Ropeginterferon alfa-2b-NJFT

Nancy Pauwels/ iStock The Taiwan-based company is establishing a manufacturing center for the U.S. market. Taiwan’s PharmaEssentia has committed $46 million to build a Puerto Rico drug manufacturing facility to serve the U.S. market, the company announced Tuesday. PharmaEssentia won FDA approval in 2021 for its monoPEGylated, long-acting interferon BESREMi in adults with the rare blood cancer polycythemia vera. To date, the company has relied on a mix of internal capacity in Taiwan and fill/finish service partners in Europe and the U.S. to serve the global market. Now, PharmaEssentia is adding a site in Puerto Rico as part of its goal to expand outside Taiwan. By 2027, the company expects to have secured approvals for the new plant and started operations in Puerto Rico. PharmaEssentia said the site will serve as a manufacturing center for the U.S. and meet long-term global demand for BESREMi. According to its announcement, the company has identified the plant as a way to enhance supply security, increase operational flexibility, improve cost efficiency and ensure access to scalable manufacturing capacity to support future growth. PharmaEssentia follows Amgen and Eli Lilly in investing in drug production in Puerto Rico. Amgen and Lilly have long-standing presences on the island, an unincorporated territory which emerged as a pharma manufacturing hub after the U.S. created tax incentives. Activity fell when the U.S. withdrew the incentives 20 years ago, although Puerto Rico is now trying to use the Trump administration’s reshoring drive to regain momentum. Manufacturing As Amgen and Lilly Recommit, Puerto Rico Seeks To Regain Manufacturing Momentum After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector. February 3, 2026 · 4 min read · Nick Paul Taylor Read more BESREMi sales increased 44% year-over-year to $127.8 million in the third quarter. PharmaEssentia has filed for FDA approvals to support further growth, it said in a December announcement. The company plans to launch an injection pen version of BESREMi in the first half of 2026 to offer polycythemia vera patients a more convenient option. PharmaEssentia currently offers BESREMi as a single-dose prefilled syringe. The FDA is set to decide whether to authorize the drug in essential thrombocythemia by Aug. 30. The company estimates there are 148,000 people with essential thrombocythemia in the U.S., compared to 163,000 patients with polycythemia vera. PharmaEssentia has started a Phase III trial in pre-fibrotic/early primary myelofibrosis, a disease that affects 14,000 people in the U.S., putting the company on track to double its current addressable market. Global approvals have unlocked additional patients, with PharmaEssentia winning polycythemia vera authorizations in almost 50 markets and awaiting essential thrombocythemia regulatory decisions in countries including China and Japan. The expanding commercial opportunity has driven PharmaEssentia to look beyond its current focus on Taiwan for in-house manufacturing. The FDA authorized PharmaEssentia to make the BESREMi drug substance, ropeginterferon alfa-2b-njft, and an intermediate at sites in Taiwan in 2021. The FDA redacted the plant where the final drug product is manufactured, filled, labeled and packaged from publicly available paperwork. PharmaEssentia said in its annual report that it outsources the filling of injections for the U.S. market to vendors in the U.S.

PharmaEssentia will spend $46 million to build a manufacturing facility in Puerto Rico. The move forms part of the company's global expansion strategy to support demand for the rare blood disease treatment Besremi. PharmaEssentia will spend $46 million to build a new manufacturing facility in Puerto Rico. The move forms part of the Taiwanese biotech’s global production expansion strategy, with the goal that the plant will eventually support the supply of PharmaEssentia's rare blood disease treatment, Besremi.The project is expected to provide PharmaEssentia with enhanced supply security, operational flexibility, cost efficiencies and scalable manufacturing capacity for the future, the company said in a Feb. 9 press release. In its first phase, the plant is expected to create nearly 100 jobs, with room for the site's workforce to eventually grow in line with further scale-up projects, a company spokesperson told Fierce.The 40,000-square-foot facility will incorporate robust redundancy and contingency measures—like backup generation and infrastructure safeguards—to ensure uninterrupted operations and product supply, the spokesperson explained.  “Expanding manufacturing capacity outside Taiwan is a core strategic priority for PharmaEssentia as we continue to strengthen supply resilience, scalability, and geographic diversification,” Ko-Chung Lin, Ph.D., PharmaEssentia’s founder and CEO, said in a statement. “We are proud to take this important step toward establishing U.S.-based manufacturing, with Puerto Rico serving as a future center for the U.S. market.”In January, the biotech unveiled plans to potentially expand the reach of its FDA-approved Besremi to another rare blood disorder after reviewing encouraging results from a phase 3 study.The company last month said it would head to regulators soon with data from its late-stage SURPASS-ET trial. In the study, which pitted Besremi against platelet-reducing anagrelide as a second-line therapy for patients with essential thrombocythemia (ET), PharmaEssentia's treatment was linked to durable clinical responses and also met a secondary endpoint concerning reductions in JAK2 V617F allelic burden.ET is a rare blood cancer typically caused by genetic mutations that cause bone marrow to produce too many platelets.The FDA approved Besremi in 2021 as the first polycythemia vera treatment that patients can take regardless of their treatment history, as well as the first interferon drug approved for the disorder.