Upadacitinib hemihydrate

- HS-20118 has shown promising efficacy signals in the evaluated participants with moderate to severe plaque psoriasis, and a favorable safety profile in both healthy volunteers from China and New Zealand and participants with moderate to severe psoriasis from China. SHANGHAI,May 15, 2026-Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced the Phase 1 data of HS-20118 were presented as an oral presentation at the Society for Investigative Dermatology Annual Meeting (SID 2026), held on May 13-16 in Chicago. HS-20118 is an orally bioavailable IL-23R antagonist under clinical development for the treatment of immune-mediated diseases. At SID 2026, data were presented from two randomized, double-blind, placebo-controlled Phase 1 studies (HS-20118-101 and 102) evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HS-20118 in healthy volunteers and participants with moderate-to-severe psoriasis, in China, New Zealand and U.S.. Both studies included a single ascending dose (SAD) and a multiple ascending dose (MAD) part. A total of 129 participants received treatment, including 48 healthy volunteers in New Zealand, 58 healthy volunteers and 23 patients with psoriasis in China. Study results showed: ● Encouraging PK profile: the terminal half-life of HS-20118 was 6–7 days, supporting weekly oral dosing regimens. PK profile was comparable between Chinese and New Zealand populations. ● Promising efficacy signals: HS-20118 showed promising efficacy signals coupled with concordant biomarker responses, achieving therapeutic effects comparable to IL-23 monoclonal antibody therapies in participants with psoriasis. ◾ Following only 4 weeks of treatment, HS-20118 demonstrated clinically significantly greater PASI improvements compared to placebo. Furthermore, PASI scores continued to decrease over the subsequent 6 weeks after treatment discontinuation. □ 100 mg QW cohort: -39.1% at week 4, -58.0% at week 10 □ 25 mg QD cohort: -54.5% at week 4, -90.5% at week 10 ◾ At week 8, PASI 75 response rates were 33.3% in the 100 mg QW cohort and 75.0% in the 25 mg QD cohort. A similar trend was observed for IGA 0/1 response rate, with the 25 mg QD cohort achieving a notably high rate of 87.5%. ● Favorable safety profile：Only mild-to-moderate TEAEs were reported, with no dose-dependent relationship observed. Most of TEAEs were transient and resolved/recovered without medical treatment. The rates of moderate TEAEs were similar between SAD parts in China and New Zealand. No SAEs or TEAEs leading to study discontinuation occurred. ● Robust pharmacodynamics：Sustained IL-17 and hBD-2 reduction in psoriasis patients following HS-20118 treatment, confirming effective blockade of IL-23/IL-17 axis. This pharmacodynamic effect correlates with durable clinical efficacy. Details of the oral presentation are as follows: ● Presentation Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20118 in Healthy Adults and Psoriasis Patients ● Session: Concurrent Minisymposium 2: Clinical Research – Interventional Research ● Abstract No.: 0459 ● Date/Time: May 14, 2026 from 9:35 AM to 9:45 AM（CDT） ● Presenter: Xiangqing Yu, Shanghai Hansoh BioMedical Co., Ltd. About HS-20118 HS- 20118 is an oral peptide developed by Hansoh Pharma that selectively targets IL-23R. It works by inhibiting the binding of IL-23 to IL-23R, thus blocking the signal transduction and cytokine cascade mediated by IL-23. It is intended for the treatment of patients with psoriasis, and with an oral formulation, it can reduce the pain of injection and improve patient compliance, thus serving as a new option for psoriasis treatment. Phase 2 studies of HS-20118 in participants with moderate to severe psoriasis are currently planning globally. About Psoriasis Psoriasis is an immune-mediated chronic, recurrent, inflammatory skin disease influenced by both genetic and environmental factors. The typical clinical manifestations of the skin lesions are scaly erythema or plaques, which can be localized or widely distributed. When accompanied by joint damage, it is referred to as psoriatic arthritis. Patients with moderate to severe psoriasis have an increased risk of developing metabolic syndrome and atherosclerotic cardiovascular disease[1]. The prevalence of psoriasis ranges from 0.5% to 3.15% in the United States and 0.75% to 2.9% in Europe[2, 3]. The prevalence in China is approximately 0.47% to 0.5%[4, 5]. Although psoriasis is not contagious, it is difficult to treat. Patients often suffer from it for a lifetime, leading to impaired quality of life and reduced work capacity. In severe cases, psoriasis can be disabling, imposing a heavy burden on the patient, their family, and society[6, 7]. Currently, there is no cure for psoriasis. The primary treatment methods focus on anti-inflammatory and symptomatic therapies, which include topical medication, phototherapy, conventional systemic medication, and biological agents or small molecule drugs[1]. Topical medications are effective in controlling mild, localized psoriasis, but their use is limited by the duration of treatment and potential adverse effects. Patients with moderate to severe psoriasis often require a combination of phototherapy or systemic medications. The use of phototherapy and conventional systemic medications is limited by long treatment duration and adverse effects such as organ toxicity. Although biological agents offer strong specificity in targeting and have a rapid onset of action, they are not always effective for all patients with psoriasis[8], and their efficacy can diminish over time by varying degrees[9]. Additionally, the high cost and the need for injection administration have somewhat restricted their clinical use, and their long-term safety still needs further evaluation[10, 11]. Small molecule targeted drugs, such as phosphodiesterase 4 (PDE4) inhibitors (apremilast), Janus kinase (JAK1-3) inhibitors (tofacitinib, upadacitinib), and tyrosine kinase (TYK2) inhibitors (deucravacitinib), show great differences in efficacy and safety in the treatment of psoriasis, and also have the risk of adverse reactions and even serious adverse reactions[1]. Existing treatments still fail to meet the medical needs of most patients, and new therapies need to be developed. References [1] Psoriasis Committee, Chinese Society of Dermatology and Venereology, Zhang Xuejun. Chinese psoriasis Diagnosis and Treatment Guidelines (2023 edition)[J]. Chinese Journal of Dermatology, 2023,56(7):573-625. [2] Helmick C G, Lee-Han H, Hirsch S C, et al. Prevalence of psoriasis among adults in the U.S.: 2003-2006 and 2009-2010 National Health and Nutrition Examination Surveys[J]. Am J Prev Med, 2014, 47(1): 37-45. [3] Zhao Na, WU Wei-Zhi, Yang Ping. Research progress in the epidemiology of psoriasis [J]. Shandong Medicine, 2013, 53(39): 95-97. [4] Ding X L, Wang T L, Shen Y W, et al. Epidemiological survey of psoriasis in six provinces and cities of China [J]. Chinese Journal of Dermatology and Venereology, 2010, 24(7): 598-603. [5] Wang Xiao-hui. An epidemiological investigation of psoriasis in 4 provinces of Southwest China [J]. Harbin Med, 2017, 37(5): 426-427. [6] Armstrong A W, Schupp C, Wu J, et al. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011[J]. PLoS One, 2012, 7(12): e52935. [7] Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey[J]. Br J Dermatol, 2006, 155(4): 729-36. [8] Furue K, Ito T, Furue M. Differential efficacy of biologic treatments targeting the TNF-alpha/IL-23/IL-17 axis in psoriasis and psoriatic arthritis[J]. Cytokine, 2018, 111: 182-188. [9] Jullien D, Prinz J C, Nestle F O. Immunogenicity of biotherapy used in psoriasis: the science behind the scenes[J]. J Invest Dermatol, 2015, 135(1): 31-38. [10] Boehncke W H, Schon M P. Psoriasis[J]. Lancet, 2015, 386(9997): 983-94. [11] Mason A R, Mason J M, Cork M J, et al. Topical treatments for chronic plaque psoriasis of the scalp: a systematic review[J]. Br J Dermatol, 2013, 169(3): 519-27. About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK). Statements 1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional. Forward-Looking Statements This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. 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Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).

AbbVie presents 18 abstracts in Crohn's disease and ulcerative colitis Breadth of data from real-world evidence and clinical trials reinforce risankizumab and upadacitinib efficacy, safety profile, and durability NORTH CHICAGO, Ill. , May 5, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI ® (risankizumab-rzaa) and RINVOQ ® (upadacitinib) in Crohn's disease and ulcerative colitis. "As a leader in gastroenterology, AbbVie remains focused on advancing the understanding of IBD and helping raise the standard of care through scientific innovation and a broad portfolio of marketed and investigational therapies," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie . "Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD." Real-World Data for Patients on Risankizumab in Crohn's Disease Sustained symptom relief and reduced need for concomitant therapy: A 52-week follow-up of adults with moderately to severely active Crohn's disease treated with risankizumab from the ASPIRE-CD study showed rapid and sustained improvements in abdominal pain, bowel urgency and liquid/soft stools. Among patients with extraintestinal manifestations of arthritis and skin conditions, 25% and 46%, respectively, reported experiencing relief at Week 52. By Week 52, the use of corticosteroids decreased from 34% at baseline to 7%, and over-the-counter therapies had decreased from 72% at baseline to 49%. Improved quality of life: In an analysis of health-related quality of life (HRQL) and treatment satisfaction after initiating risankizumab in patients enrolled in the ASPIRE-CD study, 77% reported improvement in life enjoyment by Week 52. In addition, patients had improved general wellbeing, including improved sexual health and improved work productivity and daily activity levels one year after starting risankizumab. Overall satisfaction with Crohn's disease treatments improved among all patients (from 50% at baseline to nearly 87% at Week 52), particularly patients who were still being treated with risankizumab at Week 52 (92% satisfaction). Low Switch Rate for Risankizumab Among Crohn's Disease Patients Treatment persistence: A real-world study of US claims data analyzed the switch rates over a 24-month period among patients with Crohn's disease initiating a new biologic therapy. It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. This pattern was also seen among biologic-naïve patients. Lower Odds of Hospitalization Observed After Switch to Upadacitinib Biologic dose-escalation vs. switching to upadacitinib in a real-world setting: A retrospective analysis of US claims data found that among patients with Crohn's disease or ulcerative colitis treated with a biologic therapy, patients who were switched to upadacitinib had a 31% lower odds of hospitalization and 26% lower odds of emergency department visits than those who increased average weekly dose of the biologic therapy. Endoscopic Improvements in Difficult-to-Treat Crohn's Disease Treating patients with Perianal Fistulizing Crohn's disease: Among patients with Perianal Fistulizing Crohn's disease (PFCD), in two Phase 3 trials, those who responded to upadacitinib 45 mg were re-randomized to receive maintenance treatment with upadacitinib (15 mg or 30 mg) or placebo for 52 weeks. In this post-hoc analysis, upadacitinib-treated patients showed endoscopic improvements through 52 weeks, regardless of fistula response, as demonstrated by reductions in Simple Endoscopic Score for Crohn's disease (SES-CD). Majority of these patients were without an adequate response to anti-tumor necrosis factor (TNF) therapy. Select AbbVie abstracts are highlighted below, and all the 2026 DDW Annual Meeting posters are available here : Abstract Title Presentation Number Real-World Switching Rates Among Patients with Crohn's Disease Treated with Biologics in the United States Su1657 Improvements in Simple Endoscopic Scores for Crohn's Disease in Upadacitinib-Treated Patients with Perianal Fistulizing Disease: Post Hoc Analysis of the Phase 3 Trials Su1495 Risankizumab Reduces Crohn's Disease-Related Symptoms and Concomitant Therapy Use in Adults with Crohn's Disease: Year 1 Results From the ASPIRE-CD Study Sa1504 Risankizumab Improves Health-Related Quality of Life in Adults with Crohn's Disease: Year 1 Results from the ASPIRE-CD Study Mo1674 Comparative Real-World Outcomes Following Dose Escalation of Current Biologic Therapy Versus Switching to Upadacitinib Among Patients with Crohn's Disease or Ulcerative Colitis: A Propensity Score Matched Analysis Tu1655 About SKYRIZI ® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 1 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease. 1 On April 27, 2026, AbbVie announced submission of an application to the FDA seeking approval of SKYRIZI ® for subcutaneous induction for the treatment of adult patients with moderately to severely active CD. SKYRIZI ® (risankizumab-rzaa) U.S. Uses and Important Safety Information 1 SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis. moderate to severe Crohn's disease. moderate to severe ulcerative colitis. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)? SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. The use of upadacitinib for these diseases is not FDA approved, and its safety and efficacy has not been established for these diseases. RINVOQ ® (upadacitinib) U.S. Uses and Important Safety Information 2 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with giant cell arteritis (GCA) . Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. RINVOQ/RINVOQ LQ is a prescription medicine used to treat: Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib) What is the most important information I should know about RINVOQ*? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines . This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP. These are not all the possible side effects of RINVOQ. How should I take RINVOQ/RINVOQ LQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP. *Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025 Global Media: Giovanna Chandler giovanna.chandler@abbvie.com U.S. Media: Stephanie Tennessen stephanie.tennessen@abbvie.com Investors: Liz Shea liz.shea@abbvie.com View original content: SOURCE AbbVie