Last Friday (the 18th), PharmaEssentia announced a major development: the company has submitted a New Drug Submission (NDS) in Canada for its proprietary therapy BESREMi (Ropeginterferon alfa-2b, referred to as Ropeg or P1101) for the treatment of polycythemia vera (PV), marking its official entry into the Canadian market.
Ropeg is an innovative, next-generation long-acting interferon developed and manufactured in-house by PharmaEssentia. It has already been approved for use in PV patients in approximately 40 countries worldwide, including major new drug markets such as the European Union, the United States, and Japan. Global sales of Ropeg have continued to grow steadily. Previously, Health Canada included Ropeg on the List of Drugs for Exceptional Importation and Sale, enabling it to be shipped to Canada under a special import program to help alleviate a severe drug shortage caused by disruptions in the supply of a competing product, Pegasys.
PharmaEssentia CEO Ko-Chung Lin stated, “We are committed to addressing unmet medical needs in the field of myeloproliferative neoplasms (MPNs) and to offering new treatment options for PV patients, while continuing to expand our global footprint. The application for regulatory approval in Canada represents a significant milestone in our North American strategy, further strengthening Ropeg’s presence in the Americas and benefiting more PV patients.”
On the manufacturing and supply side, PharmaEssentia noted that its active pharmaceutical ingredient (API) facility in Taichung, its drug product manufacturing site in Taipei, and its U.S.-based fill-finish contractor, Pyramid Laboratories Inc., have all received Canadian Good Manufacturing Practice (GMP) certification. These facilities are now officially listed under Canada’s Drug Establishment Licence (DEL), enhancing the company's ability to supply the North American market efficiently and underscoring its commitment to high-quality, high-efficiency international pharmaceutical supply chain management.
In 2024, PharmaEssentia licensed Canadian pharmaceutical company FORUS to handle the regulatory submission and commercialization of Ropeg in Canada. According to the agreement, FORUS is responsible for securing market approval and commercializing the drug in Canada. In return, PharmaEssentia is eligible to receive milestone payments totaling up to approximately USD 107 million, including milestones for regulatory approval and sales performance. Additionally, the agreement stipulates that FORUS will pay PharmaEssentia royalties in the double-digit percentage range on sales revenue. Market research estimates that there are approximately 17,000 PV patients in Canada. Analysts remain optimistic about Ropeg’s potential in the global PV market, with strong growth expected in the future.
Resource: 藥華藥新藥Ropeg申請加拿大藥證 擴大全球PV市場版圖
