When will Apelvis-Piqray be officially launched in China?

Alpelisib(Alpelisib)-Piqray is a targeted anti-cancer drug that has attracted widespread attention worldwide. Its mechanism of action mainly inhibits the PI3Kα isoform in the PI3K signaling pathway, thereby specifically inhibiting the growth and metabolism of tumor cells related to PIK3CA mutations. This innovative drug was the first to be approved by the U.S. Food and Drug Administration (FDA) in 2019, becoming the world's first targeted drug approved for the treatment of patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. This move is regarded as a major breakthrough in the medical field, and also makes PIK3CA mutations a key molecular marker that cannot be ignored in breast cancer treatment decisions.

However, as of now,Piqray has not yet received formal marketing approval from the National Medical Products Administration (NMPA) in mainland China. This situation has also aroused the concern and anxiety of a large number of breast cancer patients and oncologists. Today, when cancer treatment is increasingly moving towards molecular targeting and personalized medicine, the absence of Apelvis has indeed left a blank in China's breast cancer precision treatment landscape. Although domestic progress has been made in the treatment of common breast cancer subtypes such as HER2-positive and HR-positive breast cancer, there is still a lack of targeted oral targeted therapies for this subgroup with PIK3CA mutations.

In fact,The incidence of PIK3CA mutations in Chinese breast cancer patients is not low. Related studies have shown that the detection rate of this mutation in HR+/HER2- advanced breast cancer patients can reach 30%-40%. This group of patients is precisely the group most likely to fall into a treatment bottleneck after hormone therapy gradually fails, so the need for Apelvis is particularly urgent clinically.

Although it has not yet been launched in China, Apelis' overseas usage data and real-world experience have provided strong support for its future implementation in China. Especially in the strategy of combined use with fulvestrant, it has been shown to have clear disease control advantages in patients with PIK3CA mutations.

Reference materials:https://www.piqray.com/