Beijing Sungen Biomedical Technology Co., Ltd. with the mission of "Innovate to lead the future and benefit human health", is committed to developing FIC (First in class) antibody drugs, focusing on unmet clinical needs, and striving to become the world's leading antibody research and development (R & D) enterprise.
With excellent scientific and innovative drug research and development capabilities, Sungen has built a series of international standard technology platforms and innovative therapeutic antibody pipelines with great market potential. Our focus is on high-impact clinical areas including cardiovascular diseases, oncology, and other major therapeutic fields.
On December 21, 2018, Sungen Biomedical was established in Beijing, China. Professor Sun Zhiwei's research team started the development of antibody drugs of innovative targets.
In October 2021, Sungen Biomedical obtained the qualification of High-tech enterprise;
In November 2022, Sungen Biomedical obtained the qualification of Zhongguancun High-tech Enterprise;
On December 15, 2022, Sungen Biomedical's SGC001 project entered the CMC phase;
On October 31, 2023, Shenzhen Zhiyuan Biomedical Co., LTD. and Beijing Sungen Biomedical Technology Co., LTD. set up the "National Human Brain Health project" joint laboratory.
On November 20, 2023, Beijing Antai Institute of Cardiovascular Medicine and Beijing Sungen Biomedical Technology Co., LTD. established the "Joint Laboratory of Cardiovascular Disease Biological Innovation Drug Research and Development Center".
In February 2024, SGC001 project completed CMC study and non-clinical safety evaluation, and submitted the pre-IND application in China and the United States.
On May 23, 2024 (US time), clinical trial application (IND) of the world's first innovative drug SGC001 developed by Beijing Sungen Biomedical was approved by the US Food and Drug Administration (FDA).
On August 05, 2024, Sungen Biomedical SGC001 injection obtained the clinical trial implied approval from Center for Drug Evaluation, National Medical Products Administration.
On September 27, 2024, Sungen Biomedical won the Ernst & Young Fudan Most Promising Enterprise Award 2024
On November 19, 2024, Sungen Biomedical won the first prize of Beijing Science and Technology Progress Award 2023
On November 22, 2024, Sungen Biomedical won "2024 Top 10 Innovative Pharmaceutical Enterprises" selected by China Times
In 2024, the clinical trial application (IND) for SGC001, the world’s first-in-class innovative drug developed by Beijing Sungen Biomedical Technology Co., Ltd., received approval from the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA).
In March 2025, SGC001 developed by Sungen Biomedical was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).
To be an antibody therapy innovation company making major contributions to human health
Deep innovation in therapeutic antibodies
Team, Cooperation, Innovation, Kindness
Discover the precision and reliability of Hotgen IVD products. Contact us today to enrich your product portfolio & enhance your diagnostic capabilities and patient care.
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No. 55 Qingfeng West Road, Daxing District, 102629, Beijing, China