1. jinnianhui金年会|金字招牌诚信至上

      jinnianhui金年会生物

      Established in 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company committed to developing first-in-class and best-in-class drugs through original innovation.

      With an outstanding capacity for innovative drug discovery, advanced biotechnology research and development, a whole-industry-chain approach with large-scale production technology, and drug combinations with great market potential, Junshi Biosciences has endless potential in onco-immunotherapy as well as the treatment of autoimmune diseases, metabolic diseases, neurological diseases and infectious diseases.

      Our Mission

      With strong R&D capacity, Junshi Biosciences is at the cutting-edge of medical innovation. Our mission is toProvide patients with world-class, trustworthy, affordable, and innovative drugs.

      • To provide patients with treatment options that work better and cost less

      • To develop first-in-class and best-in-class drugs through original innovation

      • To become a pioneer in the area of translational medicine

      • To fulfill unmet medical needs and provide the best treatments for patients

      Our Growth Strategy

      We aim to become an innovative and globally competitive biopharmaceutical company with a whole-industry-chain layout that encompasses R&D, manufacturing and commercialization.

      Our Development Story

      Year

      2012
      • 2024
      • 2023
      • 2022
      • 2021
      • 2020
      • 2019
      • 2018
      • 2017
      • 2016
      • 2015
      • 2014
      • 2012

      Junshi Biosciences was established in Shanghai, the PRC.

      2012 Dec

      Junshi Biosciences was registered and listed on the NEEQ in China.

      2015 Aug

      UBP1211 (TNF-α) was approved by the NMPA to conduct clinical trials, being one of the first Humira biosimilars developed by PRC companies.

      2016 May

      Junshi Biosciences commenced construction of Lingang Production Base as a new manufacturing plant.

      2017 Jul

      JS001 (PD-1) obtained the IND approval by the FDA to conduct clinical trials in the United States.

      2018 Jan

      JS101 (Pan-CDK) obtained IND approval from the NMPA.

      2018 Oct

      JS004 (BTLA) was approved by the FDA to conduct clinical trials.

      2019 Apr

      Lingang Production Base obtained manufacturing permit.

      UBP1211 (TNF-α) obtained NDA acceptance from the NMPA.

      2019 Nov

      JS016 (SARS-CoV-2 S protein) was approved by NMPA and FDA to conduct clinical trials.

      2020 Jun

      Toripalimab for the treatment of nasopharyngeal carcinoma was granted Breakthrough Therapy Designation by the FDA.

      2020 Sep

      Toripalimab for the treatment of mucosal melanoma was granted Fast Track Designation by the FDA.

      JS006 (TIGIT) obtained IND approval from the NMPA.

      2021 Jan

      Toripalimab(TUOYI®)was approved by NMPA for 2L treatment of UC.

      JS111 (EGFR exon 20) obtained IND approval from the NMPA.

      JS110 (XPO1) obtained IND approval from the NMPA.

      2021 Apr

      JS007 (CTLA-4) obtained IND approval from the NMPA.

      2021 Jun

      Toripalimab for the treatment of NPC obtained BLA acceptance and priority review from the FDA.

      2021 Oct

      VV116 (RdRp) was approval for COVID-19 treatment in Uzbekistan (not within the collaboration territory).

      JS109 (CD39) obtained IND approval from the NMPA.

      2021 Dec

      JS112 (AuroraA) obtained IND approval from the NMPA.

      2022 Feb

      JS009 (CD112R) obtained IND approval from the FDA.

      Toripalimab for the treatment of small cell lung cancer (SCLC) was granted Orphan Drug Designation by the FDA.

      2022 Apr

      JS113 (EGFR 4th Gen) obtained IND approval from the NMPA.

      JS116 (KRAS) obtained IND approval from the NMPA.

      2022 Jun

      JS009 (CD112R) obtained IND approval from the NMPA.

      JS015 (DKK1) obtained IND approval from the NMPA.

      JS110 (XPO1) obtained IND approval from the FDA.

      2022 Aug

      JS015 (DKK1) obtained IND approval from the NMPA.

      2022 Oct

      Deuremidevir Hydrobromide(MINDEWEI®, VV116)was granted marketing approval by the NMPA.

      2023 Jan

      Junshi Biosciences established joint venture with Rxilient Biotech to jointly develop and commercialize toripalimab in Southeast Asia.

      JS010 (CGRP) obtained IND approval from the NMPA.

      2023 Mar

      Junshi Biosciences announced collaboration with Dr. Reddy’s to develop and commercialize toripalimab in 21 countries.

      2023 May

      Toripalimab(LOQTORZI™)was granted marketing approval by the FDA.

      2023 Oct

      Toripalimab for the treatment of NPC obtained NDA acceptance from the HSA.

      2024 Feb

      Toripalimab(TUOYI®)was approved by NMPA for 1L treatment of ES-SCLC and TNBC.

      2024 Jun

      Toripalimab (Indian trade name: ZYTORVI®, Hong Kong trade name: LOQTORZI®) approved for marketing in India and Hong Kong SAR, for treatment of recurrent or metastatic NPC.

      Ongericimab (JS002) for the treatment of primary hypercholesterolemia and mixed dyslipidemia granted marketing approval by the NMPA.

      2024 Oct

      Junshi Biosciences began to build Suzhou Wujiang Production Base.

      2014 Jul

      JS001 (PD-1) obtained IND approval from the NMPA, being the first anti-PD-1 monoclonal antibody developed by a PRC company.

      2015 Dec

      UBP1213 (BLyS) received IND approval from the NMPA. Junshi Biosciences is the first company in the PRC to obtain IND approval for anti-BLyS monoclonal antibody.

      2016 Oct

      JS002 (PCSK9) obtained IND approval from the NMPA, being the first anti-PCSK9 monoclonal antibody developed by a PRC company.

      2017 Aug

      JS003 (PD-L1) obtained IND approval from the NMPA.

      2018 Aug

      Toripalimab(TUOYI®, JS001)was granted marketing approval by the NMPA for 2L treatment of melanoma.

      Junshi Biosciences was listed on main board of HKEX (stock code:1877.HK).

      2018 Dec

      JS005 (IL-17A) IND application was approved by the NMPA.

      2019 Aug

      JS004 (BTLA) obtained IND approval from the NMPA.

      2020 Feb

      Junshi Biosciences was listed on STAR Market (stock code: 688180.SH).

      JS108 (Trop2 ADC) obtained IND approval from the NMPA.

      2020 Jul

      Toripalimab was added to the list of medicines covered by the medical-insurance system.

      2020 Dec

      The antibody therapy with etesevimab obtained EUA for the treatment of COVID-19 from the FDA. Till the end of 2021, EUAs granted in 15+ countries and regions.

      Toripalimab(TUOYI®)was approved by NMPA for 3L treatment of NPC.

      Junshi Biosciences signed exclusive licensing agreement with Coherus BioSciences for toripalimab in the US and Canada.

      JS006 (TIGIT) obtained IND approval from the FDA.

      2021 Feb

      JS201 (PD-1/TGF-β) obtained IND approval from the NMPA.

      JS103 (Uricase) obtained IND approval from the NMPA.

      2021 May

      Toripalimab in combination with chemotherapy for the 1st line treatment of NPC was granted Breakthrough Therapy Designation by the FDA.

      JS014 (IL-21) obtained IND approval from the NMPA.

      2021 Aug

      Toripalimab(TUOYI®)was approved by NMPA for 1L treatment of NPC.

      Toripalimab for the treatment of esophageal cancer was granted Orphan Drug Designation by the FDA.

      VV116 (RdRp) obtained IND approval from the NMPA.

      JS012 (Claudin18.2) obtained IND approval from the NMPA.

      2021 Nov

      Junshi Biosciences and Coherus BioSciences expanded immuno-oncology collaboration to include JS006 (TIGIT).

      2022 Jan

      Adalimumab(JUNMAIKANG®, UBP1211)was granted marketing approval by the NMPA.

      JS107 (Claudin18.2 ADC) obtained IND approval from the NMPA.

      2022 Mar

      Toripalimab(TUOYI®)was approved by NMPA for 1L treatment of ESCC.

      Shanghai Lingang Production Base was approved by the NMPA to manufacture the commercial batch of Toripalimab Injection in parallel with the Suzhou Wujiang Production Base of the company.

      JS105 (PI3K-α) obtained IND approval from the NMPA.

      2022 May

      JS105 (PI3K-α) obtained IND approval from the FDA.

      JS203 (CD20+CD3) obtained IND approval from the NMPA.

      2022 Jul

      Toripalimab(TUOYI®)was approved by NMPA for 1L treatment of NSCLC.

      2022 Sep

      Toripalimab for the treatment of NPC and ESCC obtained MAA acceptance from the EMA.

      Junshi Biosciences signed exclusive licensing agreement with Hikma for toripalimab for the Middle East and North Africa Region.

      2022 Dec

      Toripalimab for the treatment of NPC and ESCC obtained MAA acceptance from the MHRA.

      2023 Feb

      Ongericimab for the treatment of primary hypercholesterolemia and mixed dyslipidemia obtained NDA acceptance from the NMPA.

      JS401 (ANGPTL3 siRNA) obtained IND approval from the NMPA.

      2023 Apr

      JS207 (PD-1 x VEGF) obtained IND approval from the NMPA.

      2023 Jun

      Toripalimab(TUOYI®)was approved by NMPA as perioperative treatment and adjuvant therapy for NSCLC.

      VV116 was added to the list of medicines covered by the medical-insurance system.

      Toripalimab for the treatment of NPC obtained NCE acceptance from the TGA.

      2023 Dec

      Toripalimab(TUOYI®)was approved by NMPA for 1L treatment of RCC.

      Toripalimab for the treatment of NPC obtained NCE acceptance from the HSA.

      Tifcemalimab (BTLA) was approved by the PMDA to conduct clinical trials.

      2024 Apr

      Toripalimab (European trade name: LOQTORZI®) granted marketing approval by the EC, for treatment of NPC and ESCC.

      JS125 (HDACs) obtained IND approval from the NMPA.

      2024 Sep

      Toripalimab (UK trade name: LOQTORZI®) granted marketing approval by the MHRA, for treatment of NPC and ESCC.

      2024 Nov

      Our Leadership Team

      • Dr. Ning LI, M.D, Ph.DExecutive Director, Vice Chairman

        Dr. Li is Vice Chairman of Junshi Biosciences and Chairman of TopAllince Biosciences, responsible for overseas business.

        From 1997 to 2010, Dr. Li worked at US Food and Drug Administration (FDA) as a regulatory reviewer and held various positions from Oncology drug team reviewer, senior reviewer/expert reviewer, senior GCP reviewer to team leader, branch chief with increasing responsibilities. Before he joined Junshi Biosciences, Dr. Li was appointed as Vice President and Head of Region Asia Regulatory Affairs and Medical Policy in Sanofi. He has extensive experience and expertise in clinical research and medical product evaluation.

        Dr. Li obtained his bachelor’s degree in medicine from Shanghai Medical College of Fudan University, the PRC in July 1984 and his master’s degree in medicine from Shanghai Medical College of Fudan University, the PRC in October 1987. He obtained his Ph.D. degree in preventive medicine from University of lowa, the US in May 1994.

      • Dr. Jianjun ZOU, M.D, Ph.DExecutive Director, General Manager / Chief Executive Officer

        Dr. Zou is responsible for the overall work of the company.

        Dr. Zou has nearly 30 years of experience in clinical treatment of tumor, R&D of anti-tumor agents and clinical development of novel drugs. She had been working in the level 3 A hospital as a medical oncologist for 10 years from 1995 – 2005. Then she joined Bayer Healthcare pharmaceutical company and lead the clinical development programs of Sorafenib in China as the clinical trial physician, head of oncology therapeutic team in Bayer China. Then she moved to NJ, USA and worked as the global medical lead of Xofigo in the global medical affairs team in BayerhealtherCare Headquarter. In 2012, she joined Celgene and worked as the director, head of the medical department, China. Prior to joining Junshi Biosciences, she was the Vice President and chief medical officer(CMO) of JIANGSU HENGRUI MEDICINE, CO. LTD.

        Dr. Zou was trained by medical oncology in China and got her medical doctor degree in the Naval Medical University.

      • Mr. Cong LIExecutive Director, Co-Chief Executive Officer

        Mr. Li has about two decades of experience working in pharmaceutical industry. Prior to joining Junshi Biosciences, Mr. Li was a lecturer on pathological anatomy of Shanghai Tiedao University School of Medicine. He also served as the sales director of the Shanghai branch of NOVO Nordisk (China) Pharmaceuticals. and held the positions of manager of East China Region, sales director, assistant to general manager and general manager at Tonghua Dongbao Pharmaceutical. Since June 2019, Mr. Li has been serving as director and general manager of Suzhou Landing Biopharmaceutical., and the responsible person of Shanghai branch office of Suzhou Landing Biopharmaceutical.

        Mr. Li obtained his bachelor’s degree in medical science from Shanghai Railway University Medical College in July 1986.

      • Mr. Zhuobing ZHANGExecutive Director, Deputy General Manager

        Mr. Zhang was one of the founders of Junshi Biosciences when it was established. Since October 2013, Mr. Zhang has been the legal representative, executive director and general manager of Suzhou Union Biopharm.

        Mr. Zhang has over 20 years of experience in the pharmaceutical industry. Prior to joining Junshi Biosciences, he served as a scientific researcher of Viron Therapeutics Inc., Canada, and deputy director in Institute of Biopharmaceuticals of Nanjing Simcere Pharmaceutical Research Institute.

        Mr. Zhang obtained his master’s degree in biochemistry from Tsinghua University, PRC in July 1995. He was awarded the first prize of the Shandong district award for invention in 2005.

      • Dr. Sheng YAOExecutive Director, Senior Vice President

        Dr. Yao is CEO and director of TopAlliance. He took part in the invention of certain registered patents and patents in application in relation to JS002 and JS003 for the company.

        Prior to joining Junshi Biosciences, Dr. Yao worked as research fellow at the Johns Hopkins University School of Medicine in the Department of Dermatology, associate research scientist in the Human Translational Immunology Department at Yale University, and senior scientist at Amplimmune Inc., a subsidiary of AstraZeneca, where he was responsible for the tumor immunology and anti-autoimmune diseases antibody project.

        Dr. Yao obtained his bachelor’s degree in biotechnology from School of Life Sciences of Peking University, the PRC in June 1998 and his Ph.D. degree in molecular genetics from Albert Einstein College of Medicine, the US in January 2003. Dr. Yao has a number of articles published in journals including Nature Communications, Science Advances, Immunity, Jem, Blood and JI. Dr. Yao is also an inventor of six registered patents or patents in application.

      • Dr. Gang WANGExecutive Director, Senior Vice President of Industry Affairs Chief Quality Officer

        Dr. Wang is responsible for manufacturing quality and related work in Junshi Biosciences.

        He has been working in pharmaceutical industry for more than 30 years, with over 20 year experience in CGMP of biologics, and the review, manufacturing, pre-approval inspection, CGMP compliance inspection and supervision of biological products including cellular and gene therapy.

        Prior to joining Junshi Biosciences, Dr. Wang was Vice President for Quality (Shanghai) at WuXi Biologics (WuXi). Before that, he was Chief Scientist for Compliance and Inspection at Center for Drug Evaluation (CDE), CFDA, Assistant Country Director at the US FDA’s China Office in the US Embassy, etc.

        Dr. Wang received his bachelor’s degree in biochemistry from Nanjing University and Ph.D. in pharmacology and toxicology from Dartmouth Medical School in the US in 1995.

      • Dr. Xin LIExecutive Director, Senior Vice President of Government Affairs

        Dr. Li is responsible for overseeing the company’s government affairs.

        Dr. Li brings decades of expertise in government affairs, including policy research, government relations, information gathering and analysis, crisis management, and corporate branding. From 2005 to 2014, Dr. Li worked within the Shanghai International Group system, where her work encompassed financial advisory, asset management, direct investment, international mergers and acquisitions, and the establishment of an insurance exchange. Prior to joining Junshi Biosciences, she was Vice President at Greenland Financial Investment Holding Group Co., Ltd., where she oversaw investment, financing, and operations in healthcare and digital finance.

        Dr. Li received her bachelor’s degree in Economics from Renmin University of China in 1999, a Ph.D. in Management from Fudan University in 2005, and an EMBA from Tsinghua University PBC School of Finance in 2021.

      • Dr. Patricia KEEGAN, M.D, Ph.DChief Medical Officer

        Dr. Keegan is responsible for the strategy, direction and execution of the company’s clinical development plans.

        Dr. Keegan has over three decades of experience as a board-certified medical oncologist, clinical researcher, and regulatory authority at FDA. Prior to joining TopAlliance, Dr. Keegan served at FDA for 30 years, latest as Acting Associate Director of Medical Policy Oncology Center for Excellence (OCE), Office of the commissioner; 16 years as Division Director of Oncology Products; 4 years as Deputy Director Division of Clinical Trial Design and Analysis; 8 years as Chief and Medical officer at Oncology Branch. Prior to FDA, Dr. Keegan was Clinical Assistance Professor and medical oncologist at University of North Carolina at Chapel Hill.

        Dr. Keegan received her Bachelor of Science in Biology from University of Illinois Champaign-Urbana. She earned her medical degree from Loyola University Stritch School of Medicine. Dr. Keegan completed her residency in internal medicine at the Loyola University Medical Center, Maywood, Illinois, and her fellowship in medical oncology at Roswell Park Memorial Institute, Buffalo, New York.

      • Mr. Xingyuan WANGChief Commercial Officer

        Mr. Wang is responsible for overseeing the company’s commercial affairs.

        Mr. Wang has extensive experience in sales and management within the oncology field. Prior to joining Junshi Biosciences, he held several positions at Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Qilu Pharmaceutical Group Co., Ltd. During his tenure at Hengrui Pharmaceuticals, his career spanned positions such as Medical Information Specialist, Regional Manager, Provincial Manager, Regional Director, Deputy General Manager of the Group, and General Manager of the Oncology Division. His performance was outstanding, and his achievements included driving compliance transformations, building and managing customer database, establishing interactive system between doctors and patients, and cultivating high-performance teams.

        Mr. Wang received his bachelor’s degree from China Agricultural University in 2006 and an EMBA from Fudan University in 2023.

      Globalization

      In China, For Global

      Starting from its Shanghai Headquarters, Junshi Biosciences has established four Innovation Centers in China (Shanghai & Suzhou) and the US (San Francisco & Maryland), as well as two Production Bases in China (Suzhou & Shanghai). Junshi Biosciences has about 2,500 employees worldwide.

      map

      Headquarters

      Shanghai Innovation Center

      • Drug-target identification and verification
      • Candidate molecule screening and optimization
      • CMC process and analytical method development
      • Technology transfer
      • Drug registration and clinical development

      Shanghai Lingang Production Base

      • Establishment of stable cell line
      • Process optimization
      • cGMP standard
      • Establishment and maintenance of global quality system
      • Investigational products and commercial manufacturing
      Shanghai

      Guangzhou

      Suzhou Innovation Center

      • Functional validation and process development of pipeline projects
      • Pilot drug production

      Suzhou Wujiang Production Base

      • Establishment of stable cell line
      • Process optimization
      • GMP standard production
      • Establishment and maintenance of global quality system
      • Investigational products and commercial manufacturing
      Suzhou

      Beijing

      Maryland Innovation Center

      • Novel drug target screening
      • Functional antibody screening
      • Analytical method development
      • Technology transfer
      • Drug registration and clinical development
      Maryland

      San Francisco Innovation Center

      • Novel drug target screening
      • Candidate molecule screening
      • Analytical method development
      • Clinical biomarker research
      • “Bioinformatics + AI” novel drug R&D
      • Multi-relational data mining
      San Francisco
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