Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 89 |
| INN | Toripalimab |
| Status | Approved |
| Drug code(s) | JS001 |
| Brand name | LOQTORZI, Tuoyi, ZYTORVI |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Non-small cell lung cancer; advanced solid tumors, breast cancer, melanoma, bladder cancer, neuroendocrine, Phase 1/2 study including Gastric Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Nasopharyngeal Carcinoma; Head and Neck Squamous Cell Carcinoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, China, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2016 |
| Start of Phase 2 | December 15, 2016 |
| Start of Phase 3 | February 02, 2018 |
| Date BLA/NDA submitted to FDA | March 01, 2021 |
| Year of first approval (global) | 2018 |
| Date of first US approval | October 27, 2023 |
| INN, US product name | Toripalimab, toripalimab-tpzi |
| US or EU approved indications | US: LOQTORZI™ (toripalimab-tpzi) is approved in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. |
| Company | Junmeng Biosciences Co. Ltd., Shanghai Junshi Biosciences Inc. |
| Licensee/Partner | CSPC Pharmaceutical Group Ltd, Coherus BioSciences |
| Comments about company or candidate | Sep 2024: Approved in EU; EMA positive opinon announced July 26, 2024. Sep 2023 FDA's required inspection found a single observation still to be addressed. Coherus continues to anticipate potential approval for toripalimab by year end 2023. Dec 23, 2022: The FDA previously communicated that an on-site inspection of Junshi Biosciences’ manufacturing facility for toripalimab is required before the Agency can approve the application; however, they were unable to conduct the inspection during the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans. Nov 15, 2022: Shanghai Junshi Biosciences Co., Ltd announced today that the company has submitted a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for toripalimab. The indications requested in the MAA are: Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”); Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”) July 06, 2022: Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the FDA has accepted for review the BLA resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. PDUFA action date is December 23, 2022. PDUFA date is April 30, 2022; complete response letter was issued. August 12, 2021 I Shanghai Junshi Biosciences Co., Ltd and Coherus BioSciences, Inc. announced that the United States Food and Drug Administration has recently granted Breakthrough Therapy Designation for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy. BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted closer FDA guidance – including that from senior FDA officials - and various forms of support to avail patients with new therapy as soon as possible. Junshi Biosciences expects to complete the biologics license application (“BLA”) submission for toripalimab plus chemotherapy for 1st line NPC and for toripalimab monotherapy for 2nd or 3rd line NPC later this quarter. April 2021: Junshi Biosciences announced that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. The initial BLA was submitted as a rolling submission with the final component submitted on August 31,2021. March 03, 2021: Shanghai Junshi Biosciences Co., Ltd. announced the initiation of the rolling submission of the Biologics License Application (“BLA”) for toripalimab to the U.S. Food and Drug Administration (“FDA”) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed. Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Toripalimab is the first anti-PD-1 monoclonal antibody developed in China with a BLA submission to the FDA in process. Jan 2021: Junshi Biosciences announced that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. April 30, 2020: Junshi Biosciences announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for toripalimab as a treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) who failed at least two lines of systemic therapy. Dec 17, 2018: First anti-PD-1 mAb approved in China. Conditionally approved under priority review in China, toripalimab is indicated for fast-growing cases of melanoma, according to the National Medical Products Administration. (https://endpts.com/junshi-wins-the-race-for-first-made-in-china-pd-1-approval-as-execs-reap-394m-ipo-harvest/). NCT03848611 Phase 2 study in NSCLC not yet recruiting as of Feb 23, 2019. NCT03777579 Phase 3 study in triple neg breast cancer not yet recruiting as of Jan 25, 2019. NCT03430297 Phase 3 in melanoma started in Feb 2018; NCT03581786 Phase III Study of Comparing TORIPALIMAB INJECTION（JS001） Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer started in June 2018. July 2018: Shanghai Junshi Biosciences Co. Ltd. (Shanghai, China) granted CSPC Pharmaceutical Group Ltd. (HKSE:1093) exclusive rights in China, including Hong Kong and Macau, and Taiwan to develop and commercialize an undisclosed anti-PD-1 mAb in combination with albumin-bound paclitaxel to treat breast cancer. Four Phase 1 studies listed on clinicaltrials.gov as of Sep 2016 |
| Full address of company | 15F, Building 7, Crystal Plaza, No.6, Lane 100, Pingjiaqiao Road, Shanghai, China Asia China https://www.junshipharma.com/en/contact-us/ |
Immune checkpoint inhibitor. S228P hinge mutation.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |