SN Bioscience Co. Ltd., under the leadership of CEO Park Young-hwan, made an announcement on May 7th regarding the FDA's decision to grant Fast Track Designation for SNB-101 (API: SN-38), a novel polymer nanoparticle anticancer medication currently undergoing clinical trials for small cell lung cancer (SCLC).

SN生物科学有限公司在首席执行官Park Young hwan的领导下于5月7日宣布，FDA决定批准SNB-101（API:SN-38）的快速通道指定，SNB-101是一种新型聚合物纳米粒子抗癌药物，目前正在进行小细胞肺癌（SCLC）的临床试验。

This significant development follows previous designations of SNB-101 as an orphan drug for SCLC and pancreatic cancer. With this recent designation, SNB-101 is poised to address the pressing unmet medical needs in the treatment of SCLC and potentially expedite commercialization post phase 2 clinical trials.The treatment landscape for SCLC remains challenging, with limited options available.

这一重大发展遵循先前将SNB-101指定为SCLC和胰腺癌的孤儿药。通过最近的指定，SNB-101有望解决SCLC治疗中迫切未满足的医疗需求，并可能加速2期临床试验后的商业化。小细胞肺癌的治疗前景仍然具有挑战性，可用的选择有限。

Currently, the standard first-line therapy involves a combination of cisplatin and etoposide, while second-line treatments are explored in clinical trials as outlined in the NCCN guidelines.The Fast Track designation aims to streamline the drug development process, expediting both development and review for drugs targeting serious conditions with unmet medical needs.

目前，标准的一线治疗包括顺铂和依托泊苷的联合治疗，而二线治疗则在NCCN指南中概述的临床试验中进行了探索。快速通道设计旨在简化药物开发过程，加快针对严重疾病和未满足医疗需求的药物的开发和审查。

This designation facilitates enhanced communication with the FDA and allows for a rolling review of the submission package, thereby accelerating the review process. Furthermore, it opens doors for potential accelerated approval post phase 2 clinical trials and priority review following phase 3 completion, contingent upon meeting specific qualifications.SNB-101 represents a breakthrough as the world's first nanoparticle anticancer drug developed from the highly insoluble SN-38 through polymer nanoparticles.

这种指定有助于加强与FDA的沟通，并允许对提交包进行滚动审查，从而加速审查过程。此外，它为第二阶段临床试验后的潜在加速批准和第三阶段完成后的优先审查打开了大门，这取决于是否满足特定的资格要求。SNB-101是世界上第一种由高度不溶性SN-38通过聚合物纳米粒子开发的纳米粒子抗癌药物，是一项突破。

Leveraging nano micelle technology, a core platform of SN Bioscience, SNB-101 has demonstrated promising results in preclinical and phase 1 trials, notably reducing adverse events in the digestive system and exhi.

利用纳米胶束技术（SN Bioscience的核心平台），SNB-101在临床前和1期试验中显示出有希望的结果，显着减少了消化系统和EXPI的不良事件。