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    Focusing on innovation and patient accessibility, we have established a diversified and complementary R&D pipeline. Most products are independently developed through our own platform, and we have a number of potential novel antitumor targets drugs. Our products respond to a vast array of diseases, including cancer, autoimmune, metabolic, neurological, and infectious diseases.

    As we continue to enrich our pipeline and explore combination treatments, our fields of innovation R&D has expanded from monoclonal antibodies to small molecule drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bispecific antibody or multispecific antibody drugs, nucleotide drugs and etc. We will continue to further explore the next generation of innovative therapies for cancer and autoimmune diseases.

    50+Candidates

    Download Pipeline

    R&D Pipeline

    • Oncology
    • Autoimmune
    • Metabolic
    • Neurological
    • Infectious
    • Global Developed
    Preclinical
    • JS211

      PD-L1+Undisclosed

      Tumors

    • JS209

      CD112R+TIGIT

      Tumors

    • JS208

      Undisclosed

      Tumors

    • JS207

      PD-1+VEGF

      Tumors

    • JS206

      IL2+PD-1

      Tumors

    • JS205

      EGFR+cMet

      Tumors

    • JS123

      ATR

      Tumors

    • JS122

      FGFR2

      Tumors

    • JS121

      SHP2

      Tumors

      公司與微境生物共同開發的SHP2抑制剂

    • JS120

      IDH1

      Tumors

      公司與微境生物共同開發的第二代不可逆IDH1抑制剂

    • JS115

      BCMA ADC

      Multiple myeloma

    • JS114

      Nectin4 ADC

      Tumors

    • JS104

      Pan-CDK

      Breast cancer, etc

    • JS018

      IL-2

      Tumors

    • JS013

      CD93

      Tumors

    • JS011

      Undisclosed

      Tumors

    • JS008

      Undisclosed

      Undisclosed

    • JT109

      Vaccine

      ZIKA Virus

    • JT003(VV993)

      3CLpro

      COVID-19

    Phase I
    • JS203

      CD3+CD20

      Tumors

    • JS201

      PD-1+TGF-β

      Tumors

    • JS116

      KRAS

      Tumors

    • JS113

      EGFR 4th Gen

      NSCLC

    • JS112

      Aurora A

      SCLC

    • JS111

      EGFR exon 20

      NSCLC

    • JS110

      XPO1

      Multiple myeloma, etc

      A small molecule inhibitor of the nuclear export protein XPO1

    • JS108

      TROP2 ADC

      TNBC

    • JS107

      Claudin18.2 ADC

      Gastrointestinal cancer

      An antibody-drug conjugate (ADCs) targeting Claudin18.2 developed by Junshi Biosciences

    • JS105

      PI3K-α

      Breast cancer, renal cell cancer

      An oral small molecule inhibitor targeting PI3K-α jointly developed by Junshi Biosciences and Risen Biosciences

    • JS101

      Pan-CDK

      Breast cancer, etc.

    • JS019

      CD39

      Tumors

      A recombinant fully human anti-CD39 monoclonal antibody developed by Suzhou Kebo Ruijun owned by Junshi Biosciences and Beijing Enruini

    • JS015

      DKK1

      Tumors

    • JS014

      IL-21

      Tumors

      A fusion protein consisting of recombinant IL-21 and nanobody against human serum albumin (HSA) co-developed by Junshi Biosciences and Anwita Biosciences

    • JS012

      Claudin 18.2

      Gastric cancer

    • JS009(TAB009)

      CD112R/PVRIG

      Tumors

      A recombinant humanized monoclonal antibody against human CD112R developed independently by Junshi Biosciences

    • JS007

      CTLA-4

      Lung cancer, melanoma

      A recombinant humanized anti-CTLA-4 monoclonal antibody developed independently by Junshi Biosciences

    • JS006(TAB006)

      TIGIT

      Tumors

      A recombinant humanized anti-TIGIT monoclonal antibody developed independently by Junshi Biosciences

    • JS003

      PD-L1

      Tumors

    • JS001sc

      PD-1

      Tumors

      A subcutaneous injection formulation developed by Junshi Biosciences on the basis of toripalimab

    • JS026

      S protein

      COVID-19

    • UBP1213sc

      BLyS

      Systemic lupus erythematosus

    • JS401

      ANGPTL3 (siRNA)

      Metabolic diseases

      JS401 is a siRNA drug targeting ANGPTL3 mRNA jointly developed by Junshi Biosciences and its partner Risen Medical

    • JS103

      Uricase

      Hyperuricacidemia

    • JS010

      CGRP

      Migraine

    Phase II
    • Tifcemalimab

      BTLA

      Lung cancer, Melanoma, etc

      World’s first-in-human anti-BTLA mAb against tumor

    • JS005

      IL-17A

      Psoriatic, spondylitis

    Phase III
    • Senaparib

      PARP

      Ovarian cancer

    • Bevacizumab

      VEGF

      NSCLC

    • Ongericimab

      PCSK9

      Hyperlipidemia

      Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody independently developed by Junshi Biosciences for the treatment of primary hypercholesterolemia and mixed dyslipidemia

    Marketed or NDA/BLA
    • Toripalimab

      PD-1

      Tumors

    • Adalimumab

      TNF-α

      Rheumatoid Arthritis, etc

    • Deuremidevir Hydrobromide

      RdRp

      COVID-19

      VV116 is an oral nucleoside analog drug that can inhibit the replication of SARS-CoV-2

    • Etesevimab

      S protein

      COVID-19

    Product Details

    • disease-area

      Oncology

    • JS211 JS209 JS208 JS207 JS206 JS205 JS123 JS122 JS121 JS120 JS115 JS114 JS104 JS018 JS013 JS011 JS203 JS201 JS116 JS113 JS112 JS111 JS110 JS108 JS107 JS105 JS101 JS019 JS015 JS014 JS012 JS009(TAB009) JS007 JS006(TAB006) JS003 JS001sc Tifcemalimab Senaparib Bevacizumab Toripalimab
    • disease-area

      Autoimmune

    • UBP1213sc JS005 Adalimumab
    • disease-area

      Metabolic

    • JS008 JS401 JS103 Ongericimab
    • disease-area

      Neurological

    • JS010
    • disease-area

      Infectious

    • JT109 JT003(VV993) JS026 Deuremidevir Hydrobromide Etesevimab
    Toripalimab
    • Product name : TUOYI®
    • Drug Code : Toripalimab
    • Target : PD-1
    • Equity : In-house

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

    More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are six approved indications for toripalimab in China:

    • 1. unresectable or metastatic melanoma after failure of standard systemic therapy;
    • 2. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”);
    • 3. recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;
    • 4. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
    • 5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);
    • 6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small-cell lung cancer (“NSCLC”).

    The first three indications have been included in the National Reimbursement Drug List (“NRDL”) (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma.

    In the United States, the FDA is reviewing the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (“SCLC”).

    In Europe, the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) accepted the marketing authorization application (MAA) in December 2022 and February 2023 for: 1) toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC.

    Mechanism of Action

    PD-1 is a T cell surface receptor; it is an immune checkpoint molecule in the co-inhibitory signal pathway of the T cell. As shown in the following figure, the binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to the inhibition of T-cell activation and immune surveillance of tumor cells. Anti-PD-1 monoclonal antibodies can block the PD-1/PD-L1 pathway and thereby restore the immune function of T cells.

    Mechanism of Action of Anti-PD-1 Monoclonal Antibody

    Main research literature

    • Serial number Journal name Document title Published on Link
    • 1 Nature Medicine Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial 2021 Open link
    • 2 Signal Transduction and Targeted Therapy Toripalimab plus chemotherapy as second-line treatment in previously EGFRTKIs treated patients with EGFR-mutant advanced NSCLC: a multi-center phase II trial 2021 Open link
    • 3 Journal of Clinical Oncology Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02) 2021 Open link
    • 4 JAMA Network Open Safety, Antitumor Activity, and Pharmacokinetics of Toripalimab, a Programmed Cell Death 1 Inhibitor, in Patients With Advanced Non–Small Cell Lung Cancer A Phase 1 Trial 2020 Open link
    • 5 Cancer Communications A Phase I Study of Toripalimab, an anti-PD-1 Antibody, in Patients With Refractory Malignant Solid Tumors 2020 Open link
    • 6 Clinical Cancer Research Safety, Efficacy and Biomarker Analysis of Toripalimab in previously treated advanced melanoma: results of the POLARIS-01 multicenter phase II trial 2020 Open link
    • 7 European Journal of Cancer Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study 2020 Open link
    • 8 mABs Glycosylation-independent binding of monoclonal antibody toripalimab to FG loop of PD-1 for tumor immune checkpoint therapy 2019 Open link
    • 9 Acta Pharmacologica Sinica Preclinical evaluation of the efficacy, pharmacokinetics and immunogenicity of JS-001 2017 Open link
    • 10 Clinical Cancer Research Efficacy, safety and biomarkers of toripalimab in patients with recurrent or metastatic neuroendocrine neoplasms:a multiple-center phase Ib trial 2020 Open link
    • 11 Journal of Clinical Oncology Axitinib in Combination With Toripalimab, a Humanized Immunoglobulin G4 Monoclonal Antibody Against Programmed Cell Death-1, in Patients With Metastatic Mucosal Melanoma: An Open-Label Phase IB Trial 2019 Open link
    • 12 Annals of Translational Medicine JS001, an anti-PD-1 mAb for advanced triple negative breast cancer patients after multi-line systemic therapy in a phase I trial 2019 Open link
    • 13 Annals of Oncology Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemorefractory gastric cancer treated with toripalimab, a PD1 antibody in phase Ib/II clinical trial NCT02915432 2019 Open link
    • 14 Journal of Hematology & Oncology Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients 2019 Open link
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