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  • TransThera Biosciences Announces IND Clearance from FDA for Clinical Studies of TT-00420 to Treat Cholangiocarcinoma Nanjing, China, November 28th, 2020--TransThera Biosciences announces today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of TT-00420 for the indication of cholangiocarcinoma (CCA), upon which TransThera will initiate Phase 2 clinical trial in 2021 to evaluate the efficacy and safety of TT-00420 in CCA patients.

    2020-11-28

  • TransThera Biosciences presents preclinical data on phosphodiesterase 9 inhibitor TT-00920 at the American Heart Association Scientific Sessions 2020 Nanjing TransThera Biosciences Co., Ltd. today announced the presentation of preclinical data on TT-00920, the company’s clinical stage Phosphodiesterase 9 (PDE9) inhibitor, at the American Heart Association (AHA) Scientific Sessions 2020, taking place online from November 13-17, 2020. The data demonstrated that in preclinical chronic heart failure model, TT-00920 remarkably improved cardiac function and protected from cardiac remodeling and fibrosis. Compelling preclinical results provide strong evidence that TT-00920 has the potential to be a meaningful new treatment for chronic heart failure.

    2020-11-11

  • TransThera Biosciences Has Filed the Second IND of TT-00420 to FDA for New Indication of Cholangiocarcinoma Nanjing, China, October 29th, 2020--TransThera Biosciences announces today the Investigational New Drug (IND) application of TT-00420 for the indication of cholangiocarcinoma (CCA) has been submitted to Food and Drug Administration (FDA) in the United States.

    2020-10-30

  • TransThera Biosciences Lead Product TT-01025 Submitted Investigational New Drug (IND) Application to FDA Seoul, South Korea and Nanjing, China – LG Chem Life Sciences (“LG Chem”), a division of LG Chem, and TransThera Biosciences jointly announce today the Investigational New Drug (IND) application of TT-01025 has been submitted to Food and Drug Administration (FDA) in the United States.

    2020-10-30

  • LG Chem Life Sciences and TransThera Biosciences Announce License Agreement for Potential Treatment of NASH and Other Chronic Inflammatory Conditions NANJING, China, and SEOUL, Korea, August 18th, 2020 – LG Chem Life Sciences (“LG Chem”), a division of LG Chem, and TransThera Biosciences Co. Ltd. (“TransThera”), a clinical-stage biotechnology company based in Nanjing, China, announced today that LG Chem has entered an exclusive license agreement with TransThera, for the development and commercialization of TransThera’s TT-01025, a highly selective oral small molecule inhibitor of Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) that has shown promising efficacy in pre-clinical investigation in non-alcoholic steatohepatitis (NASH). TT-01025 is expected to enter Phase I trial in early 2021 in the US.

    2020-08-18

  • TransThera Biosciences Initiates First Human Dose of TT-00920, a Novel PDE9 inhibitor for Chronic Heart Failure Treatment NANJING, China, March 7, 2020 -- TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, today announced that the first cohort of healthy volunteers has been dosed in Phase 1 clinical trial with TT-00920, a novel Phosphodiesterase 9 (PDE 9) inhibitor in development for the treatment of chronic heart failure.

    2020-03-07

  • TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure NANJING, China, Dec. 16, 2019 /PRNewswire/ -- TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure.

    2019-12-17

  • TransThera Biosciences Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma NANJING, China, Nov. 6, 2019 / -- TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.

    2019-11-07

  • TransThera Biosciences initiated Preclinical Development of TT-00920 NANJING, China, March 2nd, 2019 TransThera Biosciences Co. Ltd today announced that it has initiated preclinical development of its proprietary lead compound TT-00920. TT-00920 is a first-in-class, orally bioavailable drug candidate for the treatment of heart failure disease. “The advancement of TT-00920 into preclinical development is an important milestone for TransThera. Compelling preclinical results support that TT-00920 can improve cardiac function in both HFrEF (heart failure with reduced ejection fraction) and HFpEF (heart failure with preserved ejection fraction). We hope to bring a breakthrough therapy to patients suffering from this severe disease with our innovative drug. " said Dr. Frank Wu, founder and CEO of TransThera. The company expects to submit INDs in the US in the fourth quarter of 2019.

    2019-03-02

  • TT-00420 IND granted by China NMPA and global clinical trial soon initiated February 26th, 2019 TransThera Bioscience announced that China National Medical Product Administration (NMPA) has granted IND approval of TT-00420, an investigational drug targeting triple negative breast cancer and other solid tumors, to conduct clinical trials in China. The company received TT-00420 IND approval letter from FDA in the US in September 2018. The first-in-human dose was achieved on January 8th, 2019. Today’s regulatory milestone marks the initiation of a multi-center global phase I trial for TT-00420.

    2019-02-26

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