What are the price advantages of Apelvis compared with other similar drugs?

Alpelisib (Alpelisib), an orally effective thiazopyrrolidine derivative, has been approved by the U.S. Food and Drug Administration (FDA) in combination with Fulvestrant (an intravenous estrogen receptor antagonist) for the treatment of patients with advanced hormone receptor-positive, HER2-negative, PIK3CA-mutated breast cancer. 70% of breast cancers are hormone receptor-positive, and the incidence of PIK3CA mutations in hormone-receptor-positive breast cancers is approximately 40%, suggesting that Apelix's treatment may be applicable to a large number of people.

Among patients with PIK3CA mutations, progression-free survival after 20 months (median) follow-up was 11.0 months in the apelvis plus fulvestrant group and 5.7 months in the fulvestrant plus placebo group. In patients without PIK3CA mutations, progression-free survival was 7.4 months with apelvis plus fulvestrant and 5.6 months with fulvestrant. The overall complete response rate was 26.6% in patients with cancers with PIK3CA mutations; the response rate was 12.8% in those without mutations. These results explain the FDA's rationale for approval in patients with PIKCA mutations. The most common adverse events include hyperglycemia, nausea, decreased appetite, diarrhea, vomiting, and maculopapular rash.

The original drug Apelvis has not yet appeared in the domestic market, so it has not been included in the medical insurance system, and the domestic price has not yet been determined. In overseas markets, the original Apelis drug has two versions, European and Indian. The European version may cost more than 40,000 yuan per box (150mg*56 tablets), while the Indian version (150mg*28 tablets) may cost only more than 5,000 yuan per box (the price may change due to exchange rate fluctuations). At the same time, generic versions of drugs have been released overseas. For example, the price of each box (150mg*28 tablets) produced by a Laos pharmaceutical factory may be about more than 2,000 yuan (the price may change due to exchange rate fluctuations).