Junshi Biotech and Coherus expand cooperation in the field of tumor immunity and will jointly develop and commercialize JS006 (anti-TIGIT monoclonal antibody) in the United States and Canada

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The combination of TIGIT (T cell immunoglobulin and ITIM domain, T cell immunoglobulin containing intracellular ITIM domain) blocking antibody and PD-1/PD-L1 inhibitor showed the potential for synergistic antitumor activity
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According to multiple preclinical studies, JS006 shows excellent binding affinity, as well as a strong inhibitory effect on the TIGIT pathway

"We are delighted to further expand our fruitful cooperation with Coherus in the field of tumor immunity.
On the basis of the previous phase results of toripalimab, we will now include the anti-TIGIT monoclonal antibody JS006," Junshi said.
Bio CEO Dr.
Li Ning said
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"Following the company 's international strategy of 'Based on China, Global Layout' , we have carried out a number of multinational R&D projects in China, the United States, Southeast Asia, Europe and other countries and regions.

Dr.
Yao Sheng, Senior Vice President of Junshi Biosciences, said: "Since 2012, Junshi Biosciences has built a rich and complementary product pipeline in the field of tumor immunity, with a view to combining IO drugs, or immunotherapy with traditional chemoradiotherapy, Anti-angiogenic drugs, cytokine drugs and other therapies are being explored in combination therapy to provide patients with better treatment options
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Among them, the combination therapy of anti- TIGIT monoclonal antibody and anti-PD-1 monoclonal antibody is quite promising, which is expected to increase patients' awareness of The response to immunotherapy will expand the scope of the beneficiary population

"TIGIT, as a cutting-edge target in the field of tumor immunotherapy, has shown therapeutic potential in many major tumor types
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The exercise of the option of JS006 marks the beginning of Coherus as a tumor immune development company, creating a rich clinical and preclinical product pipeline.

"Blocking the TIGIT pathway may be a key underlying mechanism to overcome resistance to checkpoint inhibition
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We believe that dual immunotherapy of TIGIT and PD-1 can enhance the efficacy of PD-1 drugs and set a new standard of care for multiple tumor types , ” said Dr.
Theresa LaVallee, Chief Development Officer at Coherus

About JS006

JS006 is a recombinant humanized IgG4κ monoclonal antibody with specific anti-human TIGIT independently developed by Junshi Bio
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Including alternate candidates, the JS006 project includes multiple molecules with silencing and active Fc functions

In early 2021, JS006 was approved for clinical trials in China and the United States
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In the same year, Junshi Biosciences launched a phase I study to evaluate the safety and tolerability of JS006 alone and in combination with toripalimab in patients with advanced cancer who have failed standard therapy or who have no standard therapy

About Toripalimab

Toripalimab injection (Tuoyi® ⁾ , as the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China, has been supported by major national science and technology projects
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The first approved indication for this product is for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy
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In December 2020, Toripalimab passed the national medical insurance negotiation for the first time, and 3 indications have been included in the "2021 Drug List"
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In February 2021, toripalimab was approved by the National Medical Products Administration (NMPA) for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed second-line or above systemic therapy
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In April 2021, toripalimab was approved by the NMPA for the treatment of locally advanced or metastatic urothelial carcinoma that has failed platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months
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In November 2021, a new indication for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma was approved by the NMPA
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In addition, Toripalimab has also obtained the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Melanoma", "CSCO Guidelines for the Diagnosis and Treatment of Head and Neck Tumors", "CSCO Guidelines for the Diagnosis and Treatment of Nasopharyngeal Carcinoma", "CSCO Urothelial Carcinoma" Diagnosis and Treatment Guidelines" and "CSCO Guidelines for Clinical Application of Immune Checkpoint Inhibitors"
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In March 2021, the first-line treatment of toripalimab for advanced mucosal melanoma was included in the breakthrough therapy drug program by the State Food and Drug Administration
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In July 2021, the NMPA accepted the new indication marketing application of toripalimab combined with platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma
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In December 2021, the NMPA accepted the new indication marketing application of toripalimab combined with standard first-line chemotherapy for untreated, driver gene-negative advanced non-small cell lung cancer
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In terms of international layout, the first marketing application (BLA) of toripalimab in the U.
S.
Food and Drug Administration (FDA) has been accepted and granted priority review.
FDA submits BLA's domestic anti-PD-1 monoclonal antibody
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Currently, toripalimab has been granted 2 breakthrough therapy designations, 1 fast track designation, 1 priority review designation and 4 orphan designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, and esophageal cancer.
drug qualification
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Toripalimab started clinical research and development in early 2016.
So far, more than 30 clinical studies covering more than 15 indications have been carried out around the world.
, gastric cancer, esophageal cancer, liver cancer, bile duct cancer, breast cancer, kidney cancer and other indications of efficacy and safety, and the combination therapy cooperation with leading innovative pharmaceutical companies at home and abroad is also in progress, looking forward to more Chinese and other countries.
Patients receive international advanced level of tumor immunotherapy
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About Junshi Bio

Junshi Bio (688180.
SH, 1877.
HK), established in December 2012, is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies
.
The company has a rich R&D pipeline consisting of 45 products under development, covering five therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurological diseases and infectious diseases
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Relying on the core platform technology of protein engineering, Junshi Biology is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA marketing approval, domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, and the world's first treatment The tumor anti-BTLA blocking antibody has been approved by the NMPA in China and FDA in the United States, and phase I clinical studies are being conducted in China and the United States
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In 2020, Junshi Bio will also join hands with domestic scientific research institutions to fight the epidemic.
The jointly developed JS016 has entered clinical trials as the first anti-COVID-19 monoclonal neutralizing antibody in China.
Currently, it has obtained emergency use authorization in more than 15 countries and regions around the world.
, and use local innovation to contribute to disease prevention and control in China and the world
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At present, Junshi Bio has more than 2,500 employees worldwide, located in San Francisco and Maryland in the United States, and Shanghai, Suzhou, Beijing and Guangzhou in China
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Official website: Official WeChat: Junshi Bio