Non-FDA-Approved ADCs

Regulators outside the US have approved several ADCs that the FDA has not yet cleared; most of these are China NMPA–only approvals, adding up to roughly 7 non-FDA ADCs within a global total of 23 ADC approvals as of mid-2026.

Big Picture

Globally, 23 ADCs have been approved by at least one regulatory agency; 16 of these also have FDA approval, leaving about 7 that are ex-US/ex-FDA only.

The non-FDA approvals are almost all from China's NMPA and are heavily HER2/TROP2/EGFR focused, often using MMAE or topo-I payloads with cleavable linkers.

Key Non-FDA ADCs (Approved Elsewhere Only)

Disitamab vedotin (Aidixi, RC48) – RemeGen

Target/payload: HER2-targeted ADC with a humanized anti-HER2 antibody linked to MMAE via a cleavable linker (Val-Cit-PABC).

Approvals: First domestically developed ADC approved in China in June 2021 for HER2-overexpressing (IHC2+/3+) locally advanced or metastatic gastric/gastroesophageal junction cancer after ≥2 prior systemic chemotherapy regimens.

Subsequent NMPA indications:

• HER2-expressing locally advanced/metastatic urothelial carcinoma after platinum therapy (approved December 2021)

• HER2-positive advanced breast cancer with liver metastases previously treated with trastuzumab and taxane (Phase 3 RC48-C006, approved 2025)

• HER2-low (IHC1+ or IHC2+/ISH–) metastatic breast cancer with liver metastases (fourth indication approved March 2026)

US status: Has FDA Breakthrough Therapy and Fast Track designations for HER2+ urothelial carcinoma, but no FDA marketing approval yet.

Sacituzumab tirumotecan (Tuo Da Wei / Jiatailai) – Kelun-Biotech / MSD

Target/payload: TROP2-targeted IgG1 conjugated to a topoisomerase I inhibitor via a cleavable linker (similar conceptual class to Trodelvy/Datroway).

Approval: Approved by China's NMPA in 2024 for triple-negative breast cancer; some sources also note non-small cell lung cancer indications.

US status: Not FDA-approved; partnered with Merck for global development, but still in clinical stages outside China.

Trastuzumab rezetecan (Aiweida) – Hengrui Pharmaceuticals

Target/payload: HER2 ADC using a trastuzumab backbone with an undisclosed topo-I payload (DXd-like) and cleavable linker.

Approval: NMPA approval reported among four China-origin ADCs between 2025 and 1H 2026 (exact first indication: HER2-positive solid tumors, including breast/gastric).

US status: No FDA approval yet; global co-development efforts are ongoing but still pre-approval.

Trastuzumab botidotin (Shutailai) – Sichuan Kelun-Biotech

Target/payload: HER2 targeting with a proprietary cytotoxic payload (botidotin; topo-I class) linked via a cleavable linker; designed as a next-generation HER2 ADC distinct from Enhertu and Kadcyla.

Approval: Listed as NMPA-approved in 2025 for HER2-positive indications; precise label includes breast and potentially gastric cancer in China.

US status: Not FDA-approved; positioned as a domestic alternative/comparator to Enhertu within China.

Becotatug vedotin (Meiyouheng) – Lepu Biopharma

Target/payload: Likely a CD30- or CD79b-family target with MMAE payload (vedotin-type) and cleavable linker, following the "-vedotin" naming convention; developed as a domestically produced ADC.

Approval: NMPA approval reported by 2025; specific indication noted as lymphoma (large B-cell or classical Hodgkin) in Chinese sources.

US status: No FDA approval or BLA accepted yet.

Sacituzumab tirumotecan vs Trodelvy

Trodelvy (sacituzumab govitecan) is FDA-approved; sacituzumab tirumotecan is a separate, China-only ADC that also targets TROP2 but uses a different topo-I payload and linker design, illustrating how China's NMPA has approved "platform derivatives" that don't yet have US counterparts.

Izalontamab brengitecan (Yizekang) – SystImmune/BMS

Target/payload: First bispecific ADC approved globally — targets EGFR × HER3 simultaneously, with a topo-I inhibitor payload (Ed-04) and cleavable GGFG tetrapeptide linker; DAR 8.

Indication: Approved by China's NMPA in June 2026 for recurrent/metastatic nasopharyngeal carcinoma, marking the world's first regulatory approval of a bispecific ADC.

US status: No FDA approval yet; BMS is co-developing globally, but US/EU filings will lag China's first-in-world approval.

Overall Patterns vs FDA Landscape

Count difference: Global landscape analyses count 23 ADC approvals worldwide vs 16 FDA approvals; the delta is almost entirely driven by Chinese NMPA approvals (disitamab vedotin, sacituzumab tirumotecan, trastuzumab rezetecan, trastuzumab botidotin, becotatug vedotin, izalontamab brengitecan, plus one or two earlier local approvals), none of which yet have full FDA approval.

Design trends: Non-FDA approvals are highly enriched for HER2 and TROP2 targets with MMAE or topo-I payloads, often in settings (e.g., HER2-low breast, HER2+ gastric, urothelial carcinoma) where Enhertu, Trodelvy, and other FDA-approved ADCs are already active — effectively creating domestic "parallel" ADC ecosystems in China.

Regulatory timing: China's NMPA has, in several cases, approved ADCs (especially domestic HER2/TROP2 agents) 6–18 months ahead of the EMA and sometimes before the FDA even receives a complete dossier, so for some tumor types Chinese patients have earlier access to ADC options that remain investigational in the US.