FAB Passes FDA Inspection with Zero Deficiencies，Accelerating FDA Approval of Nuvation Bio’s Taletrectinib

On June 11, 2025, Nuvation Bio (parent company of AnHeart Therapeutics) announced that U.S. Food and Drug Administration (FDA) approved its drug Taletrectinib Adipate Capsules (hereafter referred to as Taletrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Source: Nuvation Bio

As a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI), Taletrectinib addresses unmet clinical needs in ROS1-positive NSCLC treatment. It demonstrates high response rates, durable clinical benefits, significant intracranial activity, and favorable tolerability. This approval provides a critical new therapeutic option for advanced ROS1-positive NSCLC patients.

The approval leveraged FDA Priority Review designation and robust data from the TRUST study. Taletrectinib achieved high sustained response rates in both 1st-line and 2nd-line settings, with proven blood-brain barrier penetration. Its safety profile was consistently favorable across one of the largest ROS1-positive NSCLC clinical safety datasets.

FDA Inspection: Setting a Global Quality Benchmark

In April 2025, FDA inspectors conducted a multi-day on-site review at FAB's Shanghai office for the pivotal trial of AnHeart's Taletrectinib.

During the rigorous 5-day audit, FAB's scientific quality management and efficient teamwork enabled completion one day ahead of schedule. The company passed with zero deficiencies (no observations), establishing an internationally recognized quality standard. Public records confirm FAB is the first China-based imaging CRO to pass an FDA inspection leading to client drug approval—a milestone for China's medical imaging CRO sector.

The FDA audit covered core areas: imaging data lifecycle management, SOP compliance, system validation, and QA/QC systems. FAB fully met ICH-GCP, 21 CFR Part 11, and other regulatory requirements. This zero-deficiency outcome certifies that FAB's quality system, data integrity, and trial management capabilities satisfy the highest global standards, solidifying its international expansion.

Collaborative Excellence, Mutual Success
FAB's Clinical Operations Director Tian Mingli and Project Manager Lou Renzhi highlighted the sponsor's open trust as key to the partnership's success. FAB's team delivered high-quality, efficient clinical support, with members working late nights to prepare FDA materials. The timeline from April FDA inspection to June approval spanned under two months—validating both expertise and teamwork.

To recognize FAB's exceptional contribution, AnHeart Therapeutics issued multiple commendation letters and awarded FAB the "Outstanding Partner Award" with an honorary certificate. The sponsor praised FAB's team for "meticulous document preparation, unwavering attention to detail, and highly responsible professionalism that ensured zero critical findings."

Dr. Bing Yan, President of Nuvation Bio China, noted seamless collaboration with FAB and emphasized ongoing partnership for global compliance and future milestones.

Responding to this recognition, Dr. Luxia Liang , Founder and CEO of FAB, stated:
"Zero-deficiency FDA passage and supporting Taletrectinib's U.S. approval mark a pivotal milestone in FAB's globalization. This validates our decade-long quality system development and earns global recognition of our capabilities. Both teams embodied 'collaborative excellence, mutual success.' We deeply appreciate AnHeart's trust—this honor brings both motivation and responsibility. FAB will continue empowering high-quality Chinese drug globalization."

As China's Leading Medical Imaging CRO, FAB has supported over 320 clinical trials and 59 NDA submissions (43 approved). Notably, FAB has successfully passed inspections by four major regulators—China NMPA, U.S. FDA, UK MHRA, and Japan PMDA—demonstrating world-class regulatory compliance.

FAB remains committed to delivering independent, professional imaging evaluation services to accelerate global drug commercialization, ensuring Chinese innovation shines on the world stage.