PLB-002, PrimeLink Bio’s Anti-Claudin 6 ADC, Receives IND Acceptance from NMPA and FDA

PrimeLink Bio, an innovative biopharma focused on next-generation antibody–drug conjugates (ADCs), announced that the clinical trial application for its first pipeline PLB-002 (Anti-Claudin 6 ADC), has been officially accepted by the National Medical Products Administration (NMPA) with its acceptance number CXSL2500777, and has received an IND Acknowledgement Letter from the U.S. Food and Drug Administration (FDA).

About PLB-002

PLB-002 is an anti-Claudin 6 ADC, a tight junction protein specifically expressed in solid tumors—most notably ovarian, non-small-cell lung, endometrial and testicular cancers—while barely expressed in healthy adult tissues. Discovered and advanced using PrimeLink Bio’s proprietary technology platform, PLB-002 has a much broader therapeutic window and great PK profile. Pre-clinical data has shown that PLB-002 is highly promising for the treatment of ovarian cancer and other CLDN6-positive solid tumors.

About PrimeLink Bio

Founded in July 2021, PrimeLink Bio is an innovative biopharmaceutical company dedicated to the development of next-generation antibody–drug conjugates (ADCs). Guided by the principle of “tailoring optimal ADC structures for specific targets,” the company has developed a flexible, modular platform with high hydrophilicity, compatibility, and flexibility that enables novel strategies to overcome the safety liabilities and resistance mechanisms limiting current ADC therapies. PrimeLink Bio has built a pipeline spanning single-target ADCs and novel modalities such as bispecific ADCs and dual-payload ADCs. Three programs have already reached the PCC stage. The core pipeline has shown superior efficacy and safety with best-in-class potential in preclinical studies, and its IND application was submitted in Q3 2025.  Backed by its innovative technology platform and differentiated product pipelines, PrimeLink Bio has raised a total of RMB 150 million from leading domestic and international investors, including Vertex Ventures, Fosun Pharma, KAITAI Capital and Shenzhen Hongshulin Venture Capital. The company will continue to advance its platform and accelerate pipeline development to bring life-changing benefits to cancer patients worldwide.