pp-047 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
China
Comments
Indication: HER2-positive metastatic and locally advanced breast cancer after prior therapy; HER2-altered including HER2 exon20-mutated NSCLC. Clinical stage: Marketed in China since 2018 for HER2+ MBC; Phase III/II ongoing in breast cancer and NSCLC. Modality: Oral irreversible pan-HER small molecule TKI. Mechanism: Inhibits EGFR/HER2/HER4 signaling. Route / form: Oral, typically administered once daily in fixed dose, commonly in combination with capecitabine or taxane-based chemotherapy. Differentiation: First-in-class in China; strong efficacy vs lapatinib and CNS activity.
Manufacturer #17216
Global developer of innovative drugs in oncology, metabolic, autoimmune, and cardiovascular diseases, with 14 in-house products and multiple partnerships. Over 5,000 R&D staff across global centers and strong IP, clinical pipeline, and high-standard manufacturing.
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