Biologics

P-052 - A PHASE 1 STUDY COMPARING THE PHARMACOKINETICS, SAFETY AND IMMUNOGENICITY BETWEEN HLX12, A PROPOSED RAMUCIRUMAB BIOSIMILAR, WITH REFERENCE RAMUCIRUMAB IN HEALTHY CHINESE MALES.

P-072 - LITERATURE REVIEW OF THE DDI POTENTIAL FOR THERAPEUTIC PROTEINS (TPS) WITH PROINFLAMMATORY ACTIVITIES AND UTILIZATION OF COCKTAIL STUDIES AND IN SILICO METHODS FOR THE DDI ASSESSMENT.

P-075 - PHARMACOKINETICS AND PHARMACODYNAMICS OF GS-1423, A FIRST-IN-CLASS BIFUNCTIONAL ANTIBODY TARGETING CD73 AND TGFΒ, IN SUBJECTS WITH ADVANCED TUMORS.

P-076 - A PHASE 1 STUDY EVALUATING THE BIOEQUIVALENCE BETWEEN HLX11, A CHINA-MANUFACTURED PERTUZUMAB BIOSIMILAR CANDIDATE, AND PERTUZUMAB FROM THREE DIFFERENT SOURCES IN HEALTHY CHINESE MALE SUBJECTS.

P-084 - DEVELOPMENT AND APPLICATION OF A QSP MODEL FOR CELL THERAPIES IN DLBCL DISEASE.

P-093 - A PHASE 1 STUDY OF SERPLULIMAB (A NOVEL ANTI-PD-1 ANTIBODY) IN COMBINATION WITH HLX04 (AN ANTI-VEGF ANTIBODY) IN PATIENTS WITH ADVANCED SOLID TUMORS.

P-111 - DEVELOPMENT OF A DISEASE QSP MODEL OF CHRONIC LYMPHOCYTIC LEUKEMIA: APPLICATIONS FOR CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL THERAPY MONOTHERAPY AND COMBINATIONS.

P-146 - A MECHANISTIC MODELING FRAMEWORK INTEGRATES LONGITUDINAL CHANGES IN CAR-T CELL IMMUNOPHENOTYPES TO CHARACTERIZE CELLULAR KINETICS IN CANCER PATIENTS.

P-147 - A MULTISCALE MECHANISTIC MODEL DESCRIBES DIFFERENTIAL CELLULAR KINETICS OF CD4 AND CD8 SUBSETS OF CAR-T CELL PRODUCT IN CANCER PATIENTS.

P-148 - PHYSIOLOGICALLY-BASED PHARMACOKINETIC (PBPK) MODELING CHARACTERIZES THE INTERACTION POTENTIAL BETWEEN IMMUNOGLOBULIN AND MONOCLONAL ANTIBODIES IN PRIMARY HUMAN IMMUNODEFICIENCY PATIENTS.

P-187 - RISK ASSESSMENT FOR POTENTIAL DRUG-DRUG INTERACTIONS (DDI) FOR BINTRAFUSP ALFA: A TOTALITY OF EVIDENCE APPROACH INFORMED BY EVALUATION OF CYP3A BIOMARKER MODULATION, CYTOKINE PROFILES, AND TGF-β TRANSCRIPTOMICS.

P-188 - QUANTITATIVE COMPARISON OF PRECLINICAL AND CLINICAL CELL FUNCTIONALITIES OF APPROVED CAR-T PRODUCTS: A RETROSPECTIVE ANALYSIS TO FACILITATE TRANSLATION.

P-204 - A RANDOMIZED PHASE 1 STUDY EVALUATING THE PHARMACOKINETIC EQUIVALENCE OF PROPOSED BIOSIMILAR HLX14 AND DENOSUMAB IN HEALTHY CHINESE VOLUNTEERS.

P-206 - A RANDOMIZED PHASE 1 STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, TOLERABILITY AND IMMUNOGENICITY BETWEEN HLX02, REFERENCE US- AND EU-APPROVED TRASTUZUMAB IN HEALTHY CHINESE MALE VOLUNTEERS.

PT-015 - CHARACTERIZATION OF CAR-T CELLULAR KINETICS AND EFFICACY IN PATIENTS WITH SOLID TUMORS IN PRESENCE OR ABSENCE OF PRIOR LYMPHODEPLETION CHEMOTHERAPY USING A PBPK-PD MODEL.

PT-015 - CHARACTERIZATION OF CAR-T CELLULAR KINETICS AND EFFICACY IN PATIENTS WITH SOLID TUMORS IN PRESENCE OR ABSENCE OF PRIOR LYMPHODEPLETION CHEMOTHERAPY USING A PBPK-PD MODEL.

PT-021 - DEVELOPMENT OF A TRANSLATIONAL PBPK-PD FRAMEWORK TO CHARACTERIZE CELLULAR KINETICS AND BIODISTRIBUTION OF CAR-T CELLS IN MICE AND CANCER PATIENTS.

PT-021 - DEVELOPMENT OF A TRANSLATIONAL PBPK-PD FRAMEWORK TO CHARACTERIZE CELLULAR KINETICS AND BIODISTRIBUTION OF CAR-T CELLS IN MICE AND CANCER PATIENTS.

LB-009 - POPULATION PHARMACOKINETIC ANALYSIS OF GARADACIMAB IN SEVERE COVID-19 SUBJECTS.