Xiyi Medical Announces Strong H1 2025 Performance in Global Clinical Trials and Regulatory Submissions
MDCE CRO
Pharmaceutical Overseas Consulting Service Provider
Amid a complex and volatile global macroeconomic environment, geopolitical shifts, supply chain restructuring, and policy adjustments in major economies continue to test the resolve of Chinese biopharmaceutical and medical device companies in their global expansion. In this context, MDCE CRO paves an efficient and compliant path to globalization for its clients by providing customized one-stop solutions. Leveraging professional barriers built through deep specialization, it has become a key bridge connecting “Chinese innovation” with “global standards.”
In the first half of 2025, MDCE CRO successfully advanced 13 international multi-center clinical trials across 50 overseas clinical research centers and submitted 57 clinical and regulatory registration applications, demonstrating its industry-leading capabilities in supporting the global expansion of Chinese pharmaceutical companies. These achievements underscore MDCE CRO’s strong expertise in global clinical trial operations and overseas resource integration, accelerating the internationalization and commercialization of Chinese medical device and pharmaceutical enterprises while boosting their overseas revenue. Looking ahead, MDCE CRO will uphold its mission of “making Chinese medical innovations benefit the world,” helping more Chinese companies and innovative products enter the international market, expand overseas revenue, and provide better treatment options for patients worldwide.。
● Continuous expansion of global clinical trial footprint
In the field of clinical trials, MDCE CRO has actively established a presence and conducted clinical research in multiple key regions worldwide, leveraging its professional team, efficient execution capabilities, and extensive international cooperation network. In the first half of the year, MDCE CRO efficiently advanced 13 international multi-center study projects across 50 clinical research centers globally, in accordance with client project requirements. These research centers are widely distributed across core hubs of global pharmaceutical R&D as well as emerging high-potential markets, among which,Core regions in Europe, the United States, and Australia account for 86%, while emerging markets such as Southeast Asia, the Middle East, and North Africa account for 14%.has established a comprehensive, multi-tiered regional coverage pattern. The project coversOver 10 therapeutic areas, including cardiology, neurology, endocrinology, vascular diseases, and cancer,Demonstrating MDCE CRO'sProfessional Expertise in the Design and Execution of Multi-Domain Clinical Trials. The project types cover pre-market clinical studies, post-market clinical follow-up (PMCF), and real-world data analysis, among others. MDCE CRO builds a full-lifecycle evidence chain to comprehensively support the development, market launch, and optimization of innovative pharmaceutical products in China.
● Overseas patient recruitment continues to advance
In terms of overseas recruitment, the new projects planned for 2025 aim to enroll 782 patients this year. With the progressive launch and formal initiation of these projects, patient enrollment in the first half of the year has advanced steadily. The enrollment rate in the second quarter was significantly higher than that in the first quarter, with 217 overseas patients successfully recruited in the second quarter. All centers have entered a state of high-efficiency enrollment, demonstrating MDCE CRO’s capability in global resource integration and patient recruitment efficiency. Taking a multi-center project in Europe as an example, through MDCE CRO’s global resource integration and standardized process control,The project was simultaneously advanced in three European countries, successfully completing patient enrollment across all three nations in just nine months, thereby achieving a significant reduction in the enrollment timeline compared to the industry average.
● Continued Breakthroughs in Global Regulatory Approvals
In terms of global regulatory approvals, MDCE CRO obtained a cumulative total of eight international multi-center clinical trial approvals in the first half of 2025, covering core European markets (five approvals) and major Asia-Pacific regions (three approvals). This achievement is attributed to the company’s comprehensive lifecycle ethics and compliance management system. By implementing standardized process designs and cross-regional expert collaboration mechanisms, MDCE CRO has achieved a dual improvement in the efficiency and quality of ethical reviews while ensuring data integrity and subject protection. Furthermore, MDCE CRO maintained its momentum in the first half of 2025"Zero Violations" Track Record, thereby driving the efficient advancement of global clinical trials. By translating world-class professional expertise into clinical development efficiency, MDCE CRO has built for sponsorsHigh Certainty, Low Risk, Affordabilityglobalized clinical trial solutions, empowering partners to gain a competitive edge in the fiercely competitive international market.
● Continuous upgrading of the overseas talent pipeline
In terms of overseas clinical team building, MDCE CRO has demonstrated a robust and promising growth trajectory. In the first half of 2025, MDCE CROThe size of the overseas clinical trial team increased by 23% year-on-year compared to the same period last year., with the addition of more than 10 members to the overseas project team, who boast an average of over 19 years of industry experience. These new hires hail from countries and regions including Ireland, Italy, Belgium, Poland, Indonesia, Thailand, and Qatar, filling key roles such as Senior Project Managers (Sr. PM) and Senior Clinical Research Associates (Sr. CRA). Leveraging their extensive practical experience and deep professional expertise, they play a pivotal role in multiple critical areas of overseas clinical trials. Meanwhile, the Medical Center team has also added two experts with an average of over 10 years of work experience, covering roles in medical affairs, medical writing, data management, and device safety, further strengthening MDCE CRO’s talent pool.
● Continuous Expansion of Overseas Research Centers
The clinical research center network, as an important component of the resource integration system, has also achieved significant breakthroughs. By actively expanding cooperation channels and strengthening communication with top global research institutions, MDCE CRO in the first half of the yearThe number of top-tier global partner medical institutions increased by 28%, primarily concentrated in Europe and the United States (56%) and Australia (39%).Covering superior resources across diverse research fields such as cardiovascular, neurological, and oncological studies. Through collaborations with these leading research institutions, MDCE CRO has further perfected its comprehensive global R&D network, providing unparalleled advantages for accessing the latest scientific insights, conducting cutting-edge research projects, and facilitating hospital market entry and subsequent commercialization of products.
● Deepening Collaboration with Overseas Experts
Meanwhile, MDCE CRO places great emphasis on collaborations with internationally renowned Principal Investigators (PIs), continuously deepening the level of cooperation and expanding its scope. In the first half of 2025,MDCE CRO has established strategic partnerships with dozens of internationally renowned researchers from Europe and the United States (58%), Australia (37%), Southeast Asia (5%), and other countries and regions, covering therapeutic areas such as peripheral vascular disease, dermatology, cardiovascular disease, and endocrinology.Leveraging their extensive clinical experience and in-depth research insights, experts have provided comprehensive support for product development, clinical protocol design, and implementation. This ensures the scientific rigor and high-quality execution of clinical trials, injecting sustained and powerful momentum into the product’s commercial translation and global expansion.
H1 2025 Performance Report: A Testament to MDCE CRO’s Professional Excellence and Its Role in Facilitating Overseas Clinical Trials and Globalizing Chinese Medical InnovationsLooking ahead, we will remain steadfast in our core mission of “bringing Chinese medical innovations to benefit the world.” Through unwavering dedication and a commitment to excellence, we will deepen our efforts to support Chinese healthcare enterprises in expanding into overseas markets, facilitating efficient commercialization, and making significant contributions to the advancement of global human health.
MDCE CRO is a medical device R&D outsourcing service company with global clinical trials as its core business. Leveraging Harvard University’s global medical research resources and academic influence, MDCE CRO has established a full overseas service industry chain to provide customized global expansion solutions for Chinese medical device enterprises. Its services include overseas clinical development strategy and design, overseas clinical trial management and operations, overseas product registration, and overseas commercialization layout. Since its inception, MDCE CRO has successfully facilitated the overseas launch of more than 80 medical device and biopharmaceutical projects, generating cumulative overseas profits exceeding RMB 20 billion for its clients. Currently, MDCE CRO employs an in-house overseas clinical trial team of over 100 professionals, collaborates with more than 2,000 experts, and has signed agreements with over 100 renowned overseas hospitals, covering regions including the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, and Africa.
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