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A Phase I clinical trial for a Class 1.1 new drug from a listed company has been launched, with Eurasia Huizhi serving as the CRO.
Release time:
2020-09-24 09:25
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On April 5, the kickoff meeting for the Phase I clinical trial of a Class 1.1 new chemical drug project, developed by a well-known publicly listed company, was held. Eurasia Huizhi (Beijing) Medical Research Co., Ltd. is serving as the contract research organization for this project.
Group photo of the attending experts
This drug is a key innovative chemical entity jointly developed by a publicly listed company and the National Key Laboratory of Biotherapy at Sichuan University. Preclinical study results indicate that the new drug is a selective inhibitor of histone deacetylase (HDAC), with a clearly defined target. This new drug outperforms currently marketed products in several aspects, including drug-likeness and antitumor activity. It has now received approval from the National Medical Products Administration to proceed with clinical trials—a highly significant and critical milestone.
Experts discuss the research proposal.
The primary objective of this Phase I clinical trial is to evaluate the tolerability and safety of the drug after single or multiple intravenous infusions in patients with hematologic malignancies, predominantly B-cell-related tumors, who have relapsed or become refractory (including but not limited to B-cell lymphomas, multiple myeloma, B-cell acute leukemia, T-cell lymphomas, and T-cell acute leukemia that have experienced disease progression following standard treatment or are unsuitable for receiving standard therapy). Professor Yongsheng Wang from the National Drug Clinical Research Institution GCP Center at West China Hospital of Sichuan University and Professor Ting Niu from the Department of Hematology will jointly serve as the principal investigators. Eurasia Huizhi (Beijing) Medical Research Co., Ltd. will be responsible for the management of the clinical trial project.
Rao Yiwei, Executive Director of Eurasia Huizhi (Beijing) Medical Research Co., Ltd., delivered a speech.
Eurasia Huizhi (Beijing) Medical Research Co., Ltd. is a specialized company established by the Aotekang Group to provide clinical trial support for innovative drugs and imported originator drugs. Founded in 2006, Aotekang is a national high-tech enterprise and a key project undertaking unit under the 13th Five-Year National Key R&D Program. It has received strategic investment from SoftBank Saif. Guided by the vision and mission of "dedicating ourselves to becoming a leader in MA solutions for the pharmaceutical industry and continuously creating new value for the health sector," we offer comprehensive, timely, cost-controlled, quality-assured, and highly professional full-cycle solutions. Through these services, we consistently promote the market entry of safe, effective, and quality-controlled products, thereby safeguarding patients' lives and health. Our implementation team boasts extensive experience in clinical research for innovative drugs and originator drugs; key members of our project teams have nearly 20 years of management experience in new drug clinical trials at renowned multinational CROs and top-ten global pharmaceutical companies. Together with researchers, we will scientifically and rigorously validate the safety and efficacy of your products, accelerate their market entry, successfully translate innovative drugs into commercial success, and ultimately benefit human health.
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Eurasia Huizhi boasts more than ten Phase I strategic collaboration centers, providing high-quality, specialized resources for early-phase clinical studies of innovative drugs. For each project, our expert medical team drafts initial clinical study protocols, consults with clinical experts in relevant fields, and develops clinically feasible and regulatory-compliant implementation plans. The company has extensive experience in conducting clinical trials for a variety of new drugs, including chemical drugs, traditional Chinese medicines, and biologics. Our services include: 1) Feasibility Assessment: Clinical trial feasibility evaluation, identification of centers/researchers, and center feasibility assessment & qualification review. 2) Medical and Clinical Strategy & Planning: Clinical trial planning & execution, risk identification & management.
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Opinions of the General Office of the State Council on Conducting Evaluations of the Quality and Efficacy Consistency of Generic Drugs (Guobanfa [2016] No. 8) Generic drugs that were approved for marketing prior to the implementation of the new classification system for chemical drug registration—and which have not been approved in accordance with the principle of consistency in quality and efficacy with the originator drugs—must undergo consistency evaluations. The consistency evaluation of generic drugs refers to the phased and batch-wise assessment of the quality consistency of generic drugs already approved for marketing, based on the principle of consistency in quality and efficacy with the originator drugs. In other words, generic drugs must achieve a level of quality and efficacy that is consistent with the originator drugs. The purpose of conducting these consistency evaluations is to ensure that generic drugs are comparable to the originator drugs in terms of both quality and efficacy.
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