We deliver innovative medicines through integrated research, development, manufacturing and commercialization strategy.
With the highest ethical standards, our team is driven by a mindset of relentless innovation, and a passion for improving the lives of patients.
Our innovative discovery engine is built around a group of seasoned immunologists with extensive experience. Our world-class expertise in immunology drives the identification and development of novel targets, molecules and modalities.
Our discovery team is passionate about, and has excelled in, developing novel and highly differentiated antibodies, for example:
- Our proprietary CD47 antibody lemzoparlimab (TJC4), with a rare epitope, uniquely spares binding to red blood cells, which is different from other CD47 antibodies that typically cause hematologic side effects
- Our novel bi-specific antibody TJ-L14B is capable of reversing immunosuppression and activating immune cells for a synergistic anti-tumor effect, potentially rendering tumors more responsive to treatments
Our non-clinical team consists of seasoned scientists with extensive experience of pre-clinical development of innovative drugs in China and globally. We design and manage efficacy and safety studies using appropriate in vitro and in vivo models to support candidate selection, lead optimization and clinical development of new drugs based on the target biology and pharmacological mechanism of action.
Our focus on developing innovative drug molecules demands the ability to apply relevant biomarkers that link drug response to treatment efficacy. This translational medicine capability requires cross-functional knowledge and unique skills to link the target biology of an investigational drug to clinical responses in selected patients.
We have developed proprietary and tailor-made biomarkers for each of our investigational drugs, which are used to select potential responders, to predict and measure target engagement, to support dose selection, and to enable timely informed decisions on advancing our assets to the next phase of clinical development.
We have established a new site focusing on Translational Medicine and Formulation Research in San Diego. It further strengthens our ability to conduct global clinical studies across China and the U.S.
Our clinical development team has extensive global and local drug development experience, and operational experience with clinical networks in China and the US. Our team has the ability to integrate internal core development functions encompassing regulatory affairs, translational medicine, clinical research and operations, data management, biostatistics, clinical safety and pharmacovigilance, portfolio and project management, and global drug supplies.
We also effectively leverage external resources, including clinical contract research organizations (CROs), academic clinical centers and networks, and play critical roles in collaborating with our global partners to conduct technical assessments of in-licensing and out-licensing compounds to support business development priorities.
We have established and implemented a robust internal clinical governance system, including development governance, standard operating procedures (SOPs), protocol review committees, safety steering committee and systematic vendor assessment and management processes, all designed to safeguard patient safety and data reporting.
Our chemistry, manufacturing, and controls (CMC) team is managed by a team of experts covering the full spectrum of technical capabilities, including cell line development, cell culture and purification process development, analytical and formulation development, GMP manufacturing, quality control and assurance, as well as CMC regulatory support.
Our scientists have participated in a wide range of projects including monoclonal antibody and fusion protein, as well as challenging bi-specific or bi-functional molecules. The team actively manages contract development and manufacturing organizations (CDMOs). Meanwhile, we are establishing our own capabilities and infrastructure, including a manufacturing facility, which will provide us with enhanced control of material supply for both clinical trials and the commercial market, enable rapid implementation of process changes and help us achieve better long-term margins.
We believe it is advantageous that we own and control our GMP manufacturing process in order to ensure quality and secure production slots for clinical trial materials and commercial supplies. Our own state-of-the-art biologics manufacturing facility in Hangzhou is under construction.
- Pilot Capacity: Process and analytical development laboratories have been established and in execution for investigational new drug (IND) stage demand, currently with three 2,000-liter scale biologics manufacturing lines
- Commercial Capacity: GMP operations and quality systems will be fully compliant with standards and requirements of China’s National Medical Product Administration (NMPA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA), with nine 6,000-liter lines to be established