IL-23p19

SAN FRANCISCO and SUZHOU, China, Oct. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces the latest clinical results of a multicenter, open-label Phase 2 study (ClinicalTrials.gov, NCT05970978) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in patients with plaque psoriasis previously responded inadequately to other biologics. Robust efficacy and favorable safety profile were observed. Biologics have become the mainstream systemic treatment for psoriasis; however, a considerable proportion of patients do not respond to initial biologic agents. This is the first clinical study in China evaluating a switch from other biologics to an IL-23p19-targeted drug. The study demonstrated that after 16-week of treatment with picankibart, the majority of patients (64.6%,42/65) who had inadequate response to previous biologic agents (mainly those targeting IL-17), achieved skin clearance or near clearance with a sPGA of 0 or 1. Results from this study will provide evidence for novel long-term treatment regimens for patients with moderate to severe psoriasis. Innovent biologics will advance the Phase 3 clinical trial of picankibart. The first clinical trial in China for switching from other biologics to an IL-23p19 antibody in the field of psoriasis This study aims to evaluate the efficacy and safety in patients with plaque psoriasis who switched from other biologics to picankibart. A total of 152 patients, previously treated with marketed biologics for plaque psoriasis—including IL-17 inhibitors and TNF-α inhibitors—were enrolled. Patients with prior inadequate response at baseline (defined as a static Physician's Global Assessment [sPGA] score of ≥2, or body surface area [BSA] of ≥3%) received 200 mg of subcutaneously picankibart at weeks 0, 4, and 8 followed by dosing at every 12 weeks until week 32 and follow-up until week 44. Responders at baseline (sPGA score of 0 or 1 and BSA of <3%) received 200 mg of picankibart at week 0 and then every 12 weeks until week 36 and followed-up until week 44. The primary endpoint of the study was the proportion of patients achieving an sPGA score of 0 or 1 and BSA of < 3% at week 16. It is worthy to mention that our primary endpoint is more stringent than studies of other similar agents, which often used the proportion of patients achieving a sPGA of 0 or 1 as the primary endpoint. Patients at baseline had a long disease course with inadequate response to previous IL-17 inhibitors Of the 152 enrolled patients in the study, 83 (54.6%) were classified as inadequate responders, with a median disease course of 12 years. Among them, 80 (96.4%) had been treated with IL-17 inhibitors, 90.4% had a baseline sPGA ≥2 , and 86.7% had a baseline BSA ≥3%. The primary endpoint was met with rapid onset of efficacy. The efficacy in clearing lesions for patients with inadequate response suggests best-in-class performance Nearly half (48.2%, 40/83) of patients with prior inadequate response at baseline met the primary endpoint, achieving an sPGA of 0 or 1 and BSA of <3%; For secondary endpoints, of the 65 patients with baseline sPGA of ≥2 and BSA of ≥3%, the majority (64.6%,42/65) achieved sPGA of 0 or 1, and 15 patients (18.1%) reached sPGA of 0; Of the 71 patients with baseline sPGA of ≥2 or BSA of ≥3% and a baseline Dermatology Life Quality Index (DLQI) of >1, 27 (38.0%) achieved DLQI of 0 or 1. Favorable safety profile observed；long-term follow-up is ongoing The safety profile, which was comparable to other studies, was favorable with no new safety signals identified; The efficacy of picankibart in responders at baseline is still under follow-up, and full data of long-term efficacy and safety are expected to be published at future academic congresses or in peer-reviewed journals. Professor Furen Zhang, the Principal Investigator of the Clinical Study, Dermatology Hospital Affiliated to Shandong First Medical University, stated, "Psoriasis is a chronic condition that significantly affects patients' physical and mental well-being and quality of life. Biologics have become the primary systemic treatment for moderate-to-severe, refractory, and special types of psoriasis. Despite their significant efficacy, a considerable proportion of patients still experience inadequate response during biologic therapy, necessitating the development of alternative treatments. I am pleased to see that picankibart has demonstrated favorable efficacy and safety in psoriasis patients with an inadequate response to prior biologic treatments, suggesting that picankibart could be a potential switching option. I look forward to confirming picankibart's benefits in the upcoming Phase 3 study, which could help more psoriasis patients." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated, "As the first IL-23p19 monoclonal antibody independently developed by a Chinese biopharma, picankibart succeeded in a pivotal registration Phase 3 study and is currently under review for a New Drug Application (NDA) by the NMPA. We have initiated the lifecycle management of picankibart, aiming to address unmet clinical needs in psoriasis treatment. The results of this Phase 2 study are very encouraging. With the widespread use of biological agents, the issue of inadequate response with these drugs has gradually become more prominent in clinical practice and urgently needs to be addressed. This study shows that picankibart offers substantial skin clearance benefits even for patients with a inadequate response to other biologics (primarily anti-IL-17 agents). We will actively advance the Phase 3 clinical study to enrich the clinical evidence for picankibart in biologics switching and offer more treatment options for patients with psoriasis as soon as possible." About Psoriasis Psoriasis is a chronic, recurrent, inflammatory and systemic disease included by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately 80%~90% of patients have plaque psoriasis, with nearly 30% of the cases being moderate to severe. Global psoriasis prevalence varies significantly, with over 7 million patients in China alone. Current systemic treatments in China include methotrexate (MTX), cyclosporine A, retinoic acids and biological agents. Since 2019, biologics have become a central focus in psoriasis treatment, with IL-23 inhibitors standing out due to their rapid onset, robust efficacy, good safety, and long-lasting effects, which are more advantageous in comprehensive and deep lesion clearance and prolonging relapse-free periods. About Picankibart (IBI112) Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases. Currently, multiple clinical studies of Picankibart are underway, including: Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024; Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment; Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics; Phase 2 study in patients with moderate to severe active ulcerative colitis; In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

At three years, over 80% of patients with moderately to severely active UC who were in remission with mirikizumab sustained long-term remission and relief from disruptive symptoms, including bowel urgency Mirikizumab also helped over 50% of patients with moderately to severely active Crohn’s disease sustain long-term endoscopic remission for up to five years INDIANAPOLIS, IN, USA I October 28, 2024 I Eli Lilly and Company (NYSE: LLY ) announced results from two, multi-year, Phase 3 studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn’s disease. Data from the two trials – LUCENT-3 in moderately to severely active UC and VIVID-2 in moderately to severely active Crohn’s disease – will be presented at the American College of Gastroenterology (ACG) Annual Meeting from October 25-30, 2024 in Philadelphia. Mirikizumab is an interleukin-23p19 (IL23p19) antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of UC and Crohn’s disease. Inflammation from UC and Crohn’s disease can lead to disruptive symptoms, including bowel urgency, that can result in decreased health-related quality of life and potentially irreversible complications for patients if left untreated. Mirikizumab is approved in the United States (U.S.) for the treatment of moderately to severely active UC in adults and is under review with the U.S. Food and Drug Administration (FDA) for moderately to severely active Crohn’s disease. “Mirikizumab is the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn’s disease,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “This achievement reflects our commitment to help people with immune system conditions sustain long-standing remission and relieve disease burden.” Long-Term Data in Adults with UC In LUCENT-3, mirikizumab helped patients with moderately to severely active UC achieve long-term outcomes, including histologic-endoscopic mucosal remission, defined as mucosal healing. Mirikizumab also provided sustained benefit across symptomatic, clinical, endoscopic and histologic endpoints for up to three years, regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among those who achieved clinical remission with mirikizumab at one year in the LUCENT-2 study, the following results were achieved based upon observed case analysis after an additional two years of treatment (up to three years total): These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Ulcerative Colitis Program section below. Among patients receiving mirikizumab in the LUCENT-3 study, 7.4% of patients reported a serious adverse event (AE), while 5.3% discontinued treatment due to an AE. The long-term safety profile in patients with moderately to severely active UC was consistent with the already known safety profile of mirikizumab. These data were recently published in Inflammatory Bowel Diseases . Long-Term Data in Adults with Crohn’s Disease New data from patients in the Phase 2 program who enrolled into the VIVID-2 long-term extension study showed that patients with moderately to severely active Crohn’s disease treated with mirikizumab maintained high rates of clinical and endoscopic remission over time. The following results were achieved based upon observed case analysis after an additional three years of treatment (up to five years total): These results were also evaluated using a modified non-responder imputation and are presented in the About the Mirikizumab Crohn’s Disease Program section below. “Despite continued advances, people living with ulcerative colitis and Crohn’s disease are still seeking treatments that can address difficult-to-manage symptoms such as bowel urgency, and provide lasting results over time,” said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. “These multi-year data show mirikizumab is a targeted therapy that can provide intestinal healing over time and improvement in key symptoms that matter most to patients.” Among these patients who enrolled into the VIVID-2 long-term extension study, 8.5% reported a serious AE and 1.9% discontinued treatment due to an AE. The long-term safety profile in patients with moderately to severely active Crohn’s disease was consistent with the already known safety profile of mirikizumab. Omvoh ® (mirikizumab-mrkz) was approved by the FDA in October 2023 as the first IL23p19 antagonist for the treatment of moderately to severely active UC in adults and is also approved in 44 countries around the world. Lilly submitted marketing applications for mirikizumab in Crohn’s disease around the globe, including in the U.S., Canada, Europe, Japan and China. Additional global regulatory submissions are planned. Additionally, Lilly has a combination study in UC with mirikizumab and eltrekibart, a humanized monoclonal antibody that binds to the seven ligands that signal through the CXCR1 and CXCR2 chemokine receptors involved in neutrophil movement to sites of inflammation ( NCT06598943 ). There are also ongoing studies in both UC ( NCT05611671 ) and Crohn’s disease ( NCT06226883 ) with MORF-057, a selective oral small molecule alpha-4/beta-7 integrin inhibitor that may improve outcomes and expand treatment options for people with IBD. Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work. About the Mirikizumab Ulcerative Colitis Program Mirikizumab was studied in two, Phase 3 clinical trials which evaluated the efficacy and safety of mirikizumab in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. The induction LUCENT-1 and maintenance LUCENT-2 studies were randomized, double-blind, and placebo-controlled and included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib). Additionally, 41% of patients in LUCENT-1 had failed at least one biologic, 3% had failed a JAKi and 57% were biologic and JAKi-naïve. LUCENT-3, the ongoing long-term Phase 3 extension of LUCENT-1 and LUCENT-2 evaluated the efficacy and safety of mirikizumab in patients with UC for up to three years. Using a modified non-responder imputation analysis to handle discontinuation and missing data, among Week 52 mirikizumab remitters, 70% maintained long-term clinical remission at Week 152, and response rates for major efficacy endpoints (including endoscopic remission, histologic-endoscopic mucosal remission, corticosteroid-free remission and clinical response) ranged from 63% to 85%. About the Mirikizumab Crohn’s Disease Program VIVID-1 was a Phase 3, randomized, double-blind, treat-through study that evaluated the safety and efficacy of mirikizumab compared with placebo and an active control (ustekinumab) in adults with moderately to severely active Crohn’s disease. Patients randomized to mirikizumab were administered 900 mg of mirikizumab intravenously every four weeks from Week 0-12, then 300 mg subcutaneously every four weeks from Weeks 12-52. In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure. SERENITY, the Phase 2, multi-center, randomized, parallel-arm, double-blind, placebo-controlled trial was designed to assess the safety and efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. At baseline, participants were randomized with a 2:1:1:2 allocation across four treatment arms (placebo, mirikizumab 200 mg, mirikizumab 600 mg and mirikizumab 1000 mg). The primary endpoint was endoscopic response as determined by the proportion of participants achieving at least 50% reduction from baseline on the Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 12. In May 2019, Lilly reported Phase 2 results showing more patients with moderate to severe Crohn’s disease receiving mirikizumab compared with placebo achieved clinical response and remission at 12 weeks. Overall, the safety profile at 12 weeks was consistent with that of mirikizumab in studies of ulcerative colitis and with the IL23p19 class. VIVID-2, the ongoing long-term Phase 3 extension of SERENITY and the VIVID-1 study, evaluated the efficacy and safety of mirikizumab in patients with Crohn’s disease for up to five years. Using a modified non-responder imputation analysis to handle discontinuation and missing data, 61% and 44% achieved endoscopic response and endoscopic remission, respectively, at Week 156. In addition, 79% and 72% achieved clinical response and clinical remission, respectively, at Week 156. Indications and Usage for Omvoh ® (mirikizumab-mrkz) (in the United States) Omvoh ® is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Please click for Prescribing Information and Medication Guide for Omvoh. Please click for Instructions for Use included with the device. About Omvoh ® Omvoh ® (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of ulcerative colitis. Treatment of ulcerative colitis with Omvoh starts with 300-mg IV infusions, once every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous injections every four weeks during maintenance treatment. Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram and LinkedIn . P-LLY SOURCE: Eli Lilly

SAN FRANCISCO and SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that primary endpoint of 12-week induction period was met in a multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study (ClinicalTrials.gov, NCT05377580) of picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, in Chinese subjects with moderately to severely active ulcerative colitis (UC). This study aims to evaluate the efficacy and safety of picankibart for the treatment of moderately to severely active ulcerative colitis (modified Mayo score of 4 to 9 with an endoscopic subscore of ≥2) consisting of induction and maintenance periods. A total of 150 subjects were enrolled and randomized in a 1: 1: 1 ratio to receive intravenous infusion of placebo, picankibart 200 mg, or picankibart 600 mg at weeks 0, 4, and 8 during the induction period. During maintenance period, subjects received subcutaneous injection of picankibart 200 mg every 4 or 8 weeks. The primary endpoint was the proportion of subjects who achieved clinical remission (per modified Mayo score, defined as a rectal bleeding subscore of 0, a stool frequency subscore of ≤1, and an endoscopic subscore of ≤1) at week 12. Secondary endpoints included the proportion of subjects who achieved clinical response, symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission compared to the placebo group. The primary and secondary endpoints were met: The proportion of subjects who achieved clinical remission was significantly higher in the picankibart 200 mg group (20.0%) and 600 mg group (14.0%) than in the placebo group (2.0%; p < 0.05). Clinical response was achieved in 54.0% and 68.0% of subjects in the picankibart 200 mg and 600 mg groups, respectively, which was significantly higher than in the placebo group (22.0%; p < 0.001). In addition, the proportion of subjects who achieved symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission in the picankibart 200 mg and 600 mg groups than in the placebo group. The overall safety profile of the picankibart groups was favorable and similar to that of previous studies and other IL-23 class drugs, with no new safety signals observed. To date, the maintenance period of the study is ongoing, and the proportions of subjects who have achieved clinical remission, clinical response, symptomatic remission, endoscopic remission, or histologic-endoscopic mucosal remission have continued to increase compared to induction period. Detailed data will be further analyzed and published at future academic congresses or in clinical journals. Professor Minhu Chen, the Principal Investigator of the Clinical Study, the First Affiliated Hospital of Sun Yat-sen University, stated, "Ulcerative colitis is a chronic, recurrent inflammatory disease involving colorectal mucosa, which is related to the interaction of genetic, environmental and immune factors. its common symptoms including abdominal pain, diarrhea, rectal bleeding, weight loss and fatigue. Current treatment approaches mainly focus on controlling inflammation, alleviating symptoms, and maintaining remission. New treatment methods are urgently needed to offer more meaningful improvements. I am pleased to see that the primary endpoint was achieved in a Phase 2 clinical study of picankibart in moderately to severely active ulcerative colitis, with significant clinical benefits in the induction period and a favorable safety profile observed. I look forward to the further development of picankibart to provide more treatment options for Chinese patients with ulcerative colitis." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated: "Ulcerative colitis, as a chronic inflammatory disease, not only damages patients' physical health, but also seriously impact their daily lives and mental health. In recent years, a new generation of IL-23-targeted agents has been proven to have superior efficacy and safety for treating ulcerative colitis. Currently, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, and this Phase 2 study is the first clinical trial in China to evaluate a domestic IL-23p19 drug candidate for the treatment of ulcerative colitis. Picankibart is independently developed by Innovent, and has its first new drug application under NMPA review for treating plaque psoriasis. The encouraging results of this Phase 2 study in patients with ulcerative colitis gave us more confidence of the clinical potential of picankibart in treating more autoimmune diseases. We truly hope to bring accessible and high-quality innovative biologics to benefit a wide range of patients." 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. Ulcerative colitis is a serious threat to physical health and has an impact on daily life and mental health for patients. Ulcerative colitis 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. Ulcerative colitis is more common diagnosed in young and middle-aged people. The clinical treatment of ulcerative colitis 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 IL-12 and IL-23 have shown advantages in efficacy and safety in the treatment of ulcerative colitis. At present, no IL-23p19 targeted drugs were approved for the treatment of ulcerative colitis in China, representing a huge unmet clinical need. About Picankibart (IBI112) Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases. Currently, multiple clinical studies of picankibart are underway, including: Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024; Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment; Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics; Phase 2 study in patients with moderate to severe active ulcerative colitis. In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement 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. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED