Junshi Biosciences and Coherus BioSciences Announce Collaboration to Co-Develop Anti-PD-1 Antibody, Toripalimab, in U.S. and Canada

• Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada
  
• The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year

SHANGHAI, China, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced a collaboration with Coherus BioSciences, Inc. ("Coherus”, Nasdaq: CHRS) for the development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada.

Under the terms of the agreement, Junshi Biosciences will receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised). Junshi Biosciences and Coherus will co-develop toripalimab, and Coherus will be responsible for all commercial activities in US and Canada. Junshi Biosciences has also granted Coherus options to JS006 (an anti-TIGIT antibody) and JS018-1 (a next generation engineered IL-2 cytokine), as well as first negotiation rights to two early-stage checkpoint inhibitor antibodies.

"We believe Coherus is the ideal 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.”

"Toripalimab has a compelling clinical profile with impressive efficacy and safety, and we are thrilled to collaborate with Junshi Biosciences to deliver patient benefit in the United States and Canada,” said Denny Lanfear, CEO of Coherus. "Our mission has always been to increase patient access to important medicines and to deliver significant health care system savings. This transaction builds on that mission to include the rapidly growing checkpoint inhibitor market, which is expected to exceed US$25 billion by 2025, and provides us the essential backbone drug for development of next-generation combination therapies.”

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). Over the next three years, significant data are expected to read out from the extensive registrational development program, which includes 15 ongoing or completed international/domestic multi-center 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 a breakthrough therapy designation to toripalimab for nasopharyngeal carcinoma (NPC), and the first toripalimab Biologics License Application (BLA) is expected 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. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next two years for several rare and highly prevalent cancers, including non small cell lung cancer (NSCLC).

As part of the collaboration, Coherus has also acquired options or first negotiation rights to four of Junshi Biosciences’ novel oncology molecules. The Companies may develop toripalimab in combination with one or more of these four compounds, and potentially with other cancer drugs:

• An option to JS006, an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated significant synergistic anti-tumor activity in combination with anti-PD-1 antibodies. JS006 is expected to enter global clinical development later this year. The option term expires prior to initiation of Phase 2 development.
• An option to JS018-1, 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 term expires prior to initiation of Phase 2 development.
• First negotiation rights to two undisclosed early-stage novel oncology programs directed against immune checkpoint molecules.
  

Terms of the Junshi Biosciences – Coherus collaboration
Under the terms of the agreement, Junshi Biosciences will receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in the United States and Canada.

Junshi Biosciences will grant Coherus exclusive rights to toripalimab in the United States and Canada as well as options in these territories to Junshi Biosciences’ JS006 and JS018-1. Coherus will also have first negotiation rights to two undisclosed preclinical immuno-oncology programs. Junshi Biosciences will receive an upfront payment of US$150 million. For toripalimab, Junshi Bioscience will receive 20% royalty on the annual net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. For JS006 and JS108-1, Junshi Biosciences will receive an opt-in payment of $35 million per program. Additionally, for each program, Junshi Biosciences will receive 18% royalty on the annual net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate on the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of US$25 million per licensed compound per year.

About toripalimab (TUOYI®)
Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain a marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, toripalimab was included in the National Reimbursement Drug List (NRDL) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

In the United States, the FDA has granted toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.

About the toripalimab clinical development program
Toripalimab is being evaluated in an extensive registrational clinical development program for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

• Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma (POLARIS-01) - NCT03013101
• Phase 1b/2 trial evaluating toripalimab in patients with advanced gastric adenocarcinoma, ESCC, NPC and head and neck squamous cell carcinoma (POLARIS-02) - NCT02915432
• Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma (POLARIS-03) - NCT03113266
• A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers - NCT04603040
• Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer - NCT03581786
• Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Curative Hepatic Resection (JUPITER-04) - NCT03859128
• A Phase III Study to Investigate Toripalimab Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma (JS001) - NCT03430297
• A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC (CHOICE-01) - NCT03856411
• Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (JUPITER-06) - NCT03829969
• Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI - NCT03924050
• Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT) - NCT04085276
• Phase 3 trial comparing toripalimab + lenvantinib vs. lenvantinib alone as a 1st line treatment for patients with advanced HCC - NCT04523493
• Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer - NCT04012606
• A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC - NCT04158440
• Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer - NCT04394975
• A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma - NCT04568304

About JS006
JS006 is a recombinant humanized IgG4? monoclonal antibody against human TIGIT specifically, developed independently by Junshi Biosciences. According to the results of pre-clinical studies, JS006 can specifically block the TIGIT-PVR pathway.

About JS018-1
JS018-1 is 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.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences, Inc.
Coherus is a commercial stage biopharmaceutical company with the mission to increase patient access to cost-effective medicines that can have a major impact on their lives and to deliver significant savings to the health care system.

In January 2021, Coherus in-licensed Junshi Biosciences’ toripalimab, an anti-PD-1 antibody, which will be a cornerstone of Coherus’ strategy to build a leading immuno-oncology franchise in the United States and Canada funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

For additional information, please visit www.coherus.com.

Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com 
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com 
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com 
+ 86 021-6105 8800