Based on an in-depth analysis of product characteristics and positioning, the medical team leads the planning of customized clinical development strategies, with the clinical pharmacology, biostatistics, and pharmacovigilance teams jointly designing the optimal early-stage trial protocols. Leveraging early clinical research collaboration platforms established with leading hospitals and clinical experts in China, we can rapidly obtain early human data, providing strong support for advancing projects into the proof-of-concept stage, and actively cooperate with the product's business planning.

Before first-in-human (FIH) trials, multiple departments such as medical, clinical pharmacology, biostatistics, bioanalysis, and operations will collaborate together. Through comprehensive data evaluation—including product characteristics, dosage selection, dose escalation settings, innovative design, target and pharmacokinetic testing, risk assessment, and site survey—we formulate clinical protocols and trial plans. With efficient communication with partner centers, we rapidly advance the trial process. Meanwhile, we have our own recruitment platform—Recruitment Assistant—which efficiently aids in the rapid enrollment of subjects. For innovative drugs, abundant multi-level clinical resources are available to conduct investigator-initiated trials (IITs), facilitating rapid advancement, trial-and-error, decision-making, and plan adjustments.

In line with product characteristics and development strategies, we can also provide efficient and feasible Phase I/II adaptive clinical trial designs to obtain reliable safety and efficacy data, achieving the goal of safety confirmation and preliminary efficacy evaluation in FIH trials. We help research and development enterprises significantly compress the clinical development cycle and costs, facilitate rapid decision-making, and provide data support for broader late-stage development and collaboration pathways.