By integrating internal quality R&D resources, the Company has built a full-spectrum quality platform complying with NMPA, FDA and EMA rules. It provides end-to-end lifecycle management from early discovery, clinical filing to commercial manufacturing, supporting R&D and industrialization of mAbs, bispecifics, ADCs and recombinant nanoparticle vaccines.
We also developed a closed-loop process development system covering candidate druggability evaluation, high-yield cell line development, upstream/downstream process scaling and tech transfer for commercial production to support full-cycle drug development.
In line with ICH Q guidelines, our established protocols include forced degradation, compatibility stability and shipping simulation studies, facilitating cross-border registration in China, the US and EU and global recognition of comparability data to boost our international-compliant R&D competence.
Antibody drugs are manufactured via mammalian cell culture. Core technologies and commercial manufacturing costs depend on host cells, high-efficiency expression vectors, custom proprietary media and optimized manufacturing workflows.
Our in-house medium development supports cost-effective industrial production. Project-specific basal and feed formulations modulate charge variants and glycan profiles, improve protein purity and truncate impurities including incomplete fragments to upgrade product quality.
Self-developed media cuts costs and lessens dependence on external vendors vs. outsourced medium sourcing.
Leveraging proprietary antibody engineering technologies, we built an integrated antibody optimization platform with two core modules.
First, engineered host cell lines produce afucosylated antibodies to remove fucose-mediated inhibition on FcγRIIIa (CD16a) binding, markedly boosting ADCC for robust tumor killing via recruited immune cells. This GMP-compliant technology has been clinically validated.
Second, targeted Fc modification yields multiple long-half-life platforms that improve PK profiles for mAbs, multispecific antibodies and ADCs, enabling extended dosing intervals and superior therapeutic outcomes.
With our proprietary cleavable linkers, we conjugate antibodies to Topo I inhibitor payloads to create potent, novel ADCs. These ADCs exert robust bystander effects: the released lipophilic payload penetrates adjacent tumor cells to overcome tumor heterogeneity, while negligible free payload leakage in plasma ensures superior stability and reduced off-target toxicity. We are further developing a dual-payload ADC platform featuring bispecific/multispecific backbones. Synergistic dual payloads with divergent mechanisms are co-delivered via dual targeting to reverse drug resistance, offering next-generation cancer therapy options.
Drawing on proprietary high-quality datasets of antibody sequences, bioactivity, expression yield, thermal stability and aggregation profiles accumulated over years of R&D, we have built a high-precision database mapping sequence-structure-function.
Integrating computational biology, structural analysis and machine learning, the platform iteratively improves antibody prediction and engineering optimization. By learning from favorable attributes of validated candidates and risk indicators of failed projects, it enables targeted sequence optimization and risk mitigation at the early design stage of complex molecules including bispecific antibodies and multi-functional fusion proteins. This shortens the turnaround from in silico design to protein expression, empowering our competitive edge in tackling challenging targets and developing sophisticated antibody formats.
We have established human antibody libraries with hundreds of billions of unique clones, alongside mature phage and yeast display platforms. Based on these infrastructures, we independently developed the IDEAL (Intelligent Design and Engineering Antibody Libraries) antibody discovery engine.
Centered on intelligent screening algorithms, IDEAL efficiently identifies lead candidates with favorable binding profiles and druggability from massive human antibody sequence pools. Early-stage comprehensive evaluation is implemented to assess candidate stability, expression performance and aggregation risk under diverse complex formats, improving molecular compatibility and developmental potential at source.
Empowered by above strengths, IDEAL consistently delivers high-quality antibody hits across varied targets, serving as a robust and sustainable innovation engine fueling our in-house antibody pipeline.
