STOCKHOLM--(BUSINESS WIRE)--Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a Complete Response Letter (CRL) where additional information was requested.

斯德哥尔摩--（商业新闻短讯）--Xspray Pharma AB（publ）（纳斯达克-斯德哥尔摩：Xspray）：美国食品和药物管理局（FDA）已接受重新提交Xspray Pharma针对Dasynoc®的新药申请（NDA），此前有完整的回复信（CRL）要求提供更多信息。

The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024. This is the FDA’s deadline for completing the approval process, marking a significant milestone for Dasynoc®, Xspray’s innovative protein kinase inhibitor (PKI) product candidate for CML treatment..

美国食品和药物管理局（FDA）现已将《处方药使用费法案》（PDUFA）的日期定为2024年7月31日。这是FDA完成批准程序的最后期限，标志着Xspray创新蛋白激酶抑制剂（PKI）候选产品Dasync®（用于CML治疗）的重要里程碑。。

With an established PDUFA date set to 31st of July, Xspray Pharma continues to strategically plan for the commercial launch of Dasynoc® on September 1, 2024. These dates align with the company’s comprehensive preparation following the patent litigation settlement with Bristol Myers Squibb (BMS), paving the way for Dasynoc® to become a new option for chronic myeloid leukemia (CML) treatment pending FDA approval..

随着PDUFA的确定日期定在7月31日，Xspray Pharma将继续为2024年9月1日Dasynoc®的商业发布进行战略规划。这些日期与公司在与百时美施贵宝（BMS）达成专利诉讼和解后的全面准备一致，为Dasynoc®成为FDA批准的慢性粒细胞白血病（CML）治疗的新选择铺平了道路。。

“With the new time line communicated by the FDA, I am pleased to confirm that Xspray Pharma is on track to launch our lead product candidate Dasynoc® on September 1 if approved, as previously communicated. We appreciate the FDA’s diligent review of our resubmission and look forward to collaborating closely with the agency in the lead-up to the PDUFA date,” said Per Andersson, CEO of Xspray Pharma AB.

佩尔·安德森（Per Andersson）表示：“随着美国食品和药物管理局（FDA）传达的新时间表，我很高兴确认，如果获得批准，Xspray Pharma将于9月1日推出我们的主要候选产品Dasynoc®。我们感谢美国食品和药物管理局（FDA）对我们的重新提交进行的认真审查，并期待在PDUFA日期之前与该机构密切合作。”，Xspray Pharma AB首席执行官。

“Our team is fully committed to addressing the FDA’s requirements and ensuring that healthcare providers and patients have clear, comprehensive information on Dasynoc®’s dosing and administration.”.

“我们的团队完全致力于满足FDA的要求，并确保医疗保健提供者和患者对Dasynoc®的剂量和给药有清晰、全面的信息。”。

Dasynoc®, an optimized version of dasatinib, highlights Xspray Pharma’s dedication to advancing cancer treatment through innovative drug formulations. The product candidate has the potential to become a best-in-class product with a strong patent position for amorphous dasatinib products with improved properties for patients with CML.

达沙替尼的优化版本Dasynoc®突显了Xspray Pharma致力于通过创新药物配方推进癌症治疗。该候选产品有可能成为同类最佳产品，拥有无定形达沙替尼产品的强大专利地位，并具有改善CML患者性能的潜力。

As the PDUFA date approaches, the company remains focused on its goal to improve the lives of those affected by CML with this novel therapy..

随着PDUFA日期的临近，该公司仍然专注于通过这种新型疗法改善CML患者生活的目标。。

About Xspray Pharma AB

关于Xspray Pharma AB

Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies.

Xspray Pharma AB（publ）是一家制药公司，利用其专有的HyNap™技术平台，专注于开发用于癌症治疗的改进PKI。该公司旨在通过提高现有癌症治疗的疗效，安全性和患者体验来提高癌症患者的临床疗效。

For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com..

有关Xspray Pharma AB及其创新癌症治疗方法的更多信息，请访问www.xspraypharma.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements regarding the regulatory approval process and potential commercial launch of Dasynoc®. Actual results may vary based on the FDA’s final decision and other factors.

本新闻稿包含有关Dasync®监管审批流程和潜在商业发布的前瞻性声明。根据FDA的最终决定和其他因素，实际结果可能会有所不同。