Deucravacitinib

- 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. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. 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).

In the pivotal Phase 3 POETYK PsA clinical trials, Sotyktu demonstrated superiority compared with placebo at Week 16 across multiple endpoints, including skin and joint symptoms, with improvements in quality of life as reflected in the European Union Summary of Product Characteristics (SmPC) Sotyktu, a once-daily oral treatment, is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved in the European Union for this indication PRINCETON, N.J.--(BUSINESS WIRE)-- $BMY #POETYK -- Bristol Myers Squibb (NYSE:BMY) today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy. Sotyktu , a once-daily oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for the treatment of active PsA in the European Union (EU). “The European approval of Sotyktu for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. “This milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.” This EU approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 clinical trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active PsA. In both trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) (key secondary endpoint). The overall safety pro Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety pro those with plaque psoriasis. The most common adverse reactions (≥1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. Sotyktu is associated with the following special warnings and precautions for use: infections; pre-treatment evaluation for tuberculosis; malignancies; major adverse cardiovascular events, deep venous thrombosis and pulmonary embolism; immunizations; and excipients (lactose, sodium). “Psoriatic arthritis presents differently from patient to patient, often combining widespread musculoskeletal inflammation and challenging skin symptoms with a debilitating impact on quality of life,” said Frank Behrens, MD, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital, Frankfurt. “The impressive safety and the efficacy pro in the pivotal POETYK PsA trials demonstrate the ability of Sotyktu , the first approved TYK2 inhibitor, to provide comprehensive relief for adults living with this chronic, immune-mediated inflammatory disease.” In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary (PCS) score at Week 16 compared to placebo (key secondary endpoint), with improvements maintained in both POETYK PsA trials up to Week 52. Sotyktu was approved by the U.S. Food and Drug Administration (FDA) on March 6, 2026 for the treatment of adults with active PsA. Sotyktu was first approved in 2022 by the U.S. FDA for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Per that approval, Sotyktu is not recommended for use with other potent immunosuppressants in the PsO population. In 2023, Sotyktu was approved by the European Commission for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Since then, multiple global regulatory authorities have approved Sotyktu for that indication. Sotyktu has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis. Bristol Myers Squibb thanks the patients and investigators who participated in the POETYK PsA clinical trials. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis go on to develop PsA. In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients. Patients with PsA are also at increased risk of serious comorbidities. About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program The Phase 3 Sotyktu psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202 ) and POETYK PsA-2 (IM011-055; NCT04908189 ). POETYK PsA-1 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 included 624 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Patients met the CASPAR criteria for PsA, with ≥3 swollen and ≥3 tender joints and had an active or documented history of plaque psoriasis. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm. The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Key secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions. In both POETYK PsA-1 and POETYK PsA-2 trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) (key secondary endpoint). Efficacy Results in Adults with Psoriatic Arthritis POETYK PsA-1 POETYK PsA-2 Sotyktu (N = 336) Placebo (N = 334) Difference from Placebo (95% CI) Sotyktu (N = 312) Placebo (N = 312) Difference from Placebo (95% CI) ACR20 Response Week 16 (%) 54.2 34.1 20.0 (12.7, 27.4) a 54.2 39.4 14.8 (7.0, 22.5) a Week 52 (%) * 76.3 (212/278) 71.9 (194/270) ACR50 Response Week 16 (%) 24.7 13.5 11.2 (5.3, 17.1) c 28.8 16.3 12.5 (6.0, 19.0) c Week 52 (%) * 48.9 (136/278) 47.0 (127/270) ACR70 Response Week 16 (%) 11.6 5.4 6.2 (2.0, 10.4) d 10.6 5.4 5.2 (0.9, 9.4) d Week 52 (%) * 30.2 (84/278) 30.0 (81/270) Minimal disease activity (MDA) ** Response Week 16 (%) 19.0 10.2 8.9 (3.6, 14.2) b 25.6 14.7 10.9 (4.6, 17.1) b Week 52 (%) * 40.7 (114/280) 48.3 (130/269) Non-responder imputation (NRI) was used up to Week 16. After Week 16, observed data is shown with no imputation. N is number of randomized patients. a p≤0.0002 b p≤0.001 c Nominal p≤0.0002 d Nominal p≤0.02 * Data are shown for available subjects in the format of % (n/N) observed ** Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count ≤1; swollen joint count ≤1; Psoriasis Activity and Severity Index ≤1 or body surface area ≤3%; patient pain visual analogue scale (VAS) ≤15; patient global disease activity VAS ≤20; Health Assessment Questionnaire Disability Index ≤0.5; tender entheseal points ≤1 About Sotyktu (deucravacitinib) Sotyktu is an oral, selective, tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. It is the first selective TYK2 inhibitor in clinical studies across moderate-to-severe plaque psoriasis and active psoriatic arthritis. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby mediating the signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of plaque psoriasis and psoriatic arthritis. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in inhibition of TYK2 and mediation of its downstream functions. Sotyktu has been shown to have high selectivity for TYK2 at physiologically relevant concentrations and has not been shown to inhibit JAK1, JAK2 or JAK3 in in vitro assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is not currently known. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis and is also approved in the United States for the treatment of active psoriatic arthritis in adults. The efficacy and safety of Sotyktu in patients with moderate-to-severe plaque psoriasis were evaluated in POETYK PSO-1 and POETYK PSO-2, multi-national, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. In total, 664 patients were enrolled in POETYK PSO-1, and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy. Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most — the promise of living a better life. Full European Summary of Product Characteristics for Sotyktu will be found on the EMA website at . Sotyktu U.S. Indications and Important Safety Information IMPORTANT SAFETY INFORMATION INDICATIONS SOTYKTU ® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants. SOTYKTU ® is indicated for the treatment of active psoriatic arthritis in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU. Infections : SOTYKTU may increase the risk of infections. Serious infections have been reported in patients who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of SOTYKTU prior to initiating treatment in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated, and be closely monitored. Interrupt SOTYKTU if a serious infection occurs. Do not resume SOTYKTU until the infection resolves or is adequately treated. Viral Reactivation Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. In the 16-week placebo-controlled period of Trials PSO-1 and PSO-2, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. The clinical implications of SOTYKTU on viral hepatitis reactivation are unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C. Tuberculosis (TB) : In trials of PSO-1 and PSO-2, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment. Malignancy including Lymphomas : Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy during treatment with SOTYKTU. Rhabdomyolysis and Elevated CPK : Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Laboratory Abnormalities : Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. Treatment with SOTYKTU has been associated with liver enzyme elevation. Evaluate liver enzymes at baseline and during treatment with SOTYKTU in patients with known or suspected liver disease according to routine management. If increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded. Immunizations : Prior to initiating therapy with SOTYKTU, complete all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated. Potential Risks Related to JAK Inhibition : It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA. ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) in patients with plaque psoriasis include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne. The overall safety pro SOTYKTU observed in patients with active psoriatic arthritis was generally consistent with the safety pro in patients with plaque psoriasis. SPECIFIC POPULATIONS Pregnancy : Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072. Lactation : There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition. Hepatic Impairment : SOTYKTU is not recommended for use in patients with severe hepatic impairment. SOTYKTU is available in 6 mg tablets. Please see U.S. Full Prescribing Information , including Medication Guide , for SOTYKTU. SOTYKTU and the SOTYKTU logo are trademarks of Bristol-Myers Squibb Company. © 2026 Bristol-Myers Squibb Company About Bristol Myers Squibb: Transforming Patients’ Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn , X , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether the outcome of pricing and reimbursement negotiations in individual countries in Europe may delay or limit the commercial potential of Sotyktu (deucravacitinib) for the additional indication described in this release, that it will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use and that continued approval of Sotyktu for such indication may be contingent upon verification and description of clinical benefit in confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com