PharmaEssentia Corp (藥華醫藥) yesterday said that it has applied for marketing approval for its ropeginterferon alfa-2b drug with the China National Medical Products Administration.
The company seeks approval to use the treatment for a rare type of blood cancer, polycythemia vera, it said in a regulatory filing.
The interferon drug, sold in the US under the name Besremi, is the only approved first-line treatment for polycythemia vera, with its sole competitor being the US-based Incyte Corp’s Jakafi, which has been approved as second-line treatment.
Photo: Reuters
The drug has gained approval to be used in the treatment of adult polycythemia vera patients in Taiwan, Switzerland, Israel, South Korea, the US and the EU.
The company in October said that it was targeting China and Japan as the drug’s next markets.
PharmaEssentia did not specify the estimated date of completion for the marketing application, saying in the filing that it is subject to the Chinese agency’s procedures for case acceptance.
There are about 400,000 polycythemia vera patients in China, the company added.
Polycythemia vera is a chronic, progressive myeloproliferative neoplasm, and it is primarily characterized by a high count of red blood cells, PharmaEssentia said.
The blood disorder could result in cardiovascular complications, such as thrombosis and embolism, and often develops into secondary myelofibrosis or leukemia, it said.
Besremi is PharmaEssentia’s most significant product, helping boost its revenue 383.44 percent year-on-year to NT$2.63 billion (US$85.65 million) in the first 11 months of last year, company data showed.
The company reported a net loss of NT$1.22 billion in the first three quarters of last year, due to higher marketing, management, and research and development costs.
That translated into losses per share of NT$4.37, company data showed.
Analysts said the new drug would lead to robust sales growth and operating leverage in the long term.
The company is also conducting a phase 3 clinical trial for the drug to treat essential thrombocythemia, a rare disorder in which the bone marrow produces too many platelets.
PharmaEssentia yesterday in a separate filing said that it has received positive opinions from the Data and Safety Monitoring Board for the trial.
The board comprises independent experts who review clinical study data for new drugs.
It confirmed the safety of the trial and recommended that the firm continue conducting it according to protocols, PharmaEssentia said.
Essential thrombocythemia is a myeloproliferative neoplasm characterized by an overproduction of platelets in the blood resulting from a genetic mutation.
The number of people with essential thrombocythemia is similar to those with polycythemia vera, the company said.
PharmaEssentia has registered 90 percent enrollment for the trial and plans to complete it as soon as possible, it added.
The company’s shares rose 62.8 percent last year, closing at NT$477 on Friday in Taipei trading.
The stock last month joined MSCI Global Standard Indices after it made considerable gains last year, global index provider MSCI Inc has said.
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