The progress and prospects of the domestic listing of Apelix-Piqray

Alpelisib (Alpelisib)-Piqray has not yet been officially launched in mainland China, but its wide application in the international cancer treatment field has attracted great attention in the industry. As a precision treatment drug targeting PIK3CA mutations, Piqray has been approved by the US FDA and European EMA for the treatment of patients with specific types of advanced breast cancer. Its unique mechanism of action makes it a key drug to break through endocrine therapy resistance, especially for patients with hormone receptor-positive and PIK3CA mutations.

There is currently no public information in the country showing that the National Food and Drug Administration (NMPA) has approved Piqray for marketing. However, judging from the introduction of innovative drugs, the review speed of anti-tumor targeted drugs in China is accelerating. Piqray's overseas successful experience has laid a good foundation for its entry into the Chinese market, and has also stimulated the interest of relevant domestic research institutions in the research and development of PI3K pathways. According to industry sources, many multinational pharmaceutical companies and domestic domestic pharmaceutical companies have carried out clinical trials of PI3K target drugs in an attempt to promote localized indication expansion or the development of generic drugs.

AlthoughPiqray has not yet entered the Chinese drug market, but its generic drugs have been approved in many countries, including India and Bangladesh, and the price has dropped significantly compared with the original drug. These generic drugs are basically the same in terms of ingredients, dosage and efficacy. Some domestic patients obtain drug support treatment through overseas channels. However, this approach still faces practical challenges such as regulations, drug source safety and drug monitoring.

Looking from the future outlook,Piqray is expected to accelerate its launch in China as more Asian clinical data accumulates. Its precision treatment concept is in line with the country's policy direction of promoting personalized cancer treatment, and can also alleviate breast cancer patients' urgent need for efficient targeted drugs. If drugs are successfully included in the medical insurance catalog, their accessibility and market acceptance will be greatly improved.

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