ADC Pipeline April 2026
ADC Pipeline
April 2026
8 ADC programs received expedited review pathway designations in April 2026, spanning Breakthrough Therapy (3), Priority Review (1), Fast Track (1), and Orphan Drug (3). Top I dominates as payload across all 8 — covering CRPC, SCLC, HER2+ breast, cervical, ovarian, stomach, and pancreatic cancer indications. Three programs target CD276.
8 ADC ERP designations — April 2026
All data sourced from the April 2026 monthly report, Table 2.
| Drug | Pathway | Target | Indication | Developer | Region · Date |
|---|---|---|---|---|---|
| Ifinatamab deruxtecan | Priority Review | Top I · CD276 | Extensive Stage Small Cell Lung Cancer | Daiichi Sankyo (China) Holdings | China · Apr 28 |
| SYS-6043 | Orphan Drug | Top I · CD276 | Small Cell Lung Cancer | SystImmune Inc. | US · Apr 27 |
| Risvutatug Rezetecan | BTD | Top I · CD276 | Castration-Resistant Prostatic Cancer | Shanghai Hansoh Biomedical | China · Apr 21 |
| SIM-0505 | Fast Track | Top I · CDH6 | Platinum-Resistant Ovarian Carcinoma | Sichuan Simcere Pharmaceutical | US · Apr 17 |
| XM146-SN38 | Orphan Drug | PDL1 · Top I | Pancreatic Cancer | Xencor, Inc. | US · Apr 14 |
| Trastuzumab Rezetecan | BTD | Top I · HER2 | HER2 Positive Breast Cancer | Suzhou Suncadia Biopharmaceuticals | China · Apr 9 |
| SHR-A2102 | BTD | nectin-4 · Top I | Metastatic Cervical Carcinoma; Recurrent Cervical Cancer | Shanghai Hengrui Pharmaceutical | China · Apr 8 |
| ALK-201 | Orphan Drug | Top I · FGFR2b | Stomach Cancer | Alkem Laboratories Ltd. | US · Apr 7 |
4 signals from the April 2026 ADC ERP data
Strategic takeaways from 8 ADC ERP designations in the April 2026 monthly report.
3 CD276/Top I ADCs in April 2026 ERP — CRPC, SCLC, and extensive SCLC
Three independent CD276/Top I ADC programs received ERP designations in April 2026: Risvutatug Rezetecan (BTD, CRPC, Hansoh), SYS-6043 (Orphan Drug, SCLC, SystImmune), and Ifinatamab deruxtecan (Priority Review, extensive stage SCLC, Daiichi Sankyo China). The convergence on CD276 as an ADC targeting antigen across three developers, two indication spaces (CRPC and SCLC), and three regulatory pathways signals strong clinical and regulatory confidence in the CD276/Top I combination strategy.
Top I payload in all 8 April 2026 ADC ERPs — class-wide industry consensus
All 8 April 2026 ADC ERP designations pair a Top I (or SN38/camptothecin-derivative) payload with a targeting antibody: Risvutatug Rezetecan, Trastuzumab Rezetecan, SHR-A2102, SYS-6043, ALK-201, XM146-SN38, Ifinatamab deruxtecan, and SIM-0505. This 100% Top I rate in a single month’s ADC ERP cohort reflects the depth of industry adoption of camptothecin-class payloads following the clinical validation of T-DXd (deruxtecan) and Trodelvy (SN38) across multiple solid tumour types.
China accounts for 4 of 8 April 2026 ADC ERPs — including all 3 BTDs
4 of the 8 April 2026 ADC ERP designations are China-region: Risvutatug Rezetecan (BTD, CRPC, Hansoh), Trastuzumab Rezetecan (BTD, HER2+ breast, Suncadia), SHR-A2102 (BTD, cervical, Hengrui), and Ifinatamab deruxtecan (Priority Review, SCLC, Daiichi Sankyo China). All 3 BTDs are from China-based developers — reflecting the depth of domestic ADC innovation in China’s biopharma sector, extending beyond the T-DXd licensing model into original ADC programmes.
“Rezetecan” suffix: a shared ADC platform naming convention emerging across China developers
Two April 2026 ADC BTDs share the “Rezetecan” suffix — Risvutatug Rezetecan (Hansoh, CD276/Top I, CRPC) and Trastuzumab Rezetecan (Suncadia, HER2/Top I, breast) — suggesting adoption of a common ADC payload/linker platform naming convention among China-based developers, analogous to the “-deruxtecan” (Daiichi Sankyo) and “-govitecan” (Gilead/Immunomedics) naming patterns. This naming consistency aids competitive intelligence tracking of ADC platform breadth.
ADC pipeline April 2026 — key questions
8 ADC programs received expedited review pathway designations in April 2026, spanning Breakthrough Therapy (3), Priority Review (1), Fast Track (1), and Orphan Drug (3) pathways.
3 ADCs received Breakthrough Therapy designation in April 2026: Risvutatug Rezetecan (Top I/CD276, CRPC, Shanghai Hansoh Biomedical, China), Trastuzumab Rezetecan (Top I/HER2, HER2 Positive Breast Cancer, Suzhou Suncadia Biopharmaceuticals, China), and SHR-A2102 (nectin-4/Top I, Metastatic/Recurrent Cervical Cancer, Shanghai Hengrui Pharmaceutical, China).
Top I (Topoisomerase I) appears as a payload target in all 8 April 2026 ADC ERP designations, including Risvutatug Rezetecan, Trastuzumab Rezetecan, SHR-A2102, SYS-6043, ALK-201, XM146-SN38, Ifinatamab deruxtecan, and SIM-0505.
Ifinatamab deruxtecan, a Top I/CD276 ADC developed by Daiichi Sankyo (China) Holdings Co. Ltd., received Priority Review designation in China on April 28, 2026 for Extensive Stage Small Cell Lung Cancer.
3 CD276-targeting ADCs received ERP designations in April 2026: Risvutatug Rezetecan (BTD, CRPC, Hansoh), SYS-6043 (Orphan Drug, SCLC, SystImmune), and Ifinatamab deruxtecan (Priority Review, SCLC, Daiichi Sankyo China). This concentration signals growing confidence in CD276 as a pan-oncology ADC target.
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report, Table 2 (ERP designations). Represents a snapshot of available records as of April 2026.