ADC Pipeline Update: Four Antibody-Drug Conjugates Designated in February 2026

Updated on March 20, 2026 | Written by PatSnap Team

Four antibody-drug conjugates (ADCs) received expedited review designations in February 2026 — two Breakthrough Therapy designations and two Orphan Drug designations. The four programs target CD276 (B7-H3), DLL3, MUC1/HER3/Top I, and FGFR2b respectively — none of which have approved ADCs. The February cohort signals that ADC biology is firmly expanding beyond the HER2 and TROP2 targets that defined the first generation of approved ADCs.

All data sourced from PatSnap Synapse.

The ADC Landscape: Context

An antibody-drug conjugate consists of three components: a monoclonal antibody targeting a tumor-associated antigen, a cytotoxic payload, and a chemical linker connecting them. The antibody delivers the payload selectively to antigen-expressing tumor cells, where linker cleavage releases the cytotoxin intracellularly.

The ADC field has accelerated dramatically since 2019, driven by approvals of trastuzumab deruxtecan (Enhertu, HER2), sacituzumab govitecan (Trodelvy, TROP2), and enfortumab vedotin (Padcev, Nectin-4). As of early 2026, there are over 100 ADCs in clinical development globally and 14 approved by the FDA.

The current competitive frontier is target diversification — expanding beyond the established HER2/TROP2/Nectin-4 anchors into new antigens that are broadly expressed across tumor types. February 2026’s four designated programs all sit on this frontier.

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The Four February 2026 ADC Programs

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1. MHB088C — CD276 (B7-H3) ADC — Breakthrough Therapy

Developer: Qilu Pharmaceutical Co., Ltd. (China)
Target: CD276 (B7-H3)
Payload: Undisclosed (likely topoisomerase I inhibitor based on class trend)
Indications: Esophageal squamous cell carcinoma (ESCC); metastatic castration-resistant prostate cancer (mCRPC)
Designation: NMPA Breakthrough Therapy, February 9, 2026

Why CD276? B7-H3 (CD276) is an immune checkpoint molecule in the B7 family, broadly overexpressed across multiple solid tumors — including ESCC (>70% of tumors), NSCLC, prostate cancer, breast cancer, and glioblastoma — while having limited expression in normal adult tissue. This broad tumor expression profile, combined with relatively low expression in critical normal tissues, makes B7-H3 an attractive ADC target.

Multiple B7-H3 ADC programs are now in clinical development globally, including DS-7300a (Daiichi Sankyo/AstraZeneca) and ifinatamab deruxtecan — both in Phase 3 for multiple solid tumors. Qilu’s MHB088C is the first to receive a Breakthrough Therapy designation from the NMPA specifically for ESCC, a high-prevalence cancer in China accounting for approximately 50% of global ESCC cases. The dual-indication BTD (ESCC + mCRPC) in a single designation is unusual and reflects the pan-tumor B7-H3 expression rationale.

2. Zocilurtatug Pelitecan — DLL3 / Top I ADC — Breakthrough Therapy

Developer: Zai Lab (Shanghai) Co., Ltd. / Biocytogen
Target: DLL3 (delta-like ligand 3); Topoisomerase I (payload mechanism)
Payload: Pelitecan (topoisomerase I inhibitor)
Indication: Extensive-stage small cell lung cancer (ES-SCLC)
Designation: NMPA Breakthrough Therapy, February 9, 2026

Why DLL3? DLL3 is a Notch pathway ligand with highly restricted expression in normal adult tissue but overexpression in neuroendocrine tumors — most notably SCLC, where it is expressed in over 80% of tumor specimens. DLL3 expression is rare in normal lung and other normal tissues, providing a favorable therapeutic window.

SCLC is an aggressive cancer with a 5-year survival rate of approximately 7%. After platinum-based chemotherapy and PD-L1 inhibition (atezolizumab, durvalumab), there are very limited approved options for relapsed/refractory disease. Tarlatamab — a DLL3 × CD3 bispecific T-cell engager (Amgen) — received FDA approval in 2024 for relapsed SCLC, establishing DLL3 as a validated therapeutic target. Zocilurtatug pelitecan’s ADC approach delivers a cytotoxic payload directly, mechanistically distinct from tarlatamab’s T-cell redirecting mechanism, and may be complementary.

The topoisomerase I payload (pelitecan) is in the same class as deruxtecan — the payload in Enhertu (trastuzumab deruxtecan), which has demonstrated bystander activity that kills neighboring antigen-negative tumor cells. This bystander effect is particularly relevant in SCLC, where antigen heterogeneity is common.

3. DM-002 — MUC1 / HER3 / Top I ADC — Orphan Drug

Developer: Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Targets: Top I; MUC1; HER3 (trispecific targeting)
Indication: Pancreatic cancer
Designation: FDA Orphan Drug Designation, February 11, 2026

Why this is notable: DM-002 is a trispecific ADC — targeting three antigens simultaneously (MUC1, HER3, and delivering a topoisomerase I payload). Trispecific or multi-target ADC approaches represent a next-generation design aimed at increasing tumor selectivity by requiring co-expression of multiple antigens for efficient uptake, while reducing off-tumor toxicity.

Pancreatic ductal adenocarcinoma (PDAC) is one of the most treatment-resistant cancers, with a 5-year survival rate of approximately 12%. MUC1 and HER3 are both overexpressed in PDAC. No ADC is currently approved for pancreatic cancer. The ODD provides Xadcera with 7 years of market exclusivity upon approval in the US, in addition to tax credits and reduced FDA fees.

4. HDM-2020 — FGFR2b / Top I ADC — Orphan Drug

Developer: Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd. (China)
Targets: FGFR2b; Topoisomerase I (payload mechanism)
Indications: Gastroesophageal junction (GEJ) cancer; gastric cancer
Designation: FDA Orphan Drug Designation, February 9, 2026

Why FGFR2b? FGFR2b amplification occurs in approximately 7–10% of gastric and GEJ cancers and defines a distinct molecular subgroup with poor prognosis. Bemarituzumab — an anti-FGFR2b monoclonal antibody (Five Prime / Amgen) — has demonstrated survival benefit in FGFR2b-overexpressing gastric cancer in Phase 3. An ADC approach combines antigen-specific targeting with direct intracellular cytotoxic delivery, potentially offering greater potency than a naked antibody.

ADC Target Landscape: Where the Field Is Heading

The pattern is clear: the ADC field’s next wave is targeting antigens with no approved ADC predecessors, in tumor types (SCLC, ESCC, PDAC, gastric cancer) that have been underserved by the first generation of ADC approvals.

Key Considerations: Payload Diversification

All four February programs involve topoisomerase I payloads (or undisclosed payloads likely in that class) — reflecting the field’s broad shift from MMAE (microtubule inhibitor) to topo I inhibitors following the clinical success of Enhertu. Topo I payloads offer potent bystander activity, which is particularly valuable in solid tumors with heterogeneous antigen expression.

The question for the next 18–24 months is whether topo I payload saturation will drive differentiation back toward linker chemistry, novel payloads (STING agonists, TLR agonists, RNA-based payloads), or bispecific antibody components that improve tumor selectivity.

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Further Reading

• Breakthrough Therapy designations — February 2026
• Expedited review pathways overview — February 2026
• Global drug approvals roundup — February 2026

Data sourced by PatSnap. This post is for informational purposes only.