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Last update 23 Oct 2026

Abatacept

Last update 23 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fc fusion protein

Synonyms

Abatacept (Genetical Recombination), CTLA4-Ig(Bristol-Myers Squibb), CTLA4Ig

+ [14]

Target

CD80 x CD86

Action

modulators

Mechanism

CD80 modulators(Cluster of differentiation 80 modulators), CD86 modulators(Cluster of differentiation 86 modulators)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases+ [8]

Active Indication

Acute Graft Versus Host DiseaseJuvenile Idiopathic ArthritisArthritis, Psoriatic+ [11]

Inactive Indication

acute leukemiaAcute Lymphoblastic LeukemiaAcute Myeloid Leukemia+ [51]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Baker Heart & Diabetes Institute

Bristol Myers Squibb Co.Bristol-Myers Squibb Pharma EEIG

+ [3]

Inactive Organization

Jiangsu Simcere Pharmaceutical Co., Ltd.

Jiangsu Simcere Pharmaceutical R&D Co., Ltd.

License Organization

Repligen Corp.

Ono Pharmaceutical Co., Ltd.

Simcere Pharmaceutical Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (23 Dec 2005),

Rheumatoid Arthritis

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 19593

Source: *****

245

Clinical Trials associated with Abatacept

JPRN-jRCTs041260025

/ RecruitingNot Applicable

An Exploratory Interventional Study to Evaluate the Efficacy of Abatacept in Steroid-Resistant Central Diabetes Insipidus Associated with Lymphocytic Hypophysitis

Start Date07 Oct 2026

Sponsor / Collaborator-

CTIS2025-524593-42-00

/ Not yet recruitingPhase 4IIT

Tapering optimisation with placebo-based mechanisms in rheumatoid arthritis: the TOP-RA trial

Start Date01 Oct 2026

Sponsor / Collaborator-

CTIS2026-525221-21-01

/ Not yet recruitingPhase 4IIT

Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference

Start Date01 Oct 2026

Sponsor / Collaborator

Aalborg University Hospital

100 Clinical Results associated with Abatacept

100 Translational Medicine associated with Abatacept

100 Patents (Medical) associated with Abatacept

2,873

Literatures (Medical) associated with Abatacept

01 Dec 2026·SEMINARS IN ARTHRITIS AND RHEUMATISM

Glucocorticoid discontinuation in patients with rheumatoid arthritis who initiated biologic or targeted synthetic agents: a real-world population-based analysis

Article

Author: Jin, Yingzhao ; So, Ho ; Lam, Steven H ; Meng, Huan ; Tam, Lai-Shan ; Cheng, Isaac T

BACKGROUND:

This study aimed to evaluate glucocorticoids (GCs) discontinuation after the initiation of biological/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in rheumatoid arthritis (RA) patients, using data from a real-world population-based registry.

METHODS:

We analyzed data from RA patients who initiated their first biologics or Janus kinase inhibitors (JAKi) during the period of 2006-2021. bDMARDs included anti-tumor necrosis factor (anti-TNF), anti-interleukin6 (anti-IL6), anti-CD20, and Cytotoxic T lymphocyte-associated antigen-4-Ig (CTLA4-Ig). Patients who were concurrently on GCs at the initiation of bDMARD or JAKi therapy were included. Logistic regression models were used to calculate the odds ratios (ORs) of GC discontinuation at 3 and 6 months, adjusting for potential confounders.

RESULTS:

Out of 2865 RA patients on b/tsDMARDs, 1421 patients (49.6%) (median age: 57.0 [48.0-65.0] years; female: 1162 [81.8%]; median disease duration: 2.0 [1.0-5.0] years) were on additional GC therapy initially. The overall 3-month and 6-month GC discontinuation rates were 26.2% and 36.8%, respectively. At month 3, after adjusting for age, prior chronic GC use, current csDMARDs use and hypertension, anti-TNF (OR 0.520, 95% CI: 0.383-0.707) and anti-CD20 (OR 0.134, 95% CI: 0.057-0.278) treatments were significantly associated with a lower likelihood of GC discontinuation compared to JAKi therapy. At month 6, after adjusting for age, prior chronic GC use and hypertension, anti-TNF therapy (OR 0.560, 95% CI 0.412-0.761), anti-CD20 therapy (OR 0.461, 95% CI 0.274-0.764), and CTLA4-Ig (OR 0.492, 95% CI 0.254-0.919) were independently associated with a reduced likelihood of GC discontinuation compared to JAKi therapy. No statistically significant difference was observed between JAKi and anti-IL6 therapy at either time point.

CONCLUSIONS:

In the real-world setting, a high prevalence of RA patients was on GCs at the time of the initiation of b/tsDMARDs. However, only a limited proportion of these patients were able to discontinue GCs by months 3 and 6. Initiation of JAKi therapy was associated with a greater likelihood of glucocorticoid discontinuation compared with selected bDMARDs, while no statistically significant difference was observed relative to anti-IL6 therapy.

01 Nov 2026·DRUG SAFETY

Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A Longitudinal Analysis

Article

Author: Pratt, Nicole L ; Lai, Edward Chia-Cheng ; Lau, Chak-Sing ; Shin, Ju-Young ; Chan, Shirley C W ; Chan, Esther W Y ; Li, Xue ; Yan, Vincent K C ; Peng, Kuan

BACKGROUND:

Biologic and targeted synthetic disease-modifying antirheumatic drugs effectively manage rheumatoid arthritis but are associated with varying risks of adverse events.

OBJECTIVE:

Comparing the risk of key clinical events across biologic and targeted synthetic disease-modifying antirheumatic drugs to guide safer prescribing behavior.

METHODS:

A population-based cohort study analysed patients with rheumatoid arthritis initiated on one of 12 biologic and targeted synthetic disease-modifying antirheumatic drugs (2009-22) in Hong Kong, with adverse events assessed over 5 years, including major adverse cardiovascular events, infections, malignancies, diabetes mellitus, depression, hospitalisation and all-cause mortality. Marginal structural models with inverse probability weighting addressed time-varying confounding and selection bias. Death was treated as a competing risk, and Bonferroni correction accounted for multiple comparisons.

RESULTS:

Among 2697 patients with rheumatoid arthritis (4276 treatment episodes), the estimated 5-year cumulative probability of adverse events were broadly comparable across biologic and targeted synthetic disease-modifying antirheumatic drugs: with hospitalisation that ranged from 0.48 (95% confidence interval 0.271, 0.636) for baricitinib to 0.726 (0.665, 0.785) for tocilizumab; mortality from 0.028 (0.002, 0.049) for adalimumab to 0.07 (0.03, 0.118) for abatacept; major adverse cardiovascular events from 0.025 (0.004, 0.046) for golimumab and 0.025 (0.007, 0.046) for adalimumab to 0.072 (0.035, 0.107) for abatacept; infection from 0.213 (0.15, 0.265) for etanercept to 0.389 (0.17, 0.664) for rituximab; malignancy from 0.012 (0, 0.028) for abatacept to 0.116 (0, 0.309) for baricitinib; diabetes from 0.018 (0.003, 0.03) for etanercept to 0.079 (0.015, 0.152) for golimumab; depression from 0 (no events recorded) for baricitinib to 0.029 (0, 0.09) for rituximab; and gastritis from 0.041 (0, 0.078) for baricitinib to 0.114 (0.075, 0.157) for tofacitinib. Risks were compared with etanercept to estimate risk differences, which is the most frequently prescribed agent in Hong Kong with a well-documented safety profile. Tocilizumab was associated with a higher hospitalisation risk (risk difference 0.205; 95% confidence interval 0.104, 0.299) and tofacitinib was associated with a higher gastritis risk (risk difference 0.055; 95% confidence interval 0.001, 0.105).

CONCLUSIONS:

This study demonstrates broadly similar safety profiles among Biologic and targeted synthetic disease-modifying antirheumatic drugs after rigorous adjustment, alleviating concerns about severe adverse events. These findings provide clinicians with evidence to make informed treatment decisions for patients with rheumatoid arthritis.

01 Nov 2026·DRUG SAFETY

Implementation Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments

Article

Author: Janetzki, Jack ; Pratt, Nicole ; Kemp-Casey, Anna ; Kalisch-Ellett, Lisa

BACKGROUND:

Medication shortages are a considerable and ongoing issue in healthcare, disrupting consumer access to medicines. Since 2021, Australia's national medicines regulator has issued Serious Scarcity Substitution Instruments (SSSIs), allowing pharmacists to substitute a specific therapeutically equivalent strength and/or formulation of a medicine without prior approval from a prescriber. The impact of SSSIs on utilisation of medicines has not been investigated.

OBJECTIVE:

To determine whether SSSIs are effective in addressing medicine shortages and meeting patients' needs.

METHODS:

This retrospective cohort study used aggregated pharmacy claims to examine the utilisation of 12 medicines, which had an SSSI. We calculated the percentage change in defined daily doses dispensed per 1000 population per day in the 11 months after SSSI implementation, compared with the previous 2 years. A percentage change of less than 20% was used to indicate success.

RESULTS:

Following medicine shortages, utilisation fell for 10 of the 12 medicines examined. For eight of these medicines (amoxicillin, cefalexin, estradiol, fluoxetine, insulin degludec with insulin aspart, isosorbide mononitrate, vigabatrin, and warfarin) decreases in utilisation were minimised to < 20%. On average, SSSIs where all permitted substitute products were scarce (e.g., abatacept) were associated with larger decreases in use (between - 22 and - 68%) than those for which none or only some of the substitutes were in shortage (between - 45 and + 7%, respectively).

CONCLUSIONS:

While product shortages led to decreases in medicines consumption, SSSIs appeared to be successful in limiting decreases. However, SSSIs were less likely to be successful when many of the permitted substitute products were also scarce.

News (Medical) associated with Abatacept

28 Sep 2026

·www.biospace.com

Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of YUSIMRY®, a Biosimilar to Humira®

YUSIMRY ® (adalimumab-aqvh), a citrate-free, high-concentration formulation, is approved for nine indications of reference product Humira ® , and is now interchangeable Approval enables Meitheal to offer YUSIMRY ® in both low and high-concentration formulations Approval further expands Meitheal’s biosimilar portfolio and supports the Company’s commitment to providing sustainable access to critical medicines CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced that the U.S. Food and Drug Administration (“FDA”) has approved a high-concentration formulation (“HCF”) for YUSIMRY ® (adalimumab-aqvh), as an interchangeable biosimilar to Humira ® . Emerge Bioscience Pte. Ltd. (“Emerge”) holds the approved Biologics License Application for YUSIMRY ® . Meitheal serves as the product’s U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under its license agreement with Emerge. “With this approval, we now have FDA approval for both low and high-concentration formulations of YUSIMRY ® , marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “By leveraging our development and commercialization expertise together with the manufacturing and supply chain capabilities of our partners, we will continue working to expand access to high-quality, affordable treatment options.” Recent milestones, including the FDA approval of Garzulys™ (insulin aspart-fsan) injection in July 2026 and the approval of the interchangeable high concentration formulation of YUSIMRY ® , highlight the continued growth of Meitheal’s biologics business. Supported by its parent company, Hong Kong King-Friend Industrial Co., Ltd. (“HKF”), Meitheal continues to expand patient access to affordable therapies through more than $500 million in capital and research and development investments, including $30 million in a monoclonal antibody drug substance facility. “We are thrilled to celebrate both the FDA approval of Garzulys™ and the approval of the high-concentration formulation of YUSIMRY ® ,” said Eric Tang, President of HKF. “Together, these achievements reinforce our commitment to increasing access to affordable biologic medicines. We look forward to continuing our strategic partnership with Meitheal and investing in solutions that help improve patient access and outcomes.” YUSIMRY ® is biosimilar to Humira ® and YUSIMRY is FDA approved as interchangeable with Humira ® for all nine approved indications. YUSIMRY ® is available in both low and high concentration formulations in an autoinjector and as a prefilled syringe in the low concentration formulation. Adalimumab remains an important treatment option across multiple chronic inflammatory diseases. ABOUT YUSIMRY ® YUSIMRY ® (adalimumab-aqvh), a biosimilar to Humira ® (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Please see additional context for these indications and Important Safety Information below. IMPORTANT SAFETY INFORMATION AND INDICATIONS YUSIMRY ® (adalimumab-aqvh) is biosimilar* to Humira ® (adalimumab). See full prescribing information for complete boxed warnings. SERIOUS INFECTIONS Patients treated with YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients: 1. with chronic or recurrent infection; 2. who have been exposed to TB; 3. with a history of opportunistic infection; 4. who resided in or traveled in regions where mycoses are endemic; 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start YUSIMRY during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a tumor necrosis factor (TNF) blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of YUSIMRY with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions as well as the lack of demonstrated benefit of such combinations. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of YUSIMRY treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen plus ultraviolet A light (PUVA) therapy, for the presence of NMSC prior to and during treatment with YUSIMRY. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop YUSIMRY and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after YUSIMRY treatment. Discontinue YUSIMRY and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming YUSIMRY after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including adalimumab, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering YUSIMRY for patients with these disorders; discontinuation of YUSIMRY should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab. Consider stopping YUSIMRY if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with YUSIMRY may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on YUSIMRY should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating YUSIMRY therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to YUSIMRY in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Rheumatoid Arthritis: YUSIMRY is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: YUSIMRY is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: YUSIMRY is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: YUSIMRY is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: YUSIMRY is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis: YUSIMRY is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. YUSIMRY should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of YUSIMRY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Please see full Prescribing Information for YUSIMRY ® , including Boxed Warnings available here: Package Insert . ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of generic injectables, biologic, fertility and branded products. Meitheal currently markets more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anesthesia, diabetes, critical care and fertility. Meitheal combines an established U.S. commercial platform with regulatory expertise and strategic development and manufacturing partnerships to support complex pharmaceutical products. Building on its foundation in generic injectables, the company is making deliberate, long-term investments to expand its biologics and branded portfolio and broaden access to high-quality, fairly priced medicines. Meitheal is guided by the traditional Irish principle for which it is named—working together toward a common goal, for the greater good. Learn more at . ABOUT HONG KONG KING-FRIEND INDUSTRIAL CO., LTD. Hong Kong King-Friend Industrial Co., Ltd. is a wholly owned subsidiary of NKF, founded in 2010. ABOUT EMERGE BIOSCIENCE PTE. LTD. Established in 2024 and based in Singapore, Emerge Bioscience Pte. Ltd. (“Emerge”) is a subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) that supports NKF’s international pharmaceutical trading and supply-chain activities. Emerge coordinates with manufacturers, regulatory authorities, logistics providers and commercial partners to support the reliable, compliant and timely delivery of pharmaceutical products and NKF’s broader international growth strategy. ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO., LTD. Founded in 1986 and headquartered in Nanjing, China, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”) is an integrated biopharmaceutical company engaged in the research, development and manufacturing of active pharmaceutical ingredients and finished dosage forms. Building on its established expertise in heparin APIs and sterile injectable products, NKF has expanded its capabilities across generic, biologic and branded products in therapeutic areas including oncology, critical care, fertility and diabetes. NKF supports products and partners in the United States, China, Europe and other global markets and is publicly listed on the Shanghai Stock Exchange under stock code 603707. Humira ® is a registered trademark of AbbVie Inc. YUSIMRY ® is a registered trademark of Emerge and licensed to Meitheal Pharmaceuticals, Inc. MAT-US-YUS-00008 09/2026 Contacts MEDIA CONTACT Meitheal Pharmaceuticals, Inc. John Spilman, VP of Corporate Strategy 773 899 5910 info@meithealpharma.com

Drug ApprovalLicense out/in

17 Sep 2026

·firstwordpharma.com

Roche taps Dualitas' bispecific discovery engine in $1B immunology, inflammation deal

Having scaled its discovery engine dramatically over the last year, Dualitas Therapeutics is starting to reap the rewards, announcing Thursday its first tie-up with a big pharma player in the shape of Roche. The agreement — potentially worth up to $1 billion — is hopefully just the tip of the iceberg, as the biotech's DualScreen bispecific engine has already identified more targets "than we can handle," said Forbes Huang, co-founder and chief operating officer."We want to be known as the bispecific company," Huang told FirstWord, adding "we started Dualitas with the idea of it being partnering… So I think we will be continuing to explore partnerships."Formed in 2023, and emerging from stealth last year with a $65-million series A financing, Dualitas is focused on developing next-generation bispecific antibody therapies for immunology and inflammation (I&I) indications. The biotech's bispecific antibodies pair an internally discovered novel immune proximity engager arm with an antibody against a validated target.But unlike other approaches that may lead to incremental gains, Dualitas is only interested in synergistic pairs — those that drive amplified pharmacological effects. "We want to identify bispecific combinations that really have differentiated biology and pharmacology that would be…superior to existing drugs that are out there that target T-cell biology," CEO Karim Dabbagh explained to FirstWord.Dualitas is hoping that its lead pipeline programme DTX-102, which pairs a proximity engager arm with an optimised anti-CD28 antibody arm, can outperform existing treatments for rheumatoid arthritis, including Bristol Myers Squibb's Orencia (abatacept). "We came upon CD28 as a revalidation…through the platform and then the engager E1, which we haven't revealed publicly what it is, came out as one of the top basically bispecific combinations with CD28 in demonstrating superior T-cell inhibition compared to…the benchmarks, which is in that context…Orencia," Dabbagh said.Increasing the apertureThe biotech's rapid progress from screening to clinic — DTX-102 is expected to enter clinical studies in mid-2027 — seems to have been key in snaring Roche as a partner. "When we had discussions with Roche, I think it immediately became clear to them that this is a validated technology, this is the only platform of its kind that can do what we're doing, and our own programmes have shown that we can find drugs that can move into the clinic," Huang explained."Now we're going to…increase the aperture, if you like, the immune aperture with Roche to look at much broader immune pathways and cell types," added Dabbagh, who joined the biotech earlier this year.Under the deal, Dualitas will functionally screen over 300,000 novel bispecific combinations to discover and develop bispecific antibody therapeutics, with Roche responsible for subsequent preclinical development, regulatory, manufacturing and commercial activities. The biotech noted that the work is believed to be one of the largest-scale bispecific discovery endeavors undertaken, with the size key in attracting Roche."What's changed in the last year and what's gotten Roche very excited is our discovery engine now has scaled drastically," Huang said. "We're now at the point where we can screen 300 to 500,000 novel combinations, as opposed to 10,000 when we first started the company."The increase in scale has been driven by large libraries of antibodies against immune cells. "So T-cells, B-cells, any sort of immune cells. We have vast libraries targeting those. And our platform allows us to create bispecific combinations around those," Huang explained. However, to pass muster, Huang stressed that "if it's not synergistic or if it's not better than a benchmark, we don't even look at it."Expansion ambitionsAnd the ambition is to continue to expand. "We are still right now covering immune cells, but the goal is to over long term expand into other cell populations as well," such as for oncology, metabolism and neurology, Huang noted.But the deal with Roche is firmly rooted in I&I. "This collaboration is intended to screen along a pathway that's known for a large population disease… It's not been disclosed," Huang said, but "it is pointed towards a certain indication in particular."Under the research collaboration and license agreement, Roche will make an upfront payment of $36.5 million, with Dualitas eligible for additional research, development and commercial milestones, in addition to tiered royalties. In return, the Swiss drugmaker will have exclusive rights to the programmes they choose, which Huang said "will be a very limited" number. Those that they pass on will revert fully back to Dualitas, to potentially join a growing pipeline that already consists of five programmes. "The growth right now is basically becoming a clinical stage company," Dabbagh said, with "the next two programmes…progressing really fast towards that."

License out/inImmunotherapy

18 Jun 2026

·www.businesswire.com

Coya Therapeutics to Present ALSTARS Trial Design at the ENCALS 2026 Meeting

HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, announces that the Company will present an overview of the ongoing ALSTARS trial, outlining its design and approach to targeting neuroinflammation, at the European Network to Cure ALS (ENCALS) Meeting 2026 which will take place June 24–26, 2026, in Madrid, Spain. The details for the poster presentation, which will be presented by Tyrell Simkins, D.O., Ph.D., Senior Director, Clinical Development, are below: Poster Title: ALSTARS: A Precision Immunomodulatory Phase 2 Trial Of Coya 302 Targeting Regulatory T Cells And Neuroinflammation In ALS Authors: Tyrell J. Simkins, DO, PhD; Fred Grossman, DO; Stanley Appel, MD; Karen King, MS; and James D. Berry, MD Date of Presentation: Wednesday, June 24, 2026, 11:20 am – 1:00 pm ET (5:20 pm – 7:00 pm Madrid) Session: ENCALS Research Forum – Posters Session About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases. This cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. For more information about Coya, please visit www.coyatherapeutics.com. About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects. Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT07161999). COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Coya Therapeutics, Inc. (the “Company”) regarding the potential benefits, effectiveness and safety of its product candidates; the significance and potential benefits associated with the FDA’s Fast Track designation for COYA 302; the Company’s ability to advance its product candidates through the preclinical and clinical development processes; the Company’s expectations regarding, quality, timing and availability of data from the Company’s clinical trials; the timing of announcements, updates and results of the Company’s clinical trials and related data; the Company’s future results of operations and financial position, including cash runway; and the potential therapeutic benefits and economic value of the Company’s product candidates. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Phase 2Fast TrackCell TherapyImmunotherapy

100 Deals associated with Abatacept

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KEGG	Wiki	ATC	Drug Bank
D03203	Abatacept	L04AA24	DB01281

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Graft Versus Host Disease	United States	Bristol Myers Squibb Co.	15 Dec 2021
Juvenile Idiopathic Arthritis	United States	Bristol Myers Squibb Co.	25 Aug 2009
Arthritis, Psoriatic	European Union	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Iceland	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Norway	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	European Union	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Iceland	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Norway	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Rheumatoid Arthritis	United States	Bristol Myers Squibb Co.	23 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocarditis	Phase 3	United States	Bristol Myers Squibb Co.	02 Jul 2022
Myocarditis	Phase 3	Canada	Bristol Myers Squibb Co.	02 Jul 2022
Polymyalgia Rheumatica	Phase 3	France	Bristol Myers Squibb Co.	13 Dec 2018
Giant Cell Arteritis	Phase 3	United States	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Australia	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Austria	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Belgium	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Bulgaria	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Canada	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Denmark	Bristol Myers Squibb Co.	15 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


LIMIT-JIA (ACR2026)	Not Applicable	Juvenile Idiopathic Arthritis	96	Abatacept plus usual care (NSAID and/or intra-articular glucocorticoids)	chppfhpygp(hzqjpqjydk) = abdwzzuwco wsoroyznkh (xcvynpqhxw )	Negative	06 Nov 2026
				Usual care alone (NSAID and/or intra-articular glucocorticoids)	chppfhpygp(hzqjpqjydk) = npxkoddasx wsoroyznkh (xcvynpqhxw )
ACR2026	Not Applicable	Rheumatoid Arthritis	116	Abatacept (IMTmax >1.1)	gwdeexckaa(jtfrwtegxd) = pexyniycml dspbmlvsaf (pzeodudcrn ) View more	Positive	06 Nov 2026
				Abatacept (IMTmax ≤1.1)	gwdeexckaa(jtfrwtegxd) = uuujzysvgo dspbmlvsaf (pzeodudcrn ) View more
ACR2026	Not Applicable	Sjogren's Syndrome	29	abatacept	wpqlszberb(kjosubrzgp) = elfvxmciby bixopxqvln (ofwlqnryoy ) View more	Positive	06 Nov 2026
NCT05822583 (STRIVE, CTgov)	Phase 4	COVID-19	285	abatacept infusion (Active Treatment Group)	qzunkdicfi = xdafozvmlo erjvoynuxh (uhzyzobyur, niozeaxlrh - cgzseaqlby) View more	-	31 Aug 2026
				Placebo group (Control Group)	qzunkdicfi = thhctynodw erjvoynuxh (uhzyzobyur, mxlwpctgfs - ngcpbupftt) View more
ESC2026	Not Applicable	Myocarditis	23	Ruxolitinib + Abatacept + Glucocorticoids	apoixsczrr(flhwxjhzpg) = cmzhszzjdo fjiecyzsla (zhkhudrodr ) View more	Positive	19 Jun 2026
AMPLE (EULAR2026)	Phase 3	Rheumatoid Arthritis	103	Abatacept+Methotrexate (DAS28≥3.2 + Rheumatoid Arthritis + biologic naive + symptom duration <5 years)	jxflbwfzrl(gixrcgwpjb) = nfnmlzrktr mkofovxumy (tfvhnqwbwo, 41.0 - 73.2)	Positive	11 Jun 2026
				Adalimumab+Methotrexate (DAS28≥3.2 + Rheumatoid Arthritis + biologic naive + symptom duration <5 years)	jxflbwfzrl(gixrcgwpjb) = nrnefbzvau mkofovxumy (tfvhnqwbwo, 47.6 - 65.0)
CURACTA (EULAR2026)	Phase 1/2	ACPA-POSITIVE	3	Abatacept+Methotrexate+Daratumumab	prkkzapmit(adlinctunl) = Most AEs were mild or moderate. All patients experienced transient non-severe symptoms indicative of systemic infusion-related reactions (IRR; e.g. erythema, hyperhidrosis), and one patient experienced local IRR. One patient had transient grade 4 neutropenia with leukopenia, which resolved without intervention. Total IgG levels decreased in all patients, and one patient received immunoglobulin replacement therapy due to IgG levels below 4g/l (week 24). No severe infections occurred. lbvztvzpys (rksdndshze ) View more	Positive	11 Jun 2026
EULAR2026	Not Applicable	Rheumatoid arthritis with rheumatoid lung disease	1,162	JAK inhibitors	wipwtsnkxk(ondgzfeppt): HR = 1.59 (95.0% CI, 1.17 - 2.17) View more	Negative	11 Jun 2026
				Abatacept
EULAR2026	Not Applicable	Rheumatoid Arthritis	72,000	Tocilizumab	grbpvwwwdf(qtahdiqqel) = cepzmabwwv bsvrgmuaid (mllcwsbvlb )	Positive	11 Jun 2026
				Rituximab	grbpvwwwdf(qtahdiqqel) = tuklgmbrak bsvrgmuaid (mllcwsbvlb )
EULAR2026	Not Applicable	Rheumatoid Arthritis	347	Tapering of b-/tsDMARDs	aqrwtruwjn(qhfvdicmbf) = qlwvpujdeq bwrwksyfpd (ympzkoyirz )	Positive	11 Jun 2026
				Continuation of stable b-/tsDMARDs	aqrwtruwjn(qhfvdicmbf) = qywuprkbct bwrwksyfpd (ympzkoyirz )

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