PegBio Co., Ltd. (2565) Announces NMPA Approval for PB-119

Bulletin Express
4 hours ago

PegBio Co., Ltd. (the “Company”) has officially received approval from the China National Medical Products Administration for the new drug application concerning PB-119, a core product developed by the Company. PB-119, also known as Paidakang®, is a new-generation, once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist and is categorized as a national novel Class 1 drug in the “Significant New Drugs Development” program.

From Phase I to Phase III clinical studies, PB-119 demonstrated an effective blood glucose control profile alongside favorable tolerance. According to disclosures, it not only improves overall blood glucose management but also helps manage blood pressure, blood lipids, and weight through notable enhancement of β-cell function. Its differentiated advantages stem from an innovative site-specific PEGylation technology that resists enzymatic degradation, slows renal clearance, and enables efficient binding to GLP-1 receptors.

Despite receiving approval, there is no assurance of successful large-scale commercialization. The disclosure advises exercising caution when dealing in the Company’s securities.

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