Palbociclib

HR-positive/HER2-negative breast cancer accounts for approximately 70% of all breast cancer cases. The proliferation of tumor cells in such patients is highly dependent on the abnormal activation of cyclin-dependent kinase 4/6 (CDK4/6). Palbociclib is the world's first orally administered selective CDK4/6 inhibitor approved for marketing. It blocks the progression of the cell cycle from the G1 phase to the S phase, thereby inhibiting the proliferation of tumor cells. In clinical practice, it is mainly used in combination with aromatase inhibitors or fulvestrant for the first-line and subsequent treatment of patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer. It significantly prolongs the progression-free survival of patients, shifts the treatment mode of advanced breast cancer from traditional chemotherapy to precise targeted therapy, and remarkably improves the quality of life of patients.

The peak global market size of palbociclib once exceeded 5 billion US dollars. With the expiration of patents and the successive launch of generic drugs, its market size has declined to some extent. However, driven by the overall market growth of CDK4/6 inhibitors, it still maintains stable clinical demand. In terms of the domestic market, more than 30 enterprises have submitted marketing applications for generic palbociclib, among which products from more than 10 enterprises have been approved for marketing. In addition, this variety has been included in the National Medical Insurance Catalogue, and the price has dropped by more than 80% after medical insurance negotiations, which greatly improves the accessibility for patients and drives the continuous increase in demand for active pharmaceutical ingredients (APIs).

The original research enterprise of palbociclib is Pfizer, with the trade name Ibrance. The expiration date of its core compound patent in China is January 10, 2023. The main dosage form approved for the original drug is capsules, with three specifications including 75mg, 100mg and 125mg. It has been included in the Catalogue of Marketed Drugs in China as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalogue. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has publicly announced more than 20 registration entries of palbociclib APIs, most of which are in status A and can support the associated review for the marketing of domestic preparations. A number of oral palbociclib preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of palbociclib impurity reference standards. Most products are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for API and preparation enterprises in links such as quality research, stability study, registration and declaration.