Is Capivasertib tablets/capivasertib officially launched in China?

Capivasertib (Capivasertib) is a new type of targeted anti-cancer drug. It mainly inhibits the activity of AKT kinase and blocks the PI3K/AKT signaling pathway, thereby interfering with the proliferation and survival of tumor cells. Currently, the drug has been approved by the US FDA for the treatment of estrogen receptor-positive, HER2-negative advanced breast cancer, especially for patients with PIK3CA, AKT1 or PTEN mutations. This approval marks the international recognition of its value in precision therapy, and also makes it one of the hot drug concerns in the international oncology community.

As of April 2025, the drug has been approved by the China National Medical Products Administration (NMPA), marking its official entry into the Chinese market. However, due to the short time for approval, it is still difficult to see its regular sales in most domestic pharmacies, hospitals or mainstream platforms. Specific supply channels and medical insurance coverage policies are still being gradually implemented. Despite this, capositinib has already been approved by regulatory agencies in many European and American countries, and is mainly used to treat breast cancer patients with abnormalities in the PI3K/AKT/PTEN pathway. For domestic patients who do have target abnormalities, if it is difficult to obtain drugs through formal channels in the short term, they still need to obtain them through overseas drug service agencies. It is recommended to use drugs under the guidance of oncologists to ensure the standardization and safety of treatment.

In addition, capositinib, as a drug precisely positioned on theAKT pathway, has important future potential in the eyes of Chinese clinicians. Especially for breast cancer patients whose traditional endocrine therapy is ineffective or has developed drug resistance, this type of drug is expected to provide a new treatment path. Whether it can successfully enter medical insurance in China in the future will depend on many aspects. Therefore, it is recommended that patients with potential medication needs pay close attention to the domestic progress of this drug and consult professional doctors to obtain authoritative information and medication guidance.

Reference materials:https://www.drugs.com/mtm/capivasertib.html