Taiwan drugmaker PharmaEssentia plans US$46 million Puerto Rico plant as it expands global reach

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.