We are a clinical stage biopharmaceutical company that integrates the capacities of discovery, research, development, manufacturing and business development. Our management team and the key operations, including clinical development, regulatory access and business development are based both in China and the United States, whereas our discovery, research and development, process development and manufacturing teams are based in China. We adopt a global approach to maximize operational efficiency. Concurrently, we leverage the efficient regulatory approval pathway to accelerate the Investigational New Drug (IND) applications and early-phase clinical trials in the United States and to advance clinical trials in the indications with significant unmet medical needs from the large patient population in China. We design trials that allow clinical data from each trial to be used for pooled analysis and for supporting registration, including China, the United States and countries in Europe. In addition, clinical data from multi-regional clinical trials will enable future indication expansion for the drug(s) investigated in the countries and regions where we plan for.
We have developed a unique antibody discovery platform, the Immune Tolerance Breaking (IMTB) technology platform, which enables us to generate antibodies to both non-conserved and conserved proteins that are difficult to generate in rodents and to discover hidden epitopes that are challenging to discover by using conventional platforms. Our IMTB technology platform allows us to obtain lead candidate antibodies with expanded epitope diversity, differentiated biological properties (specificity, affinity and pharmacokinetics) and desirable CMC (chemistry, manufacturing and controls) profiles, resulting in selecting candidate molecules with enhanced druggability attributes and strong intellectual property position. Leveraging this IMTB technology platform, we have generated TST001, which targets a conserved epitope on Claudin 18.2, and MSB2311, an antibody targeting programmed death-ligand 1 (PD-L1), a type of protein that controls immune responses, and binding to an epitope that conferred MSB2311 with pH-dependent antigen binding property. Furthermore, we established a translational research team that is capable of (i) conducting an IHC-based protein expression analysis of the drug target protein in both human and animal tissue samples of various disease models or cell lines; (ii) conducting studies to evaluate the in vivo disease intervention activities of the investigational agents using tumor models grown in mouse or models of bone and kidney diseases; and (iii) analyzing the pharmacokinetics and pharmacodynamics profile of the investigational agents. Our translational research team enables us to model tumor responses to our investigational agents and to better understand pharmacokinetics/pharmacodynamics (PK/PD) profiles, which guides design and conduct of clinical study and evaluates the options of combination therapy with agents targeting different signaling disease pathways. We also have a platform that allows us to screen antibodies for target-detection using immunohistochemistry and to develop immunohistochemistry detection assay for patient selection in clinical trials, which allows us to maximize potential trial success by enrolling patients with a high probability of responding to the drug treatment in selected indications.
Our discovery and global development capabilities have enabled us to build diversified pipeline of innovative and promising antibodies in therapeutic areas with unmet medical needs including oncology, nephrology and bone diseases. As of the Latest Practicable Date, we have discovered and developed eight of nine drug candidates in-house, covering both validated, partially validated and novel biological pathways. In particular, we have one core product: MSB2311, a humanized PD-L1 monoclonal antibody (mAb) candidate for TMB-H solid tumors; and four key drug candidates: TST001, a humanized Claudin 18.2 mAb candidate for solid tumors such as gastric cancer; TST005, a PD-L1/TGF- (transforming growth factor beta is a multipotent growth factor affecting cell differentiation, proliferation, apoptosis and matrix production) bi-functional antibody candidate for solid tumors including certain lung cancers; TST002 (Blosozumab), a humanized sclerostin mAb candidate for osteoporosis; and TST004, a humanized MASP-2 (mannan-binding lectin serine protease 2, an indispensable enzyme for the activation of the lectin pathway of complement) mAb candidate for IgA kidney diseases. In addition to the above drug candidates, we are also developing a number of early-stage innovative biotherapeutic candidates. For example, we are developing TST003, a potentially the first therapeutic antibody candidate around the world targeting a novel immune regulatory protein produced by tumor-associated fibroblasts or tumor cells with mesenchymal phenotype. In addition, we have developed TST008, a tri-functional antibody combining a MASP2 antibody fused with a truncated transmembrane activator and CAML interactor (TACI) protein, which has the potential for the treatment of autoimmune disease such as systemic lupus erythematosus (SLE).
Our CMC function is capable of developing efficient manufacturing processes to support speed to clinical trial and speed to market while ensuring products meet regulatory requirements and are safe, efficacious and consistent between batches throughout product life cycle. We have established a modular GMP (good manufacturing practice) facility, T-BLOC, in Hangzhou, which has two 500L and one 2,000L single use bioreactor and two downstream purification trains. This highly flexible facility supports both fed-batch and continuous perfusion processes with an overall projected annual capacity of over one metric ton (1,000 kg). To increase productivity of conventional fed-batch processes, we have implemented intensified fed-batch processes (high seeding cell density using perfusion seed bioreactor), in which we have demonstrated increases in process output by greater than 100% over conventional fed-batch processes. To maximize facility output with significant lower cost of goods, improve process robustness and minimize operational risks, we are developing and implementing a continuous manufacturing platform called Integrated Continuous Bioprocessing (ICB), where a proprietary and highly productive continuous upstream perfusion process will be integrated with an automated and continuous downstream process that we are co-developing with Merck. By leveraging the power of ultra-high cell density continuous perfusion process and our proprietary cell culture media, we have demonstrated industry leading volumetric productivities of over 6 g/L-day and output increases for multiple cell lines of up to 10 to 20-fold when compared to conventional fed-batch processes. As of the Latest Practicable Date, we have successfully implemented continuous upstream perfusion process into GMP manufacturing for TST005 and will also apply to TST001 in the second quarter of 2021. According to the CIC Report, we are one of the only three companies in China that has implemented continuous perfusion process for GMP clinical supply. This platform can also enhance the control of product quality and can produce both stable and less stable antibodies such as some multi-specific antibodies or novel protein formats, which facilitates standardization of biomanufacturing.
Our core management team members have an average of greater than 15 years of industry experience with proven track record and a well-balanced combination of expertise spanning research, clinical development, manufacturing, planning and financing. Our shareholders consist of global and Chinese biotechnology-focused specialist funds and biopharmaceutical platforms experienced in supporting and growing biopharmaceutical companies. Therefore, we benefit from their resources and industry expertise. As of the Latest Practicable Date, in relation to our core product, we owned one issued patent in each of China, the United States, Macau and Hong Kong, one pending patent application in each of China and the United States and seven pending patent applications in other jurisdictions. As of the Latest Practicable Date, in relation to our key products, we owned three PCT priority applications, one pending PCT application and one pending patent application in Taiwan, and co-owned one PCT priority application with our collaborator, Beijing Cancer Hospital. In addition, we also in-licensed one issued Chinese patent in relation to TST002.
Source: Transcenta-B (06628) Prospectus (IPO Date : 2021/09/14) |