BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that it has entered into an exclusive licensing agreement with FORUS Therapeutics Inc (“FORUS”) for the registration and distribution of BESREMi® (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera (PV), in Canada..

马萨诸塞州伯灵顿市。--（商业新闻短讯）--PharmaEssentia Corporation（TWSE:6446），一家总部位于台湾的全球生物制药创新者，利用深厚的专业知识和经验证的科学原理，在血液学和肿瘤学领域提供新的生物制剂，今天宣布，它已与FORUS Therapeutics Inc（“FORUS”）签订独家许可协议，在加拿大注册和分销用于治疗真性红细胞增多症（PV）的BESREMi®（ropeginterferon alfa-2b-njft）。。

FORUS focuses on the hematology and oncology market in Canada, with extensive experience in local drug registration and commercialization. Under the terms of the agreement, PharmaEssentia is licensing BESREMi for PV to FORUS in Canada, with potential expansion to other investigational myeloproliferative neoplasms (MPN) indications in the future.

FORUS专注于加拿大的血液学和肿瘤学市场，在当地药物注册和商业化方面具有丰富的经验。根据协议条款，PharmaEssentia正在向加拿大的FORUS许可BESREMi用于PV，未来可能会扩展到其他研究性骨髓增生性肿瘤（MPN）适应症。

FORUS will oversee the drug registration and commercialization of BESREMi in Canada, with potential milestone payments of up to $107 million USD – including for securing approval of BESREMi in PV and meeting sales milestones. FORUS will make a portion of the milestone payments within 2024 and pay PharmaEssentia double-digit percentage royalties on sales..

。FORUS将在2024年内支付里程碑付款的一部分，并向PharmaEssentia支付两位数的销售特许权使用费。。

“FORUS and PharmaEssentia are aligned in our missions to bring new treatments to patients with hematologic and oncologic conditions that may meaningfully enhance their lives,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “We continue to expand scientific data to demonstrate the clinical value of BESREMi for patients with MPNs such as PV, and we look forward to collaborating with FORUS to introduce BESREMi in Canada, to expand our footprint in North America and to benefit even more patients with PV.”.

PharmaEssentia创始人兼首席执行官Ko Chung Lin博士说：“FORUS和PharmaEssentia在我们的使命中保持一致，为血液和肿瘤患者带来新的治疗方法，这可能会有意义地改善他们的生活。”。“我们继续扩大科学数据，以证明BESREMi对PV等MPN患者的临床价值，我们期待与FORUS合作，在加拿大引入BESREMi，扩大我们在北美的足迹，并使更多PV患者受益。”。

“Strategic partnerships pave the way to unlocking innovation and advancing healthcare solutions,” said Kevin Leshuk, President and CEO of FORUS. “We are extremely pleased and honored to be partnering with PharmaEssentia so that we can deliver potentially transformative outcomes for those living with PV and hopefully other hematologic conditions in the future.”.

FORUS总裁兼首席执行官凯文·莱舒克（KevinLeshuk）表示：“战略合作伙伴关系为解锁创新和推进医疗保健解决方案铺平了道路。“我们非常高兴和荣幸能够与PharmaEssentia合作，以便我们能够为患有PV的患者提供潜在的变革性结果，并有望在未来为其他血液病患者提供。”。

BESREMi has been approved for the treatment of PV in approximately 40 countries and regions, including the United States, Japan, China, and the European Union.

BESREMi已被批准用于大约40个国家和地区的PV治疗，包括美国，日本，中国和欧盟。

About PharmaEssentia

关于PharmaEssentia

PharmaEssentia (TWSE: 6446), 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 the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline.

PharmaEssentia（TWSE:6446）总部位于台湾台北，是一家全球快速发展的生物制药创新者。凭借深厚的专业知识和成熟的科学原理，PharmaEssentia旨在通过一种经批准的产品和多样化的渠道，为血液学，肿瘤学和免疫学领域的挑战性疾病提供有效的新生物制剂。

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..

PharmaEssentia成立于2003年，由美国生物技术和制药公司的台湾裔美国高管和著名科学家组成，如今PharmaEssentia正在扩大其全球业务，在美国、日本、中国和韩国开展业务，并在台湾台中建立了世界级的生物制剂生产设施。。

For more information about PharmaEssentia USA, visit the website, LinkedIn or Twitter.

有关PharmaEssentia USA的更多信息，请访问网站LinkedIn或Twitter。

About FORUS Therapeutics

FORUS Therapeutics is a Canadian biopharmaceutical company dedicated to advancing differentiated, novel medicines for hematologic malignancies and other forms of cancer. Our mission is to bring solutions to cancer patients, caregivers, physicians and our partners by accelerating unique and important treatments that meaningfully enhance life.

FORUS Therapeutics是一家加拿大生物制药公司，致力于开发用于血液恶性肿瘤和其他形式癌症的分化型新药。我们的使命是通过加速独特而重要的治疗方法，为癌症患者、护理人员、医生和我们的合作伙伴带来解决方案，从而有意义地改善生活。

www.forustherapeutics.com.

www.forustherapeutics.com。

About Polycythemia Vera (PV)

关于真性红细胞增多症（PV）

Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia.

真性红细胞增多症（PV）是一种癌症，起源于骨髓中引发疾病的干细胞，导致红细胞，白细胞和血小板的慢性增加。PV可能导致心血管并发症，如血栓形成和栓塞，并经常转化为继发性骨髓纤维化或白血病。

While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1.

虽然PV的分子机制仍然是深入研究的主题，但目前的结果指出了一组获得性突变，最重要的是JAK2.1的突变形式。

About BESREMi® (ropeginterferon alfa-2b-njft)

关于BESREMi® （干扰素α-2b-njft）

BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients..

BESREMi是一种创新的单聚乙二醇化长效干扰素。凭借其独特的聚乙二醇化技术，BESREMi在体内具有长时间的活性，旨在每两周给药一次（或每四周给药一次，血液学稳定性至少一年），从而可以灵活给药，有助于满足患者的个人需求。。

BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023.

BESREMi被指定为孤儿药，用于治疗美国成年人的真性红细胞增多症（PV）。BESREMi已在40多个国家获得批准，2019年获得欧洲药品管理局（EMA）的批准，2021年获得美国食品和药物管理局（FDA）的批准，2023年获得日本药品和医疗器械管理局（PMDA）的批准。

It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications..

它由PharmaEssentia发明，并在公司台中工厂制造，该工厂于2017年获得TFDA的cGMP认证，并于2018年1月获得EMA的cGMP认证。PharmaEssentia保留该产品在所有适应症中的全部全球知识产权。。

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

BESREMi被批准患有严重疾病的风险，包括神经精神疾病，自身免疫性疾病，缺血性疾病和感染性疾病的恶化。

Please see full Prescribing Information, including Boxed Warning.

请参阅完整的处方信息，包括盒装警告。

Indication

指示

BESREMi is indicated for the treatment of adults with polycythemia vera.

BESREMi适用于治疗成人真性红细胞增多症。

Important Safety Information

重要安全信息

WARNING: RISK OF SERIOUS DISORDERS

警告：有严重疾病的风险

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.

干扰素α产品可能导致或加重致命或危及生命的神经精神疾病，自身免疫性疾病，缺血性疾病和感染性疾病。应通过定期的临床和实验室评估对患者进行密切监测。对于这些症状或体征持续严重或恶化的患者，应停止治疗。

In many, but not all cases, these disorders resolve after stopping therapy..

。。

CONTRAINDICATIONS

禁忌症

Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt

存在或有严重精神疾病史，特别是严重抑郁症、自杀念头或自杀未遂

Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi.

对干扰素过敏，包括干扰素α-2b或贝塞米的任何非活性成分。

Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

中度（Child-Pugh B）或重度（Child-Pugh C）肝损伤

History or presence of active serious or untreated autoimmune disease

活动性严重或未经治疗的自身免疫性疾病的病史或存在

Immunosuppressed transplant recipients

免疫抑制移植受者

WARNINGS AND PRECAUTIONS

警告和注意事项

Depression and Suicide: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa-2b products, including BESREMi. These reactions may occur in patients with and without previous psychiatric illness.

抑郁症和自杀：接受干扰素α-2b产品（包括贝塞米）的患者发生了危及生命或致命的神经精神反应。。

Other central nervous system effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa products.

其他干扰素α产品也观察到其他中枢神经系统影响，包括自杀意念，自杀未遂，攻击性，双相情感障碍，躁狂和困惑。

Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue BESREMi therapy.

。

Endocrine Toxicity: These toxicities may include worsening hypothyroidism and hyperthyroidism. Do not use BESREMi in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi therapy.

。不要在患有与自身免疫性疾病相关的活动性严重或未经治疗的内分泌疾病的患者中使用BESREMi。评估BESREMi治疗期间出现甲状腺疾病症状的患者的甲状腺功能。

Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi..

对于在使用贝雷米治疗期间无法充分管理的内分泌紊乱患者，停止服用贝雷米。。

Cardiovascular Toxicity: Toxicities may include cardiomyopathy, myocardial infarction, atrial fibrillation and coronary artery ischemia. Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi therapy. Avoid use of BESREMi in patients with severe or unstable cardiovascular disease, (e.g., uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction..

心血管毒性：毒性可能包括心肌病，心肌梗塞，心房颤动和冠状动脉缺血。在贝塞米治疗期间，应密切监测有心血管疾病史的患者的心血管毒性。避免在患有严重或不稳定心血管疾病（例如，不受控制的高血压，充血性心力衰竭（≥NYHA 2级），严重心律失常，严重冠状动脉狭窄，不稳定型心绞痛）或近期中风或心肌梗塞的患者中使用BESREMi。。

Decreased Peripheral Blood Counts: These toxicities may include thrombocytopenia (increasing the risk of bleeding), anemia, and leukopenia (increasing the risk of infection). Monitor complete blood counts at baseline, during titration and every 3-6 months during the maintenance phase. Monitor patients for signs and symptoms of infection or bleeding..

外周血细胞计数降低：这些毒性可能包括血小板减少症（增加出血风险），贫血和白细胞减少症（增加感染风险）。在基线，滴定期间和维持阶段每3-6个月监测一次全血细胞计数。监测患者感染或出血的体征和症状。。

Hypersensitivity Reactions: Toxicities may include serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis). If such reactions occur, discontinue BESREMi and institute appropriate medical therapy immediately. Transient rashes may not necessitate interruption of treatment..

超敏反应：毒性可能包括严重的急性超敏反应（例如荨麻疹，血管性水肿，支气管收缩，过敏反应）。如果发生此类反应，请停止服用BESREMi并立即进行适当的药物治疗。短暂性皮疹可能不需要中断治疗。。

Pancreatitis: Pancreatitis has occurred in 2.2% of patients receiving BESREMi. Symptoms may include nausea, vomiting, upper abdominal pain, bloating, and fever. Patients may experience elevated lipase, amylase, white blood cell count, or altered renal/hepatic function. Interrupt BESREMi treatment in patients with possible pancreatitis and evaluate promptly.

胰腺炎：接受BESREMi治疗的患者中有2.2%发生胰腺炎。症状可能包括恶心、呕吐、上腹痛、腹胀和发烧。患者可能会出现脂肪酶，淀粉酶，白细胞计数升高或肾/肝功能改变。中断可能患有胰腺炎的患者的BESREMi治疗并及时评估。

Consider discontinuation of BESREMi in patients with confirmed pancreatitis..

考虑在确诊胰腺炎的患者中停用BESREMi。。

Colitis: Fatal and serious ulcerative or hemorrhagic/ischemic colitis have occurred in patients receiving interferon alfa products, some cases starting as early as 12 weeks after start of treatment. Symptoms may include abdominal pain, bloody diarrhea, and fever. Discontinue BESREMi in patients who develop these signs or symptoms.

结肠炎：接受干扰素α产品的患者发生致命和严重的溃疡性或出血性/缺血性结肠炎，有些病例早在治疗开始后12周就开始了。症状可能包括腹痛、血性腹泻和发烧。出现这些体征或症状的患者停止服用贝塞米。

Colitis may resolve within 1 to 3 weeks of stopping treatment..

结肠炎可能在停止治疗后1至3周内消退。。

Pulmonary Toxicity: Pulmonary toxicity may manifest as dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis. Some events have resulted in respiratory failure or death. Discontinue BESREMi in patients who develop pulmonary infiltrates or pulmonary function impairment..

肺毒性：肺毒性可能表现为呼吸困难，肺浸润，肺炎，闭塞性细支气管炎，间质性肺炎，肺动脉高压和结节病。一些事件导致呼吸衰竭或死亡。对于出现肺浸润或肺功能损害的患者，停止服用贝塞米。。

Ophthalmologic Toxicity: These toxicities may include severe eye disorders such as retinopathy, retinal hemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness. During BESREMi therapy, 23% of patients were identified with an eye disorder. Eyes disorders ≥5% included cataract (6%) and dry eye (5%).

眼科毒性：这些毒性可能包括严重的眼部疾病，如视网膜病变、视网膜出血、视网膜渗出物、视网膜脱离和视网膜动脉或静脉阻塞，可能导致失明。在贝塞米治疗期间，23%的患者被确定患有眼疾。眼部疾病≥5%包括白内障（6%）和干眼症（5%）。

Advise patients to have eye examinations before and during BESREMi therapy, specifically in those patients with a retinopathy-associated disease such as diabetes mellitus or hypertension. Evaluate eye symptoms promptly. Discontinue BESREMi in patients who develop new or worsening eye disorders..

建议患者在BESREMi治疗之前和期间进行眼部检查，特别是那些患有视网膜病变相关疾病（如糖尿病或高血压）的患者。及时评估眼部症状。对于出现新的或恶化的眼部疾病的患者，停止服用BESREMi。。

Hyperlipidemia: Elevated triglycerides may result in pancreatitis. Monitor serum triglycerides before BESREMi treatment and intermittently during therapy and manage when elevated. Consider discontinuation of BESREMi in patients with persistently, markedly elevated triglycerides.

。在贝塞米治疗前和治疗期间间歇性监测血清甘油三酯，并在升高时进行管理。考虑在甘油三酯持续显着升高的患者中停用BESREMi。

Hepatotoxicity: These toxicities may include increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and bilirubin. Liver enzyme elevations have also been reported in patients after long-term BESREMi therapy. Monitor liver enzymes and hepatic function at baseline and during BESREMi treatment.

肝毒性：这些毒性可能包括血清丙氨酸氨基转移酶（ALT），天冬氨酸氨基转移酶（AST），γ-谷氨酰转移酶（GGT）和胆红素升高。长期服用贝瑞米后，患者的肝酶也有升高的报道。在基线和BESREMi治疗期间监测肝酶和肝功能。

Discontinue BESREMi in patients who develop evidence of hepatic decompensation (characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage) during treatment..

。。

Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min. Discontinue BESREMi if severe renal impairment develops during treatment.

肾毒性：在基线和治疗期间监测血清肌酐。。

Dental and Periodontal Toxicity: These toxicities may include dental and periodontal disorders, which may lead to loss of teeth. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with BESREMi. Patients should have good oral hygiene and regular dental examinations..

牙齿和牙周毒性：这些毒性可能包括牙齿和牙周疾病，这可能导致牙齿脱落。此外，在长期服用贝塞米期间，口干可能会对牙齿和口腔粘膜产生破坏性影响。患者应保持良好的口腔卫生并定期进行牙科检查。。

Dermatologic Toxicity: These toxicities have included skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, and hyperhidrosis. Consider discontinuation of BESREMi if clinically significant dermatologic toxicity occurs.

皮肤病毒性：这些毒性包括皮疹，瘙痒，脱发，红斑，牛皮癣，干皮病，痤疮样皮炎，角化过度和多汗症。。

Driving and Operating Machinery: BESREMi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi affects their abilities. Patients who experience dizziness, somnolence or hallucination during BESREMi therapy should avoid driving or using machinery..

驾驶和操作机器：BESREMi可能会影响驾驶和使用机器的能力。患者在知道BESREMi如何影响其能力之前，不应驾驶或使用重型机械。BESREMi治疗期间出现头晕、嗜睡或幻觉的患者应避免驾驶或使用机器。。

Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended in females of reproductive potential prior to treatment with BESREMi. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi and for at least 8 weeks after the final dose..

胚胎-胎儿毒性：根据作用机制，BESREMi给孕妇服用时会造成胎儿伤害。建议在用BESREMi治疗之前对具有生殖潜力的女性进行妊娠测试。建议有生殖潜力的女性在服用贝塞米期间以及服用最终剂量后至少8周内使用有效的避孕方法。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%)..

PEGINVERA研究（n=51）中>40%的患者报告的最常见不良反应是流感样疾病，关节痛，疲劳，瘙痒，鼻咽炎和肌肉骨骼疼痛。在汇总的安全人群（n=178）中，最常见的不良反应大于10%是肝酶升高（20%），白细胞减少（20%），血小板减少（19%），关节痛（13%），疲劳（12%），肌痛（11%）和流感样疾病（11%）。。

DRUG INTERACTIONS

药物相互作用

Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression.

应监测正在接受CYP450底物治疗指数较窄的伴随药物的BESREMi患者，以告知这些伴随药物的剂量调整需求。避免与骨髓抑制剂一起使用，并监测接受联合用药的患者过度骨髓抑制的影响。

Avoid use with narcotics, hypnotics or sedatives and monitor patients receiving the combination for effects of excessive CNS toxicity..

避免与麻醉剂、催眠药或镇静剂一起使用，并监测接受联合用药的患者中枢神经系统过度毒性的影响。。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy: Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy.

怀孕：根据作用机制以及干扰素α在怀孕和胎儿发育中的作用，贝塞米可能会对胎儿造成伤害，并且在给孕妇服用时应被认为具有堕胎潜力。妊娠期真性红细胞增多症对母体和胎儿结局有不利影响。

Advise pregnant women of the potential risk to a fetus..

建议孕妇注意胎儿的潜在风险。。

Lactation: There are no data on the presence of BESREMi in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children from BESREMi, advise women not to breastfeed during treatment and for 8 weeks after the final dose..

哺乳期：没有关于人或动物乳汁中存在贝塞米的数据，对母乳喂养的孩子的影响，或对产奶量的影响。由于BESREMi母乳喂养的儿童可能会产生严重的不良反应，因此建议女性在治疗期间和最终剂量后8周内不要母乳喂养。。

Females of Reproductive Potential: BESREMi may cause embryo-fetal harm when administered to a pregnant woman. Pregnancy testing prior to BESREMi treatment is recommended for females of reproductive potential. Advise female patients of reproductive potential to use effective contraception during treatment with BESREMi and for at least 8 weeks after the final dose..

具有生殖潜力的女性：服用BESREMi可能会对孕妇造成胚胎-胎儿伤害。对于有生殖潜力的女性，建议在贝塞米治疗前进行妊娠测试。建议有生殖潜力的女性患者在服用贝瑞米期间以及服用最终剂量后至少8周内使用有效的避孕措施。。

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

儿科使用：尚未确定儿科患者的安全性和有效性。

Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy.

老年使用：一般来说，老年患者的剂量选择应该谨慎，通常从剂量范围的低端开始，反映出肝，肾或心脏功能下降以及伴随疾病或其他治疗的频率更高。

Forward Looking Statement

前瞻性声明

This press release may contain forward looking statements, including statements regarding the clinical benefits to be derived from ropeginterferon alfa-2b, the commercial opportunity and competitive positioning, new indications or labeling for ropeginterferon alfa-2b, and business prospects for ropeginterferon alfa-2b.

本新闻稿可能包含前瞻性声明，包括关于罗佩金特隆阿尔法-2b的临床益处，商业机会和竞争定位，罗佩金特隆阿尔法-2b的新适应症或标签以及罗佩金特隆阿尔法-2b的商业前景的声明。

For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward looking statements as a result of various factors.

对于这些声明，我们要求保护《1995年私人证券诉讼改革法案》以及台湾法律下类似立法和法规中所载前瞻性声明的安全港。这些前瞻性声明基于截至本新闻稿发布之日的管理层预期和假设，由于各种因素，实际结果可能与这些前瞻性声明中的结果存在重大差异。

These factors include whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof..

这些因素包括BESREMi是否成功商业化并被医生和患者采用，BESREMi可获得报销的程度，以及获得FDA和其他监管机构批准BESREMi其他适应症的能力。我们不承诺更新任何前瞻性声明，以反映本协议日期后发生的事件或情况。。

© 2024 PharmaEssentia Corporation. All rights reserved.

©2024 PharmaEssentia Corporation。保留所有权利。

PharmaEssentia, the PharmaEssentia logo, and BESREMi are trademarks or registered trademarks of PharmaEssentia Corporation.

PharmaEssentia、PharmaEssentia徽标和BESREMi是PharmaEssentia Corporation的商标或注册商标。

1 Cerquozzi S, Tefferi A. Blast transformation and fibrotic progression in polycythemia vera and essential thrombocythemia: a literature review of incidence and risk factors. Blood Cancer J. 2015;5, e366; DOI:10.1038/bcj.2015.95

1 Cerquozzi S，Tefferi A.真性红细胞增多症和原发性血小板增多症的急变和纤维化进展：发病率和危险因素的文献综述。血癌J.2015；5，e366；内政部：10.1038/bcj.2015.95