Science and Therapeutic Area
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.
Breast cancer, etc
EGFR 4th Gen
EGFR exon 20
Multiple myeloma, etc
A small molecule inhibitor of the nuclear export protein XPO1
An antibody-drug conjugate (ADCs) targeting Claudin18.2 developed by Junshi Biosciences
Breast cancer, renal cell cancer
An oral small molecule inhibitor targeting PI3K-α jointly developed by Junshi Biosciences and Risen Biosciences
Breast cancer, etc.
A recombinant fully human anti-CD39 monoclonal antibody developed by Suzhou Kebo Ruijun owned by Junshi Biosciences and Beijing Enruini
A fusion protein consisting of recombinant IL-21 and nanobody against human serum albumin (HSA) co-developed by Junshi Biosciences and Anwita Biosciences
A recombinant humanized monoclonal antibody against human CD112R developed independently by Junshi Biosciences
Lung cancer, melanoma
A recombinant humanized anti-CTLA-4 monoclonal antibody developed independently by Junshi Biosciences
A recombinant humanized anti-TIGIT monoclonal antibody developed independently by Junshi Biosciences
A subcutaneous injection formulation developed by Junshi Biosciences on the basis of toripalimab
Systemic lupus erythematosus
JS401 is a siRNA drug targeting ANGPTL3 mRNA jointly developed by Junshi Biosciences and its partner Risen Medical
Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody independently developed by Junshi Biosciences for the treatment of primary hypercholesterolemia and mixed dyslipidemia
Lung cancer, Melanoma, etc
World’s first-in-human anti-BTLA mAb against tumor
Rheumatoid Arthritis, etc
VV116 is an oral nucleoside analog drug that can inhibit the replication of SARS-CoV-2
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 forty 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 Europe. 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 seven approved indications for toripalimab in China:
The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma.
In the United States, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).
In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.
In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.
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.