Medical - Registration Affairs

2020-09-10

Customized services, a trusted partner Well-versed in domestic and international laws, regulations, and technical guidelines: Accurately grasp the current review philosophies and cutting-edge information from NMPA, FDA, and EMA, maintaining forward-looking insights to provide clients with feasible strategies and solutions. Embedding registration-outcome-oriented and closely integrated strategies into clinical solutions: We have a deep understanding of local culture and have maintained excellent, open communication channels with regulatory authorities—from CFDA through NMPA—accumulating extensive experience and resources in both technical and regulatory matters. Gained drug registration experience from over 200 projects: Our registration strategies have been recognized by NMPA; several emerging biologics—including cell therapies and oncolytic viruses—have received accelerated reviews, facilitating conditional marketing approval for rare-disease projects, and cell therapy projects have steadily increased year after year. Efficient clinical study design—effectively controlling drug development costs: Thanks to our specialized medical team and experienced expert panel’s advanced strategy formulation and scientific design, we’ve participated in the evaluation of nearly 1,000 drug candidates, with innovative drug services accounting for over 60% of our work in the past five years.

Clinical Operations

2020-09-10

The core management team excels in strategic and tactical operational coordination and demonstrates strong capabilities in identifying and managing policy risks!

Clinical Resources

2020-09-10

Over 300 nationally accredited GCP clinical centers More than 1,200 experts at or above the level of associate chief physician in long-term collaboration Clinical operations teams covering over 30 regions nationwide The above research center resources are recommended and matched to PIs based on the specific project.

Project Experience

2020-09-10

Value-added services

2020-09-10

Providing value-added services for strategic partners Professional Project Evaluation Multi-dimensional assessments including drug-likeness analysis, clinical operational risk analysis, and clinical value analysis Professional Registration Support Registration feasibility assessment, issue resolution, and regulatory affairs support

Reflect deeply, pool wisdom, and pursue excellence.

2020-09-10

Hematologic Malignancies Two-thirds of our project managers and directors have experience in hematologic oncology. Our research network covers the entire country; a single pivotal clinical study alone manages 80 hematology clinical sites, with collaboration involving key opinion leaders and department directors. Over the past five years, our team has conducted more than 20 clinical trials for hematologic malignancies, enrolling over 3,000 patients across the following indications: Leukemia Lymphoma Multiple myeloma Chronic Myelomonocytic Leukemia Non-Hodgkin Lymphoma Myeloproliferative Neoplasms Cell Therapy (Stem Cells and Immune Cells) Over the past five years, our team has conducted more than 10 cell therapy studies and successfully helped clients overcome numerous technical challenges, enabling them to obtain clinical approvals. We possess specialized expertise, technical skills, and extensive experience. We have a deep understanding of the regulatory policies specific to this field. We have extensive experience in registering clinical trials and conducting Investigational New Drug (IIT) studies. Immune cells are primarily used in cancer treatment, while stem cells are more focused on tissue repair and the treatment of chronic diseases. Currently, cell therapy has already seen widespread application in hematologic disorders and demonstrates favorable outcomes—for example, CAR-T cell therapy has achieved an 82% response rate in patients with acute lymphoblastic leukemia. Cell therapy is also playing an increasingly important role in the exploration and treatment of solid tumors.

Early clinical development

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.

Generic Drug Clinical Studies

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.

Post-Marketing Reevaluation Study

2020-09-25

Phase II-IV Clinical Study

2020-09-25

Personnel Outsourcing (FSP) Services

Quality Assurance Services

2020-09-25

Registration Affairs

2020-09-25