Indication:
The treatment of Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.
Fulvestrant in women with disease progression following endocrine therapy.
Strength: 75mg/100mg/125mg
Innovator: Pfizer Limited/ Pfizer Europe MA EEIG
Innovative Brand: IBRANCE
Has passed Consistency Evaluation
(2023.11)
Qualification: Approved in China. Preparing to export to Central America
1. The BE study conducted using the RLD produced by the original Pfizer European site can meet the requirements of the European Medicines Agency (EMA).
2. The stability of the API and the formulation is currently only evaluated in accordance with Chinese requirements. If stability data for other climatic zones is required, additional stability data can be provided based on different market demands.
Key selling points: 
1. Palbociclib, as a CDK4/6 inhibitor, exhibits high specificity and selectivity, demonstrating significant efficacy in the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
2. With the broadening of its indications, palbociclib is no longer limited to the treatment of breast cancer but also shows potential in other cancer types. For instance, it has demonstrated notable efficacy in clinical trials for HR+/HER2- metastatic gastric cancer, suggesting its potential use in other tumor types as well.