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 www.meithealpharma.com.

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

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