When will Alpelisib be launched in China?

Alpelisib (Alpelisib)-Piqray’s original drug has not yet received official marketing approval in China. Therefore, domestic patients cannot purchase it through conventional channels for the time being, nor can it be included in the medical insurance system. Its price and reimbursement status are still unclear. Apelvis is mainly used internationally for patients with HR-positive, HER2-negative advanced or metastatic breast cancer with PIK3CA mutations, and is usually used in combination with the endocrine drug fulvestrant. The clinical application of this drug emphasizes precision medicine, that is, the best efficacy can be achieved in patients with clear PIK3CA mutations. Therefore, molecular testing is an important step before treatment.

Apelixin treats HR-positive, HER2-negative advanced breast cancer by selectively inhibiting the PI3Kα signaling pathway and blocking tumor cell proliferation and survival signals, thereby restoring sensitivity to endocrine therapy and delaying disease progression. It is considered in international guidelines as a key supplement after the progression of endocrine therapy, especially for postmenopausal women and men. Overseas clinical studies have shown that combined use with fulvestrant can significantly improve patients' progression-free survival and treatment response rate, and is well tolerated.

In China, although the launch time has not yet been determined, with the increase in the approval speed of precision medicine and targeted drugs, as well as the growing demand for PIK3CA mutation detection, Apelvis is expected to be introduced into the domestic market in the future to provide new treatment options for eligible breast cancer patients. While waiting for launch, domestic doctors and patients should pay attention to the progress of drug approval, understand overseas drug use experience, and evaluate potential benefits and risks under professional guidance. Scientific management of medication time and dosage, combined with molecular testing results, can help ensure the safety and efficacy of treatment and provide more precise and personalized treatment plans for patients with advanced breast cancer.

Reference materials:https://go.drugbank.com/drugs/DB12015