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Changchun High-Tech unit's RSV antibody clinical trial application accepted by NMPA
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Changchun High-Tech (stock code: 000661) announced that its subsidiary, Baike Biotech, has received an Acceptance Notice from China's National Medical Products Administration (NMPA) for a clinical trial application. The application, numbered CXSL2601038, is for a recombinant human anti-respiratory syncytial virus (RSV) monoclonal antibody injection combination formulation. The drug is intended to prevent lower respiratory tract infections caused by RSV in newborns and infants. The acceptance of the application marks the formal start of the regulatory review process for the clinical trial. The announcement was made via the stockstar_stock_live platform, which covers stock market news.
Source report
Changchun High-Tech (Shenzhen-listed) has announced that its subsidiary, Baike Bio, has received a "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the clinical trial application of a recombinant human anti-respiratory syncytial virus (RSV) monoclonal antibody injection combination formulation.
The drug is intended for the prevention of lower respiratory tract infections caused by RSV in newborns and infants.
Key details:
- Drug type: Recombinant human anti-RSV monoclonal antibody injection combination formulation
- Target indication: Prevention of RSV-induced lower respiratory tract infections in newborns and infants
- Regulatory milestone: Domestic drug clinical trial application accepted
- Acceptance number: CXSL2601038
- Date of announcement: Recent (as per the original notice)
Source
证券之星-股市直击Neutral / independent
Part of this Story
Baike Bio’s RSV antibody trial application accepted by Chinese regulator for infant protection