Group Photo
The Launch of Macau's First Novel Drug Clinical Trial & Signing Ceremony for Strategic Collaboration between Boehringer Ingelheim and Macau University of Science and Technology Clinical Trials Centre was held at MUST on 29 August, 2025. This milestone lays a solid foundation for building a comprehensive clinical trial execution system in Macau. More importantly, it signifies a historic step forward—empowering Macau to host and conduct innovative drug clinical trials for the very first time—while completing the “last piece of the puzzle” in the Greater Bay Area’s (GBA) clinical research network. This achievement brings full coverage across the region and injects fresh momentum into medical innovation in the GBA.
The officiating guests for the ceremony were: Dr. Alvis Iek Long Lo, Director of Health Bureau of Macau SAR Government; Mr. Sai Ian Lei, Deputy Director of Pharmaceutical Administration Bureau of Macao SAR Government; the sponsor, Dr. Wei Zhang, Senior Vice President, Head of Medicine, T.C.M. of Boehringer Ingelheim; Mr. Henry Kwong Chi Yau, Managing Director of the University of Hong Kong Clinical Trials Centre; Dr. Creany Ka Wai Wong, Deputy Managing Director of the University of Hong Kong Clinical Trials Centre; Dr. Tong Yan Wang, DIA China Managing Director; Prof. Manson Fok, President of University Hospital and Dean of Faculty of Medicine of MUST; Dr. Tai Yip Chan, Deputy Director of Kiang Wu Hospital; Dr. Xiao Mei Leng, Department head of internal Medicine of Islands Healthcare Complex – Macao Medical Center of Peking Union Medical College Hospital; Mr. Ka Wai Ching, Hospital Superintendent Assistant of Yin Kui Hospital.
Our distinguished guests from the Macau University of Science and Technology include: Vice Chancellor and President, Chair Professor Joseph Hun-wei Lee; Vice President and Chief Director of Clinical Trials Centre, Chair Professor Paul Kwong-Hang Tam; Associate Vice President and Director of School of Pharmacy and Faculty of Chinese Medicine, Chair Professor Yi Zhun Zhu; Associate Vice President and Dean of School of Liberal Arts, Professor Aliana Man Wai Leong; Development and Clinical Director of Medical Sciences Division and Executive Director of Clinical Trials Centre, Dr. Valencia Chang, and also our esteemed deans, directors, executives, department heads, officers, teachers and students from Medical Sciences Division.
Group Photo of the Launch of Macau’s First Novel Drug Clinical Trial
Vice President Paul Tam Kwong-Hang and Senior Vice President Wei Zhang signed the Memorandum of Understanding on behalf of both parties. The signing signifies the inclusion of MUST-CTC as the 9th clinical trial site in the GBA under Boehringer Ingelheim’s HOPE (HOspital Partnership Excellence) Program—a cornerstone initiative of the company’s “China Key” strategy (As of the end of August 2025, Boehringer Ingelheim has partnered with 38 leading clinical trial institutions nationwide through HOPE). This program accelerates trial deployment in key disease areas, improving both efficiency and quality. With the joining of Macau, HOPE project has now covered the entire GBA, further enabling regional collaboration, capacity building, and translational research to create more value for patients.
Signing Ceremony Group Photo
Vice President Paul Tam Kwong-Hang (right) and Head Clinical Development Operations, T.C.M., Boehringer Ingelheim Ms. Yin-Ying SONG (Left) signed on the Memorandum of Understanding.
The event was witnessed by: President Lee (right), Senior Vice President Zhang (left)
Macau’s First Novel Drug Clinical Trial Targets Lung Disease, SARD-ILD is often diagnosed at advanced stages, with limited treatment options, and patients face severe threats such as progressive respiratory decline. Nerandomilast is an oral, preferential inhibitor of PDE4B investigated by Boehringer Ingelheim, it has demonstrated encouraging efficacy and safety in Phase III trials for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It has been granted “Breakthrough Therapy” by FDA and priority review designations in both the U.S. and Europe, while China’s Center for Drug Evaluation (CDE) under the NMPA has also officially granted it priority review status.
This trial marks Macau's first Phase IIIb Multi-Regional Clinical Trial (MRCT)—the FIBRONEER™-SARD study. Sponsored by Boehringer Ingelheim, it will be conducted by the MUST Clinical Trial Center (MUST-CTC), with the University Hospital (UH) serving as the study site and the University of Hong Kong Clinical Trials Centre (HKU-CTC) providing strategic support. The study will evaluate the efficacy and safety of nerandomilast in patients with systemic autoimmune rheumatic diseases-associated interstitial lung disease (SARD-ILD). This is a randomized, double-blind, placebo-controlled trial to be conducted in approximately 15 countries and regions worldwide.
Deputy Director Lei Delivered a Speech
Mr. Sai Ian Lei, Deputy Director of the Pharmaceutical Administration Bureau(ISAF), offered his congratulations on the launch of Macao’s first novel drug clinical trial. He confirmed that since its establishment, MUST-CTC has made efforts in clinical trial quality management and research team building, laying a solid foundation for the approval of this trial.
The selection of Macao as a trial site by Boehringer Ingelheim is a clear recognition of Macao’s advanced medical standards and significant scientific research potential, aligning closely with the Macao SAR Government’s goals for promoting the development of the health industry.
The launch of Macao’s first novel drug clinical trial is not only the initiation of a research project but also a milestone in Macao’s “industry-academia-research” sector. It reflects Macao’s commitment not only to advancing its health industry and enhancing local clinical research capabilities. Macau is striving to build the capacity and environment to undertake international pharmaceutical R&D projects, thereby strengthening its competitiveness in the biomedical field within the Guangdong-Hong Kong-Macao Greater Bay Area. This initiative is expected to attract more outstanding pharmaceutical research institutions and professionals to Macao, injecting new momentum into its scientific research landscape.
For the residents of Macao, this trial offers the opportunity to access cutting-edge global treatments at an earlier stage, which is a significant development for major diseases that currently have limited treatment options.
This clinical trial is the first to be initiated since the Good Clinical Practice (GCP) Guidelines were issued by the Macao Pharmaceutical Administration Bureau in December 2024 and came into effect this March. ISAF will continue to fulfill its duties by conducting rigorous and lawful supervision of drug clinical trials, ensuring that the process is standardized, scientific, and credible, and protecting the rights, safety, and well-being of participants. It will also play a guiding and facilitating role in regulatory efforts to support the growth of the health industry.
Chair Professor Paul Kwong-Hang TAM Delivered a Speech
Chair Prof. Paul Kwong Hang Tam, Vice President of MUST and Chief Director of Clinical Trials Centre said: “Partnering with Boehringer Ingelheim, a global leader in biopharmaceutical innovation, and HKU-CTC to launch Macau’s very first novel drug clinical trial at MUST is a significant milestone. This initiative not only reflects the transformation of MUST medical education and research capabilities into tangible outcomes but also marks an important step in building an international research platform. It will have a profound and lasting impact on the advancement of medical education and clinical capacity in Macau.”
Senior Vice President Wei ZHANG Delivered a Speech
Dr. Wei Zhang, Head of Medicine, Senior Vice President of Boehringer Ingelheim Greater China commented: “For years, Boehringer Ingelheim has remained committed to accelerating innovation for the benefit of patients. As part of ‘China Key’ strategy, Boehringer Ingelheim has continued to expand the reach of the HOPE Program. Today, through close collaboration with MUST-CTC and HKU-CTC, Boehringer Ingelheim is honored to witness the approval and launch of Macau’s first-ever novel drug clinical trial. This marks both the completion of HOPE’s full coverage in the GBA and another successful step forward in exploring new models of innovation under our ‘China Key’ strategy.”
Historically, Macau lacked the infrastructure and management systems required to conduct clinical trials in line with international standards, which had directly limited patients’ access to cutting-edge clinical treatments. MUST-CTC, established in September 2023 as Macau’s first clinical trial center, drew extensively on the rich experience and advanced management systems of its partner, the HKU Clinical Trials Centre (HKU-CTC), in organizational structure and management model during its inception. MUST-CTC also joined the ClinCluster® clinical trial institution management platform led by HKU-CTC, marking Macau's advancement towards international standards in clinical research management. The launch of FIBRONEER™-SARD—the first novel drug clinical trial in Macau not only marks a leap “from zero to one” in local clinical trial capacity, but will also help the GBA become an international hub for clinical trials, driving comprehensive improvements in regional medical innovation and access to cutting-edge treatments.
Professor Manson Fok Delivered a Speech
Professor Manson Fok, Director of University Hospital and Dean of the Faculty of Medicine of Macau University of Science and Technology, stated that University Hospital, as a site for clinical trials, has strictly followed the National Medical Products Administration’s standards for the management of clinical trial institutions. The hospital has established relevant facilities for its clinical trial centre, which has been accredited by the Macau Health Bureau and the Pharmaceutical Administration Bureau of Macau, under the guidance of the Clinical Trials Centre of The University of Hong Kong.
In addition, the hospital has formed a professional clinical research team. All clinical researchers involved in the project have received training in ICH GCP and project-specific protocols.
University Hospital is committed to ensuring the highest quality in clinical trials and patient safety, adopting a rigorous approach and maintaining strict criteria. The aim is to contribute to the gradual development of a comprehensive clinical trial system in Macau and to cultivate more talent in clinical research.
Managing Director Henry Kwong-Chi YAU Delivered a Speech
Mr. Henry Yau, Managing Director of HKU Clinical Trials Centre said: “Building cross-regional clinical research platforms in the GBA is critical to improving patient access and enhancing clinical capacity. Over the past decade, my team has worked tirelessly toward this goal. With Macau’s inclusion, the ‘last piece of the puzzle’ is now complete, enabling a fully connected regional clinical research network. HKU Clinical Trials Centre believe this collaboration will further elevate the GBA’s influence within the global clinical research landscape.”
As Macau’s local clinical-trial infrastructure continues to improve, the territory is poised to take on more high-level clinical research responsibilities in the future, contributing to the development and delivery of innovative treatments for patients across the region and around the world. This advancement will not only strengthen Macau’s trial capabilities but also provide the GBA with a new platform for deep collaboration in medical innovation.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry‘s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer Ingelheim - Life Forward | Boehringer Ingelheim.
About HKU-CTC
The University of Hong Kong Clinical Trials Centre (HKU-CTC) is a one-stop professional management platform dedicated to facilitating clinical studies under HKUMed. Since its establishment in 1998, HKU-CTC has facilitated some 2,000 clinical studies in collaboration with biomedical corporations, research institutions and investigators around the world. In 2019, HKU-CTC spun off the HKU Clinical Research Group (HongCRES) to better support the thriving development of the clinical research ecosystem in the Greater Bay Area. For more information about HKU-CTC, please visit www.hkuctc.com.
About MUST-CTC
The Macau University of Science and Technology Clinical trials Center (MUST-CTC) was established on 19th September 2023. It is a professional clinical trial management platform under Medical Science Division of MUST and is also the first clinical trials center in Macau. MUST-CTC is dedicated to conducting ethical, patient-centric, and cutting-edge clinical research to enhance patient treatment outcomes and advance medical progress. For more information, please visit MUST-CTC website: https://ctc.must.edu.mo.
About UH
University Hospital, which established on March 2006, is a subsidiary of Macau University of Science and Technology (MUST) Foundation. Being the teaching arm of the Faculty of Medicine and the Faculty of Chinese Medicine of MUST, UH is the only medical system in Macau that combines clinical, teaching, and research support. The Hospital is a comprehensive medical facility with comfortable environment and state-of-the-art medical equipment. A wide range of hospital services are provided by a team of professionals and specialists from overseas, mainland China, Hong Kong and Macau. For further information, please visit the UH website: www.uh.org.mo
