Orencia® (abatacept injection), the innovative drug in the field of rheumatology immunity co-developed by BMS and Simcere, is approved

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On January 19 2020, Bristol-Myers Squibb Company (shortened to BMS) and Simcere announced that Orencia® (abatacept injection), the innovative drug in the field of autoimmune diseases co-developed in China, was recently approved by the China National Medical Products Administration (NMPA), which will bring new hope to Chinese rheumatoid arthritis patients.


Abatacept is the first and only selective T-cell co-stimulation modulator. It binds to CD80 and CD86 on antigen-presenting cells (APCs), preventing its interaction with CD28 on T cells. By preventing this interaction, abatacept prevents activation of T cells, and then reduces downstream inflammation resulting in the inhibition of joint damage[1]. 

 

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Studies show that abatacept can improve symptoms, reduce disease activity, delay the progress of structural joint damage, and improve physical function [2][3]. Abatacept also has a proven safety profile, the risk of hospitalized infection of patients who use abatacept was 22.6% lower than the currently used biological agent, TNF-α inhibitor, according to a US claims database[4], and there is no serious warning regarding the risk of hospitalized infection. Integrated analyses of international multicenter studies support a low risk of TB with abatacept, [5] and there is no ethnic difference between the Chinese and global populations in the safety and efficacy of abatacept. Its original imported pre-filled injection formulation is also more convenient for patients.


Head of the Rheumatology and Immunology Department, Peking Union Medical College Hospital, Professor Zeng Xiaofeng says, “I am very pleased that abatacept has been approved in China, and sincerely congratulate Simcere and BMS. I think abatacept is an innovative biological agent for CTLA-4 in the treatment of rheumatoid arthritis, which has been widely used worldwide, and its unique mechanism of action brings obvious clinical benefits. The results of its Phase III clinical trial in China are consistent with overseas clinical studies. It is believed that the launch of this product offers a new treatment option to patients with rheumatoid arthritis in our country.”


Chief Operating Officer of Simcere, Zhang Cheng says, “we are so excited about the result, which comes from the cooperation of BMS and Simcere. I believe the pipeline and capabilities of Simcere for commercial launch will help more Chinese patients get Orencia very soon. With innovative products getting benefits from medical and health reform and more frequent NRDL updates, we are full of confidence in persisting in cooperation and innovation and making better medicines available to patients sooner.”


Orencia® has been marketed in the United States, Europe, Japan and other countries and regions. 

In June 2013, Simcere signed a strategic cooperation with BMS under which the parties collaborate in China on the development and commercialization of Orencia ®.



About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease with erosive arthritis as its main clinical manifestation and can occur at any age. The pathogenesis of RA is not yet clear. The basic pathological manifestations are synovitis and pannus formation, articular cartilage and bone destruction gradually appear, eventually leading to joint deformities and loss of function, which can be complicated with lung disease, cardiovascular disease, malignancy and depression. RA lead to disability, inability to work, and increased mortality, bringing huge economic burden on patients' families and society [6].



About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. 


About Simcere

Simcere Pharmaceutical Group is China's leading R&D-driven pharmaceutical company, who own State Key Laboratory of Translational Medicine and Innovative Drugs and focus on major disease areas such as tumors, nerves, and autoimmunity, striving to make better medicines available to patients sooner. Simcere adheres to an open innovation research and development strategy, and has become a strategic partner with a number of multinational pharmaceutical companies to promote the value of global life science achievements in China.


References:

1. Bonelli M, Scheinecker C. How does abatacept really work in rheumatoid arthritis?[J]. Current opinion in rheumatology, 2018, 30(3): 295-300.

2. Bathon J, Robles M, Ximenes A C, et al. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes[J]. Annals of the rheumatic diseases, 2011, 70(11): 1949-1956.

3. Kremer J M, Peterfy C, Russell A S, et al. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial[J]. The Journal of rheumatology, 2014, 41(6): 1077-1087.

4. Chen S K, Liao K P, Liu J, et al. Risk of Hospitalized Infection and Initiation of Abatacept versus TNF Inhibitors among Patients with Rheumatoid Arthritis: a Propensity Score‐Matched Cohort Study[J]. Arthritis care & research, 2018.

5. Genovese M C, Schiff M, Luggen M, et al. Longterm safety and efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy[J]. The Journal of rheumatology, 2012, 39(8): 1546-1554.

6. 2018中国类风湿关节炎诊疗指南[J].中华内科杂志,2018,57(4):242-251.


 

References

1. Bonelli M, Scheinecker C. How does abatacept really work in rheumatoid arthritis?[J]. Current opinion in rheumatology, 2018, 30(3): 295-300.

2. Bathon J, Robles M, Ximenes A C, et al. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes[J]. Annals of the rheumatic diseases, 2011, 70(11): 1949-1956.

3. Kremer J M, Peterfy C, Russell A S, et al. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial[J]. The Journal of rheumatology, 2014, 41(6): 1077-1087.

4. Chen S K, Liao K P, Liu J, et al. Risk of Hospitalized Infection and Initiation of Abatacept versus TNF Inhibitors among Patients with Rheumatoid Arthritis: a Propensity Score‐Matched Cohort Study[J]. Arthritis care & research, 2018.

5. Genovese M C, Schiff M, Luggen M, et al. Longterm safety and efficacy of abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy[J]. The Journal of rheumatology, 2012, 39(8): 1546-1554.

6. 2018中国类风湿关节炎诊疗指南[J].中华内科杂志,2018,57(4):242-251.


References
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