Clinical Translation of Innovative Drugs Reaches Inflection Point: This Two-Year-Old CRO Already Serves 100+ Clients
After two decades of accumulation and development in China’s innovative drug industry, domestically developed innovative drugs have been launched across various disease areas. Looking at the industry as a whole, milestone achievements such as “positive preclinical results,” “IND approval,” “completion of Phase I clinical dosing,” and “Phase II clinical trial approval” continue to emerge, signaling that Chinese innovative pharmaceutical companies have entered the era of “preclinical and clinical validation.”
Different stages of development correspond to distinct challenges and needs. The "drug discovery" phase has spurred the rapid advancement of AI algorithms and bioinformatics technologies in China, allowing professionals in bioengineering, information technology, and related interdisciplinary fields to shine within the industry. As we enter the next era of "preclinical/clinical validation," what new demands will emerge during the translation of drug pipelines into clinical applications? Furthermore, in which directions will this trend drive the development of clinical translation service providers within the industry?
VCBeat recently interviewed Shanghai Paisixin Biomedical Technology Co., Ltd. (hereinafter referred to as “Paisixin”), a comprehensive provider of new drug R&D and clinical translational medicine services under the Sunshine Noah Group. Through an examination of the company’s business layout across the three stages of drug discovery, preclinical research, and clinical trials, this article provides a holistic understanding of the operational models currently required for innovative drug development.
Under the leadership of its founding team, Shanghai Paisixin Biomedical Technology Co., Ltd. has established six major service segments: a clinical central laboratory, an oncology pharmacology research platform, platforms for inflammatory and autoimmune diseases as well as CNS and other disease pharmacology, an in vitro research platform, a pharmacokinetics platform, and a non-GLP toxicology platform. These services cover in vitro (immunological and non-immunological) and in vivo efficacy studies, pharmacokinetics, and non-GLP toxicology experiments related to oncology, inflammation, autoimmune disorders, CNS conditions, dermatology, and other diseases. The company’s capabilities encompass small molecule compounds and cytotoxic drugs, combinations of immune checkpoint inhibitors with small molecule inhibitors, mono-/bi-/multi-specific antibodies, PDC/ADC drugs, TCR-T/CAR-T therapies, oncolytic viruses, cancer vaccines, gene and stem cell therapies, as well as peptide and nucleic acid-based drugs, thereby covering the vast majority of innovative therapies in the field of novel drug development.
Unlike traditional early-phase clinical drug studies based on blood biochemistry and immunological markers, the clinical central laboratory of Shanghai Paisixin Biomedical Technology Co., Ltd. primarily focuses on innovative therapies such as mono-/bi-/multi-specific antibodies, PDC/ADC drugs, TCR-T/CAR-T cell therapies, oncolytic viruses, tumor vaccines, gene therapy, and stem cell therapy. It provides technical services including clinical immunophenotyping, TBNK subset analysis, phosphorylation detection, clinical pharmacokinetic (PK) analysis, pathological examination of clinical samples, hematological disease analysis, receptor occupancy analysis, drug toxicity assessment, tumor mutational burden (TMB) testing, and minimal residual disease (MRD) detection. As one of the few platforms capable of comprehensively meeting the needs of innovative drug clinical research, it boasts significant technological and service barriers.
In terms of the preclinical immunology platform, Shanghai Paisixin Biomedical Technology Co., Ltd. can provide precise analysis for needs such as immune cell phenotyping, functional cell profiling, immune checkpoint characterization, biomarker detection, PD/PK studies, receptor occupancy, and tumor microenvironment immune profiling, having already accumulated a substantial portfolio of case studies.
Shanghai Paisixin Biomedical Technology Co., Ltd. possesses compliant sources of PBMCs and HSC hematopoietic stem cells, facilitating the construction of various humanized mouse models to support its oncology pharmacology research platform. Currently, the platform’s humanized mouse models encompass more than 20 cancer types and over 200 tumor models. Additionally, the platform offers services including analysis of the tumor immune microenvironment, as well as detection of cytokines and chemokines.
Paisixin Humanized Mouse Models: Covered Disease Indications (Image source: Compiled by Paisixin)
At Shanghai Paisixin’s new inflammatory pharmacology platform, in addition to focusing on autoimmune diseases such as inflammatory bowel disease, arthritis, psoriasis, atopic dermatitis, experimental autoimmune encephalomyelitis (EAE), systemic lupus erythematosus (SLE), and IgA nephropathy, disease models for respiratory, cardiovascular, hepatic, renal, diabetic, bone-related disorders, sepsis, and rare diseases have also been established, with stability reaching industry-leading standards.
Paisixin Inflammation Pharmacology Platform (Image source: Compiled by Paisixin)
In building its in vitro research platform services, Shanghai Paisixin Biomedical Technology Co., Ltd. not only provides basic offerings such as traditional in vitro diagnostic analysis, drug target discovery, and clinical sample testing, but is also currently conducting research on artificial livers. The company plans to establish a differentiated advantage with high patent barriers for this platform through its organoid projects.
Under the years-long guidance of expert teams specializing in EU CE, US FDA, UK UKCA, and China GMPA certifications, Shanghai Paisixin Biomedical Technology Co., Ltd. has established an innovative pharmacokinetics (PK) and toxicokinetics (TK) research and testing platform featuring high-throughput, high-sensitivity, scalable capabilities, and full international alignment at an advanced global level. This platform comprehensively supports drug development from early-stage screening through to preclinical Investigational New Drug (IND) requirements. Demonstrating its distinctive expertise, the company provides tailored services based on diverse drug delivery systems, covering physicochemical properties, permeability studies, transporter studies, drug distribution and protein binding studies, metabolic stability studies, metabolite identification, and metabolism-related drug-drug interaction studies, backed by a robust portfolio of real-world case studies.
Overall, Paisixin has implemented the majority of innovative therapies across multiple disease areas, including oncology, immune diseases, and metabolic disorders, providing support services ranging from drug discovery and preclinical studies to clinical trials.
In addition to its high-quality, comprehensive technical service platform, Shanghai Paisixin Biomedical Technology Co., Ltd. also clearly recognizes its advantages in corporate nature, model quality control, and customized services.
Shanghai Paisixin Biomedical Technology Co., Ltd. holds the filing for international collaborative clinical trials involving Chinese human genetic resources. Leveraging its status as a fully Chinese-funded enterprise, it possesses distinct competitive advantages in the translational services of large-molecule drugs. In contrast to the significant hurdles posed by the Human Genetic Resources Administration regulations—such as prolonged application timelines and complex procedures—entrusting international multi-center collaborative projects to Shanghai Paisixin enables rapid and compliant completion of the required filings, thereby accelerating the new drug development process.
In the realm of pharmacological research platforms and model development, Shanghai Paisixin Biomedical Technology Co., Ltd. has reaped the rewards of its persistent efforts. The company has established stable models for complex diseases, such as IgA nephropathy and severe sepsis, along with specialized drug delivery systems. As these areas remain challenging frontiers for CRO companies both in China and abroad, Paisixin’s ability to consistently deliver such disease models has quickly attracted industry interest, successfully paving the way for new forms of business collaboration.
From technical capabilities to service offerings, “small but comprehensive”—this is precisely the key that enables Shanghai Paisixin Biomedical Technology Co., Ltd. (“Paisixin”) to more accurately grasp customer needs and provide customized services with greater flexibility. As a niche contract research organization (CRO), Paisixin boasts higher flexibility in protocol adjustments and experimental scheduling, and can devote more time and manpower to thoroughly understand client requirements. This is particularly crucial for innovative drug R&D, which is characterized by high levels of innovation, diverse technologies, and complex breakdowns of requirements. Meanwhile, the company ensures result quality and enhances customer stickiness through flexible, customized services. Furthermore, based on in-depth communication with clients, it promptly keeps abreast of industry dynamics, thereby maintaining the advanced nature of its services.
Shanghai Paisixin, established in 2021, has set up a facility of nearly 3,000 m² in Zhangjiang Science City, Pudong, Shanghai.2standalone R&D center, which includes an SPF-grade laboratory animal center and a P2-registered clinical central laboratory. It is fully registered with the Human Genetic Resources Administration of China (HGRAC) as a domestically funded entity and has served over 100 client companies to date.
Paisixin Human Genetic Resources Service Qualification (Source: Paisixin)
In 2022, Shanghai Paisixin Biomedical Technology Co., Ltd. was recognized as a “National High-Tech Enterprise” by virtue of its outstanding independent innovation capabilities and R&D organizational management standards.
A company established just two years ago has managed to build such a rich and comprehensive technical platform, lay out its business projects, and successfully accumulate a substantial customer base, all thanks to the resource and financial support from Sunshine Noah. However, “one must be strong oneself to forge iron.” The founding team and core talent team of Shanghai Paisixin Biomedical Technology Co., Ltd. have played an indispensable role in achieving the current stage of success.
Paisixin’s Partial Patent Certificates (Image Source: Paisixin)
The founding team of Shanghai Paisixin Biomedical Technology Co., Ltd. boasts complementary academic backgrounds and professional experiences. The founders have accumulated 15 to 25 years of research and work experience in fields such as immunology, pharmacological platforms, mechanism-of-action studies, disease model development, tumor stem cell diagnostics, and safety assessment. All founders have previously worked at leading pharmaceutical companies and pharmaceutical CXO firms both in China and abroad. Meanwhile, the company’s overall R&D service team also possesses extensive experience in standardized quality systems from large domestic pharmaceutical enterprises. Currently, the company is actively establishing its own standardized system, focusing on operational standards, technical standards, process standards, management specifications, and software infrastructure.
Report on the Results of the Second 2022 Shanghai External Quality Assessment for Clinical Laboratories (Image source: Paisixin)
In the second round of 2022 Shanghai External Quality Assessment for Clinical Laboratories, Shanghai Paisixin Biomedical Technology Co., Ltd. achieved perfect scores in all six flow cytometry parameters it participated in, as assessed by the Shanghai Center for Clinical Laboratory Quality Control. A total of 106 laboratories nationwide participated in this assessment. Shanghai Paisixin’s perfect performance highlights its national leadership in flow cytometry testing capabilities and quality control standards, serving as robust validation of the company’s testing technology and stable quality control system.
With the surging popularity of innovative drug R&D in the domestic market and continuous capital infusion, leading experts and professors from universities and research institutes are increasingly engaging in the market-driven competition for scientific and technological translation. Consequently, the demand for clinical validation in China is expected to maintain a sustained high growth rate in the future.
The sustained boom in the “upstream” sector presents a challenging yet significant opportunity for clinical translation services. On one hand, clinical translation services for innovative drugs demand high technical barriers and a comprehensive strategic layout; on the other hand, regulatory compliance and standardization in this increasingly crowded landscape must never be taken lightly. This is particularly true in niche areas where product regulations and guidance standards are not yet fully established, requiring the core team to possess extensive experience in drug approval processes.
Therefore, Shanghai Paisixin will continue to increase its investment in standardizing its internal systems, further expand its differentiated advantages in specialized fields such as companion diagnostics, organoid platforms, medical imaging, brain science, and CIS-related diseases, while continuously optimizing its hardware and software infrastructure and strengthening intellectual property protection for clients, thereby serving them with a scientific and rigorous approach.
As data, cases, and experience continue to accumulate, Shanghai Paisixin Biomedical Technology Co., Ltd. plans to elevate its service offerings from outstanding biotech companies to large-scale biopharmaceutical enterprises. The company also intends to gradually establish business centers in overseas regions such as Southeast Asia, Europe, and the United States, thereby helping client companies maintain acute awareness of cutting-edge information and bolstering their sustainable innovation capabilities.