pp-171 Concentrate for solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Comments
Indication: HER2-positive gastric/gastroesophageal junction cancer (1L); HER2+ breast cancer
Clinical stage: Phase 3 — HLX22-GC3L (1L HER2+ gastric) ongoing
Modality: Biologic (anti-HER2 monoclonal antibody — novel epitope)
Mechanism / Target: Binds a distinct HER2 epitope (domain II) different from trastuzumab (domain IV) — potential for complementary or non-cross-resistant activity; blocks HER2 homodimerization and signalling
Route / form: Intravenous infusion
Differentiation: Novel HER2 epitope differentiated from trastuzumab; may be active in trastuzumab-resistant settings; combination potential with pembrolizumab/chemotherapy in 1L gastric cancer
Manufacturer #15340
Clinical-stage and commercial biopharmaceutical company specialising in oncology biologics. Combines proprietary monoclonal antibody and ADC technologies for gastrointestinal and lung cancers. Wholly owned pipeline with Phase 3 and Phase 2 assets advancing globally.
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