ASN-001 targets the substantially larger population of moderate infantile hemangiomas currently treated off-label with topical timolol

ASN-001 针对的是目前超说明书使用外用噻吗洛尔治疗的、数量大得多的中度婴儿血管瘤患者群体。

Complementary product to HEMANGEOL

HEMANGEOL 的互补产品

®

®

(propranolol hydrochloride) oral solution, positioning Eton, if approved, to treat full spectrum of infantile hemangioma patients

（盐酸普萘洛尔）口服溶液，若获批准，将把Eton定位为用于治疗全谱系婴儿血管瘤患者

ASN-001 Phase II/III trial results showed week 24 elimination or near-elimination rates of 56% (BID) and 42% (TID) compared with 15% for placebo

ASN-001 II/III期临床试验结果显示，第24周时，每日两次（BID）和每日三次（TID）给药组的清除或近清除率分别为56%和42%，而安慰剂组为15%。

Anticipate NDA submission in 2H 2027 for potential approval and launch in 2028

预计于2027年下半年提交新药申请（NDA），有望在2028年获得批准并上市

Estimated 20,000 to 30,000 patients annually could be candidates for ASN-001, pathway to potentially be the largest revenue generating product in Eton’s portfolio

每年估计有2万至3万名患者可能成为ASN-001的适用人群，该产品有望成为伊顿产品组合中收入贡献最大的产品。

Leverages Eton’s existing pediatric dermatology commercial infrastructure and expands Company’s leadership in infantile hemangioma space

利用伊顿现有的儿科皮肤科商业基础设施，并扩大公司在婴儿血管瘤领域的领导地位

DEER PARK, Ill., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the Company has licensed U.S. rights to rare disease product candidate ASN-001 (timolol topical gel) from Auson Pharmaceuticals (“Auson”).

伊利诺伊州迪尔帕克，2026年8月5日（环球电讯社）——专注于罕见病治疗药物开发与商业化的创新制药公司伊顿制药股份有限公司（“Eton”或“公司”）（纳斯达克股票代码：ETON）今日宣布，公司已从Auson Pharmaceuticals（“Auson”）获得罕见病候选产品ASN-001（噻吗洛尔外用凝胶）的美国权利许可。

ASN-001 is under development for the treatment of proliferating superficial infantile hemangiomas..

ASN-001 正在开发中，用于治疗增殖性浅表婴儿血管瘤。

Auson previously completed a three-arm Phase II/III trial of 168 patients that showed efficacy results for ASN-001. In the study, 56% of patients applying ASN-001 twice daily and 42% of patients taking ASN-001 three times per day showed elimination or near-elimination of their infantile hemangiomas at week 24, compared with 15% in the placebo group.

Auson此前完成了一项纳入168名患者的三臂II/III期临床试验，结果显示了ASN-001的疗效。在该研究中，每日两次外用ASN-001的患者中有56%、每日三次服用ASN-001的患者中有42%在第24周时其婴幼儿血管瘤完全消退或接近完全消退，而安慰剂组这一比例为15%。

Eton will run a bioavailability bridging study for ASN-001 and intends to submit the New Drug Application (NDA) upon completion of the study in the second half of 2027..

Eton 将为 ASN-001 开展一项生物利用度桥接研究，并计划在 2027 年下半年完成该研究后提交新药申请（NDA）。

“Our acquisition of HEMANGEOL

“我们收购HEMANGEOL

®

®

(propranolol hydrochloride) oral solution gave us a unique view into the infantile hemangioma treatment landscape. We consistently observed that physicians rely on HEMANGEOL for patients requiring systemic therapy, while a much larger group of moderate patients are treated with ophthalmic timolol products used off-label because no FDA-approved topical option exists.

（盐酸普萘洛尔）口服溶液让我们对婴幼儿血管瘤治疗格局有了独特的认识。我们一致观察到，对于需要系统性治疗的患者，医生依赖 HEMANGEOL；而大量中度患者则因缺乏 FDA 批准的外用药物选择，接受超说明书使用的眼用噻吗洛尔产品进行治疗。

ASN-001 is designed specifically for this population, making it highly complementary to HEMANGEOL and positioning Eton to potentially address the full spectrum of infantile hemangioma treatment. We’re highly committed to investing in the development of new therapies and are excited to collaborate with Auson to bring ASN-001 to patients as quickly as possible,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals..

“ASN-001 专为该人群设计，与 HEMANGEOL 高度互补，使 Eton 有望覆盖婴儿血管瘤治疗的全谱系。我们坚定致力于投资新疗法的开发，并期待与 Auson 合作，尽快将 ASN-001 带给患者。”Eton Pharmaceuticals 首席执行官肖恩·布林杰尔森表示。

“This transaction adds yet another high-value, late-stage candidate to our pipeline, and showcases Eton’s unique ability to effectively enter new therapeutic areas and leverage its commercial infrastructure and relationships to quickly expand within a specialty,” concluded Brynjelsen.

“这笔交易为我们的产品管线又增添了一位高价值、后期阶段的候选药物，并彰显了伊顿在有效进入新治疗领域以及利用其商业化基础设施和合作关系以在专科领域快速扩张方面的独特能力。”布林杰尔森总结道。

Infantile hemangiomas are non-cancerous vascular tumors that typically appear in the first days or weeks of a newborn’s life. In severe cases, infantile hemangiomas can lead to serious complications including loss of vision, trouble breathing, or physical deformities, and require intervention with systemic therapy.

婴幼儿血管瘤是一种非癌性血管肿瘤，通常在新生儿出生后的最初几天或几周内出现。在严重情况下，婴幼儿血管瘤可能导致视力丧失、呼吸困难或身体畸形等严重并发症，需要系统性治疗干预。

They affect more than 100,000 infants annually in the United States and exist across a broad spectrum of severity..

它们每年在美国影响超过10万名婴儿，并且严重程度各不相同。

HEMANGEOL is the established standard of care for proliferating infantile hemangiomas requiring systemic therapy, representing an estimated 10,000 to 15,000 patients annually.

HEMANGEOL 是需要系统性治疗的增殖期婴儿血管瘤的既定标准治疗药物，预计每年惠及 10,000 至 15,000 名患者。

For the substantially larger population of moderate infantile hemangiomas, physicians frequently prescribe ophthalmic timolol products to be used off-label. These products were not developed or approved for infantile hemangiomas and present practical limitations, including variable dosing, formulation challenges, and the absence of FDA-approved labeling for this indication.

对于数量大得多的中度婴儿血管瘤患者群体，医生经常超说明书处方眼科用噻吗洛尔产品。这些产品并非为婴儿血管瘤开发或获批，存在实际局限性，包括剂量可变、制剂挑战以及缺乏针对该适应症的FDA批准标签。

The Company estimates that more than 10,000 patients annually currently use timolol ophthalmic products off-label to treat infantile hemangiomas, and the total market opportunity for an FDA-approved product is estimated to be 20,000 to 30,000 patients..

该公司估计，目前每年有超过10,000名患者超说明书使用噻吗洛尔眼科产品治疗婴儿血管瘤，而获得美国食品药品监督管理局（FDA）批准的产品的总市场机会预计为20,000至30,000名患者。

If approved, ASN-001 would become the first FDA-approved topical therapy for infantile hemangiomas and complement HEMANGEOL by serving a different segment of the disease spectrum.

如果获得批准，ASN-001 将成为首个获美国食品药品监督管理局（FDA）批准的用于婴幼儿血管瘤的外用疗法，并通过服务于疾病谱系中的不同细分领域，与 HEMANGEOL 形成互补。

ASN-001 is expected to be prescribed by the same healthcare professionals as HEMANGEOL, allowing Eton to leverage its existing pediatric dermatology commercial infrastructure and its strong relationships with infantile hemangioma thought leaders and vascular anomaly centers. ASN-001 has patent protection through 2044 and an additional patent application pending with the United States Patent and Trademark Office..

预计 ASN-001 将由与 HEMANGEOL 相同的医疗保健专业人员处方，从而使 Eton 能够利用其现有的儿科皮肤科商业基础设施，以及其与婴儿血管瘤领域意见领袖和血管异常中心建立的牢固关系。ASN-001 的专利保护期至 2044 年，另有一项专利申请正在美国专利商标局待审。

IMPORTANT SAFETY INFORMATION FOR HEMANGEOL

HEMANGEOL 的重要安全信息

USE

使用

HEMANGEOL (propranolol hydrochloride) oral solution is a prescription medicine used to treat proliferating infantile hemangioma (a type of birthmark) requiring treatment throughout the body.

HEMANGEOL（盐酸普萘洛尔）口服溶液是一种处方药，用于治疗需要全身性治疗的增殖性婴儿血管瘤（一种胎记）。

Who should NOT take HEMANGEOL?

谁不应该服用HEMANGEOL？

Do not give HEMANGEOL to your child if they:

如果您的孩子存在以下情况，请勿给予HEMANGEOL：

Were born early and are less than 5 weeks corrected age

早产且矫正胎龄不足5周

Weigh less than 4.5 lbs

重量小于4.5磅

Have asthma or a history of breathing problems (bronchospasm)

患有哮喘或有呼吸困难史（支气管痉挛）

Have certain heart conditions (such as slow heart rate, heart block, or heart failure)

患有某些心脏疾病（如心动过缓、心脏传导阻滞或心力衰竭）

Have very low blood pressure

血压非常低

Have high blood pressure caused by a tumor on the adrenal gland, called “pheochromocytoma”

患有由肾上腺肿瘤（称为“嗜铬细胞瘤”）引起的高血压

Are allergic to propranolol or any of the ingredients in HEMANGEOL

对普萘洛尔或HEMANGEOL中的任何成分过敏

IMPORTANT SAFETY INFORMATION

重要安全信息

HEMANGEOL may cause serious side effects, including:

HEMANGEOL 可能引起严重的副作用，包括：

Low blood sugar (hypoglycemia), which can be serious and may lead to seizures, loss of consciousness, or even death. This is more likely if your child is not eating well, is vomiting, or is sick. Always give HEMANGEOL during or right after feeding. Do not give a dose if your child is not eating. Signs of low blood sugar may include pale skin, sweating, irritability, unusual sleepiness, or seizures..

低血糖（低血糖症）可能很严重，并可能导致癫痫发作、意识丧失，甚至死亡。如果您的孩子进食不佳、呕吐或生病，发生低血糖的风险更高。务必在喂奶期间或喂奶后立即给予HEMANGEOL。如果孩子未进食，请勿给药。低血糖的迹象可能包括皮肤苍白、出汗、易怒、异常嗜睡或癫痫发作。

Bradycardia and hypotension. HEMANGEOL may slow your child’s heart rate or lower their blood pressure. Call your healthcare provider if your child seems unusually tired, dizzy, faints, or has pale or cold skin.

心动过缓和低血压。HEMANGEOL 可能会减慢您孩子的心率或降低其血压。如果您的孩子异常疲倦、头晕、昏厥，或出现皮肤苍白或发冷，请立即联系您的医疗保健提供者。

Bronchospasm. HEMANGEOL can cause breathing problems or make them worse. Get medical help right away if your child has wheezing or trouble breathing.

支气管痉挛。HEMANGEOL 可能导致呼吸问题或使其加重。如果您的孩子出现喘息或呼吸困难，请立即寻求医疗帮助。

Cardiac failure. In certain patients with preexisting heart conditions, HEMANGEOL can worsen the heart’s ability to pump blood.

心力衰竭。对于某些已有心脏疾病的患者，HEMANGEOL 可能会削弱心脏泵血能力。

Increased risk of stroke. HEMANGEOL may increase the risk of stroke in children with certain blood vessel conditions (such as PHACE syndrome). Your healthcare provider may check for these conditions, especially in infants with large facial hemangiomas, before starting treatment.

卒中风险增加。HEMANGEOL 可能会增加患有某些血管疾病（如 PHACE 综合征）儿童的卒中风险。在开始治疗前，您的医疗保健提供者可能会检查是否存在这些情况，尤其是在面部有较大血管瘤的婴儿中。

Hypersensitivity. HEMANGEOL may make severe allergic reactions worse and may make it harder to treat these reactions with epinephrine (a medicine used in emergencies).

超敏反应。HEMANGEOL 可能加重严重过敏反应，并可能使使用肾上腺素（一种用于紧急情况的药物）治疗这些反应变得更加困难。

What are the most common side effects of HEMANGEOL?

HEMANGEOL 最常见的副作用有哪些？

The most common side effects include trouble sleeping, respiratory infections (such as colds or bronchitis), diarrhea, and vomiting.

最常见的副作用包括失眠、呼吸道感染（如感冒或支气管炎）、腹泻和呕吐。

Drug interactions

药物相互作用

Tell your healthcare provider about all medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect how HEMANGEOL works or increase the risk of side effects, including medicines that affect how the body processes propranolol or increase the risk of low blood sugar (such as corticosteroids)..

请告知医护人员您的孩子正在服用的所有药物，包括处方药、非处方药、维生素和草本补充剂。某些药物可能会影响HEMANGEOL的疗效或增加副作用的风险，包括影响身体代谢普萘洛尔或增加低血糖风险的药物（例如皮质类固醇）。

You are encouraged to report negative side effects of prescription drugs by contacting Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at https://www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

我们鼓励您通过拨打1-855-224-0233联系Eton Pharmaceuticals, Inc.，或通过https://www.fda.gov/safety/medwatch访问美国食品药品监督管理局（FDA）网站，或拨打1-800-FDA-1088，报告处方药的不良反应。

Please see full

请查看完整内容

Prescribing Information

处方信息

for more information.

欲了解更多信息。

About

关于

Eton

伊顿

Pharmaceuticals

制药

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI

Eton 是一家创新的制药公司，专注于罕见病治疗药物的开发与商业化。公司目前拥有十一款已上市的罕见病产品：KHINDIVI

®

®

, INCRELEX

，INCRELEX

®

®

, ALKINDI SPRINKLE

，阿利金迪洒剂

®

注册商标

, DESMODA™, GALZIN

，DESMODA™，GALZIN

®

注册商标

, HEMANGEOL

，HEMANGEOL

®

®

, PKU GOLIKE

，PKU GOLIKE

®

注册商标符号

, IMPAVIDO

，无畏者

®

注册商标符号

, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia

、卡格鲁酸、无水甜菜碱和尼替西农。该公司另有四种处于后期开发阶段的产品候选药物：Amglidia

®

®

, ET-700, ET-800 and ZENEO

、ET-700、ET-800 和 ZENEO

®

®

hydrocortisone autoinjector. For more information, please visit our website at

氢化可的松自动注射器。欲了解更多信息，请访问我们的网站

www.etonpharma.com

www.etonpharma.com

.

。

Forward-Looking Statements

前瞻性陈述

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives.

本新闻稿中涉及非历史事实的陈述属于1995年《私人证券诉讼改革法》意义上的“前瞻性陈述”，包括与Eton预计能够开展某些活动并实现某些目标和目的相关的陈述。

These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates.

这些陈述包括但不限于有关Eton的业务战略、Eton开发和商业化其产品候选品的计划、Eton产品候选品的安全性和有效性、Eton在监管申报和审批方面的计划和预期时间安排，以及Eton产品候选品市场的规模和增长潜力。

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements.

由于此类陈述受风险和不确定性的影响，实际结果可能与这些前瞻性陈述所表达或暗示的结果存在重大差异。“相信”、“预计”、“计划”、“预期”、“打算”、“将”、“目标”、“潜在”等词语及类似表述旨在识别前瞻性陈述。

These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

这些前瞻性陈述基于Eton当前的预期，并涉及可能永远不会实现或可能被证明不正确的假设。由于各种风险和不确定性，实际结果和事件的时间可能与这些前瞻性陈述中预期的存在重大差异，其中包括但不限于与发现、开发和商业化安全有效的人类治疗药物相关的风险，以及围绕此类药物开展业务的风险。

These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Ex.

有关伊顿公司发展计划和财务状况的这些及其他风险，在伊顿公司向证券交易委员会提交的文件中有更详细的描述。

Investor Relations:

投资者关系：

Lisa M. Wilson, In-Site Communications, Inc.

丽莎·M·威尔逊，In-Site Communications 公司

T: 212-452-2793

电话：212-452-2793

E:

东：

lwilson@insitecony.com

lwilson@insitecony.com