JADE Biomedical Files for IPO: China's Differentiated, International CQO Providing Integrated Quality Solutions for Biopharma
As early as 2015, when the wave of China’s biopharmaceutical industry was just beginning to rise, Dr. Lin Qiao keenly identified market opportunities in quality management for biological drugs.
Dr. Claudia Lin is a global expert in GMP quality management operations across the entire lifecycle of biopharmaceutical development, from development to commercial launch. She holds a bachelor’s degree from Fudan University in Shanghai and a Ph.D. in Cell and Molecular Biology from the University of California, Berkeley. Dr. Lin has worked in CMC and GMP quality for innovative biologics at leading global pharmaceutical companies, serving as a GMP quality executive at Genentech, Roche, and Bayer in California, USA, including as Head of Biologics Quality for North America. With nearly 30 years of study and professional experience overseas, she has led or participated in QA, QC, and overall quality leadership roles for more than 20 international large-molecule biologics through clinical filing, manufacturing, market approval, and commercial production stages. Her portfolio includes quality management for well-known products such as Avastin, Herceptin, Rituxan, Kadcyla, Elea, Perjeta, Tecentriq, Kovoltry, and Jivi, accumulating extensive hands-on experience aligned with top-tier international standards.
After returning to China in 2015, Dr. Lin Qiao became the inaugural Head of Quality and Compliance at Innovent Biologics, where she led her team in establishing an international GMP quality system for biopharmaceuticals that was unique in China at the time, and oversaw the clinical sample production and IND submissions for multiple products.
Upon returning to China, Dr. Lin Qiao observed the rapid rise of China’s biopharmaceutical industry, as well as the significant gap between domestic pharmaceutical companies and overseas advanced standards in GMP quality management: “When I first returned in 2015, I was surprised to find that no Chinese large-molecule drugs had successfully been marketed in Europe or the United States. This indicates that, by international advanced market standards, the industrialization success rate of Chinese large-molecule biologics is very low, and substantial efforts are still needed to improve quality management in GMP manufacturing.”
Thus, in 2017, Dr. Lin Qiao founded JADE Biomedical, the first company in China dedicated to providing third-party GMP quality management and testing services for the biomacromolecule sector, and exclusively registered the trademark: Bio CQO.®。
JADE Biomedical is committed to providing contract quality services to biopharmaceutical companies in areas such as manufacturing, GMP operations, quality systems, product testing, clinical and commercialization, and drug registration.The company has successfully served over 50 projects., including quality assurance activities and product quality control testing throughout the IND-to-BLA submission processes in China, the United States, and Europe. We have served leading enterprises and CDMOs in the large-molecule industrialization sectors of China, the US, and Europe, with client products covering monoclonal antibodies, ADCs, CAR-T and other CGTs, mRNA, and more.
In 2020, JADE Biomedical’s unique service focus, along with its international expertise in macromolecular technology and GMP concepts and experience, attracted the attention of Charles River Laboratories, Inc., a U.S.-based CXO giant in the pharmaceutical industry primarily focused on biological products, becomingThe Only Chinese Domestic CXO Enterprise in China and Asia to Secure Charles River’s Series A Investment and Establish a Long-Term Strategic Partnership for Collaborative Development.
In recent years, China’s biopharmaceutical industry has experienced rapid growth, characterized by high capital market enthusiasm, a large number of investigational projects, and accelerated drug industrialization. In November 2021, the Center for Drug Evaluation (CDE) released the Annual Report on the Status of Clinical Trials for New Drug Registration in China (2020), which showed a substantial increase in the number of clinical trials for new drugs in 2020. A total of 2,602 clinical trials were registered, representing an overall increase of 9.1% compared with 2019.
Amid the booming Chinese biopharmaceutical industry, the critical importance of quality management for biologics is becoming increasingly prominent. Furthermore, many pharmaceutical companies have recently accelerated their internationalization efforts by conducting overseas clinical trials and expediting their global expansion. However, the significant gap between domestic drug quality management standards and those in Europe and the United States, along with discrepancies in the understanding and implementation of quality standards between China and overseas markets, has posed substantial obstacles to the successful global market entry of Chinese pharmaceutical products.
How Critical Is Quality Management for Biologics? Dr. Lin Qiao stated, “The ultimate goal of drug development is to achieve successful industrialization, thereby truly benefiting patients. This can only be accomplished through a robust quality management system. All activities related to drug manufacturing are subject to regulatory oversight by pharmaceutical authorities. Without comprehensive quality management, clinical and post-approval production would lack standards and remain uncontrolled, exerting direct and severe impacts on industrialization.”
For example, prior to market approval, manufacturing enterprises, including Marketing Authorization Holders (MAHs), must undergo Good Manufacturing Practice (GMP) audits by drug regulatory authorities. If a robust quality system is not in place, or if the company fails to execute all steps of drug production in accordance with the established system, product commercialization cannot be achieved.
As the pace of industrialization in China's biopharmaceutical sector accelerates, Chinese regulatory standards and processes are rapidly aligning with international norms, while Chinese enterprises are strengthening their understanding of and emphasis on GMP quality management.However, due to a shortage of experienced professionals in this field, pharmaceutical companies often find themselves unable to act on their intentions, resulting in low industrialization efficiency and, in particular, significant difficulties in obtaining market approval from European and American regulatory authorities. Dr. Lin pointed out that pharmaceutical companies must first understand the relevant regulations, translate them into an effective quality system, and implement efficient, product-specific operations. This demands a sophisticated understanding of the rapidly evolving latest technologies and process quality requirements for biologics, placing exceptionally high demands on quality management personnel. Yet, as China’s biopharmaceutical industry is still in its early stages, quality management professionals with both international and domestic perspectives and substantial experience remain a scarce resource.It is precisely for this reason that JADE Biomedical has pioneered the emerging sector of quality warranty services.
JADE Biomedical is the first company in China dedicated to providing third-party GMP quality management and testing services for the field of biological macromolecules. Centering on the critical needs from clinical development to commercial regulatory submissions, it has established a one-stop GMP quality service platform for biopharmaceuticals, currently covering all major classes of biological macromolecule drugs, including monoclonal antibodies, antibody-drug conjugates (ADCs), cell and gene therapies, and mRNA therapeutics.
According to our understanding,Regarding quality management services, biopharmaceutical companies prioritize three key factors when making their selection: technical capability, regulatory compliance, and intellectual property protection.
First, technical capabilities: assess whether the enterprise can meet the quality and service requirements for various types of products.Biopharmaceuticals encompass a wide variety of categories, including recombinant proteins, monoclonal antibodies, antibody-drug conjugates (ADCs), cell therapies, gene therapies, and mRNA-based products. Their complexity and variability necessitate that quality service providers possess robust technical capabilities to develop and implement tailored solutions for each client’s unique products and manufacturing processes.
For years, JADE Biomedical has been continuously enriching and deepening its technical capabilities, covering a wide range of biologics including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and cell and gene therapies. Meanwhile, the company possesses profound expertise in manufacturing processes and process control, enabling close collaboration with clients to establish tailored quality systems and product testing solutions. Currently, the company’s service offerings extend beyond quality systems and product testing to encompass technology transfer, comparability studies, and cold chain management—areas that have garnered increasing attention in recent years.
Furthermore, for market segments that remain underserved, JADE Biomedical can independently develop testing methods. For instance, many cell and gene therapy products require replication-competent lentivirus (RCL) testing at various stages, from the cell bank and viral vectors to the final therapeutic product; however, mature solutions are not yet available in the market. To address this gap, the company has independently developed RCL detection technology. Currently, JADE Biomedical offers over 100 testing methods, with a substantial number of additional assays under development and validation.
Next is compliance.Whether establishing a quality system for clients or for the company’s own testing center, compliance with the regulatory requirements of the respective countries is mandatory. All processes at JADE Biomedical are executed in accordance with international GMP quality standards. Furthermore, product support projects at both the clinical development stage and the Biologics License Application (BLA) stage are always open to on-site or remote audits by regulatory authorities in China, the United States, and Europe, thereby meeting the regulatory requirements for filings in these regions, particularly for late-stage clinical products.
Next is intellectual property protection and integrity,Enterprises must not only strictly adhere to contractual obligations with clients but also safeguard their intellectual property rights. JADE Biomedical has established a comprehensive project management framework to protect clients’ intellectual property, ensuring the confidentiality of their proprietary technologies and product information.
Driven by its exceptional professionalism, extensive service offerings, and rigorous compliance and intellectual property protection systems, it has promotedChina’s first approved CAR-T product, China’s first monoclonal antibody, China’s first biologic drug launched under the MAH system, China’s first successful overseas BLA submission for a CAR-T product, China’s first UCAR-T product filed for regulatory approval in both China and the US, and China’s first iPSC-based therapeutic product with an IND filingWait.
In the future, as China’s biopharmaceutical industry evolves from “incremental innovation” to “global first-in-class,” demand for high-end quality management services will surge. Moving forward, JADE Biomedical will continue to uphold the professionalism, comprehensiveness, and international compliance of its service technologies, while expanding its market coverage. The company aims not only to rapidly penetrate the Chinese market but also to leverage its deep partnership with Charles River Laboratories to go global, providing professional, end-to-end GMP quality services worldwide. This will help ensure rigorous quality control for Chinese biopharmaceuticals, facilitating more efficient industrialization and successful entry into advanced international markets.