Focus Stock] Yuhua Pharmaceutical's US ET Drug Approval Expected This Month, Stock Price Surges

Yuhua Pharmaceutical (6446-TW) is awaiting the approval of its core new drug Ropeg for the treatment of essential thrombocythemia (ET) in the US, with the Prescription Drug User Fee Act (PDUFA) target completion date set for August 30. This news has driven the company's stock price to surge on May 5, closing at 1335 yuan.

Yuhua Pharmaceutical opened at 1245 yuan this morning, rising high throughout the day, and hit the limit up at 1335 yuan. The company ranks 36th among the top 1000 stocks and maintains its position as the king of biotech stocks. It has also stabilized all moving averages, with about 1000 buy orders in the queue and trading volume exceeding 3000 shares.

In addition to the imminent US ET drug approval, Yuhua Pharmaceutical is also simultaneously advancing drug approval applications in Japan, China, and South Korea, with related review procedures ongoing. Additionally, the company has recently completed the application to the Macau Drug Supervision and Administration Bureau for the "preliminary import drug permit" for BESREMi (Ropeginterferon alfa-2b, Ropeg) with a new indication. The new indication is for the treatment of adult ET patients who have developed resistance or intolerance to hydroxyurea treatment.

For the treatment of polycythemia vera (PV), Ropeg has been approved by the Canadian Health Department and is expected to be launched in Canada, completing the North American PV layout. Ropeg has also been approved in approximately 50 countries worldwide for PV, including major new drug markets such as the European Union, the United States, and Japan.