August 29, 2025 — The inauguration of Macau’s first new drug clinical trial, combined with the strategic partnership signing ceremony between Boehringer Ingelheim and the Clinical Trial Center of the Macau University of Science and Technology (MUST-CTC), was successfully held today at MUST. This event lays a solid foundation for the establishment of a comprehensive clinical trial execution system in Macau. It not only marks a historic milestone—signifying Macau’s initial capability to undertake and conduct clinical trials for new drugs—but also represents the placement of the “final puzzle piece” in the clinical research network of the Guangdong-Hong Kong-Macau Greater Bay Area (GBA), achieving full regional coverage and injecting new vitality into the region’s medical innovation.
Distinguished Guests and Attendees Key dignitaries attending the ceremony included: Dr. Alvis Lo, Director of the Health Bureau of the Macao SAR Government; Mr. Li Shi En, Deputy Director of the Pharmaceutical Administration Bureau (ISAF) of the Macao SAR Government; Dr. Zhang Wei, Senior Vice President and Head of R&D and Medicine, Greater China, Boehringer Ingelheim (Sponsor); Mr. Henry Yau, Managing Director of the Clinical Trial Centre, The University of Hong Kong (HKU-CTC); Ms. Ka Wai Wong, Deputy Managing Director of HKU-CTC; Ms. Wang Tongyan, Managing Director of DIA China; Professor Manson Fok, Director of University Hospital and Dean of the Faculty of Medicine at MUST; Dr. Chan Tai Ip, Deputy Director of Kiang Wu Hospital; Dr. Leng Xiaomei, Head of Internal Medicine, Macao Medical Center of Peking Union Medical College Hospital (Islands District Medical Complex); Dr. Ching Ka Wai, Assistant Medical Director of Yin Kui Hospital.
Representatives from MUST included Chair Professor Joseph Hun-wei Lee (Vice-Chancellor and President), Chair Professor Tam Kwong Hang (Vice-President and Chief Director of MUST-CTC), Chair Professor Zhu Yizhun (Associate Vice-President and Dean of the School of Pharmacy/School of Chinese Medicine), Chair Professor Liang Wenhui (Associate Vice-President), and Dr. Tsang Chi Wai (Director of Medical Development and Clinical Director/Executive Director of MUST-CTC), alongside administrative heads, faculty, and students from the Medical Faculty.
Strategic Partnership: The HOPE Project The agreement between Boehringer Ingelheim and MUST-CTC marks the 9th strategic collaboration with a clinical trial institution in the GBA under Boehringer Ingelheim’s HOspital Partnership Excellence (HOPE) project. HOPE is a key clinical research initiative launched in China under the company’s “China Key” strategy. It aims to sign strategic agreements with top-tier domestic hospitals to accelerate clinical trial deployment in key therapeutic areas, thereby enhancing trial efficiency and quality. As of late August 2025, Boehringer Ingelheim has established HOPE partnerships with 38 institutions. This signing signifies that the HOPE project has achieved full coverage of the GBA, positioning it to play a greater role in regional synergy, capacity building, and the translation of scientific research into patient value.
Focus on Respiratory Disease: The FIBRONEER™-SARD Trial Macau’s first new drug clinical trial focuses on lung disease, specifically Systemic Autoimmune Rheumatic Diseases-associated Interstitial Lung Disease (SARD-ILD). SARD-ILD is often diagnosed at moderate to advanced stages with limited treatment options, posing serious health threats such as respiratory decline. The investigational drug, Nerandomilast, is a PDE4B selective inhibitor developed by Boehringer Ingelheim. It has demonstrated favorable efficacy and safety in Phase III studies for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). The drug has received Breakthrough Therapy Designation from the U.S. FDA and priority review status in the U.S. and Europe. The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has also officially granted it Priority Review status.
The approved FIBRONEER™-SARD trial is a global multi-center Phase IIIb clinical trial. It is sponsored by Boehringer Ingelheim, implemented by MUST-CTC, conducted at the University Hospital (as the clinical trial site), and supported by HKU-CTC as a strategic collaborator. The study is a double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of Nerandomilast in patients with SARD-ILD, planned for simultaneous conduct in approximately 15 countries and regions worldwide.
Regulatory and Industry Significance Mr. Li Shi En, Deputy Director of ISAF, congratulated the launch of the trial and affirmed MUST-CTC’s efforts in quality management and team building, which laid the groundwork for this approval. He noted that Boehringer Ingelheim’s selection of Macau as a pilot site for new drug trials reflects recognition of Macau’s medical standards and research potential, aligning with the SAR government’s goal to develop the “Big Health” industry.
The initiation of this trial is a milestone in Macau’s “Industry-University-Research” development. It demonstrates Macau’s commitment to elevating local clinical research standards and building the capacity to undertake international pharmaceutical R&D projects. This enhances Macau’s competitiveness in the GBA biomedical sector, attracting top institutions and talent. For Macau citizens, it offers the opportunity to access cutting-edge global therapies, bringing new hope for treating major diseases with limited existing options.。
This is the first trial approved since the implementation of Macau’s Good Clinical Practice (GCP) in March 2024 (released in Dec 2024). ISAF pledges to continue strictly supervising clinical trials to ensure standardization, scientific credibility, and the protection of subjects’ rights, safety, and well-being, while facilitating the growth of the health industry.
Chair Professor Tam Kwong Hang (MUST): Stated that collaborating with a leading global biopharmaceutical company like Boehringer Ingelheim is a crucial practice for translating medical education and research into results. It is a significant milestone in building an international research platform that will profoundly impact Macau’s medical education and clinical capabilities.
Dr. Zhang Wei (Boehringer Ingelheim): Emphasized the company’s commitment to accelerating innovation. With the deepening of the “China Key” strategy, the HOPE project’s scope continues to expand. The collaboration with MUST-CTC and HKU-CTC to launch Macau’s first new drug trial is a major achievement in covering the GBA and a breakthrough in exploring innovative cooperation models.
A Leap from “0 to 1” Historically, Macau lacked a clinical trial infrastructure aligned with international norms, delaying the introduction of innovative drugs compared to other GBA regions. MUST-CTC, established in September 2023 as Macau’s first clinical trial center, adopted the management experience of HKU-CTC and joined the ClinCluster® platform. The approval of the FIBRONEER™-SARD trial marks a “0 to 1” leap in capability, helping to position the GBA as an international hub for clinical trials.
Professor Manson Fok (University Hospital/MUST): Affirmed that the University Hospital, as the trial site, strictly adheres to NMPA standards for clinical trial institution management. Under the guidance of HKU-CTC, the hospital completed the necessary site construction and received accreditation from the Macau ISAF and Health Bureau. A professional clinical research team has been assembled, with all personnel trained in ICH GCP and project-specific protocols.
He pledged the hospital would uphold the highest standards to ensure trial quality and patient safety.
Mr. Henry Yau (HKU-CTC): Highlighted that linking medical research platforms across the GBA is key to improving patient accessibility and clinical capabilities—a mission his team has pursued for over a decade. Macau’s inclusion completes the GBA clinical research network.
Future collaborations will focus on regulatory synergy, talent cultivation, and joint research, promoting the efficient flow and sharing of medical resources across the region.