PrimeLink Bio’s PLB-002 Wins NMPA IND Approval, Marking China-US Dual Filing

On November 20, 2025, PrimeLink Bio, an innovative biopharma focused on the development of next-generation antibody-drug conjugates (ADCs), announced that its Investigational New Drug (IND) application for PLB-002, the company's lead pipeline candidate, has been formally approved by the National Medical Products Administration (NMPA), clearing the way for Phase I clinical trials.

PLB-002 is a Claudin 6-targeting ADC identified through PrimeLink Bio's proprietary flexible and modular-design next-generation ADC platform. Designed for the treatment of advanced solid tumors in adults, the candidate features a broad therapeutic window (TI>25), a favorable safety profile, and low potential for off-target toxicity, positioning it as a promising best-in-class contender. In September of this year, PLB-002 secured FDA IND clearance.

PrimeLink Bio’s flexible, modular-design ADC platform

Leveraging its differentiated ADC technology platform, PrimeLink Bio is advancing multiple pipeline programs, encompassing not only single-target ADCs but also novel modalities such as bispecific ADCs and dual-payload ADCs. Going forward, the company will continue to advance additional competitive pipeline assets into clinical development.

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. PLB-002, developed on PrimeLink Bio's proprietary platform, offers a broad therapeutic window and favorable PK profile. Pre-clinical data has shown that PLB-002 is highly promising for the treatment of ovarian cancer, non-small cell lung cancer (NSCLC) and other CLDN6-positive solid tumors.

About PrimeLink Bio

PrimeLink Bio, founded in July 2021 by Dr. Yin Mao, is an innovative biopharmaceutical enterprise dedicated to developing next-generation antibody-drug conjugates (ADCs). Guided by the core philosophy of "tailoring the optimal ADC structure for each target," the company has independently developed a flexible, modular-design technology platform. Featuring high hydrophilicity, compatibility, and flexibility, the platform provides a novel approach to addressing safety and resistance challenges in ADC therapeutics.

Leveraging its innovative technology platform and differentiated product pipeline, PrimeLink Bio has established a robust portfolio encompassing single-target ADCs and novel modalities such as bispecific ADCs and dual-payload ADCs. The company has secured investments from leading domestic and international institutional investors including Vertex Ventures, Fosun Pharma, Kaitai Capital, and Shenzhen Mangrove Capital, raising a total of RMB 150 million. PrimeLink Bio has also been honored with multiple prestigious awards, including the "Top 100 Chinese Pharmaceutical Innovation Value Discovery Companies 2022-2023," National "Technology-based SME," Shenzhen "Innovative SME," "Specialized and Innovative SME," and "Seed Unicorn Enterprise" designations, as well as "Outstanding Enterprise" at the 13th China Innovation and Entrepreneurship Competition.

Moving forward, PrimeLink Bio will continue to evolve its platform technology and advance its product pipeline to benefit cancer patients worldwide.