Antibody-drug conjugates

• ClinicalTrials.gov lists 2,351 ¹ interventional studies of antibody-drug conjugates; 1,488 ² are active and 355 ³ are Phase 3.
• 1,225 ⁴ ADC studies started between January 2023 and September 2026: 638 ⁵ with a site in China and 428 ⁶ with a site in the United States.
• Among studies started since 2023, trastuzumab deruxtecan leads with 139 ⁷. Three Chinese-origin assets follow closely: disitamab vedotin (120 ⁸), SHR-A1811 (109 ⁹) and sacituzumab tirumotecan (105 ¹⁰).
• Breast cancer is the largest indication with 315 ¹¹ new studies, followed by lung cancer (193 ¹²).

ADC trial starts rose from 101 ¹³ in 2020 to 349 ¹⁴ in 2025. Nearly all of that growth came from studies with a China site, which went from 25 ¹⁵ in 2020 to 120 ¹⁶ in 2023 and 177 ¹⁷ in 2025. Studies with a US site grew more slowly, from 73 ¹⁸ to 144 ¹⁹, and were flat between 2021 and 2023.

China's registry footprint is only part of the picture, because many China-only trials are never registered on ClinicalTrials.gov. Official figures show the same direction: China approved 3 new ADCs in 2025 ²⁰, and its innovative-drug out-licensing deals exceeded $130 billion in total value ²¹ across more than 150 deals that year ²².

The eight most active assets are concentrated on two targets. HER2 ADCs are trastuzumab deruxtecan (139 ⁷ studies since 2023), RemeGen's disitamab vedotin (120 ⁸) and Hengrui's SHR-A1811 (109 ⁹). TROP2 ADCs are Kelun-Biotech and Merck's sacituzumab tirumotecan (105 ¹⁰), Gilead's sacituzumab govitecan (98 ³⁴) and datopotamab deruxtecan (29 ³⁵).

Two assets point to what comes next. Enfortumab vedotin (60 ³⁶) shows how a single-tumour-type leader, in urothelial cancer, can build a franchise through combinations. BL-B01D1 (55 ³⁷), an EGFR x HER3 bispecific ADC from Sichuan Baili and partnered with Bristol Myers Squibb, is the most advanced example of a bispecific ADC.

Phase 3 studies started in 2026 lean towards new targets: c-Met (AbbVie's telisotuzumab adizutecan), B7-H3 (GSK's risvutatug rezetecan and BioNTech's BNT324), CEACAM5 (Merck KGaA's precemtabart tocentecan) and HER3. Several of these assets were licensed from Chinese developers.

Breast cancer was a listed condition in 315 ¹¹ ADC studies started since 2023. Lung cancer follows with 193 ¹² and gynaecological cancers with 195 ³⁸. Gastric and oesophageal cancer (121 ³⁹), lymphoma (119 ⁴⁰) and urothelial cancer (116 ⁴¹) form the next group.

Prostate, pancreatic and colorectal cancers have far fewer ADC studies despite large patient numbers. These are the tumour types that B7-H3, CEACAM5 and other new-target ADCs are now entering.

• Emrelis (telisotuzumab vedotin, c-Met), approved 14 May 2025 (BLA 761384)
• Datroway (datopotamab deruxtecan, TROP2), 17 January 2025 (BLA 761394)
• Elahere (mirvetuximab soravtansine, FRα), 14 November 2022 (BLA 761310)
• Trodelvy (sacituzumab govitecan, TROP2), 22 April 2020 (BLA 761115)
• Enhertu (trastuzumab deruxtecan, HER2), 20 December 2019 (BLA 761139)
• Padcev (enfortumab vedotin, Nectin-4), 18 December 2019 (BLA 761137)

Most approved ADCs still use one of two payload families: topoisomerase-I inhibitors (deruxtecan, govitecan) or tubulin inhibitors (vedotin, emtansine). Resistance to those payloads is the scientific opening for the next generation.

• Avoid me-too HER2 and TROP2 programmes. Six of the eight most active assets hit these two targets. A new entrant there needs a clear edge on safety, such as lower interstitial lung disease or ocular toxicity, and that edge is hard to show early.
• Differentiate on target plus payload. Examples are B7-H3, CEACAM5, CDH17 and HER3 targets, and payloads with a different mechanism, such as immune-stimulating or degrader payloads, or dual-payload designs.
• Use China's speed, but plan the exit. China-based Phase 1 and 2 studies are fast. The common exit is a regional or global licence before Phase 3, and most 2026 Phase 3 starts by global companies use in-licensed assets.
• Budget for large pivotal trials. With 355 ³ Phase 3 ADC studies registered, standard-of-care comparators are strong and pivotal trials are big. Few start-ups should plan to run one alone.

Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies that mention an antibody-drug conjugate by class or by a payload or brand stem (deruxtecan, vedotin, govitecan, emtansine, tirumotecan, rezetecan and others).

Site-country counts overlap and do not sum to the total. China-only trials registered only with China's drug trial platform are missing, so China's share is understated. Asset counts match names and development codes and count every indication. A study can list several conditions and count in several bars. Approval dates come from Drugs@FDA; China approval and licensing totals are cited to their official publishers.