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The DIA China 2025 Annual Meeting successfully concluded its four-day run from May 22-25 at Shanghai's Zhangjiang Science Hall. Under the theme "Harnessing Global Expertise to Drive Pharmaceutical Innovation," the conference brought together regulatory authorities, academic leaders, and industry experts from around the world to engage in dynamic discussions on China's evolving pharmaceutical innovation landscape.
During the conference, senior officials from regulatory agencies including the U.S. FDA and European EMA engaged in strategic dialogues to promote international regulatory alignment. Meanwhile, leading Chinese medical institutions proposed establishing a global clinical trial collaboration network to enhance research quality. Participating companies showcased innovative technologies such as AI-enabled decision platforms and intelligent clinical trial solutions, highlighting China's pioneering role in pharmaceutical digital transformation.
SDM Bioservices' cross-functional team of clinical development experts - spanning medical affairs, bioanalysis, vaccine research, regulatory strategy, and clinical operations - actively participated throughout the event. Also SDM team shared insights and experience on global expansion strategies, clinical trial optimization approaches, and solutions for navigating evolving EU regulations, demonstrating SDM's position as a globally competitive CRO with deep China expertise.
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Navigating New EU Regulations: SDM Experts Outline Strategies for Chinese Biopharma's European Expansion
At the "Breaking into the European Market" roundtable, Dr. Yuwen, SVP Global Regulatory Affairs and CBO at SDM Bioservices, provided an in-depth analysis of key regulatory updates, including the EU’s Clinical Trial Regulation (CTR), Proposed Revision to Pharmaceutical Legislation (GPL), and Health Technology Assessment (HTA) frameworks. He emphasized that increasingly stringent and harmonized EU regulations necessitate Chinese biopharma companies to adopt a "global submission strategy" as early as the R&D phase.
To address these challenges, Dr. Yuwen introduced SDM’s integrated global regulatory services, which leverage the team’s extensive international submission expertise and tailored approaches for Chinese innovators. From dossier preparation to EMA engagement strategies, SDM offers end-to-end support to help companies navigate complex regulatory requirements efficiently.
"Success in internationalization requires Chinese companies to adopt a ‘two-way approach’—not only understanding Western regulatory frameworks but also effectively translating China’s R&D strengths into globally recognized evidence," Dr. Yuwen noted. "SDM serves as this critical bridge, and our synchronized submission strategies—including simultaneous China-U.S., China-EU, or even China-U.S.-EU filings—maximize global value for our clients."
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SDM Bioservices' 20-Year Expertise in Clinical Development: Leveraging Specialized Experience to Enhance Trial Efficiency and Quality
At the DIA China Annual Meeting’s "Clinical Trial Quality and Efficiency" session, Dr. Yuwen engaged in an in-depth discussion with clinical development leaders from Pfizer and Johnson & Johnson, as well as experts from Fudan University Cancer Hospital.
Drawing on SDM’s two decades of clinical development expertise across therapeutics, vaccines, medical aesthetics, and medical devices, Dr. Yuwen shared key insights on optimizing trial efficiency. He emphasized that fostering deep trust and collaboration between sponsors and investigative sites is fundamental to accelerating clinical trials while maintaining high-quality standards.
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Empowering China's Pharmaceutical Innovation with Global Expertise
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
Building on our "China-rooted, specialized focus" advantage, we will continue to develop customized international strategies supporting Chinese pharmaceutical companies' global expansion, while strengthening partnerships with multinational corporations to co-develop innovative therapies for both global and China markets. In this era of borderless medical innovation, SDM remains committed to accelerating worldwide patient access to breakthrough treatments through scientific excellence and operational expertise.
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
Beijing Shouyan Lab is certified by NGSP in the United States.
Provide diverse and better treatment options for patients worldwide.
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
On October 24-25 2024, Dr. Yuwen, CBO and SVP of SDM Bioservices, was invited to attend the 2024 International Biomedical Industry Innovation Beijing Forum co-sponsored by DIA and Beijing Advanced Medical Equipment Industry Innovation Alliance. The forum brings together representatives of global regulators, leading experts in biomedicine, industry leaders and academics to discuss the latest trends and industry innovations in global drug development.
AMWC China 2024 World Congress on Aesthetics and Anti-Aging was successfully carried out in Chengdu on October 18-20, 2024, with medical and aesthetic experts, scholars, and industry practitioners from all over the world participating and presenting their latest achievements.
On July 24, SDM Bioserices and Australia JP Medical Consulting Pty Ltd (hereinafter referred to as "JP Medical Consulting") announced a strategic cooperation. The cooperation aims to make full use of the clinical resources and professional advantages of the two sides in the field of medicine in China and Australia, promote the internationalization of clinical trials and new drug research and development, and provide one-stop services for Chinese biopharmaceutical enterprises in Australian clinical trials.
August 1, China, Beijing, Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical Industry Base to investigate the development and construction of pharmaceutical research and development service platform enterprises.
On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
On July 11-12, 2024, MedDRA MSSO successfully held the fourth offline face-to-face training of 2024 at the Shenyang office of SDM. As the organizer of this event, SM gathered together with more than 40 experts from various fields such as CRO, pharmaceutical companies and partners, including medical coders, data management and statistics, drug safety/pharmacovigilance, medical writers and other modules.
On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
The laboratories operated by SDM in the North and South have their own specialties and technical advantages. Among them, Beijing Shouyan, with several P2 and P2+ laboratories and complete PCR testing facilities, is one of the few testing organizations in China focusing on bioanalysis of vaccines and traditional Chinese medicines; Hangzhou Amador focuses on XDC, macromolecules, and CGT, etc., and provides one-stop bioanalytical services for ADC drugs, which is a technological leader in the industry.
Meiji has advanced its oral paclitaxel softgel capsule, MJC-001, to clinical trial stage. With support from SDM Bioservices, Meiji received FDA clearance for its Investigational New Drug (IND) application, positioning it among the leading developers of oral paclitaxel formulations.
Listen to Dr. Liping Shen: Innovating Vaccine Bioanalysis for Change
KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services.
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
Get in touch with SDM experts for your questions or comments and a member of our team will get back to you directly.
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