Ropeginterferon alfa-2b-NJFT

A pivotal step in PharmaEssentia's dual-site U.S.-Taiwan manufacturing strategy, with 2027 operations in sight BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical company headquartered in Taiwan, announced that on Thursday, March 26, it signed an investment agreement for a new manufacturing facility in Toa Baja, Puerto Rico. The signing ceremony marks an important milestone in the company’s strategy to establish a dual-site manufacturing network in Taiwan and the United States, strengthening global supply chain resilience and supporting long-term growth. The signing ceremony was attended by Puerto Rico Governor Jenniffer González Colón, Secretary of Economic Development and Commerce Sebastián Negrón Reichard, U.S. Department of Commerce Director for Puerto Rico and the U.S. Virgin Islands Jose Burgos, Director General of the Taipei Economic and Cultural Office (TECO) in Miami Chi Yu Chou, Director of Economic Development of the Municipality of Toa Baja James Ramos, and CEO of Invest Puerto Rico Ella Woger-Nieves, among other distinguished officials. Their participation underscores the strong bilateral collaboration between Taiwan and the United States in advancing life sciences manufacturing and innovation. Chairperson Dr. Ching-Leou Teng opened the ceremony with a clear statement of intent: "This is not just a closing — it is the start of a long-term partnership and a clear demonstration of our commitment to patients." “This investment reaffirms Puerto Rico’s position as a reliable and competitive U.S. jurisdiction for advanced biopharmaceutical manufacturing. We continue to attract projects that strengthen our economy, create specialized jobs, and contribute to the resilience of the United States’ supply of critical medicines,” said Governor Jenniffer González Colón. Director General Chi Yu Chou of TECO Miami stated that PharmaEssentia's investment in Puerto Rico reflects the strengthening economic ties between Taiwan and the United States. “The company's dual production strategy embodies the symbiotic partnership between the two sides, as emphasized by Foreign Minister Lin Chia-lung. This project demonstrates the breadth and resilience of Taiwan's industries, extending beyond AI and semiconductors into biotechnology and healthcare. It also underscores the potential for deeper bilateral economic cooperation and the continued global competitiveness of Taiwanese enterprises in high-value sectors.” The Puerto Rico facility is designed to the same high-quality standards of PharmaEssentia's existing manufacturing site in Taichung, Taiwan, while optimizing production efficiency and diversifying manufacturing risk. Personnel from the Puerto Rico facility will complete intensive training at the Taichung site to support knowledge transfer and operational readiness. The company is planning for the facility to begin operations in 2027 and is committed to engaging with regulators to obtain all necessary approvals. “Expanding manufacturing capacity outside Taiwan is a core strategic priority for PharmaEssentia,” said Dr. Ko-Chung Lin, Founder and Chief Executive Officer. “We are proud to establish U.S.-based manufacturing, with Puerto Rico serving as a key hub to support the U.S. market and our commitment to patients worldwide – including those benefiting from BESREMi® (ropeginterferon alfa-2b-njft).” About PharmaEssentia PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in hematology, oncology, and immunology, with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website , LinkedIn or X (formerly Twitter) . About BESREMi® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA. BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications. INDICATION BESREMi® is indicated for the treatment of adults with polycythemia vera. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy. CONTRAINDICATIONS Existence of or history of severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons or any inactive ingredients Moderate or severe hepatic impairment History or presence of active serious or untreated autoimmune disease History of transplantation and receiving immunosuppressant agents WARNINGS AND PRECAUTIONS Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Depression and Suicide: Monitor closely for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis Colitis: Discontinue if signs or symptoms of colitis Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Please see full Prescribing Information , including Boxed Warning. Contacts Media Contact Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

真性红细胞增多症（PV）行业相关概述 真性红细胞增多症（PV）是费城染色体阴性的骨髓增殖性肿瘤（myelo proliferative neoplasms，MPN）中常见的亚型之一，其主要血液学特征为红细胞数量、血红蛋白含量或红细胞比容（HCT）增加，往往同时伴有白细胞和血小板增高，临床上以血栓形成、出血、皮肤瘙痒、微循环障碍以及脾大等为突出表现，部分患者可能进展为骨髓纤维化或急性白血病。 PV一般见于中老年患者，起病较隐匿，很多患者是体检时发现血红蛋白水平和其他血细胞计数增高而诊断，部分患者就诊时可有多血症、瘙痒、头痛、乏力等症状，也有患者确诊前就已发生动静脉血栓或消化系统出血等情况。 相关报告：智研咨询发布的《中国真性红细胞增多症（PV）药物行业市场竞争现状及发展潜力研判报告》 真性红细胞增多症（PV）药物行业发展背景 国外报道的PV年发病率为(1.0～2.0)/10万，男性（1.46/10万）略高于女性（0.93/10万），是骨髓增殖性肿瘤（MPN）中发病率最高的疾病之一，无明显的地区和国家差别。中老年患者多见，中位发病年龄为65岁，部分儿童和青年也可发病，中位生存时间约为148.6个月，明显差于健康人群，危害不容小觑。近年来，全球真性红细胞增多症（PV）患病人数不断增加，截至2025年患病人数已超198万人。 在中国，人口老龄化不断加剧，数据显示，截至2025年末，我国60岁及以上人口3.23亿人，占全国人口的23.0%，其中65岁及以上人口2.24亿人，占全国人口的15.9%。在此背景下，中国真性红细胞增多症（PV）患病人数也呈增长态势，截至2025年末，患病人数超34万人，占全球总数量的17%左右。 PV的治疗目标是避免初发或复发的血栓形成、控制疾病相关症状、预防PV后骨髓纤维化（post-PVMF）和/或急性白血病转化。目前PV一线治疗主要包括静脉放血、血细胞分离、药物治疗。根据国家指南《真性红细胞增多症诊疗指南（2025）》，治疗药物包括如下： 真性红细胞增多症（PV）药物行业市场现状 药物治疗是真性红细胞增多症（PV）治疗的重要方式。近年来，全球患病人数增加，带动真性红细胞增多症（PV）药物市场规模稳步扩张，全球市场规模由2020年的20亿美元增长至2025年的29亿美元，期间实现年复合增长率7.7%。 真性红细胞增多症（PV）药物市场较为集中，美国作为全球医药研发大国，也是最大的真性红细胞增多症（PV）药物市场，2025年美国真性红细胞增多症（PV）药物市场规模为12亿美元，占全球总规模的41%。2025年中国市场规模仅为1亿美元，主要系患者基数小、一线治疗以廉价老药为主等因素影响。 真性红细胞增多症（PV）药物获批情况 1、羟基脲 目前适用于PV患者的降细胞药物包括羟基脲、干扰素、芦可替尼等。1）羟基脲：用于一线降细胞治疗；2）聚乙二醇干扰素（PEG-IFN）：用于一线降细胞治疗，或HU不耐受/耐药后的治疗；3）芦可替尼：用于HU不耐受/耐药后的治疗，适用于症状严重患者。与其他药物相比，芦可替尼可显著改善瘙痒、盗汗和早期饱腹感等症状，缓解持续时间延长，有效改善无事件生存率。 羟基脲作为一种非烷化抗肿瘤和抗病毒药物，最初于1869年由Dressier和Stein合成，随后被用于治疗SCD及真性红细胞增多症(PV)、原发性血小板增多症(ET)、慢性粒细胞白血病(CML)和原发性骨髓纤维化(PMF)等骨髓增殖性疾病。截至2025年末，中国NMPA批准了9款羟基脲药品上市，涉及广西南宁百会药业集团有限公司、安国亚东生物制药有限公司、北京市燕京药业有限公司等9家企业。 PV患者通常需长期接受治疗，但既往国内无PV适应证药物获批，传统治疗方案也存在诸多局限性。放血治疗仅能缓解PV症状，无法根本改善干细胞的过度增生和阻止病情进展；并且超72.6%的PV患者因羟基脲治疗中的不良反应或疗效欠佳而中断治疗，而传统降细胞治疗药物如常规干扰素和JAK抑制剂均为超适应证用药，临床效果和副作用都未得到大型研究验证。罗培干扰素作为全球首个，也是唯一一个拥有PV适应证的超长效干扰素，最早于2019年在欧盟上市，并于2021年在美国获批用于治疗所有PV患者（低危、高危、一线、二线），为高危或难治PV患者提供了更多治疗选择。2024年6月，中国NMPA批准了药华医药的创新型超长效干扰素罗培干扰素α-2b（英文商品名：Besremi）在中国的上市申请，用于治疗治疗成人真性红细胞增多症患者。该药物的成功上市不仅填补我国在PV领域治疗空白，也宣布我国PV治疗将踏入全新的征程。《中国临床肿瘤学会（CSCO）恶性血液病诊疗指南（2024）》也在PV相关治疗内容中，将罗培干扰素α-2b列为低危/高危PV患者的首选Ⅰ级推荐，明确了该药物在PV一线治疗中的重要地位。 2、芦可替尼 约95%的PV患者存在JAK2V617F突变。JAK2V617F位于JAK2的假激酶结构域，假激酶结构域是抑制JAK2激酶活性的区域，其突变可导致JAK2基因14号外显子第617位的缬氨酸被苯丙氨酸所取代，从而使JAK2可不依赖细胞因子而持续活化，进而通过JAK2/STAT、RAS/MAPK和PI3K/AKT等通路促进细胞分裂、肿瘤形成并抑制肿瘤细胞凋亡。芦可替尼是一种强效的JAK1/2抑制剂，可有效抑制PV中失调的JAK2/STAT通路（Fig.1），已被批准用于羟基脲耐药或不耐受的PV患者二线治疗。 磷酸芦可替尼片原研企业为美国Incyte，是一种选择性抑制JAK1/2通路的口服小分子靶向药，主要用于原发性血小板增多症、骨髓纤维化、真性红细胞增多症、移植物抗宿主病等血液系统疾病的治疗。在国内，原研产品于2017年3月以商品名“捷恪卫”上市。随后国产仿制竞争不断升温，2024年，成都苑东生物制药率先拿下首仿，随后青峰医药与南京正科医药同日获批，2026年1月，山东新时代药业的磷酸芦可替尼仿制药获批上市，成为国内第四家具备该品种生产资质的企业，标志着国产仿制阵营“四强格局”正式确立。 真性红细胞增多症（PV）药物发展展望 以前，治疗PV的目标是预防血栓形成，但最近关注的焦点是如何减轻患者长期治疗的负担以及如何彻底治愈疾病。随着对PV疾病的认识以及分子检测的日益普及，从以往的终身治疗向限时治疗的模式转变将成为可能。这种限时治疗可基于预先定义的临床症状和分子参数，例如，Kiladijan等提出了停止治疗的标准（JAK2V617FVAF<10%，持续CHR≥2年，并且在整个治疗期间无疾病进展、无血栓栓塞事件、疾病相关体征或症状无恶化趋势）。未来，仍需要新的前瞻性研究，以无进展生存期和总生存期等为终点来推进PV患者的更安全、更有效的治疗。 ●以上数据及信息可参考智研咨询（www.chyxx.com）发布的《中国真性红细胞增多症（PV）药物行业市场竞争现状及发展潜力研判报告》。 ● 您可以关注【智研咨询】公众号，每天及时掌握更多行业动态。 往期推荐 智研推荐丨2026年 中国白银行业市场供需现状及发展趋势研判报告 智研推荐丨2025年 中国中空纤维膜行业市场规模分析及未来趋势研判报告 智研推荐丨2025年 中国节水装备行业发展现状分析及需求前景研判报告 智研推荐丨2025年 中国大丝束碳纤维行业发展现状分析及市场趋势研判报告 智研推荐丨2025年 中国量子计算产业市场现状及发展前景研究报告 中国专业的产业咨询服务平台 智研咨询（www.chyxx.com）专注产业咨询十五年，是中国产业咨询领域专业服务机构。公司以“用信息驱动产业发展，为企业投资决策赋能”为品牌理念。为企业提供专业的产业咨询服务，主要服务包含精品行研报告、专项定制、月度专题、市场地位证明、专精特新申报、可研报告、商业计划书、产业规划等。提供周报/月报/季报/年报等定期报告和定制数据，内容涵盖政策监测、企业动态、行业数据、企业排行、产品价格变化、投融资概览、市场机遇及风险分析等。 智 研 产 研 中 心 深度剖析  全景思维  优质服务 部分案例 智 研 咨 询 优 势 专业   严谨   权威   客观 15年产业研究经验 自主研发数据库 10000+客户选择 100+团队成员 质量领先保障 精密准确的研究方法 权威资质 99.9%客户满意率 完善的售后保障 文章转载、引用说明： 智研咨询推崇信息资源共享，欢迎各大媒体和行研机构转载引用。但请遵守如下规则： 1.可全文转载，但不得恶意镜像。转载需注明来源（智研咨询）。  2.转载文章内容时不得进行删减或修改。图表和数据可以引用，但不能去除水印和数据来源。 如有违反以上规则，我们将保留追究法律责任的权力。