First Patient Dosed in Innovent’s Groundbreaking Phase 3 Psoriasis Clinical Trial: Clearing the Way to a Potential Breakthrough Treatment

Innovent Biologics, Group (HKEX: 01801), a world-class biopharmaceutical company, has made a major breakthrough in the treatment of plaque psoriasis with the successful dosing of the first patient in a Phase 3 clinical trial (CLEAR) of its picankibart (R&D code: IBI112). Picankibart is a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection, developed and manufactured by Innovent, and is aimed at providing an effective treatment for moderate-to-severe plaque psoriasis.

The CLEAR study (, NCT05645627) is a groundbreaking, multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to evaluate the efficacy and safety of picankibart in patients with moderate to severe plaque psoriasis. With the aim of enrolling approximately 500 subjects, this study seeks to assess the impact of two different dosing regimens of picankibart compared to placebo over the course of 68 weeks. After 4 weeks of screening, eligible participants will be randomized in a 2:2:1 ratio to receive either an initial dose of 200mg with subsequent dosing of 200mg every 12 weeks, an initial dose of 200mg with subsequent dosing of 100mg every 12 weeks, or placebo. The results of this study have the potential to revolutionize the treatment of moderate to severe plaque psoriasis.

Innovent is pioneering the development of IL-23 class innovative drugs in China with the CLEAR study, their first phase 3 clinical trial. Committed to providing better treatment options for psoriasis patients, Innovent is leveraging their leadership in clinical development to ensure the highest quality of these innovative drugs. With their dedication to excellence, they are determined to make these treatments available as soon as possible.

Professor Yuling Shi of Shanghai Skin Disease Hospital, the Principal Investigator of the Study, remarked that psoriasis is a systemic disease that affects millions of people in China. Despite the slow progression of the disease, many patients require long-term treatment and lifelong medication to manage the effects of the disease, as well as its comorbidities, which have a significant impact on their quality of life and mental health. Fortunately, Picankibart, a biological drug independently developed in China, has shown promising clinical results in a phase 2 clinical study, with significant improvement in the quality of life of patients who were treated with it. Professor Shi looks forward to the results of the upcoming phase 3 clinical study, as well as the launch of more innovative drugs in the future, to benefit more people in China.

Dr. Qian Lei, Vice President of Clinical Development at Innovent, is confident in the potential of Picankibart, the first anti-IL23p19 antibody drug that has completed phase 2 clinical study in China for the treatment of moderate-to-severe plaque psoriasis. Results of the study show that 66.7-86.0% of the subjects achieved PASI 90, 81.6-88.0% achieved PASI 75, and up to 48.0% achieved complete skin lesion clearance (PASI 100). Compared to current drugs on the market, Picankibart has demonstrated greater efficacy and safety, with long-term efficacy and long-dose interval. Innovent is thus investing efforts to advance the development of the CLEAR study, with plans to synchronize the use of the auto-injector in this study. This is done in hopes of providing more convenient, user-friendly and effective treatment options for patients with moderate and severe plaque psoriasis.

About Picankibart (Anti-IL23p19 Monoclonal Antibody)

Picankibart, an innovative monoclonal antibody developed by Innovent, is set to revolutionize the treatment of autoimmune diseases including psoriasis. With its unique ability to bind to the IL-23p19 subunit, it prevents IL-23 from binding to cell surface receptors, leading to the inhibition of the IL-23 receptor-mediated signaling pathway. Preclinical studies have shown that Picankibart has a clear target and well-elucidated mechanism of action, offering a significant anti-inflammatory effect. Moreover, phase 1 and 2 clinical studies have demonstrated its excellent safety and tolerability, along with its long-dose interval and long-term efficacy advantages. In short, Picankibart is a promising new treatment option for those with autoimmune diseases.

About Psoriasis

Psoriasis is a chronic, recurrent and inflammatory condition affecting all age groups, with no gender preference. It is a life-long and non-infectious condition, which is very difficult to treat. Approximately, 80-90% of patients suffer from plaque psoriasis, with up to 30% of cases being moderate to severe. With over 6 million cases in China, the main systemic treatments include methotrexate (MTX), cyclosporine A, retinoic acids and biological agents, with the latter becoming the first-line treatment in 2019. Psoriasis can be classified into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis, with prevalence varying significantly around the world.

About Innovent

Innovent is dedicated to making a difference in the world of biopharmaceuticals. Since our foundation in 2011, we’ve been working hard to bring high-quality and affordable treatments to those who need them most. On October 31, 2018, our hard work and commitment was recognized when we were listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. We are driven by the spirit of “Start with Integrity, Succeed through Action,” and our mission is to develop, manufacture and commercialize innovative medicines that can make a real impact in the lives of those suffering from oncology, autoimmune, metabolic, ophthalmology and other major diseases.

Innovent has made remarkable progress since its inception, developing a comprehensive multi-functional platform that encompasses R&D, CMC, clinical development, and commercialization. This platform has enabled them to assemble an impressive pipeline of 36 assets, spanning cancer, autoimmune, metabolic, and ophthalmology treatments. Of these, seven have been selected for the national ‘Major New Drug Creation’ project, eight products have already been approved for marketing in China, three are currently under NMPA NDA review, six are in Phase 3 or pivotal clinical trials, and a further 19 molecules are in clinical studies.

Innovent is leading the way in China’s biopharmaceutical industry with an international team of experts, advanced talent in high-end biological drug development, and strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. By combining forces with these world-renowned partners, Innovent is committed to improving drug availability and enhancing the quality of life for patients everywhere.

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