BEIJING, November 9, 2021 - Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing proprietary antibody drugs, announced that the China National Medical Products Administration (NMPA) has approved YH001 for phase II Multi-Regional Clinical Trials (MRCT) in China.
NMPA has approved Eucure Biopharma to conduct a phase II MRCT: a phase II, open-label, multi-center study (No. YH001004) will evaluate the safety and efficacy of YH001 in combination with Toripalimab (anti-PD-1 monoclonal antibody) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). The MRCT will be conducted in the United States, Australia and China. The trial has been previously approved by the US Food and Drug Administration (FDA) and Australia regulatory authorities.
Phase I dose-escalation study of YH001 in combination with Toripalimab in Australia (No. YH001002) evaluated the safety, tolerability, pharmacokinetics and preliminary efficacy of YH001 in patients with advanced solid tumors. 24 subjects with advanced solid tumors were enrolled and YH001 in combination with Toripalimab was well tolerated. Most of adverse events (AE) were grade 1 (22) and 2 (19), and Grade 3 or above AE were rare (2). No dose-limiting toxicity (DLT) event was observed. YH001 in combination with Toripalimab showed exciting antitumor activity in subjects with advanced solid tumors. There were 3 PR and 7 SD. YH001 in combination with Toripalimab showed a very benign safety profile and encouraging anti-tumor activity.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approval of the phase II MRCT of YH001 by China NMPA is a milestone for Biocytogen and Eucure Biopharma. Following the approval of the phase II MRCT of YH003 by the US FDA and China NMPA, YH001 is also approved for the phase II MRCT by the US FDA and China NMPA. This is an endorsement for YH001 and YH003 as well as Biocytogen’s antibody discovery platforms and Eucure Biopharma’s clinical development abilities. We will continue making rapid progress in the clinical development of YH001 in China and around the world and bring benefits to patients with new treatment options as soon as possible.
YH001 is an anti-CTLA-4 monoclonal antibody which enhances our immune responses to tumor cells and the removal of regulatory T cells (Treg) from tumor microenviroment so as to treat multiple tumors. Blocking the inhibitory signals of anti-tumor responses to enhance the anti-tumor responses is considered to be the most promising tumor immunotherapy. CTLA-4 and PD-1 are considered as two important immune checkpoints. They control the activation of anti-tumor immune responses by regulating different types of T cells and they are considered to be the fundamental targets for tumor immunotherapy.
About Eucure Biopharma
Eucure Biopharma, a subsidiary of Biocytogen, is a China based innovative biotechnology company with global vision, specializing in developing innovative antibody drugs with independent intellectual property rights. Relying on a strong clinical development team with extensive experiences, the company has established a product pipeline for more than 10 targets. At present, four products have received clinical trial approvals in the US and China including that two products have obtained the phase II clinical approvals from both FDA and NMPA, two products have entered the phase I clinical trials in China, four products have entered Phase I clinical stages in Australia. As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is focused on clinical development. For more information, please visit www.eucure.com.
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to patients around the world. Based on the fully human antibody RenMabTM and RenLiteTM mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in single-cell antibody discovery, gene editing, large-scale animal model supply, and screening to form a new approach to streamline the entire drug development process. Biocytogen actively promotes the independent and cooperative development of new drugs. For more information, please visit http://en.biocytogen.com.cn.