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Coherus Coherus BioSciences to expand late - stage pipeline to immuno - oncology with in - license of Junshi Biosciences ' PD - 1 , toripalimab , in United States and Canada Feb 1 , 2021 - Coherus to pay $ 150 million upfront for U.S. and Canada rights to toripalimab , an extensively studied , late - stage anti - PD - 1 antibody - First U.S. BLA filing expected this year for nasopharyngeal carcinoma with breakthrough therapy designation - Options to PD - 1 combination agents , TIGIT and IL - 2 , add long - term growth potential - Conference call at 8:00 am Eastern Time today REDWOOD CITY , Calif . , Feb. 01 , 2021 ( GLOBE NEWSWIRE ) -- Coherus BioSciences , Inc. ( " Coherus " , Nasdaq : CHRS ) today announced a collaboration with Shanghai Junshi Biosciences , Co. , Ltd ( " Junshi Biosciences " , HKEX : 1877 ; SSE : 688180 ) for the development and commercialization of toripalimab , Junshi Biosciences ' anti - PD - 1 antibody , in the United States and Canada . Upon satisfaction of closing conditions , Coherus and Junshi Biosciences will co - develop toripalimab , and Coherus will be responsible for all commercial activities in the licensed territory . Under the terms of the agreement , Coherus will also be granted options to Junshi Biosciences ' TIGIT - targeted antibody and next generation engineered IL - 2 cytokine for evaluation as potential combination therapies with toripalimab , as well as certain negotiation rights to two early - stage checkpoint inhibitor antibodies . " Toripalimab has a compelling late - stage clinical profile and will be the cornerstone of our immuno - oncology franchise . This transaction expands our late - stage pipeline into the rapidly growing checkpoint inhibitor market , which is expected to exceed $ 25 billion in the United States by 2025 , and provides us a PD - 1 backbone for potential long - term growth with next - generation immuno - oncology combinations , " said Denny Lanfear , CEO of Coherus . " Junshi Biosciences is an innovation - driven biopharmaceutical company with global clinical research capabilities , and we are excited to collaborate with them as we build on our success in oncology with biosimilars and broaden our mission of expanding patient access and delivering health care system savings to larger markets . " " We believe Coherus is the right partner for us in North America . Their commercial team has demonstrated remarkable ability to gain significant share of the oncology market against entrenched large competitors , " said Dr. Ning LI , CEO of Junshi Biosciences . " Toripalimab could be the first marketed Chinese anti - PD - 1 antibody in the overseas market . The collaboration with Coherus will be a critical step to build up our global commercial network . We look forward to working closely with Coherus to establish toripalimab's position in the United States and Canadian markets in order to provide patients with affordable high - quality innovative care . " More than 2,100 patients have received toripalimab treatment in clinical trials , and toripalimab is approved for second - line treatment of unresectable or metastatic melanoma in China where it is marketed by Junshi Biosciences and is included on the National Reimbursement Drug List ( " NRDL " ) for the treatment of melanoma . Over the next three years , significant data are expected to read out from the extensive registrational development program , which includes 15 ongoing and completed pivotal clinical trials evaluating toripalimab in multiple treatment settings for a broad range of solid tumor types including cancers of the lung , nasopharynx , esophagus , stomach , bladder , breast , liver , kidney and skin . The United States Food and Drug Administration ( " FDA ” ) has granted breakthrough therapy designation to toripalimab for 3 rd line nasopharyngeal carcinoma ( " NPC " ) , and Coherus expects the first toripalimab biologics license application ( " BLA " ) to be filed with the FDA for this indication later this year . Additionally , FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma , and orphan drug designation for NPC , mucosal melanoma and soft tissue sarcoma . Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers , including non - small cell lung cancer ( " NSCLC " ) . As part of the collaboration , Coherus will also be granted options and certain negotiation rights to four of Junshi Biosciences ' novel oncology molecules for potential development in combination with toripalimab : • JS006 , an antibody targeting TIGIT , a clinically validated immune inhibitory checkpoint . Anti - TIGIT antibodies have demonstrated synergistic anti - tumor activity in combination with anti - PD - 1 antibodies . Coherus expects this compound to enter clinical development later this year . The option to JS006 is exercisable prior to initiation of Phase 2 clinical development . • JS018 , a next - generation engineered IL - 2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer ( " NK " ) cells . The option to JS018 is exercisable prior to initiation of Phase 2 clinical development . • Two additional undisclosed early - stage novel immuno - oncology drug candidates to which Coherus will also be granted certain negotiation rights . Mr. Lanfear provided further comment on Coherus ' corporate strategy : " We plan to invest the cash generated by our biosimilar commercial business to build a focused immuno - oncology franchise , which will leverage our development and commercial capabilities into large and growing markets . We will prudently allocate our R & D resources to realize the exciting potential of toripalimab in both the monotherapy and combination settings . With respect to biosimilars , our focus will be commercialization , as we continue to pursue UDENYCAⓇ market share growth and prepare for projected launches through 2023 of biosimilars of Humira® , Avastin® and Lucentis® , if approved . " Coherus is discontinuing the development of CHS - 2020 ( EyleaⓇ biosimilar candidate ) and will direct those capital and development resources to the toripalimab monotherapy and combinations program . Terms of the Coherus - Junshi Biosciences collaboration Under the terms of the agreement , Coherus will pay $ 150 million upfront for exclusive rights to toripalimab in the United States and Canada , options in these territories to Junshi Biosciences ' anti - TIGIT antibody and next - generation engineered IL - 2 cytokine , and certain negotiation rights to two undisclosed preclinical immuno - oncology drug candidates . Coherus will also pay Junshi Biosciences a 20 % royalty on net sales of toripalimab and up to an aggregate $ 380 million in one - time payments for the achievement of various milestones , including up to $ 290 million for attainment of certain