Press Release

Apr 28, 2019

Strong alliance for finding a new treatment of liver cancer: Antengene cooperates with Junshi Biosciences to conduct clinical research on the combination therapy of ATG-008 and Toripalimab to treat advanced liver cancer

SHANGHAI, China - On April 28, 2019, Antengene announced a strategic partnership with Junshi Biosciences (1877. HK, 833330.OC) to conduct a clinical study of ATG-008 in combination with Toripalimab in the field of oncology.

ATG-008 is a new generation of TORC1/TORC2 kinase dual-targeted inhibitors acting on the mTOR pathway. Antengene is currently conducting an international multicenter phase II clinical trial for advanced liver cancer in mainland China, Taiwan and South Korea.

Toripalimab (trade name: Tuoyi) is China's first NDA approved domestic anti-PD-1 monoclonal antibody for injection. It obtained approval for the new drug application (NDA) from the National Medical Products Administration of China (NMPA) on December 17, 2018 and is used for treatment of unresectable locally advanced or metastatic melanoma after a failure of standard systemic treatment. In addition, Junshi Biosciences has been carrying out more than 20 clinical trials of Toripalimab for treating a variety of malignant tumors, and has shown good anti-tumor effect.

"Exploring new solutions for cancer treatment has always been our quest and we are pleased to have a strategic partnership with Junshi Biosciences in the field of oncology." said Jay Mei, CEO of Antengene, “In the field of cancer treatment, joint cooperation and exploration are more conductive for the development of each party’s respective product and for the continuous progress of cancer treatment methods," Toripalimab is the first domestically developed PD-1 monoclonal antibody and ATG-008 is a new generation of TORC1/2 dual-targeted inhibitors, we believe that the combination therapy of Toripalimab and ATG-008 will bring new hope for the vast number of liver cancer patients. "

About Junshi Biosciences

Junshi Biosciences is an innovation-driven biopharmaceutical company which is dedicated to the discovery and development of innovative drugs and their clinical research and commercialization on a global scale. Based on the core platform technology of protein engineering, Junshi Biosciences stands at the frontier of R&D of macromolecular drugs. It has a leading edge in the PRC in the emerging field of immuno-oncology and for the treatment of autoimmune and metabolic diseases,and has a rich pipeline of products under research, including 16 innovative drugs and 1 biological analog. Junshi Biosciences is the first PRC company to obtain NDA approval from the NMPA for anti-PD-1 monoclonal antibody, and also the first PRC company to receive IND approvals from the NMPA for anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody.

About Toripalimab (trade name: Tuoyi)

As the first domestic MCAB drug with PD-1 as the target, Toripalimab injection has been approved for marketing in China, and has obtained the support of major national science and technology projects. Since the beginning of 2016, clinical research and development of this product has been started, and so far, more than 20 clinical trials are in progress, including those in the United States. In March 2018, the State Drug Administration officially accepted the listing registration application of this product, and included it in the priority review and approval varieties to speed up the review and approval. The clinical trial results showed that the objective remission rate, disease control rate and 1-year survival rate of patients with unresectable or metastatic melanoma who had previously failed to receive systemic therapy were 17.3%, 57.5% and 69.3%, respectively. The approval of this product on the market is of positive significance to the choice of clinical medication for cancer patients in China.

About Antengene

Antengene Corporation is a biopharmaceutical company focused on drug discovery, clinical development and the commercialization of innovative therapeutics to meet unmet medical needs. Antengene aims to provide the most advanced and first-in-class anti-cancer drug treatments for patients around the world. On April 13, 2017, Celgene Corporation (NASDAQ: CELG), a global leading innovative biopharmaceutical company became a long-term strategic partner and obtained an equity position in Antengene. Antengene's pipeline includes six commercial and clinical stage products: ATG-010 (selinexor), in combination with the corticosteroid dexamethasone, has been approved by the U.S. Food and Drug Administration, for the treatment of adult patients with relapsed or refractory multiple myeloma. The compound is also in late clinical development for various other hematologic malignancies and solid tumors. ATG-008, a second-generation dual mTORC1/2 inhibitor, is in a multi-regional clinical trial for treatment of hepatocellular carcinoma and multiple other solid tumors. Two other Phase 1 and Phase 2 clinical stage drugs, ATG-016 and ATG-019, are being studied in multiple cancer types, including MDS, colorectal and prostate cancers. ATG-527 is being explored for multiple anti-viral indications, including respiratory syncytial virus (RSV), and Epstein-Barr virus (EBV) related diseases, etc. ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor, in clinical development for multiple solid tumors. Antengene drug discovery team focuses on development of first-in-class novel products.