NEWS
News Updates
MA Achievement Release | Agomelatine Tablets Have Obtained Registration Approval!
Release time:
2024-12-06 16:30
Source:
MA New Achievement
Congratulations to Chongqing Huasen Pharmaceutical Co., Ltd. on obtaining the registration certificate for its Agomelatine Tablets project. Recently, the project received the "Drug Registration Certificate" (Certificate No.: 2024S02963) approved and issued by the National Medical Products Administration. Eurasia Huizhi (Beijing) Medical Research Co., Ltd. has been fully responsible for the clinical operations and organizational implementation of this project. Thanks to the joint efforts of both parties, the efficient execution and professional design by all participating research institutions, the clinical trials and application submission have been successfully completed.
Agomelatine tablets are a novel antidepressant that breaks through the traditional monoamine neurotransmitter system in their mechanism of action. By activating melatonin receptors (MT1 and MT2) and antagonizing the 5-HT2C receptor, this drug not only exerts antidepressant effects but also helps regulate circadian rhythms.
About Huasen Pharmaceutical
Chongqing Huasen Pharmaceutical Co., Ltd. (stock abbreviation: Huasen Pharmaceutical; stock code: 002907) is located in the High-tech Zone of Rongchang District, Chongqing City, and the Liangjiang New Area of Chongqing City. The company is a national key high-tech enterprise integrating pharmaceutical research and development, production, and sales.
About Eurasia Huizhi
Eurasia Huizhi (Beijing) Medical Research Co., Ltd. is a Contract Research Organization (CRO) that provides comprehensive, specialized services for clinical trials to pharmaceutical companies. The company adheres to the principles of integrity, win-win cooperation, diligence, and professionalism, offering holistic solutions to its partners for new drug development. By adopting the best practices, we help clients enhance R&D efficiency, reduce R&D risks, save R&D costs, and accelerate the time-to-market of their products. With patients at the core, guided by clinical value, and driven by the goal of addressing unmet clinical needs, we continuously create new value for the healthcare industry.
Recommended Services
2020-09-25
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.
2020-09-25
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.
Leave a message for inquiry
Follow us
Address: Room 3008, Building I, Yingkun Century, No. 6 Courtyard, East Road of the Automobile Museum, Fengtai District, Beijing
Phone: +86 10 86229816 Fax: 010-83739030
Email: bd-oyhz@healtech.com.cn (Business Cooperation)
ouyahuizhi-hr@healtech.com.cn (Resume Submission)
Follow the official account
WeChat Official Account
Friendship Links:Beijing Aotekang Pharmaceutical Technology Development Co., Ltd. Suzhou Suhao Biomaterials Technology Co., Ltd. Beijing Dikang Pharmaceutical Investment Management Co., Ltd. Center for Drug Evaluation, National Medical Products Administration National Medical Products Administration
Copyright © Eurasia Huizhi (Beijing) Medical Research Co., Ltd.