FUKUOKA, Japan & NEW YORK--(BUSINESS WIRE)--FELIQS®, a clinical stage multinational biopharmaceutical company focused on the development of first-in-class small molecules targeting lipid oxidation, announced today that the U.S. Food and Drug Administration (FDA) has granted its lead asset, FLQ-101, Fast Track designation for the prevention of retinopathy of prematurity (ROP).

日本福冈（FUKUOKA）和纽约（BUSINESS WIRE）--临床阶段的跨国生物制药公司FELIQS®今天宣布，美国食品和药物管理局（FDA）已批准其主要资产FLQ-101，用于预防早产儿视网膜病变（ROP）的快速通道指定。

The company plans to conduct a Phase1b/2 study of FLQ-101 (tROPhy-1 study) both in the US and Japan in 1Q2025. The FDA grants investigational medicines Fast Track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need..

该公司计划于2025年第1季度在美国和日本进行FLQ-101的1b/2期研究（奖杯-1研究）。FDA授予研究药物快速通道指定，以促进开发并加快对证明有潜力治疗严重疾病并满足未满足医疗需求的药物的审查。。

FLQ-101 is a once-daily oral/intravenous solution that enhances the physiologic response of vascularization in retina and protects from inflammation and abnormal neovascularization. In 2024, the U.S. Food and Drug Administration (FDA) granted FLQ-101 Orphan Drug designation. Additionally, the company is on track to submit an IND for its second asset, FLQ-104, for intermediate dry-AMD in 2H2025..

FLQ-101是一种每日一次的口服/静脉注射溶液，可增强视网膜血管形成的生理反应，并防止炎症和异常新血管形成。2024年，美国食品和药物管理局（FDA）授予FLQ-101孤儿药称号。。。

'With no approved preventative treatments available for retinopathy of prematurity, receiving the Fast Track designation for FLQ-101 is an important milestone for our company. This designation will facilitate the review process and give us better access to FDA which should shorten the clinical development program timeline and improve the chances of designing and conducting a successful program.' said Ken-ichiro (Nobu) Kuninobu, Ph.D., RPh, Co-founder and Chief Executive Officer at FELIQS.

“由于没有批准的早产儿视网膜病变预防治疗方法，因此获得FLQ-101快速通道指定对我们公司来说是一个重要的里程碑。这种指定将有助于审查过程，并使我们更好地接触FDA，这将缩短临床开发计划的时间表，并提高设计和实施成功计划的机会。”FELIQS联合创始人兼首席执行官Ken ichiro（Nobu）Kuninobu博士说。

He continues, “We are excited that FDA recognized the unmet medical need in the target population and that FLQ-101 could potentially close this gap. At FELIQS, we are committed to help the most vulnerable members of society. This is exemplified by our focus on extremely premature neonates with the FLQ-101 program and the elderly patients with intermediate dry-AMD with the FLQ-104 program.'.

他继续说：“我们很高兴FDA认识到目标人群的医疗需求尚未得到满足，FLQ-101可能会缩小这一差距。在FELIQS，我们致力于帮助社会中最脆弱的成员。这一点可以通过FLQ-101计划关注极早产新生儿和FLQ-104计划关注中度干性AMD老年患者。”。

About ROP

关于ROP

Retinopathy of prematurity (ROP) is a developmental vascular disorder characterized by abnormal growth of retinal blood vessels in the incompletely vascularized retina of extremely premature neonates. In the United States, ROP afflicted about 27,000 premature neonates in 2019 and remains one of the leading causes of childhood blindness.

早产儿视网膜病变（ROP）是一种发育性血管疾病，其特征是极早产儿不完全血管化视网膜中视网膜血管异常生长。在美国，2019年，ROP折磨了约27000名早产儿，仍然是儿童失明的主要原因之一。

Currently available FDA approved treatments of ROP, namely laser photocoagulation and anti-VEGF therapy, are utilized after ROP development, require anesthesia, are associated with retinal detachment, and may increase the risk of intraocular infection. The efficacy of these treatments is dependent on early detection and management of the disease and may be associated with long term sequalae..

目前可用的FDA批准的ROP治疗方法，即激光光凝和抗VEGF治疗，在ROP发展后使用，需要麻醉，与视网膜脱离有关，并可能增加眼内感染的风险。这些治疗方法的疗效取决于疾病的早期发现和管理，可能与长期红杉有关。。

About FELIQS

关于FELIQS

FELIQS Corporation is a clinical stage multinational biopharmaceutical company. FELIQS is headquartered in Fukuoka, JAPAN and has a US office in JLABS@NYC. For more information, please visit our website at www.feliqs.com, which does not form a part of this release.

FELIQS Corporation是一家临床阶段的跨国生物制药公司。FELIQS总部位于日本福冈，在美国设有办事处JLABS@NYC.有关更多信息，请访问我们的网站www.feliqs.com，该网站不构成本版本的一部分。

FLQ-101 is an investigational medicine that has not been approved for the prevention of ROP by regulatory authorities.

FLQ-101是一种研究药物，尚未被监管机构批准用于预防ROP。