Press | China clinical trial approval of bgb-a317

Beijing, September 12, 2016 - Baiji Shenzhou (NASDAQ: bgne) is a biomedical company focusing on the development of innovative molecular targeting and tumor immune drugs for cancer treatment, and its products under research are in the stage of clinical research Today, the company announced that the product under development, PD-1 monoclonal antibody bgb-a317, has obtained the approval of clinical trials of drugs issued by the State Food and Drug Administration (CFDA) for the treatment of advanced solid tumors China has become the fifth region after Australia, New Zealand, the United States and Taiwan for bgb-a317 to obtain clinical trial license Up to now, more than 200 patients have participated in the clinical trials of bgb-a317 The preliminary data of phase I clinical dose increasing study of bgb-a317 has also been published at the annual meeting of the American Society of clinical oncology in June this year ▲ Mr ou leiqiang, one of the founders, chief executive officer and chairman of Baiji Shenzhou (photo source: Baiji Shenzhou), one of the founders and chief executive officer and chairman of Baiji Shenzhou, said: "the clinical trial approval document of bgb-a317 means that the products under research in four clinical stages of Baiji Shenzhou can already carry out clinical trials in China The sustained and steady growth of domestic pharmaceutical market is crucial to the development of Baiji Shenzhou We are very pleased to receive this approval and look forward to officially launching clinical trials of bgb-a317 in mainland China, while continuously promoting global clinical development of bgb-a317 and providing the latest clinical data " Yan Xiaojun, head of Baiji Shenzhou pharmaceutical affairs, said: "bgb-a317 is an innovative biological drug independently developed in China In the overseas phase I clinical dose increasing trial, we have accumulated safety and effectiveness data for patients with advanced solid tumors, which provides a good support for bgb-a317 to obtain the approval of clinical trials in Mainland China We will continue to keep close communication with CFDA to promote the development process of bgb-a317 in China " About bgb-a317 Bgb-a317 is a humanized monoclonal antibody in clinical trials, which belongs to a new type of tumor immune agent called "immune checkpoint" inhibitor The mechanism of bgb-a317 is binding with PD-1 receptor on the cell surface, which is an important immunosuppressive molecule, which can inhibit the activation of T cells and thus reduce the role of the immune system Bgb-a317 has high affinity and specificity for PD-1, and the binding ability with FC γ receptor I has been specifically removed by bioengineering technology, which is the difference between bgb-a317 and the currently approved PD-1 antibody Bgb-a317 is being developed as a monotherapy as well as a combination of other therapies for a variety of cancers About Baiji Shenzhou, a global R & D-based biotechnology company, currently has more than 250 scientists, clinical physicians and employees in mainland China, the United States, Australia and Taiwan The company focuses on the development and promotion of targeted and immunotherapy of tumor The product line under research includes new small molecule targeted and monoclonal antibody anti-cancer drugs, and some products have entered the clinical trial stage Baiji Shenzhou is committed to improving the quality of life and survival period of cancer patients by finding the optimal combination therapy of tumor drugs Forward looking statements This press release contains forward-looking statements made in accordance with the U.S Private Securities Litigation Reform Act of 1995 and other federal securities laws, including the expected clinical development and Drug Administration milestones and related plans for the bgb-a317 project Due to many important factors, the true results may differ significantly from the forward-looking statements made These factors include: 1 Can Baiji Shenzhou prove the effectiveness and safety of its candidate drugs; 2 The clinical trial results of the candidate drugs may not support the later development; 3 The management organization may interfere with the start, time process and clinical development process of the clinical trials; 4 Can Baiji obtain the approval of the pharmaceutical industry to achieve commercial success; 5 Can Baiji Shenzhou provide its technology And drugs to obtain and maintain the protection of intellectual property rights; 6 Baiji Shenzhou needs to rely on a third party to carry out pre clinical research and clinical trials; 7 Baiji Shenzhou's short operating history and whether it can obtain more funds for clinical trials, and complete the development and listing of its candidate drugs; 8 Baiji Shenzhou is filed under section 424 (b) of the securities and Exchange Commission's 1933 Securities Act Other risks discussed comprehensively and in detail in the "risk factors" section of the latest quarterly report of ji'an-q; 9 Potential risks, uncertainties and other important factors discussed in the subsequent filing submitted by Bai'an to the U.S Securities and Exchange Commission All information contained in this press release is made on the date of publication of this press release Except as required by law, baichi is not obliged to update such information