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    News Center

    Sunshine Guojian Obtains Marketing Authorization of YISAIPU in Indonesia

    2020-03-11

    (Jakarta, Indonesia, March 10, 2020) YISAIPU, an antibody drug independently developed by Sunshine Guojian Pharmaceuticals (Shanghai) Co., Ltd., a subsidiary of 3SBio, has recently been approved by the National Agency of Drug and Food Control (NA-DFC) in Indonesia for launch, adding another overseas market for the product. Up to now, YISAIPU has obtained marketing authorization in 15 countries including Colombia, Mexico, India and Thailand, where physicians and patients widely affirm the drug.


    The successful launch of YISAIPU in Indonesia demonstrates the company’s philosophy of “making innovative antibody drugs within reach” to a broader overseas audience, marking a new milestone for Sunshine Guojian in its business expansion globally. The company will continue to leverage its advantages in products and overseas business channels to bring China’s high-quality biologics to overseas markets for the benefit of patients worldwide.


    About YISAIPU

    YISAIPU (Recombinant Human Tumor Necrosis Factor-α Receptor II: IgG-Fc Fusion Protein) is used for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis. It is the first fully human antibody drug listed in China and the first tumor necrosis factor (TNF-α) inhibitor listed in the field of rheumatism in China, which has filled the gap of domestic enterprises in fully human therapeutic antibody drugs. In addition, YISAIPU’s domestic market share has been in a leading position since 2006.


    About Sunshine Guojian

    Sunshine Guojian was established in 2002 and is one of the first batch of innovative biopharmaceutical companies focusing on antibody drugs in China. It is a domestic pharmaceutical company that has two launched therapeutic antibody drugs, and had emerged as a leader in antibody drug with its capabilities of independent R&D, manufacturing and commercialization in China. Sunshine Guojian orients its R&D efforts primarily towards innovative therapeutic antibody drugs, and provides quality, safe and effective clinical solutions to the therapeutic areas of major diseases such as auto-immune diseases and tumors. Currently, Sunshine Guojian has 15 anti-body drug candidates (including 7 drug candidates in clinical and new drug registration stage and 8 drug candidates in pre-clinical stage) which are under different development stages, targeting tumor, auto-immune diseases and ophthalmological diseases. Most of those drug candidates are Category I biological products for therapeutic use or monoclonal antibodies, 2 of which are in application for launching, and 5 are in clinical stage. Sunshine Guojian may submit applications to both the National Medical Products Administration and the US Food and Drug Administration for some of those drug candidates, or some may be admitted for priority evaluation. Please visit www.husker-doo.com for additional information.

    Media contact

    Ren Yuanyuan

    renyuanyuan@3s-guojian.com

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