US$2 billion level: Everolimus will compete fiercely in the future market!

Everolimus, an mTOR inhibitor first developed by Novartis, Switzerland, is a 40-O-(2-hydroxyethyl) derivative of rapamycin, suitable for use Treatment of patients with advanced renal cell carcinoma after sunitinib or sorafenib treatment fails. The drug was first launched in Sweden in 2003, and in 2006 it has fully occupied the European market. In August 2013, Everolimus (Chinese trade name Finitor) was approved to officially enter the Chinese market. Everolimus (Finitor) was included in the National Medical Insurance Drug List in 2017.

Everolimus global sales

In recent years, the global sales of Novartis' everolimus tablets have grown steadily. In 2016, global sales were 1.914 billion US dollars, 2017 global sales were 1.939 billion US dollars, 2018 global sales were 2.02 billion US dollars, and 2019 global sales were 2.024 billion US dollars.

Domestic registration status

In China, only the original research Novartis was approved by the CFDA for marketing in June 2013. CP Tianqing's listing application was accepted by CDE in November 2018, but it has not been approved for listing so far.

In addition to Novartis and Chia Tai Tianqing, there are currently eight domestic companies that have applied for clinical approval, namely Jichuan Pharmaceutical Group, Jiangsu Hausen, Lianyungang Hongchuang Pharmaceutical, Lianyungang Runzhong, Zhejiang Hisun Pharmaceutical, and Chengdu Yatu Biotechnology, Chengdu Huide Pharmaceutical, Shandong New Times Pharmaceutical. It is foreseeable that the market competition will be fierce in the future.

Domestic sales

According to the sales data of domestic sample hospitals in 2017, the sales of everolimus was 16.97 million yuan; the sales in 2018 was 23.2 million yuan, an increase of 36.71% over the previous year; the sales in 2019 was 30.18 million yuan, an increase of 30.09% over the previous year. It can be seen that the sales of Everolimus has been growing rapidly in the past three years.

This may be due to the fact that everolimus was included in the scope of medical insurance category B through the "National Medical Insurance Negotiations" in 2017, and the sales of everolimus began to increase. In 2019, everolimus successfully renewed the national health insurance contract and added new reimbursement indications. The market will further increase, and sales in 2020 are also expected to increase further.

Based on comprehensive considerations, everolimus is currently monopolized by Novartis in the domestic market, and there is no generic drug competition on the same platform. It has entered medical insurance in China, and the market is in an upward phase, and the future development is good.

However, there are currently 8 domestic companies that have obtained clinical approvals, and the fastest progress is Chia Tai Tianqing, which is already in the listing stage. It can be seen that in the near future, competition may also be very fierce.