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STSA-1002/STSA-1005
Release time:
2020-12-31 16:26
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STA-1002 and STSA-1005 are two Class 1 biologics projects, dual-registrations in China and the U.S., targeting C5a and GM-CSF respectively. These products, which inhibit the body’s inflammatory storm, have already established a strategic clinical registration partnership with the company.
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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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