000661SZSE
🚨 Material Event

Announcement on Approval of Clinical Trial Application for GenSci144 Tablets by Subsidiary

✨ AI Summary

Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial application of GenSci144 tablets. This drug targets phenylketonuria (PKU) and is classified as a Class 1 chemical drug. The approval marks a significant step in providing new treatment options for PKU patients.

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Full Translation

AI Translation· azure_openai

Changchun High-tech Industry (Group) Co., Ltd. (hereinafter referred to as "the Company") announces that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (hereinafter referred to as "JinSai Pharmaceutical"), has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial application for the domestic production of GenSci144 tablets has been approved. The relevant details are as follows:

1. Basic Information of the Drug

  • Product Name: GenSci144 Tablets
  • Application Matter: Clinical trial acceptance for domestic production
  • Acceptance Numbers: CXHL2600475, CXHL2600476
  • Applicant: Changchun JinSai Pharmaceutical Co., Ltd.
  • Approval Conclusion: After review, the clinical trial for this product is approved.
  • Indication: Phenylketonuria (PKU)

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