The platform provides end‑to‑end quality development through a closed‑loop system spanning candidate assessment, cell line development, upstream/downstream processing (culture, purification, formulation, scale‑up), tech transfer, and commercial manufacturing. With >100 advanced analytical instruments (HRMS, CE, flow cytometry, etc.), it supports structural characterization, impurity profiling, bioactivity/immunogenicity testing, residual analysis, and stability studies for comprehensive quality characterization. Aligned with ICH Q guidelines, it also performs forced degradation, compatibility, and shipping simulation studies to support US/China/EU filings, ensuring global data mutual recognition and enhanced international regulatory compliance.
Core technologies and commercial manufacturing costs are driven by host cells, high-efficiency expression vectors, proprietary media formulations, and optimized manufacturing workflows. Our in-house medium development supports cost-effective industrial production. Optimizing project-specific basal media and feed formulations enables us to modulate product charge variants (acidic/basic isoforms) and glycan profiles, improve protein purity, and reduce impurities such as incomplete fragments. These improvements are critical to enhancing overall product quality. Self-developed media cut costs and reduce dependence on external vendors compared to outsourced alternatives.
Leveraging proprietary antibody engineering technologies, we have established a comprehensive antibody optimization platform featuring two core modules. The first enables production of fully afucosylated antibodies through a proprietary host cell engineering system, eliminating fucose-mediated hindrance of FcγRIIIa (CD16a) binding to significantly enhance ADCC activity for more effective immune cell-mediated tumor killing—this platform is GMP-compliant and clinically validated. The second comprises multiple long-acting antibody platforms developed through rational Fc engineering to optimize pharmacokinetic profiles across monoclonal antibodies, bispecific/multispecific antibodies, and ADCs, enabling extended dosing intervals and improved efficacy.
Leveraging our proprietary cleavable linker technology, the company has developed novel ADCs that conjugate antibodies with topoisomerase inhibitor payloads, enabling potent antitumor activity. These next-generation ADCs exhibit a strong bystander effect, driven by the high membrane permeability of the payloads. Upon tumor cell killing, the payloads are released and penetrate into adjacent cancer cells, effectively overcoming tumor heterogeneity. Meanwhile, minimal payload release in plasma ensures exceptional stability and safety, significantly reducing off-target toxicity. Building on this, we are advancing a dual/multi-specific dual-payload ADC platform that enables precise dual-targeting and synergistic delivery of two distinct payloads. This approach coordinates dual mechanisms of action to combat drug resistance and offers a transformative solution for enhanced cancer therapy.
Leveraging proprietary high-quality data accumulated through years of R&D—including antibody sequences, activity, expression levels, thermal stability, and aggregation propensity—we have built a high-resolution "sequence–structure–function" mapping database. Integrating computational biology, structural analysis, and machine learning, our platform continuously enhances antibody prediction and engineering capabilities. By systematically capturing success drivers and risk signals from failed candidates, it enables early-stage sequence optimization and risk correction for complex molecules such as bispecific antibodies and multifunctional fusion proteins. This approach accelerates the translation from sequence design to expression development, offering distinct advantages in tackling difficult targets and developing novel antibody formats.
We have established a human antibody library system with hundreds of billions of unique clones, coupled with mature phage display and yeast display technology platforms. Building on these capabilities, we developed IDEAL (Intelligent Design and Engineering Antibody Libraries), our proprietary antibody discovery engine. Powered by intelligent screening strategies, IDEAL efficiently identifies candidate molecules from vast human antibody sequence spaces that exhibit both favorable binding characteristics and strong developability. Critically, it incorporates early-stage systematic assessment of stability, expression efficiency, and aggregation risk—even for complex antibody formats—enhancing format compatibility and drug-like properties at the source.