Innovent Announces First Patient Dosed in a Phase 2 Clinical Trial of IBI112 (IL-23 Monoclonal Antibody) in Patients with Moderate-to-severe Plaque Psoriasis

SAN FRANCISCO and SUZHOU,China,Sept. 24,2021 -- Innovent Biologics,Group. ("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 the first patient with moderate-to-severe plaque psoriasis has been successfully dosed in a Phase 2 clinical trial (clinicaltrials.gov,NCT05003531) of recombinant anti-interleukin 23p19 subunit antibody injection (R & D code: IBI112)in China.

Study CIBI112A201 is a multicenter,randomized,double-blind,parallel,placebo-controlled Phase 2 clinical trial,evaluating the efficacy and safety of IBI112 at different doses administered subcutaneously in the treatment of moderate-to-severe plaque psoriasis. The primary objective of the study is to evaluate the efficacy of subcutaneous injection of IBI112 at different doses in Chinese subjects with moderate-to-severe plaque psoriasis. The safety of drugs and the difference of administration interval between different therapeutic regimens will also be investigated,so as to provide dose information for Phase 3 clinical studies. This is also the first Phase 2 clinical study of domestic innovative drugs targeting IL-23p19,which is a significant milestone.

Professor Jianzhong Zhang from Peking University People's Hospital,principal investigator of the study,stated,"The pathogenesis of psoriasis is complex. Psoriasis is difficult to treat,and the patients often suffer for a lifetime. Currently about 2% to 3% of the world's population suffers from psoriasis; about 80% to 90% of patients have plaque psoriasis,and nearly one third of the cases are moderate to severe. There are about 6 million patients with psoriasis in China. According to the literature,IL-23 monoclonal antibody has gained increasing attention in recent years due to its favorable efficacy and safety profiles. IBI112 is a novel IL-23p19 monoclonal antibody independently investigated and developed by Chinese enterprises. The results of Phase 1 clinical trial showed favorable safety and tolerability as well as potential advantages in the route of administration. We hope that IBI112 will be successful in the Phase 2 clinical trial,and provide an alternative treatment option for Chinese patients with psoriasis."

Dr. Qian Lei,Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent,stated: "With the introduction of biologics drugs such as adalimumab and IL-17 into the clinic,compared with traditional systemic treatments,they undoubtedly offer alternative treatment options for patients with psoriasis,but there is still room for further improvement in terms of efficacy,safety,as well as maintaining a durable effect. Recently,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. In contrast to IL-17 monoclonal antibody,antibodies against IL23p19 have significant advantages in terms of generating a durable effect. IBI112plays an anti-inflammatory role by blocking IL-23-mediated signaling pathway and has the potential to treat autoimmune diseases such as psoriasis and inflammatory Bowel disease (IBD). 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 more patient-friendly treatment regimen. We are greatly encouraged that it can provide strong foundation for the subsequent clinical development. Based on this,in collaboration with our study sites,we are confident to advance the clinical development of IBI112 in moderate to severe plaque psoriasis as well as other indications to fulfill our mission of providing high-quality innovative biopharmaceuticals that are accessible to the vast majority of patients."

About IBI112

IBI112 is a monoclonal antibody independently developed by Innovent,with independent 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 demonstrated that IBI 112 has a,clear target and well-elucidated mechanism of action,and significant anti-inflammatory effect,suggesting that it may provide a more effective treatment option for patients with psoriasis or other autoimmune diseases.

About Psoriasis

Psoriasis is a chronic,recurrent,inflammatory and systemic disease mediated by both genetic and environmental factors,which can occur in all age groups with no gender preference . The typical clinical presentation includes scaly erythema or plaque with localized or widespread distribution. It is,a lifetime long noninfectious condition,which is very difficult to treat. Psoriasis can be classified into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis),pustular psoriasis,erythrodermic psoriasis and arthropathic psoriasis. Approximately,80 ~ 90% of patients have plaque psoriasis,and nearly 30% of the cases are moderate and severe. There are significant differences in the prevalence of psoriasis around the world,with more than 6 million patients in China. At present,in China,the main systemic treatments include methotrexate (MTX),cyclosporine A,retinoic acids and biological agents. Since 2019,psoriasis treatment in China has gradually entered the era of biological agents.

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 26 valuable assets in the fields of cancer,autoimmune disease and other major therapeutic areas,with 5 products – TYVYT® (sintilimab injection),BYVASDA® (bevacizumab biosimilar injection),SULINNO® (adalimumab biosimilar injection),HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing in China,1 asset's NDA under NMPA review,sintilimab's Biologics License Application (BLA) acceptance in the U.S.,5 assets in Phase 3 or pivotal clinical trials,and an additional 15 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.

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