ADC Breakthroughs March 2026
ADC Breakthroughs
March 2026
12 ADC programs received expedited review pathway designations in March 2026, spanning Breakthrough Therapy, Conditional Marketing Approval, Priority Review, Fast Track, and Orphan Drug pathways. Top I dominated as the shared payload target across oncology indications including SCLC, NSCLC, ovarian cancer, sarcoma, and GI cancers.
12 ADC programs in the March 2026 ERP pipeline
All data sourced from the March 2026 monthly pharmaceutical report, Table 1 (ERP table).
| Drug | Pathway | Target | Indication | Developer | Region · Date |
|---|---|---|---|---|---|
| Sacituzumab tirumotecan | Priority Review | Top I · Trop-2 | Metastatic NSCLC; Locally Advanced NSCLC | Sichuan Kelun Botai Biomedicine | China · Mar 31 |
| Fam-trastuzumab deruxtecan-NXKI | Cond. Marketing Approval | HER2 · Top I | HER2 Positive Breast Cancer | AstraZeneca · Daiichi Sankyo | China · Mar 27 |
| Risvutatug Rezetecan | Orphan Drug | Top I · CD276 | Small Cell Lung Cancer | GSK Plc | Japan · Mar 23 |
| ZW-191 | Fast Track | Top I · FOLR1 | Platinum-Resistant Ovarian Carcinoma | Zymeworks, Inc. | US · Mar 30 |
| ADCE-D01 | Orphan Drug | Top I · MRC2 | Soft Tissue Sarcoma | ADCendo ApS | US · Mar 16 |
| YL-201 | BTD | CD276 · Top I | Extensive stage Small Cell Lung Cancer | Suzhou Medilink Therapeutics | China · Mar 10 |
| HDM-2017 | Orphan Drug | CDH17 · Top I | Pancreatic Cancer | Hangzhou Zhongmeihuadong Pharmaceutical | US · Mar 10 |
| Fam-trastuzumab deruxtecan-NXKI | Priority Review | HER2 · Top I | HER2 Positive Solid Tumors | Daiichi Sankyo (China) Holdings | China · Mar 10 |
| HDM-2017 | Orphan Drug | CDH17 · Top I | Stomach Cancer | Hangzhou Zhongmeihuadong Pharmaceutical | US · Mar 9 |
| HDM-2017 | Orphan Drug | CDH17 · Top I | Bile Duct Neoplasms | Hangzhou Zhongmeihuadong Pharmaceutical | US · Mar 8 |
| AMT-253 ADC | Orphan Drug | Muc18 · Top I | Soft Tissue Sarcoma | Multitude Therapeutics (China) | US · Mar 5 |
| ABBV-706 | Orphan Drug | Top I · SEZ6 | Neuroendocrine Carcinoma | AbbVie, Inc. | US · Mar 2 |
Four notable ADC programs from March 2026
Selected from the 12 ADC ERP designations in the March 2026 monthly report.
YL-201 — CD276/Top I ADC in extensive stage SCLC
YL-201 is an antibody drug conjugate (ADC) targeting CD276 and Top I, developed by Suzhou Medilink Therapeutics Ltd. It received Breakthrough Therapy designation from China’s NMPA on March 10, 2026 for extensive stage Small Cell Lung Cancer — a high-unmet-need indication where first-line platinum-based chemotherapy responses are typically short-lived. CD276 is an immune checkpoint expressed on tumour vasculature and tumour cells in SCLC.
CD276 · Top I · ADC · Extensive SCLC · BTDFam-trastuzumab deruxtecan-NXKI — HER2+ breast cancer
Fam-trastuzumab deruxtecan-NXKI is an ADC targeting HER2 and Top I, developed by AstraZeneca PLC and Daiichi Sankyo Co., Ltd. It received Conditional Marketing Approval in China on March 27, 2026 for HER2 Positive Breast Cancer. The same drug also received Priority Review designation in China for HER2 Positive Solid Tumors on March 10, 2026, from Daiichi Sankyo (China) Holdings Co., Ltd.
HER2 · Top I · ADC · CMA + Priority ReviewSacituzumab tirumotecan — Top I/Trop-2 in NSCLC
Sacituzumab tirumotecan is an ADC targeting Top I and Trop-2, developed by Sichuan Kelun Botai Biomedicine Co., Ltd. It received Priority Review designation from China’s NMPA on March 31, 2026 for metastatic non-small cell lung cancer and locally advanced lung non-small cell carcinoma. Trop-2 is broadly expressed across epithelial tumour types, making it a versatile ADC targeting antigen.
Top I · Trop-2 · ADC · NSCLC · Priority ReviewRisvutatug Rezetecan — Top I/CD276 ADC in SCLC
Risvutatug Rezetecan is an ADC targeting Top I and CD276, developed by GSK Plc. It received Orphan Drug designation in Japan on March 23, 2026 for Small Cell Lung Cancer. Like YL-201, its CD276 targeting reflects the emerging strategy of combining an immune checkpoint antigen with a Top I payload to address SCLC’s typically poor response to later-line therapies.
Top I · CD276 · ADC · SCLC · Orphan Drug4 signals from the March 2026 ADC ERP data
Strategic takeaways derived from the 12 ADC ERP designations in the March 2026 monthly report.
Top I as payload: 9 of 12 March 2026 ADC ERPs
Topoisomerase I (Top I) appears as a payload target in 9 of the 12 March 2026 ADC ERP designations: YL-201, Fam-trastuzumab deruxtecan (×2), Sacituzumab tirumotecan, ZW-191, Risvutatug Rezetecan, ADCE-D01, HDM-2017 (×3), AMT-253 ADC, and ABBV-706. This dominance reflects the validated clinical utility of camptothecin-class payloads demonstrated by T-DXd and Trodelvy, and the broad industry adoption of Top I payloads across diverse tumour antigens.
SCLC attracting ADC investment: YL-201 and Risvutatug both CD276/Top I
Two independent CD276/Top I ADC programs — YL-201 (Suzhou Medilink, BTD, China) and Risvutatug Rezetecan (GSK, Orphan Drug, Japan) — received ERP designations in March 2026 for SCLC indications. The convergence on the same target/payload combination across two developers and two regulatory regions signals growing confidence in CD276 as an SCLC antigen and Top I as its paired payload in this indication.
HDM-2017: single ADC, three Orphan Drug designations across GI cancers
HDM-2017, a CDH17/Top I ADC from Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd., received three separate Orphan Drug designations in the United States in March 2026: for Pancreatic Cancer (Mar 10), Stomach Cancer (Mar 9), and Bile Duct Neoplasms (Mar 8). CDH17 (Cadherin-17) is expressed across GI epithelial tumours, positioning HDM-2017 as a potential pan-GI ADC candidate with a broad multi-indication development strategy.
China leads ADC regulatory activity with 4 of 12 March 2026 designations
4 of the 12 March 2026 ADC ERP designations were granted in China: YL-201 (BTD, SCLC, Suzhou Medilink), Fam-trastuzumab deruxtecan-NXKI (CMA, HER2+ breast, AstraZeneca/Daiichi Sankyo), Fam-trastuzumab deruxtecan-NXKI (Priority Review, HER2+ solid tumors, Daiichi Sankyo China), and Sacituzumab tirumotecan (Priority Review, NSCLC, Kelun Botai). This concentration — spanning BTD, CMA, and Priority Review — reflects China’s rapidly deepening ADC regulatory infrastructure.
ADC breakthroughs March 2026 — key questions
12 ADC programs received expedited review pathway designations in March 2026, spanning Breakthrough Therapy, Conditional Marketing Approval, Priority Review, Fast Track, and Orphan Drug pathways.
YL-201, an ADC targeting CD276 and Top I developed by Suzhou Medilink Therapeutics Ltd., received Breakthrough Therapy designation in China (NMPA) on March 10, 2026 for extensive stage Small Cell Lung Cancer.
Fam-trastuzumab deruxtecan-NXKI (T-DXd), an ADC targeting HER2 and Top I developed by AstraZeneca PLC and Daiichi Sankyo Co., Ltd., received Conditional Marketing Approval in China on March 27, 2026 for HER2 Positive Breast Cancer.
Top I (Topoisomerase I) appears as a payload target in the majority of March 2026 ADC ERP designations, including YL-201, Fam-trastuzumab deruxtecan-NXKI, Sacituzumab tirumotecan, ZW-191, Risvutatug Rezetecan, ADCE-D01, HDM-2017, AMT-253 ADC, and ABBV-706.
ZW-191, an ADC targeting Top I and FOLR1 developed by Zymeworks, Inc., received Fast Track designation in the United States on March 30, 2026 for Platinum-Resistant Ovarian Carcinoma.
7 ADC programs received Orphan Drug designations in March 2026: Risvutatug Rezetecan (GSK, SCLC, Japan), ADCE-D01 (ADCendo, Soft Tissue Sarcoma, US), HDM-2017 in three indications — Pancreatic Cancer, Stomach Cancer, Bile Duct Neoplasms (Hangzhou Zhongmeihuadong, US), AMT-253 ADC (Multitude Therapeutics, Soft Tissue Sarcoma, US), and ABBV-706 (AbbVie, Neuroendocrine Carcinoma, US).
Data on this page is sourced from the PatSnap March 2026 monthly pharmaceutical report, Table 1 (ERP designations). Represents a snapshot of available records as of March 2026.