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 GenSci155 injection has been approved. The relevant details are as follows:
1. Basic Information of the Drug
- Product Name: GenSci155 Injection
- Application Matters: Domestic production drug registration clinical trial
- Acceptance Numbers: CXSL2600459, CXSL2600460, CXSL2600461, CXSL2600462
- Applicant: Changchun JinSai Pharmaceutical Co., Ltd.
- Approval Conclusion: After review, the clinical trial for this product is approved.
- Indications: Prevention of bronchopulmonary dysplasia (BPD) in premature infants and acute ischemic stroke (AIS).