A next generation, global biopharmaceutical company

TopAlliance Biosciences is a next-generation biopharmaceutical company dedicated to the discovery and development of innovative drugs towards clinical research and commercialization. Since our establishment in 2012, we have leveraged our advanced discovery platforms, research tools and globally integrated R&D processes, in developing a portfolio of drug candidates across broad therapeutics areas.

Our parent company, Shanghai Junshi Biosciences, is the first biopharmaceutical company in China to obtain approval of anti-PD-1 monoclonal antibody and the first company to obtain approval for clinical trial for anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody among the Chinese companies.

Our flagship therapy TUOYI ( Toripalimab) – an anti-PD-1 monoclonal antibody injection), the first product marketed by the Company, has delivered impressive clinical data, and has shown satisfying efficacy and safety on various indications. We are aiming to bring these novel medicines to the U.S. patient population and countries across the globe.

TopAlliance Biosciences has rapidly created the foundational infrastructure to advance novel therapies for patients across the globe

2013

  • Established U.S. operations in Menlo Park, CA

2014

  • Established discovery engine and research facility in Rockville, MD
  • Toripalimab (anti-PD-1) IND filed to NMPA

2015

  • Toripalimab IND approval from the NMPA, the first anti-PD-1 monoclonal antibody developed by a Chinese company to receive IND approval in Dec 2015

2016

  • Toripalimab in first pivotal clinical trial

2018

  • IND filing/Initiation of U.S. clinical trial for Toripalimab
  • JS003(PD-L1) obtained IND approval from the NMPA
  • Parent company listed on HKEX (stock code:1877.HK)

2019

  • Anti-BTLA (First in Human Globally) IND was approved by FDA
  • Obtained the drug production license for GMP manufacturing facility

 

2020

  • COVID-19 neutralizing antibody(JS016) completed Phase I enrollment in collaboration with IMCAS
  • U.S. orphan designation of Toripalimab
  • Anti-BTLA IND approved by NMPA
  • Parent company listed on SSE STAR Market

2023

  • U.S. FDA Approval of LOQTORZI™ (toripalimab-tpzi) for All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

2024

    • EU European Commission granted LOQTIRZI® (LOQTORZI – toripalimab) to use for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC/OSCC).