The official launch time and domestic approval progress of Inalise (Ihelai)

Inavolisib is a selective PI3K alpha inhibitor, mainly used to treat breast cancer and other related tumors carrying PIK3CA mutations. The domestic launch of this drug marks the further development of PI3Kα targeted therapy, providing patients with new precision treatment options. At present, Inarisep has been officially approved for marketing in China, but it has not yet been included in the national medical insurance system. Therefore, patients need to bear the cost of the drug when using it.

In terms of domestic approval progress, Inalise has undergone strict review by the National Medical Products Administration (NMPA), including review of data on drug safety, efficacy and quality control. The approval of the marketing authorization was mainly based on the results of clinical trials showing its good objective response rate and disease control ability in patients with PIK3CA mutation-positive breast cancer. This also reflects the prudent attitude of domestic regulatory authorities towards innovative targeted drugs and their balanced consideration of patients’ clinical needs.

From a price point of view, the sales price of inalisate in China is relatively high. Each box has specifications of 3mg 7 tablets 4 tablets or 9mg 7 tablets 4 tablets. The price is about 30,000 yuan. Due to the short time on the market, there are no generic drugs available in China yet, so patients currently mainly rely on the supply of original drugs. In overseas markets, the price per box is higher, about 200,000 yuan. The price may fluctuate due to exchange rates and regional differences, which also gives the domestic market a certain cost advantage for patients.

It is worth noting that there are currently no generic drugs of Inalise on the market, which means that patients need to purchase the original drug through a regular medical institution when obtaining the drug, and use it strictly in accordance with the physician's instructions. In the future, as the domestic market and research and development progress, more supply channels and generic drug options may emerge, thereby reducing patient medication costs and improving accessibility. At the same time, continued clinical research and market observation will also help to further clarify its scope of indications and personalized treatment strategies.

Reference link:https://www.drugs.com