3SBio's 707 injection receives breakthrough therapy designation
3SBio Inc. announced that its independently developed 707 Injection has received Breakthrough Therapy Designation (BTD) from the NMPA in China. The designation applies to the first-line treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 707 Injection is a bispecific antibody targeting VEGF/PD-1, and is based on 3SBio's proprietary CLF2 platform. The drug is currently undergoing multiple clinical studies in China, including a phase III clinical study for the specified NSCLC treatment already approved by the CDE of the NMPA. It is also undergoing phase II studies in China for combination therapy with chemotherapy for the first-line treatment of advanced NSCLC, metastatic colorectal cancer, and advanced gynecological tumours, and has received FDA approval in relation to its investigational new drug application. The BTD is expected to provide policy support, prioritize resource allocation, enhance guidance, and accelerate drug development. 3SBio cautioned that there is no assurance that the product will be successfully commercialized.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
News Alerts
Get instant email alerts when 3SBio Inc publishes news
Free account required • Unsubscribe anytime