TopAlliance Biosciences

TopAlliance Biosciences is a next-generation, innovation-driven biopharmaceutical company that serves as the U.S. and global development arm of Shanghai Junshi Biosciences. Established in December 2012, the company is dedicated to the discovery and development of innovative drugs and their clinical research and commercialization on a global scale. It operates with advanced discovery platforms, research tools and globally integrated R&D processes, building a portfolio of drug candidates across broad therapeutic areas. The company's flagship therapy is TUOYI (toripalimab), an anti-PD-1 monoclonal antibody injection and the first product marketed by the company. Toripalimab has delivered impressive clinical data and shown satisfying efficacy and safety across various indications. In the United States, the therapy is commercialized under the brand name LOQTORZI (toripalimab-tpzi), which received FDA approval, and in Europe it is approved by the European Commission as LOQTORZI (toripalimab). TopAlliance Biosciences has rapidly built foundational infrastructure to advance novel therapies for patients worldwide. It established U.S. operations in Menlo Park, California, in 2013, and in 2014 established its discovery engine and research facility in Rockville, Maryland, where the company is now headquartered. The company's parent, Shanghai Junshi Biosciences, is recognized as the first biopharmaceutical company in China to obtain approval of an anti-PD-1 monoclonal antibody and the first Chinese company to obtain clinical trial approval for anti-PCSK9 and anti-BLyS monoclonal antibodies. TopAlliance Biosciences positions itself as a global biopharmaceutical company with state-of-the-art manufacturing capable of meeting the demands of the global patient population. Its activities span discovery, research and development, manufacturing science, clinical trials, and commercialization, with a focus on bringing novel medicines to the U.S. patient population and countries across the globe.

TopAlliance Biosciences was established in December 2012 as a next-generation biopharmaceutical company dedicated to the discovery and development of innovative drugs and their clinical research and commercialization on a global scale. It is the U.S.-based subsidiary of Shanghai Junshi Biosciences, a Chinese biopharmaceutical company that was the first in China to obtain approval for the marketing of an anti-PD-1 monoclonal antibody and the first among Chinese companies to obtain clinical trial approval for anti-PCSK9 and anti-BLyS monoclonal antibodies. In 2013, TopAlliance Biosciences established U.S. operations in Menlo Park, California. The following year, in 2014, the company established its discovery engine and research facility in Rockville, Maryland, which became its headquarters. Also in 2014, the company filed an Investigational New Drug (IND) application for toripalimab (anti-PD-1) to the National Medical Products Administration (NMPA) of China. In 2015, toripalimab received IND approval from the NMPA, marking the first anti-PD-1 monoclonal antibody developed by a Chinese company to reach that stage. Toripalimab, marketed as TUOYI, became the first product commercialized by the company. It is an anti-PD-1 monoclonal antibody injection that has delivered impressive clinical data and shown satisfying efficacy and safety across various indications. In the United States, the therapy is commercialized under the brand name LOQTORZI (toripalimab-tpzi) and received FDA approval. In Europe, LOQTORZI (toripalimab) received approval from the European Commission. TopAlliance Biosciences has rapidly created the foundational infrastructure to advance novel therapies for patients across the globe, leveraging advanced discovery platforms, research tools and globally integrated R&D processes. The company's activities span discovery, research and development, manufacturing science, clinical trials, and commercialization, with a focus on bringing novel medicines to the U.S. patient population and countries across the globe.

• 2015

  Toripalimab IND approval from the NMPA, the first anti-PD-1 monoclonal antibody developed by a Chinese company.

• 2014

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

• 2013

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

• 2012

  TopAlliance Biosciences established in December 2012.

• FDA approval of LOQTORZI (toripalimab-tpzi).

• European Commission approval of LOQTORZI (toripalimab).

A next-generation, global biopharmaceutical company developing innovative therapies with state-of-the-art manufacturing to serve patients in the U.S. and worldwide.

• LOQTORZI (toripalimab-tpzi)

  Anti-PD-1 monoclonal antibody approved by the FDA for the U.S. market.

• TUOYI (toripalimab)

  Anti-PD-1 monoclonal antibody injection, the first product marketed by the company.

• LOQTORZI (toripalimab)

  Anti-PD-1 monoclonal antibody approved by the European Commission for the European market.

1. 1Top Alliance – Next generation biopharmaceuticalstopalliancebio.com
2. 2Our History – Top Alliancetopalliancebio.com
3. 3Our Company – Top Alliancetopalliancebio.com
4. 4TopAlliance Biosciences (United States) – Wikidatawikidata.org
5. 5Our Company – Top Alliancetopalliancebio.com