CAMBRIDGE, Mass.--(BUSINESS WIRE)-- July 15, 2025 -- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for SH-110, a palatable oral suspension to treat Glioma - a rare brain cancer - by providing a liquid form of treatment for patients who have difficulty swallowing..

马萨诸塞州剑桥市--（BUSINESS WIRE）-- 2025年7月15日 -- 美国-爱尔兰专业制药公司Shorla Oncology（“Shorla”）今日宣布，美国食品药品监督管理局（FDA）已授予SH-110孤儿药资格。SH-110是一种可口的口服悬浮液，用于治疗胶质瘤（一种罕见的脑癌），为吞咽困难的患者提供液体形式的治疗方案。

While SH-110 will increase coverage and compliance by allowing more flexibility in dose preparation and site of care, its biggest impact will be for patients with Glioma who develop dysphagia, or have difficulty swallowing. These patients often rely on obtaining compounded treatments from a specialized pharmacy or self-compound capsules to fight their disease..

虽然SH-110通过在剂量准备和治疗地点上提供更大的灵活性，将会提高覆盖率和依从性，但其最大的影响将体现在那些患有胶质瘤并出现吞咽困难或难以吞咽的患者身上。这些患者通常依赖从专业药房获取复方药物或自行配制胶囊来对抗疾病。

“For too long, many patients with Glioma and their pharmacists and caregivers had no other choice but to break open capsules and expose themselves to unnecessary hazards,” said Sharon Cunningham, chief executive officer of Shorla. “SH-110 is a proprietary product that offers them a safer and more convenient formulation to treat this rare brain cancer.”.

“长期以来，许多胶质瘤患者及其药剂师和护理人员别无选择，只能打开胶囊，使自己暴露在不必要的风险中，”Shorla首席执行官 Sharon Cunningham 表示。“SH-110 是一种专利产品，为他们提供了更安全、更便捷的配方来治疗这种罕见的脑癌。”

SH-110 will join a growing portfolio of patient-friendly cancer medications developed by Shorla that have recently been approved by regulators.

SH-110 将加入 Shorla 开发的、近期已获监管机构批准的、日益增多的患者友好型癌症药物组合。

“This is a difference maker in the lives of those who suffer from Glioma,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “SH-110 complements our other Shorla treatments that are designed to be easier for patients to use, and for caregivers and providers to administer.”

“这对那些患有胶质瘤的人来说是一个改变生活的差异，”Shorla的首席技术官兼联合创始人奥拉希斯·瑞安说道。“SH-110补充了我们的其他Shorla治疗方法，这些方法旨在让患者更容易使用，并方便护理人员和医疗服务提供者进行管理。”

According to the National Brain Tumor Society, about 13,000 adults and 2,000 children are diagnosed each year in the U.S. with Glioma, an orphan disease.

根据国家脑肿瘤协会的数据，美国每年约有 13,000 名成人和 2,000 名儿童被诊断出患有胶质瘤，这是一种罕见病。

About SH-110

关于SH-110

SH-110 is a palatable oral suspension to treat Glioma addressing the unmet medical need for patients with difficulty swallowing. This proprietary product will benefit patients by reducing treatment burden and providing a palatable age-appropriate treatment. SH-110 represents the third oral liquid in Shorla’s growing portfolio of products..

SH-110 是一种口感良好的口服悬浮液，用于治疗胶质瘤，满足了吞咽困难患者的未满足医疗需求。这款专有产品将通过减轻治疗负担并提供适合年龄的可口治疗来使患者受益。SH-110 代表了 Shorla 不断增长的产品组合中的第三种口服液体。

About Shorla Oncology

关于Shorla肿瘤学

Shorla Oncology is a privately- held, U.S. and Ireland- based commercial stage specialty pharmaceutical company established by Sharon Cunningham and Orlaith Ryan. The company has an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers. Shorla is focused on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population.

Shorla Oncology是一家私人控股的美国和爱尔兰专业制药公司，由Sharon Cunningham和Orlaith Ryan创立，专注于商业阶段的特种药物。该公司拥有一系列针对孤儿药和儿童癌症的创新肿瘤药物的先进管线。Shorla致力于治疗选择有限、短缺或现有药物对目标人群不适用的适应症。

The company’s growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. Shorla currently markets four products, a reliable supply of Nelarabine for the treatment of T-cell leukemia, JYLAMVO™ an oral liquid methotrexate for the treatment of acute lymphoblastic leukemia and other indications, IMKELDI an oral liquid imatinib for acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors and other indications, and TEPYLUTE® the first and only ready-to-dilute multi-dose vial of thiotepa to treat breast and ovarian cancer..

公司不断扩展的产品组合为患者带来可及、可负担且挽救生命的治疗方案，为患者护理作出重大贡献。Shorla目前上市的四种产品包括：用于治疗T细胞白血病的可靠供应的奈拉滨、用于治疗急性淋巴细胞白血病及其他适应症的口服液体甲氨蝶呤JYLAMVO™、用于治疗急性淋巴细胞白血病、慢性髓性白血病、胃肠道间质瘤及其他适应症的口服液体伊马替尼IMKELDI，以及用于治疗乳腺癌和卵巢癌的首个也是唯一一个即用型多剂量硫替哌注射液TEPYLUTE®。