INCHEON, South Korea--(BUSINESS WIRE)--(BUSINESS WIRE)-- Celltrion presented positive data from a Phase III clinical trial of CT-P47 at the 2024 European College of Rheumatology (EULAR) Annual Meeting today. CT-P47 is a biosimilar candidate for RoActemra for the treatment of patients with moderate to severe rheumatoid arthritis (RA). Data from the Phase III controlled clinical trial demonstrated a high degree of similarity between the biosimilar candidate CT-P47 in development and the reference drug tocilizumab in terms of efficacy, safety, and immunogenicity. ®

The phase III study randomized 471 patients with moderate to severe rheumatoid arthritis to receive a dose of 8mg/kg CT-P47 or the reference drug tocilizumab every 4 weeks for the first 20 weeks. Prior to dosing at Week 24, patients receiving tocilizumab were re-randomized to receive the reference drug tocilizumab and partially converted to CT-P47 until Week 48.

The primary endpoints were disease activity score by 28 joints (DAS28), erythrocyte sedimentation rate (ESR), and improvement in disease activity at weeks 12 and 24. The estimated difference between the two groups was -0.01 at week 12 and -0.1 at week 24, and the confidence intervals for the difference were well within the pre-set equivalence ranges at both time points (95% confidence interval at week 12: -0.26 to 0.24, 90% confidence interval at week 24: -0.30 to 0.10). Prior to week 32, the two groups were highly similar in mean serum concentrations, rates of treatment-emergent adverse events, and positive rates of anti-drug antibodies, indicating equivalence in pharmacokinetics, safety, and immunogenicity.

Dr. Josef S. Smolen, Professor Emeritus of Medicine at the Medical University of Vienna, Austria, said, "Biosimilars offer an opportunity to address unmet medical needs by expanding access to high-quality biologics. The positive results of the Phase III study not only confirm the biosimilarity between CT-P47 and the reference drug tocilizumab, but also provide clinical evidence for the conversion of the reference drug tocilizumab to CT-P47."

In addition, a phase I/III study compared the pharmacokinetic (PK) similarities of the CT-P47 autoinjector (AI) and prefilled syringe (PFS) and evaluated the usability of the CT-P47 autoinjector.2The CT-P47 autoinjector has been shown to be similar to the pharmacokinetics of the prefilled syringe in healthy subjects. In addition, patients with rheumatoid arthritis had a higher rate of use of the CT-P47 autoinjector compared with prefilled syringes. In the study, the CT-P47 autoinjector was well tolerated and no new safety concerns were identified.

"We believe that in clinical practice, the CT-P47 autoinjector can be used as an alternative to prefilled syringes to help improve patient adherence," said Taehun Ha, Vice President and Head of Europe, Celltrion. Celltrion will continue to expand its portfolio of biosimilars in immunology, improving patient quality of life, enhancing the sustainability of healthcare systems, and expanding the choice of biologics for physicians and patients."

About rheumatoid arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease that causes pain, swelling, and stiffness in the joints.3About 1% of the world's population is affected by the disease4, but the exact cause is unknown. Symptoms of rheumatoid arthritis stem from an abnormality in the immune system, which causes autoimmune cells to attack healthy cells, but the mechanism by which this abnormal trigger is currently unknown. Although there is no cure for rheumatoid arthritis, early treatment, such as disease-modifying antirheumatic drugs (DMARDs) and biologics, can be effective in slowing joint damage and reducing the impact of the disease.5

About CT-P47 (Tocilizumab Biosimilar)

CT-P47 is a recombinant humanized monoclonal antibody with tocilizumab as the active ingredient that acts as an interleukin-6 (IL-6) receptor antagonist. Based on data from a global Phase III clinical trial to evaluate the similarity of CT-P47 to the reference drug RoActemra in terms of efficacy, pharmacokinetics, safety and immunogenicity, Celltrion Ceterion has submitted marketing authorization applications to the U.S. Food and Drug Administration (FDA) in January and February 2024, respectively. ®

About Celltrion:

Celltrion is a leading biopharmaceutical company headquartered in Incheon, South Korea, that researches, develops, manufactures, and markets innovative therapies to improve the lives of patients worldwide. The company offers a number of world-class monoclonal antibody biosimilars, such as Remsima, Truxima, Herzuma, Yuflyma and Vegzelma, as well as novel therapies such as RemsimaSC (U.S. brand name Zymfentra), providing a wider range of treatment options for patients around the world. For more details, please visit the www.Celltrion.com/en-us. ®®®®®® ®

Forward-Looking Statements

本新聞稿所載之部分資訊，包含與本公司及子公司未來業務、財務表現以及未來事件或發展有關之陳述，根據相關證券法，這些聲明可能構成前瞻性陳述。

這些陳述可透過「準備」、「希望」、「即將到來」、「計畫」、「旨在」、「將要推出」、「正在準備」、「一旦獲得」、「可能」、「以期」、「可以」、「一旦發現」、「將會」、「努力達成」、「到期」、「可用時」、「可望」等字詞，這些字詞的否定形式或變化形式或類似的術語加以辨識。

此外，本公司代表可能會做出口頭的前瞻性陳述。這些陳述是基於 Celltrion 賽特瑞恩 Inc. 及其子公司管理階層目前預期和某些假設，其中許多假設並非其所能控制。

提供前瞻性陳述是為了讓潛在投資人有機會瞭解管理層對未來的信念和意見，以便他們能夠利用這些信念和意見作為評估投資的一個因素。這些陳述不是未來業績的保證，不應過分依賴這些陳述。

這類前瞻性陳述必然涉及已知和未知的風險和不確定性，這可能導致未來期間的實際業績和財務結果與這類前瞻性陳述所明示或暗示的對未來業績或結果任何預測大相逕庭。

雖然本簡報中的前瞻性陳述是根據 Celltrion 賽特瑞恩 Inc. 及其子公司管理階層認為合理的假設，但無法保證前瞻性陳述將獲證明準確，因為實際結果和未來事件可能與這些陳述中的預期存在重大差異。Celltrion 賽特瑞恩 Inc. 及其子公司沒有義務在情況、管理層估計或意見發生變化時更新前瞻性陳述，除非適用證券法另有規定。請讀者不要過度依賴前瞻性陳述。

商標

RoActemra是 Roche Group 成員 Chugai Pharmaceutical Co., Ltd. 之註冊商標。 ®

參考文獻

1Josef S. Smolen et al. Similar Efficacy, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate–to Severe Active Rheumatoid Arthritis: Week 32 Results from the Phase 3 Single Transition Study. (Patients with moderately to severely active rheumatoid arthritis receiving tocilizumab biosimilar CT-P47 are similar in efficacy, safety, and immunogenicity to the reference drug tocilizumab: 32-week results from a phase III single-conversion study.) Poster (POS0610). Presented at EULAR 2024.
2Edward Keystone et al. Pharmacokinetics, Usability and safety of Tocilizumab Biosimilar (CT-P47) administered subcutaneously by auto-injector or pre-filled syringe. (Biometrics of tocilizumab injected subcutaneously using an autoinjector or prefilled syringe are to be used to determine the pharmacokinetics, usability, and safety of CT-P47.) Poster (POS0634). Presented at EULAR 2024.
3British Arthritis Research. Rheumatoid arthritis. For details, please visit https://www.versusarthritis.org/about-arthritis/conditions/rheumatoid-arthritis.
4Allan Gibofsky. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. American Journal of Management Nursing. 2012; 18:S295-302。
5Arthritis Foundation. Rheumatoid arthritis. For more information, please visit https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/ [Last visit in June 2024]. The National Health Service of the United Kingdom. Treatment is available at the following institutions: https://www.nhs.uk/conditions/rheumatoid-arthritis/treatment/.

Disclaimer: The original version of this announcement is the officially authorized version. Translations are provided for convenience only, please refer to the original version, which is the only legally binding version.