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PharmaEssentia's Ropeg further expands international evidence footprint; six studies to be presented at international MPN congress 2026.10.21 13:34 Commercial Times, Peng Xuanyi PharmaEssentia (6446) continues to expand the international research evidence for its new drug Ropeginterferon alfa-2b (Ropeg, also known as P1101). After Ropeg was approved by the U.S. Food and Drug Administration (FDA) in August for adult essential thrombocythemia (ET), PharmaEssentia announced that it will present six research abstracts at the 18th International Congress on Myeloproliferative Neoplasms (MPN Congress), to be held at the end of October; the research brings together data from the United States, Japan, and China, ranging from unmet needs in current therapies and real-world treatment patterns to JAK2 V617F molecular response, further expanding the clinical evidence for Ropeg in ET and polycythemia vera (PV). PharmaEssentia said Ropeg has been approved in about 50 countries worldwide for the treatment of PV and is the first new therapy in nearly 30 years to receive U.S. FDA approval for ET, providing ET patients with a treatment option beyond hydroxyurea (HU) and anagrelide (ANA); the studies presented this time further focus on the challenges ET and PV patients still face under current treatments, as well as the use of Ropeg in clinical practice and its molecular response. Among the six studies presented by PharmaEssentia, three use U.S. medical insurance claims and community oncology care data to analyze ET treatment patterns and unmet needs, the treatment sequence and persistence of Ropeg use in PV patients, and the characteristics of patients receiving different first-line cytoreductive therapies; one systematic literature review and meta-analysis evaluates long-term outcomes in ET and PV patients after first-line treatment with HU. The other two studies come from an exploratory analysis of a Japanese phase 3 study and a multicenter real-world retrospective analysis in China, respectively, focusing on changes in JAK2 V617F allele burden after Ropeg treatment and providing more data for understanding its effects at the molecular level. PharmaEssentia noted that an analysis of U.S. medical insurance claims data estimated that among approximately 159,000 ET patients, only about one-third had ever received treatment; HU accounted for 94% of first-line therapies, and those who switched therapies mostly switched between HU and ANA. In the phase 3 SURPASS-ET study, Ropeg has demonstrated a durable response rate superior to that of ANA. Exploratory analyses of two Japanese phase 3 studies showed that in PV patients receiving the 250-350-500 mcg rapid dose-escalation (HIDAT) regimen, the reduction in JAK2 V617F allele burden at week 24 was numerically greater than with the slower dose-escalation regimen, at 12.66% versus 7.50%, respectively, while complete hematologic response was similar. This rapid dose-escalation regimen has been approved for PV in Japan and is also the dosing regimen approved for ET in the United States. Another multicenter retrospective analysis including 87 Chinese MPN patients, mainly with ET and PV, showed that after use of the HIDAT regimen, the complete hematologic response rate rose from 62% at month 3 to 78% at month 12; JAK2 V617F allele burden decreased by an average of 1.89% per month with treatment. The adverse events reported in the study were all grade 1 to 2, with liver function test abnormalities being the most common.

Drugmaker plans Puerto Rico plant. Mon, oct 19, 2026 page9. * Drugmaker plans Puerto Rico plant EXPANSION: PharmaEssentia has market capitalization near US$20 billion and subsidiaries in the US, Japan, Hong Kong, China, South Korea and Singapore * Staff writer, with CNA * * Add TT as Preferred Source Biopharmaceutical company PharmaEssentia Corp (藥華醫藥) is expanding its global manufacturing and commercial footprint, planning a US$46 million production facility in Puerto Rico to begin operations next year while consolidating its North American business to support the international growth of its blood cancer drug ropeginterferon alfa-2b (Ropeg). The company said the expansion is part of its strategy to establish manufacturing bases in Taiwan and the US, enhance supply chain resilience and support Ropeg's global growth following regulatory approvals for the drug to treat essential thrombocythemia (ET), a rare blood cancer characterized by excessive platelet production. PharmaEssentia said that its board of directors in February approved the US$46 million investment in a Puerto Rico subsidiary, and it signed an investment agreement for the new facility in March. People visit the PharmaEssentia Corp booth at the BIO Asia-Taiwan Exhibition at the Taipei Nangang Exhibition Center on July 16. Photo: CNA The plant outside of San Juan, Puerto Rico, is expected to begin operations next year, subject to regulatory approvals. It would be designed to meet the same quality standards as PharmaEssentia's manufacturing facility in Taichung, with local staff scheduled to receive training in Taiwan as part of the technology transfer process, PharmaEssentia said. The company said expanding manufacturing capacity outside Taiwan would help diversify production risks and enhance the resilience of its global supply chain. PharmaEssentia also completed the acquisition of Canadian pharmaceutical company FORUS Therapeutics Inc in June for US$36.5 million, acquiring 100 percent of its shares. PharmaEssentia said the acquisition would enable the company to integrate the two businesses' teams and resources, expand its presence in Canada and build a broader North American operating platform. The overseas investments come as the company expands the applications of Ropeg, marketed under the brand name BESREMi, which was developed by PharmaEssentia founder and CEO Lin Ko-chung (林國鐘). Lin developed Ropeg using proprietary PEGylation technology and advanced small-molecule synthesis techniques to link polyethylene glycol to interferon alpha, producing a long-acting interferon with a stable chemical structure and uniform composition, PharmaEssentia said. Ropeg was first approved to treat polycythemia vera (PV), another rare blood cancer classified as a myeloproliferative neoplasm (MPN), in the EU in 2019, followed by the US in 2021 and Japan in 2023. It has since been approved and launched for PV treatment in about 50 countries, the company said. In May, Taiwan approved Ropeg for adults with ET who are resistant to or intolerant of hydroxyurea treatment. Japan and the US followed with approvals in August, the company said. PharmaEssentia said Ropeg is the first new treatment approved by the US Food and Drug Administration for ET in nearly three decades and the only drug currently approved by the agency to treat both ET and PV. Clinical trials have shown that Ropeg can be administered once every two weeks, compared with the standard once-weekly regimen for Pegasys, a conventional pegylated interferon therapy, offering a less frequent injection schedule, the company said. Meanwhile, the company said it is conducting a global Phase 3 clinical trial, HOPE-PMF, to evaluate Ropeg as a potential treatment for primary myelofibrosis (PMF), another rare blood cancer with limited treatment options. The study focuses on patients with early-stage PMF, who are typically monitored without treatment because no drug therapies are approved for this stage of the disease, PharmaEssentia said. From PV and ET to PMF, PharmaEssentia said it is expanding its MPN portfolio, hoping to bring accessible treatment options to more people worldwide. Founded in 2003, PharmaEssentia specializes in biologics for hematologic cancers and has developed capabilities spanning drug discovery, clinical trials, manufacturing and global commercialization. The company has established subsidiaries in the US, Japan, Hong Kong, China, South Korea and Singapore since 2017, while expanding into Europe and Latin America through licensing partnerships. This year, PharmaEssentia's market capitalization approached US$20 billion, making it Taiwan's only biotechnology company among the country's 50 largest listed companies by market value. * Most Popular * 1 Taiwan closely monitoring plague rumors: premier * 2 Forecasters watch progress of Pacific storm * 3 Taiwan to buy 292 VTOL drones from Shield AI * 4 Taiwan monitoring China pneumonic plague rumors, premier says * 5 Paraguay and Belize condemn China sanctions

Taiwan drugmaker PharmaEssentia plans US$46 million Puerto Rico plant as it expands global reach. 10/17/2026 10:48 AM Taipei, Oct. 17 (CNA) Taiwan-based biopharmaceutical company PharmaEssentia Corp. is expanding its global manufacturing and commercial footprint, planning a US$46 million production facility in Puerto Rico to begin operations in 2027 while consolidating its North American business to support the international growth of its blood cancer drug ropeginterferon alfa-2b (Ropeg). The company said the expansion is part of its strategy to establish manufacturing bases in Taiwan and the United States, strengthen supply chain resilience and support Ropeg's global growth following regulatory approvals for the drug to treat essential thrombocythemia (ET), a rare blood cancer characterized by excessive platelet production. PharmaEssentia's board approved the US$46 million investment in a Puerto Rico subsidiary in February 2026, and the company signed an investment agreement for the new facility in March, according to the company. Located in Toa Baja, Puerto Rico, the plant is expected to begin operations in 2027, subject to regulatory approvals. It will be designed to follow the quality standards of PharmaEssentia's manufacturing facility in central Taiwan's Taichung, with local staff scheduled to receive training in Taiwan as part of the technology transfer process, PharmaEssentia said. The company said expanding manufacturing capacity outside Taiwan would help diversify production risks and strengthen the resilience of its global supply chain. PharmaEssentia also completed the acquisition of Canadian pharmaceutical company FORUS Therapeutics Inc. in June for US$36.5 million, acquiring 100 percent of its shares. PharmaEssentia said the acquisition will enable the company to integrate the two businesses' teams and resources, expand its presence in Canada and build a broader North American operating platform. The overseas investments come as the company expands the applications of Ropeg, marketed under the brand name BESREMi, which was developed by PharmaEssentia founder and CEO Lin Ko-chung (林國鐘). Lin developed Ropeg using proprietary PEGylation technology and advanced small-molecule synthesis techniques to link polyethylene glycol (PEG) to interferon alfa, producing a long-acting interferon with a stable chemical structure and uniform composition, according to PharmaEssentia. Ropeg was first approved to treat polycythemia vera (PV), another rare blood cancer classified as a myeloproliferative neoplasm (MPN), in the European Union in 2019, followed by the United States in 2021 and Japan in 2023. It has since been approved and launched for PV treatment in approximately 50 countries, the company said. In May 2026, Taiwan approved Ropeg for adult ET patients resistant to or intolerant of hydroxyurea treatment. Japan and the United States followed with approvals in August, according to the company. PharmaEssentia said Ropeg is the first new treatment approved by the U.S. Food and Drug Administration (FDA) for ET in nearly three decades and the only drug currently approved by the agency to treat both ET and PV. Clinical trials have shown that Ropeg can be administered once every two weeks, compared with the standard once-weekly regimen for Pegasys, a conventional pegylated interferon therapy, offering a less frequent injection schedule, the company said. PharmaEssentia said it had also adopted an optimized High-Initial-Dose Accelerated Titration (HIDAT) regimen in both its Phase 3 SURPASS-ET and Phase 2 single-arm EXCEED-ET clinical trials, allowing patients to reach the target dose more quickly. Under the HIDAT regimen, the initial dose of 250 micrograms is increased to 350 micrograms in the second week and to the target dose of 500 micrograms by the fourth week, it said. Meanwhile, the company said it is conducting a global Phase 3 clinical trial, HOPE-PMF, to evaluate Ropeg as a potential treatment for primary myelofibrosis (PMF), another rare blood cancer with limited treatment options. The study focuses on patients with early-stage PMF, who are typically monitored without treatment because no drug therapies are approved for this stage of the disease, PharmaEssentia said. From PV and ET to PMF, PharmaEssentia said it is expanding its MPN portfolio, hoping to bring accessible treatment options to more patients worldwide. Founded in 2003, PharmaEssentia specializes in biologics for hematologic cancers and has developed capabilities spanning drug discovery, clinical trials, manufacturing and global commercialization. The company said its experience holds broader significance for Taiwan's biotechnology industry, demonstrating how home-grown drug candidates can reach international markets when research, manufacturing, regulatory and commercial capabilities are developed in tandem. Since 2017, PharmaEssentia has established subsidiaries in the United States, Japan, Hong Kong, China, South Korea and Singapore, while expanding into Europe and Latin America through licensing partnerships. In 2026, PharmaEssentia's market capitalization approached US$20 billion, making it Taiwan's only biotechnology company among the country's 50 largest listed companies by market value. (By Ho Hsiu-ling and Chen Chia-yu)