/PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted

/PRNewswire/ -- Hemispherian AS，一家致力于开发针对侵袭性癌症的下一代疗法的先锋生物技术公司，今天宣布美国食品和药物管理局 (FDA) 已授予

Orphan Drug Designation (ODD)

孤儿药认定 (ODD)

for

为了

GLIX1

GLIX1

for the treatment of

用于治疗

malignant glioma

恶性胶质瘤

, a category of devastating brain cancers that includes glioblastoma.

，一类包括胶质母细胞瘤在内的严重脑癌。

Significant clinical benefit beyond current therapies.

超出当前疗法的显著临床益处。

The designation marks a major regulatory milestone for Hemispherian, recognizing both the urgent unmet medical need in glioma and the potential of GLIX1 to offer significant clinical benefit beyond current therapies.

该指定标志着 Hemispherian 的一个重要监管里程碑，既认可了胶质瘤领域迫切未满足的医疗需求，也认可了 GLIX1 在现有疗法之外提供显著临床益处的潜力。

'This designation from the FDA further validates our scientific approach and mission to address high unmet needs in oncology,'

“FDA的这一指定进一步验证了我们在科学方法和解决肿瘤学中高度未满足需求的使命。”

said

说

Zeno Albisser

泽诺·阿尔比塞

, CEO of Hemispherian.

，Hemispherian公司首席执行官。

'GLIX1 is a first-in-class small molecule with a unique mechanism of action, and we are encouraged by the recognition from both U.S. and EU regulators of its potential to offer meaningful benefit to patients with malignant glioma.'

“GLIX1 是一种具有独特作用机制的首创小分子，我们受到美国和欧盟监管机构对其有可能为恶性胶质瘤患者带来显著益处的认可而备受鼓舞。”

About the Designation

关于指定

The FDA's Office of Orphan Products Development granted ODD under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). The designation is based on GLIX1's potential to treat a rare and life-threatening disease affecting fewer than 200,000 people in

美国食品药品监督管理局（FDA）孤儿产品开发办公室根据《联邦食品、药品和化妆品法案》（21 U.S.C. 360bb）第526条授予了孤儿药资格认定（ODD）。该认定是基于GLIX1在治疗一种影响不到20万人的罕见且危及生命的疾病方面的潜力。

the United States

美国

. GLIX1 demonstrated substantial preclinical efficacy, including tumor regression and survival benefit in validated models of glioma.

GLIX1在胶质瘤的验证模型中显示出显著的临床前疗效，包括肿瘤消退和生存获益。

Benefits of Orphan Drug Designation

孤儿药指定的好处

The Orphan Drug Designation from the FDA provides several benefits intended to support and accelerate the development of promising therapies for rare diseases, including:

FDA的孤儿药认定提供了多项旨在支持和加速罕见病有前景疗法开发的益处，包括：

7 years of market exclusivity in the U.S. upon FDA approval

在美国，获得FDA批准后可享有7年的市场独占期

Tax credits for qualified clinical trial expenses

合格临床试验费用的税收抵免

Exemption from FDA application fees

免于FDA申请费用

Eligibility for accelerated regulatory pathways

符合加速监管途径的条件

About GLIX1 and Hemispherian

关于GLIX1和Hemispherian

GLIX1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells. Hemispherian's proprietary GLIX platform enables the selective elimination of cancer cells with minimal impact on healthy tissue. In preclinical studies, GLIX1 has shown the ability to eradicate tumors in validated animal models with limited side effects, making it a highly promising candidate for the treatment of glioma and other aggressive cancers..

GLIX1 是一种首创的小分子治疗药物，靶向癌细胞中的 DNA 修复脆弱性。Hemispherian 专有的 GLIX 平台能够选择性地消除癌细胞，同时对健康组织的影响极小。在临床前研究中，GLIX1 已显示出在经过验证的动物模型中根除肿瘤的能力，并且副作用有限，这使其成为治疗胶质瘤和其他侵袭性癌症的极具前景的候选药物。

Hemispherian is an Oslo

Hemispherian 是 奥斯陆

-based pharmaceutical company focused on developing breakthrough cancer therapies. The company is supported by a growing global network of academic and clinical partners.

总部位于 的制药公司，专注于开发突破性的癌症治疗方法。该公司得到了不断增长的全球学术和临床合作伙伴网络的支持。