Amador Bioscience Files IPO Prospectus: A Global Translational Science and Clinical Pharmacology CRO Empowering Nearly 100 Chinese Biopharma Companies to Go Global
AMADOR BIOSCIENCE China Headquarters Building
On June 21, 2022, Amador Bioscience, a global translational and clinical development CRO, officially inaugurated its China headquarters at No. 18 Zhiheng Lane, Xiaoshan District, Hangzhou (Kaifeng Technology Park), covering an area of over 6,400 square meters. This milestone not only marks a comprehensive upgrade of the company’s hardware and software infrastructure but also represents a significant step in advancing Amador Bioscience’s strategic initiatives in China. In addition to Hangzhou, Amador Bioscience maintains offices and teams in Beijing and Shanghai, aiming to better serve Chinese pharmaceutical enterprises by accelerating the development of innovative drugs through translational science and clinical development, thereby facilitating their entry into the global market.
AMADOR BIOSCIENCE China Headquarters Grand Opening Ceremony
At the launch ceremony, the following guests were invited to attend:Xu Chang, Member of the Standing Committee of the Xiaoshan District Committee of the Communist Party of China, Secretary of the Party Working Committee and Director of the Administrative Committee of Xiaoshan Economic and Technological Development Zone，Lai Gang and Zhu Guojun, Members of the Party Working Committee and Deputy Directors of the Management Committee of the Development Zone, as well as the principal heads of various departments in the Development Zone, and also invitedMr. Chang Nannan, Executive Director of Hillhouse Ventures, and fromSequoia China, CMB International, HS Investment, HuaAn Fund, Kaifeng Zinaninvestors from institutions such as VCBeat, and also invitedDr. Haifeng Bao, Co-founder and CEO of Baikai Pharma、Dr. Xu Junfang, CMO of Huadong Medicine、Dr. Zhao Yongxin, CEO of Duoxi Biotechand other partners, jointly witnessing Amador Bioscience’s advancements in China. That afternoon, the Antibody-Drug Conjugate (ADC) Drug Development Symposium, initiated by Amador Bioscience, was also held at its headquarters. The event gathered many prominent companies involved in ADC drug development in Hangzhou, including Duoxi Biotech, Biolicscon, BioKai Therapeutics, and Shangjian Biopharma.
Symposium on Challenges and Strategies in ADC Drug Development
Amador Bioscience is a global contract research organization (CRO) specializing in translational science and clinical development. With established business hubs in the United States and Europe, the company’s recent renovation and upgrade of its China headquarters not only underscores its commitment to the Chinese innovative drug market but also aims to create an enhanced service platform to support Chinese pharmaceutical companies in their international expansion.
CROs specializing in translational science and clinical pharmacology are rare worldwide. This is because such CROs not only demand exceptionally high team capabilities but also require a global strategic vision to advance the clinical translation of scientific achievements. This entails establishing technically proficient teams with extensive drug development experience in core countries and regions around the world, as well as deploying corresponding hardware and facilities locally.
In China and globally, AMADOR BIOSCIENCE is the first CRO to possess such dual capabilities. Since its inception, AMADOR BIOSCIENCE has established a development path centered on clinical pharmacology with a global strategic layout. Its team brings together numerous experts in the field of new drug development, such asDr. Bing Wang, Former Executive in Clinical Pharmacology and Quantitative Pharmacology at AstraZeneca、Dr. Mei-Na Liang, Former Global Head of Bioanalysis at AstraZeneca、Dr. Rong Zeng, Former OncoMed R&D Executive、Dr. Wonkyung Byon, Former Quantitative Pharmacology Executive at Pfizer and RegeneronWith Dr. Nidal Hunitiand more, aiming to provide high-quality R&D services for innovative drug companies and safeguard the successful global launch of their products.
Clinical pharmacology is pivotal to the success or failure of innovative drug development, spanning the entire process from preclinical trials following drug discovery to regulatory approval. By the end of 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration had successively issued the Technical Guidelines for Model-Informed Drug Development, the Technical Guidelines for Population Pharmacokinetic Studies, and the Technical Guidelines for Clinical Pharmacology Studies in Pediatric Drug Development. These guidelines have established industry standards and charted the course for research in clinical pharmacology.
Based on clinical pharmacology research, it is possible to facilitate the translation of data from non-clinical to clinical settings, optimize study designs, predict clinical trial outcomes, assess intrinsic and extrinsic factors affecting PK/PD, optimize drug dosing regimens, select patients or subpopulations and conduct bridging studies, and evaluate benefit-risk ratios. These are critical milestones in the drug development process. Professional and efficient clinical pharmacology research can significantly increase the success rate of innovative drug development and substantially shorten the drug development timeline.
AMADOR BIOSCIENCE’s most formidable capability lies in clinical pharmacology, a reputation widely acclaimed within the industry. The company has established a comprehensive suite of drug development models, including population pharmacokinetic (PopPK) models, population pharmacodynamic (PopPD) models, quantitative systems pharmacology (QSP) models, disease progression models, and PK/PD models. These models facilitate thorough analysis and guidance for both preclinical and clinical data, providing efficient and professional decision-making support for the development of peptides, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and small-molecule drugs.
“At AMADOR BIOSCIENCE, we are committed to leveraging our professional expertise to excel in clinical pharmacology and scientific translation for pharmaceutical companies, and even to rescue those ‘failed’ drugs.”Ms. Chen Xiaomin, Chief Operating Officer of AMADOR BIOSCIENCEhe stated. Throughout the entire drug development lifecycle, the transition from preclinical stages to Phase I and II clinical trials represents the period with the highest failure rate. By optimizing clinical pharmacology and translational medicine during this phase, many drug candidates can be salvaged, thereby maximizing cost reduction and efficiency improvement for pharmaceutical companies.
As the “premier strategic partner” for global innovative drug R&D enterprises, AMADOR BIOSCIENCE has maintained international high standards in pharmacology research services. Coinciding with the inauguration of its Hangzhou, China headquarters, the company has also upgraded its laboratory testing and clinical development capabilities.
In terms of hardware, AMADOR BIOSCIENCE has designed and renovated its internal facilities in strict accordance with the standards of top-tier international laboratories and office spaces, equipped them with advanced international analytical instruments and standard equipment, and established a system of standard operating procedures.
From a software perspective, AMADOR BIOSCIENCE leverages next-generation innovative technologies to provide high-quality, efficient, and customized services compliant with GxP standards, including laboratory bioanalysis and biomarker testing, thereby establishing close partnerships with innovative pharmaceutical companies. In clinical project management, the company has assembled a professional team with an average of over 10 years of experience per member, coordinating communications between pharmaceutical companies and regulatory authorities, research centers, and ethics committees to advance clinical projects and deliver true one-stop “safeguarding” support.
The global market is the true market. Investors in the pharmaceutical industry have bluntly stated that drugs incapable of entering international markets are not considered at all. This not only demands originality in the drug itself but also requires pharmaceutical companies to adopt a global strategic perspective from the early stages of drug development.
“Timing in drug development is crucial,” stated Ms. Chen Xiaomin, Chief Operating Officer of AMADOR BIOSCIENCE. “If we assume that an innovative drug files for an Investigational New Drug (IND) application only in China, a time lag will emerge between the completion of early-stage clinical trials in China and the subsequent consideration of overseas regulatory submissions. Once Phase I clinical trials of the innovative drug yield favorable data, foreign pharmaceutical companies—with financial resources thousands of times greater than yours—can rapidly invest and catch up.” Therefore, AMADOR BIOSCIENCE is dedicated to helping pharmaceutical companies cultivate a mindset of international strategic planning from the very outset of drug development.
In December 2021, AMADOR BIOSCIENCE established its European center in the province of Limburg, Belgium, thereby completing the company’s business layout.China, the United States, and the European Union: The Three Major Pharmaceutical Marketsthe international triangular landscape. Currently, most pharmaceutical CROs still assist domestic pharmaceutical companies in “going global” primarily through collaborations with overseas CROs. In contrast, AMADOR BIOSCIENCE is one of the few global translational science and clinical development CROs that has established its own international sub-centers and can simultaneously execute business operations in the world’s two largest pharmaceutical markets—the United States and Europe.
Having established its presence in the three major pharmaceutical markets of China, the United States, and Europe, Amador Bioscience’s next step is to collaborate with partners to develop markets in South America, Southeast Asia, and other regions. Ms. Chen Xiaomin, Chief Operating Officer of Amador Bioscience, explained, “Once an innovative drug receives FDA marketing approval, it only requires simple registration to enter the South American market, enabling rapid market penetration. Although South America’s economy is not as developed as China’s, it boasts a substantial economic volume and a large population. The same applies to Southeast Asia; Vietnam alone has a population of over 100 million, and the region’s future market size continues to grow, presenting significant potential.”
Therefore, AMADOR BIOSCIENCE not only assists Chinese clients in clinical translation and marketing applications for the largest European and American markets but also helps pharmaceutical companies expand their businesses into larger international markets beyond Europe and America. Just like the company's logo, AMADOR BIOSCIENCE serves as a "bridge," connecting Chinese pharmaceutical companies to global markets while also facilitating the entry of outstanding overseas pharmaceutical companies into China.
Pharmaceutical CRO is an industry that relies heavily on talent. As a CRO focused on translational science and clinical development within the pharmaceutical sector, AMADOR BIOSCIENCE places significant emphasis on building its talent team. In addition to its founding team members from global pharmaceutical giants such as AstraZeneca, Novartis, and Pfizer, the company has successively recruited experienced expert teams in areas including clinical pharmacology, laboratory testing, clinical development, and regulatory affairs.
Recently,Dr. Wonkyung Byon, with 15 years of experience at Pfizer in the United StatesJoin AMADOR BIOSCIENCE to lead the company's quantitative pharmacology team;Dr. Kamali Chance, with 25 years of regulatory affairs experience in the industryShe joined AMADOR BIOSCIENCE to oversee the company’s global regulatory registration affairs, having previously served as CEO of KC Biopharma Consulting; andDr. Hu Zhiqiang, M.D., a licensed physician with 38 years of practice in the United StatesThe addition marks AMADOR BIOSCIENCE's official entry into clinical development operations.
The senior technical expert team is one of the reasons why Amador Bioscience is trusted and continuously chosen by customers. It is reported that Amador BioscienceSuccessfully completed over 210 market authorization submissions (NDA, BLA, MAA) in Europe and the United States for domestic and international clients, with projects in Europe and the United States accounting for approximately 65% and those for leading Chinese innovative pharmaceutical companies accounting for approximately 35%.For example,The clinical pharmacology of Hu5F9-G4, the world’s first CD47 antibody drug, was supported and completed by Amador Bioscience.。
Maximizing Drug Value: Assisting Pharmaceutical Companies in Developing New Therapies to Meet Patient NeedsDiscussing the founding vision of Amador Bioscience, Ms. Chen Xiaomin, Chief Operating Officer of the company, told VCBeat that Amador Bioscience has consistently focused on serving as a “translator” and “bridge.” Since the inception of its collaborations with pharmaceutical companies, the firm has been dedicated to helping clients identify the most appropriate drug dosages, targets, indications, and optimal market positioning. Regulatory submissions in Europe and the United States are merely the starting point; in the long term, the company aims to help clients broaden their global perspective and expand into international markets.
“We believe that China can also cultivate major pharmaceutical companies like Novartis and Pfizer, ultimately securing a significant position in the global market,” said Ms. Chen Xiaomin, Chief Operating Officer of AMADOR BIOSCIENCE, in her closing remarks.