leivice-president of clinical development of Innovent, said: “Ulcerative colitis is a kind of inflammatory bowel disease characterized by persistent and recurrent diarrhea, mucus and bloody stools, abdominal pain and severe internal urgency. The number of patients has increased rapidly over the past 20 years.With the increase in incidence rate, ulcerative colitis has become a common disease of the digestive system. China. As a chronic inflammatory disease, in addition to harming physical health, it also seriously interferes with the daily life of patients and has a huge negative impact on the psychological health of patients. In recent years, a new generation of drugs targeting IL-23 has attracted particular interest due to its excellent efficacy and favorable safety profile. IL-23 plays a key role in the T cell-mediated response and is considered a key initiator of immune-mediated diseases. IBI112 plays an anti-inflammatory role by blocking the 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 are no self-developed IL-23p19 inhibitors on the market in China. Results from the first-in-man Phase 1 clinical study of IBI112 confirmed its favorable safety and tolerability profiles, and preliminary demonstrated its potential to serve a longer dosing interval and a longer treatment regimen. patient friendly. We are greatly encouraged that it can provide a solid foundation for further clinical development. Based on this, we are confident to collaborate 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 innovative high quality biopharmaceuticals. quality that are affordable for ordinary people. .”

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

About Ulcerative Colitis Ulcerative colitis is a chronic inflammatory disease characterized by inflammation of the mucous membranes of the colon and rectum, with typical symptoms such as recurrent diarrhea, mucus, pus and bloody stools with abdominal pain and urgency. UC is a serious threat to physical health and has an impact on the daily life and mental health of patients. UC is common in Europe and North America. And in China, the prevalence rate has gradually increased over the past 20 years with a prevalence rate of 11.6/100,000. UC is most commonly diagnosed in young and middle-aged people. The clinical treatment of UC is mainly drug and surgical. Thiopurine is the most traditional immunosuppressant, but the incidence of adverse effects 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 terms of efficacy and safety in the treatment of UC. Currently, there are no self-developed IL-23p19 inhibitors for the treatment of ulcerative colitis in Chinaand there is still a huge unmet clinical need.

About Innovent

Inspired by the spirit “Begin with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high-quality biopharmaceutical products that are affordable for everyday people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing high quality, innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018Innovent was listed on the main board of the Stock Exchange of Hong Kong Limited under stock code: 01801.HK.

Since its creation, Innovent has developed a fully integrated multifunctional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a strong pipeline of 32 valuable assets in cancer, autoimmunity, metabolism, 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® (oral pemigatinib inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza ® (ramucirumab), 3 assets under NMPA NDA review, 3 assets in Phase 3 or pivotal clinical trials, and 19 additional molecules in clinical studies.

Innovent has assembled an international team with advanced talents in the development and commercialization of high-end biologic drugs, 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 advance China the biopharmaceutical industry, improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

To note:

Sintilimab is not an approved product in United States.

BYVASDA® (biosimilar bevacizumab injection), HALPRYZA® (biosimilar rituximab injection) and SULINNO® (biosimilar adalimumab injection) are not approved products in United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (biosimilar injection of bevacizumab, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (biosimilar injection of adalimumab, Innovent)

Pemazyre® (oral pemigatinib 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 active under NMPA NDA review, 5 active in phase 3 or pivotal clinical trials, and 19 additional molecules in clinical studies.

Forward-looking statements

This press 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, when referring to Innovent, are intended to identify certain of these forward-looking statements. Innovent does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on Innovent’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees 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. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions.

Innovent, the directors and 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 do not materialize or prove to be incorrect.

SOURCE Innovative Biologics

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