PharmaEssentia announced that it has submitted an application to the National Medical Products Administration (NMPA) in China for a drug license for polycythemia vera (PV). The company is likely to obtain new drug licenses for Japan and other Southeast Asian countries this year, and the number of drug users in the US will grow year on year.

According to the company, sales of the new drug Besremi in the first three quarters of 2022 exceeded NT$1 billion in the US and NT$500 million in Europe, making them the two largest markets. Although the company has not yet announced the number of users in the US, it is estimated that the number of users at the end of last year will be less than the original target of 800, but the positive publication of papers at the ASH Annual Meeting, the 100% coverage by public insurance and the high coverage rate of 86% by commercial insurance will help accelerate the willingness to use the drug.

As for this year's growth momentum, the average price of new drugs in the U.S. increases by 5-6% a year, and that the price of drugs was raised by the company twice in July and December last year, and that the number of drug users will increase each year.

For markets outside of the US, PharmaEssentia applied for a drug license in Japan in April last year, and a facility inspection was conducted in December. The company has also recently submitted an application for a drug licence to China and will receive a response within 200 working days once the official letter is accepted.

In terms of new indications, the phase III clinical trial of essential thrombocytosis currently underway has received 90% of the cases. According to external sources, all cases will be completed in the first half of this year, and all subjects will be completed within one year. After completing all the medications, if it goes well, the NDA will be sent in the second half of 2024, and the US drug license will be obtained in the second half of 2025.