Amador Bioscience: A Translational Science and Clinical Pharmacology-Focused CRO That Has Supported 5+ Regulatory Submissions
In June 2017, the China Food and Drug Administration (CFDA), now known as the National Medical Products Administration (NMPA), formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ushering in an era of pharmaceutical innovation aligned with international standards. This move aimed to encourage active innovation among pharmaceutical companies and promote the development of innovative drugs. Since then, supported by historical opportunities and national policies, China’s new drug R&D sector has taken off, with innovative pharmaceutical enterprises emerging in large numbers. Meanwhile, the pharmaceutical outsourcing (CRO/CDMO) services market has also begun to seize opportunities and revitalize.
Amid the favorable macroeconomic and policy environment, many top-tier professionals have turned their attention to China. After more than two decades of experience in new drug research and development (R&D) and management at multinational pharmaceutical companies, Dr. Wang Bing, a renowned expert in clinical pharmacology and pharmacokinetics, has also recognized the opportunities in the Chinese market. Dr. Wang has published nearly 100 academic papers and abstracts and holds 12 patents in biopharmaceutical R&D. He has previously worked in the pharmacokinetics and clinical pharmacology departments of internationally renowned pharmaceutical companies, including Amgen, Abgenix, and AstraZeneca. He directly participated in or led Investigational New Drug (IND) applications and global marketing authorization submissions (BLA/NDA) for numerous drug candidates across multiple therapeutic areas, encompassing dozens of small molecules, recombinant proteins, monoclonal antibodies, immunotoxins, antibody–drug conjugates (ADCs), and bispecific antibodies.
Born from the convergence of expertise and opportunity, Amador Bioscience was established. As Co-Founder and CEO, Dr. Bing Wang led a team of former senior drug R&D experts from AstraZeneca to build a professional group dedicated to providing translational and clinical development services for innovative pharmaceutical companies in China, the United States, and Europe.
The other members of the founding team at AMADOR BIOSCIENCE are also exceptionally talented.Dr. Rong Zeng, Chief Operating OfficerA renowned expert in the fields of bioanalysis and immunogenicity, with over 20 years of experience in immunological research and the development of biologic drugs;Ms. Chen Xiaomin, Senior Vice PresidentWith 12 years of experience in global clinical drug development, including 6 years of project management experience in clinical development at Novartis US; the companyScientific Advisor Dr. Bao HaifengAn expert in translational medicine, with over 20 years of experience in drug development in the United States.
In 2018, AMADOR BIOSCIENCE was registered and established in Hangzhou, China. As a CRO specializing in translational science and clinical pharmacology, the company provides innovative pharmaceutical enterprises with clinical pharmacology, clinical project management, laboratory testing, and regulatory submission services that comply with international standards for filing and market approval, both within and outside China. Clinical pharmacology, as a signature service of AMADOR BIOSCIENCE, aims to leverage Dr. Wang Bing’s over two decades of extensive experience in new drug development, thereby safeguarding the successful market launch of R&D products for pharmaceutical companies.
Clinical pharmacology primarily evaluates the efficacy and toxic side effects of new drugs in humans. It is a critical determinant of the success or failure of innovative drug development, spanning the entire process from preclinical trials following drug discovery to regulatory approval after clinical trials. “During the clinical drug development process, nearly 50% of the drug labeling information in new drug marketing application dossiers consists of clinical pharmacology data. Sufficient data are required to support the effectiveness and safety of the drug in real-world settings,” emphasized Ms. Chen Xiaomin, Senior Vice President of AMADOR BIOSCIENCE.
The emphasis on the importance of clinical pharmacology research stems from the high standards and rigorous requirements for its technical proficiency, necessitating a highly skilled pharmacology team leveraging professional, high-quality hardware and software infrastructure. For new drug development companies, partnering with a clinical pharmacology CRO that boasts top-tier expertise and robust capabilities will undoubtedly significantly shorten the drug development cycle, providing a competitive advantage in both time and cost.
“All clinical pharmacology studies currently undertaken by our team at AMADOR Bioscience have essentially passed regulatory review and scrutiny in the U.S. market on the first attempt,” introduced Ms. Chen Xiaomin, Senior Vice President of AMADOR Bioscience. Leveraging fully validated and compliant cloud-based server systems for SAS programming, PK/PD computational modeling, and clinical trial simulations, AMADOR Bioscience delivers specialized clinical pharmacology services. The company has completed nearly 100 preclinical and clinical projects for innovative drugs both domestically and internationally, covering chemotherapeutic agents, targeted small-molecule drugs, peptides, monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs). Its high-quality services have earned widespread recognition from international clients in the European and American markets.
In 2020, the Clinical Pharmacology team at Amador Bioscience successfully supported three market approval submissions (NDA/BLA) in the United States for a leading Chinese innovative pharmaceutical company and two multinational pharmaceutical companies. Within China, the team also completed multiple preclinical translational modeling and simulation projects as well as clinical population pharmacokinetic data analysis services. As of January 2021, Amador’s Clinical Pharmacology team had completed five market approval submission projects across China and the United States. At the time of publication, the team was providing support for a sixth market approval submission for a European client.
In addition to clinical pharmacology, another core business of AMADOR BIOSCIENCE is the bioanalysis and testing of macromolecular compounds. AMADOR’s laboratories provide clients with data generation, analysis, and reporting services, including immunoassays, cell-based assays, cytokine release assessments, and biomarker expression profiling. According to AMADOR BIOSCIENCE, the company has recently tripled the size of its bioanalytical laboratory. Building upon its existing platform for pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) analysis of large-molecule biologics, it has added mass spectrometry and flow cytometry platforms. These enhancements enable AMADOR to offer comprehensive method development and validation, as well as sample testing services, supporting the R&D of small molecules, antibody–drug conjugates (ADCs), CAR-T therapies, and other drug modalities.
Through collaborative team efforts, the AMADOR BIOSCIENCE bioanalytical team has leveraged the technical expertise and strengths of its laboratory researchers to successfully complete dozens of clinical and preclinical projects. These include immunogenicity testing for bispecific antibody drugs; development and method validation of biomarker assays; pharmacokinetic (PK) assay development for bispecific antibody drugs and protease-based therapeutics; establishment and method validation of cell-based assays (CBA) for neutralizing antibody detection; establishment and method validation of competitive ligand-binding assays (CLBA) for neutralizing antibody detection; and domain-specific characterization of anti-drug antibodies (ADA).
Notably, AMADOR BIOSCIENCE’s laboratory has not only successfully passed quality assurance audits by U.S. clients but also completed GLP toxicokinetic and pharmacokinetic sample testing for multiple Chinese clients, while developing and validating analytical methods that were successfully transferred to the U.S. laboratories of multinational CROs.
AMADOR BIOSCIENCE has also assembled an excellent clinical and medical team, dedicated to providing services such as regulatory submission and registration, medical protocol writing, clinical development strategy, and clinical trial management. Under challenging timelines and with limited background information, this team successfully fulfilled client mandates by delivering high-quality content and professional services, resolving project schedule bottlenecks. It helped clients achieve critical milestones despite prior delays in R&D progress, earning high praise from clients.
As one of the few companies in China offering global clinical pharmacology services, AMADOR BIOSCIENCE has earned a strong reputation within the industry. Since its establishment in 2018, the company has leveraged its widely recognized expertise to complete more than 30 clinical projects by 2019 and advance one U.S. project to marketing application submission. Meanwhile, AMADOR BIOSCIENCE has built and cultivated a team of clinical pharmacology professionals in China with specialized academic backgrounds and extensive experience, and has also completed its plan to establish a GLP/GCLP-compliant laboratory in Hangzhou equipped with advanced instrumentation and meeting international standards.
In 2020, AMADOR BIOSCIENCE maintained its strong growth momentum, completed its Series A financing round, and achieved remarkable progress in market expansion and team building. The company has cumulatively served over 100 projects and advanced the U.S. marketing authorization applications for three additional projects.
Ms. Chen Xiaomin, Senior Vice President of AMADOR BIOSCIENCE, stated that in 2020, despite the impact of the pandemic, the company achieved remarkable results: its customer base grew by 120%, and order value nearly doubled. Such genuine market feedback serves as a testament to the company’s strength. With this rapid growth and impressive performance, AMADOR BIOSCIENCE, as an emerging player, has established its own distinctive reputation within the industry. In the same year, the company was recognized with several honors, including “Zhejiang Province Technology-Based SME,” “Hangzhou City Fledgling Eagle Plan Enterprise,” and “Category A High-Level Talent Entrepreneurship Project in Qiantang New Area.”
In the future, Amador Bioscience will continue to build a professional, high-quality service system characterized by clinical pharmacology, further expand the team size of its service divisions, and look forward to providing more Chinese new drug R&D enterprises with professional services in clinical pharmacology, laboratory analysis and testing, and clinical trial management, thereby contributing to the success of China’s new drug R&D companies!