Press Release

Jan 29, 2019

ATG-010, China's first Selective Inhibitor of Nuclear Export obtains IND approval for the treatment of multiple myeloma

SHANGHAI, China - Antengene announced recently that ATG-010, a new Category I drug developed by the company to treat patients with relapsed and/or refractory multiple myeloma, received the IND approval from the National Medical Products Administration on January 28, 2019. ATG-010 is the world's first Selective Inhibitor of Nuclear Export (SINE) for the treatment of relapsed/refractory multiple myeloma. As a key new Category I drug supported by the state, ATG-010’s approval for clinical trial fully reflects the national support for research and development of innovative antineoplastic.

The IND approval of ATG-100 obtained by Antengene is used for the treatment of relapsed and/or refractory multiple myeloma patients who have already been treated by the program of immunomodulators and protease inhibitors. The clinical trial is an open, one-armed clinical study whose primary purpose is to assess the clinical pharmacokinetics, effectiveness, safety and tolerance of ATG-010 combined with low-dose dexamethasone for the treatment of relapsed and/or refractory multiple myeloma patients who have previously received the treatment program of immunomodulators and protease inhibitors.

ATG-010 is the second drug approved for clinical trials developed by Antengene in Chinese mainland after the clinical trials of Category I drug ATG-008 used to treat advanced liver cancer,started and it is also a globally new anti-cancer drug with new target and new mechanism. ATG-010 can be used to treat a variety of hematological tumors and solid tumors. In addition to the first indication of multiple myeloma, Antengene has recently submitted to the drug regulatory agency a second clinical trial application of ATG-010 for the treatment of rela[psed diffuse large B-cell lymphoma.

“Chinese patients with relapsed and/or refractory multiple myeloma, urgently need innovative therapies with a new mechanism," said Dr. Jay Mei, founder and chairman of Antengene. The successful IND approval of ATG-010 marks a promising step of achieving oral ATG-010 in China. ”

This year will be a "harvest year" of IND approval for Antengene since a series of drugs come into clinical phase 2/3, but patients could only share the results of global development of innovative drugs once the drugs come into the market. Therefore, this year is also a "sowing year". The ultimate goal of the company is to make Chinese and Asia-Pacific patients benefit as soon as possible from drugs that are currently at clinical stage. With the spirit of clinical research and development- —"being rigorous, scientific, patient-centered" , Antengene will perform high-quality ATG-010 clinical trials and strive for makeing the drug go public as soon as possible.

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.