Overview of the international registration and marketing of 3SBio Group products
At present, 3SBio products that are registered overseas include Etanercept, TPIAO, EPIAO, Intefen and SEPO, etc. The registration has covered nearly 40 countries and regions around the world, with the business and customer scope basically covering all the developing countries. After years of hard work, these products have also been registered and listed in many countries.
Latin American region with Mexico, Colombia, Brazil, etc. being the centers
South Asia Region with India and Pakistan being the centers
East Asian region with Thailand, Bangladesh, Sri Lanka and Philippines being centers
The Commonwealth of the Independent States (CIS) region with Russia, Belarus and Ukraine being centers
Middle Eastern & Northern Africa (MENA) region with Turkey and Egypt being centers
Summary of the products that have been registered and listed overseas
Etanercept has obtained marketing approval from total 10 countries, and it is under registration application in over 20 countries.
TPIAO has obtained marketing approval from total 5 countries, and it is under registration application in nearly 10 countries.
EPIAO has obtained marketing approval from total 21 countries, and it is under registration application in nearly 20 countries.
|Trinidad and Tobago|
Intefen has obtained marketing approval from total 3 countries, and it is under registration application in nearly 10 countries.
SEPO has obtained marketing approval from total 6 countries, and it is under registration application in nearly 10 countries.
Clinical experience (important internationally published papers)
Application of Etanar® Therapy in Patients with Rheumatoid Arthritis
Published at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR), Atlanta, Georgia, USA, in November 10, 2010.
Abstract 1811. In the “real life” environment, the 20-week efficacy and safety analysis was conducted in the 110 patients who received Etanar® (25 mg, subcutaneous injection, twice a week) in combination with multiple DMARD anti-RA treatment for a long time.
ETANAR - Generic drug Etanercept is as effective as adalimumab and infliximab in treating a group of patients with rheumatoid arthritis
This article was published as a poster in EULARL 2015 (Rome, Italy) (P. Santos-Moreno et al. Ann Rheum Dis 2015; 74:789-790).
The descriptive cross-sectional study included 158 RA patients who visited at least 6 rheumatologists within the past 24 months, and respectively received adalimumab (61 (38.6%), infliximab (35 (22.2 %) and etanercept biosimilar products (62 (39.2%) (Etanar® CP Guojian Pharmaceutical Co., Ltd. (China)).
Clinical Outcomes of Etanar - a New Biotype of rhTNFR:Fc in Colombian Patients with Rheumatoid Arthritis
(PISantos-Moreno, G. Sánchez, D. Gómez, C. Castro. Clinical and Experimental Rheumatology, 2015; 33: 858-862.) A multicenter observational cohort study evaluated the clinical reactions at the 12th month in 105 RA patients treated with Etanar (rhTNFR:Fc) and the incidence of the adverse reactions was recorded.
Comparison of the direct effects of three anti-tumor necrosis factor biologics in the cohort of patients with rheumatoid arthritis
(Pedro Santos-Moreno, Guillermo Sánchez, Danny Gómez. et al; JCR-Journal of Clinical Rheumatology, 2016; 22 (2):57-62) The observational retrospective cohort study compared the clinical reactions at 36 months after treatment in 307 RA patients who received Etanercept (Etanar®), infliximab (Remecade®) or adalimumab (Humira®) and evaluated the adverse events.