TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
Innovation
Through the IMTB technology platform, we are able to generate antibodies targeting both non-conserved and conserved protein sequences. Such antibodies are difficult to generate in rodents using conventional platform technologies, which also face challenges in identifying these otherwise hidden epitopes. The IMTB technology platform enables us to obtain antibody candidates targeting a broad diversity of epitopes, with superior pharmacological efficacy and robust CMC manufacturability, providing our antibody candidates with enhanced drug-like properties and a strong intellectual property position. Leveraging the IMTB technology platform, we have generated a number of antibody candidates, including Osemitamab (TST001), TST005, TST003, TST004, TST010, TST012, TST013, TST008, and TST801.
Our translational research leverages validated quantitative platforms to generate PK, PD, toxicology, and immunogenicity data to support the modeling of clinical responses to investigational drugs, enabling a more comprehensive understanding of their PK/PD and safety profiles and informing the design and execution of clinical studies. We provide scientific evidence to support the selection of best-in-class drug candidates and evaluate combination therapy options involving agents targeting different disease signaling pathways. In addition, we have established and utilized target detection platforms based on immunohistochemistry (IHC)-screenable antibodies and developed companion diagnostics for patient selection and stratification in clinical trials, enabling us to enroll patients who are more likely to respond to treatment in selected indications and thereby improve the probability of clinical trial success.
Process development plays a critical role throughout biopharmaceutical candidate lifecycle from early discovery all the way to post-marketing surveillance, including target validation, genetic engineering, cell line development, cell culture/purification process development, analytical method development, formulation development and GMP manufacture. In the race to IND filing and clinical trials, companies with deep CMC knowledge and capability often find themselves have an edge over their competitors.
Transcenta has a highly capable and well-rounded CMC development team covering all technical aspects of biologics development. By effectively balancing speed, quality and cost, the team can rapidly advance promising drug candidates toward IND filings and clinical development.
In terms of manufacturing processes, Transcenta has established its HiCB (Highly Intensified Continuous Bioprocessing) platform. It replaces stop-and-go batch processing with 30-day continuous perfusion, where cells are maintained at high densities in a tightly controlled and optimized environment, delivering 10–15x productivity gains.
Perfusion is especially advantageous for certain less stable bispecifics, multispecifics and other complex formats, helping reduce degradation or aggregation while ensuring product quality and batch-to-batch consistency. Complementing continuous perfusion upstream, the platform adopts a hybrid continuous downstream approach to improve efficiency and maximize facility output while remaining robust and easy to implement.
Leveraging our expertise, global footprint and perspective, we adopt a global approach to maximize operational efficiency. Concurrently, we leverage the efficient regulatory approval pathway in the United States to accelerate IND applications and early-phase clinical trials in the United States, while continuing to advance clinical trials in China across multiple indications with large patient populations and significant unmet medical needs.
Our global, multi-regional clinical trials are designed to allow clinical data from individual trials to be used for pooled analysis and to support global registration, and to enable future indication expansion of the drug(s) investigated in the countries and regions where we plan to operate. Based in Beijing, Shanghai, Guangzhou and Princeton, US, our global clinical development and regulatory teams focus on indications with significant unmet medical needs globally and have extensive knowledge and experience in designing and executing clinical trials at all stages.
