Chinese Manufacturer Enters U.S. Oncology Market With EGFR Approval

Dizal (Jiangsu) Pharmaceutical Co., Ltd. secured FDA approval on July 2, 2025 for ZEGFROVY (sunvozertinib), a kinase inhibitor indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The approval marks a direct entry by a China-based manufacturer into the U.S. prescription oncology market, placing foreign facility compliance, GMP inspection readiness, and supply chain continuity squarely on the agenda for QA directors and regulatory affairs leads monitoring Asia-Pacific manufacturing activity.

The approval was supported by a single multinational trial, WU-KONG1B (NCT03974022), enrolling 202 patients across 89 sites in the United States, Argentina, Australia, Canada, China, Chile, France, Italy, Malaysia, South Korea, Spain, and Taiwan. The trial was an open-label, dose-randomization study; patients were randomized 1:1 to ZEGFROVY 200 mg orally once daily with food or an unapproved dose. The approved 200 mg arm enrolled 85 randomized patients. The efficacy population had a median age of 61 years, was 67% female, 65% Asian, and 33% White, with 43% of patients aged 65 or older. The primary efficacy endpoint was confirmed overall response rate (ORR) assessed by blinded independent review committee (BIRC) per RECIST v1.1, with duration of response (DOR) as a secondary measure. ZEGFROVY is administered as a tablet taken orally once daily with food.

Regulatory and manufacturing implications: For plant heads and QA teams, a China-domiciled NDA holder manufacturing for the U.S. market triggers specific considerations under 21 CFR Part 211 and FDA's foreign facility inspection program. Supply continuity planning, site qualification documentation, and post-approval change management under ICH Q10 principles will be areas of active scrutiny. The growing role of Asia-Pacific sponsors and manufacturers in oncology drug supply -- particularly for targeted therapies -- signals that compliance infrastructure at these sites will face increasing regulatory attention from both FDA and international counterparts.

Source: FDA Drug Trials Snapshots -- ZEGFROVY, published April 28, 2026. Approval date cited as July 2, 2025.