SHAOXING and SHANGHAI, China, Dec 5, 2018 (Antengene) —Rencently, the Development Center for Medical Science & Technology of National Health and Family Planning Commission issued “Notice on the 2018 Project Approval of the National Major Science and Technology Special Project for ‘Significant New Drugs Development’” to the enterprises with project support . Antengene’s project named “the phase II/ III clinical development of ATG-008, a new Category 1 drug for treatment of Hepatocellular Carcinoma, acting on the dual target of TORC1 / 2” obtained the special project approval support for “Significant New Drugs Development Project” during the “13th Five-Year Plan” period and received the first central financial support fund in 2018. As the world’s first new drug working on advanced HCC with positive hepatitis B virus and selected as “Significant New Drugs Development Project”, it indicates that Antengene, as one of the most innovative companies in the treatment of Hepatocellular Carcinoma in China, is expected to fill the gap for new drugs urgently needed by patients in China and Asia Pacific region.
During the “13th Five-Year Plan” period, the “National Major Science and Technology Special Project for ‘Significant New Drugs Development’”, mainly targeting on major diseases such as malignant tumors, cardiovascular and cerebrovascular diseases, drug-resistant pathogens infection, virus infection, etc., focuses on supporting the research and development of original chemical drugs, traditional Chinese medicine and biological drugs with independent intellectual property rights, great clinical value, good market prospects, and in the preclinical and clinical research stages, as well as the research on related key technologies of these new drugs. It encourages research and development of fixed dose compounds, new drug administration technologies and new preparations with advantages and characteristics. Based on long-term development needs, the project actively transforms and applies the latest achievements in basic research related to new drug research and development at home and abroad, and also carries out innovative drug discovery and research with new drug targets and that based on new targets and new mechanisms of action.
As one of the pharmaceutical enterprises responsible for the National Major Science and Technology Special Projects during the “13th Five-Year Plan” period, Antengene has five products under research in clinical stage, including ATG-008 project for treating solid tumor and ATG-010 project for treating hematological tumour. ATG-008 was selected as a major special project, which means that the selected products have entered the national new drugs development during “13th Five-Year Plan” period, and Antenegne team has also shown strong R&D capabilities as well as implementation capabilities.
Dr. Jay Mei, person in charge of the national major special project, and also founder and chairman of Antengene Corporation, introduced, “After several rounds of strict review by the experts from the National Health and Family Planning Commission and the Ministry of Science and Technology along with several defenses by Antengene, the project applied by Antengene, has met the requirements of the “National Major Science and Technology Special Project for ‘Significant New Drugs Development’” during the 13th Five-Year Plan period. Antengene has been determined by the National Health and Family Planning Commission as one of the pharmaceutical enterprises undertaking the major national subject during the 13th Five-Year Plan period, becoming the only pharmaceutical enterprise specializing in innovative drugs in Shaoxing whose project was selected. At the same time, TORC1 / 2 dual-targeted inhibitor has been listed as a project supported by national major special project for the first time, which shows its great potential in the treatment of malignant tumor diseases such as HCC and also reflects Antengene’s development strategy that ‘faces Chinese patients ’ .”
The study shows that under the effect of Antengene ATG-008, the median survival time of patients with hepatitis B virus-positive HCC on whom both sorafenib and chemotherapy fail is 12.1 months, while that of patients with hepatitis B virus-negative HCC is only 5.2 months. ATG-008 has also obtained the approval documents of clinical trials in Taiwan of China and South Korea, and started the drug administration on enrolled patients in August this year. Various clinical studies are progressing smoothly.
In the future, Antengene, taking this opportunity of being selected into the “National Major Science and Technology Special Project for ‘Significant New Drugs Development’” during 13th Five-Year Plan period, will continue to focus on solving unmet medical needs in China and other Asia Pacific region and also vigorously promote the R&D and production of high-end innovative drugs. By the standard of “Global New” and “International First-Class”, Antengene will promote more high-end innovative drugs to serve and benefit Chinese patients as soon as possible.
About National Science and Technology Major Project
National Science and Technology Major Project consists of some major strategic products, key generic technologies or major projects screened by Outline of the National Medium and Long Term Science and Technology Development Program (2006-2020), under the circumstance of defining a number of priority themes in key areas, focusing on the national goals, and further highlighting the key points. Among them, “National Major Science and Technology Special Project for ‘Significant New Drugs Development’” is practical application and industrial development oriented. Targeting 10 categories (species) of major diseases (malignant tumors, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, diabetes, mental diseases, autoimmune diseases, drug-resistant pathogens infection, pulmonary tuberculosis, viral infectious diseases and other common and frequently-occurring diseases) that seriously endanger Chinese people’s health, this special project mainly aims to develop a number of significant drugs, to improve the national drugs innovation system, to enhance the ability of independent innovation, and to accelerates the transformation of China from imitation to creation and from a large pharmaceutical country to a powerful pharmaceutical country.
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.