Global ADC Landscape 2026H1

2026-07-03 13:43:27
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Global ADC Landscape 2026H1: 23 Approved Drugs, 4+2 in Review

A data-driven, source-traceable analysis of every approved and late-stage antibody-drug conjugate (ADC) and antibody-oligonucleotide conjugate (AOC) worldwide, as of June 30, 2026.

At a Glance: The Global ADC Pipeline in 2026

As of June 30, 2026, 23 antibody-drug conjugates (ADCs) have received regulatory approval worldwide, spanning more than ten molecular targets — including HER2, TROP2, CD30, CD33, BCMA, EGFR, FRα, Nectin-4, c-Met, and CD123 — and covering more than ten tumor types, from breast, lung, and gastric cancer to multiple myeloma and nasopharyngeal carcinoma.

A further 4 ADCs and 2 antibody-oligonucleotide conjugates (AOCs) are currently under BLA/NDA review, extending the ADC modality beyond oncology into genetic disease, with two AOC programs targeting Duchenne muscular dystrophy (DMD).

This article compiles a fully sourced, field-by-field breakdown of every program — generic name, company, target, antibody format, payload, linker chemistry, drug-to-antibody ratio (DAR), indication, and regulatory status — followed by an analysis of the three trends defining the sector's next chapter.

Why the ADC Modality Still Matters

Antibody-drug conjugates combine the tumor-targeting precision of a monoclonal antibody with the cell-killing potency of a cytotoxic payload, linked by a chemically engineered bridge. The approach lets clinicians deliver a lethal dose of chemotherapy-grade payload directly to tumor cells while limiting exposure to healthy tissue — a balance that conventional chemotherapy cannot achieve.

Pfizer's Mylotarg (gemtuzumab ozogamicin) became the world's first approved ADC in May 2000. Over the following two-plus decades, the technology has progressed through three generations, with steady improvements in target selection, linker stability, and payload design widening the therapeutic window between efficacy and toxicity.

Twenty-six years later, ADCs are one of the most active fields in oncology drug development — and China-originated programs are increasingly setting the pace rather than following it.

China's ADC pipeline: from fast follower to first-in-class

Between 2025 and the first half of 2026, four China-originated ADCs secured NMPA approval: Hengrui Pharmaceuticals' trastuzumab rezetecan (Aiweida), Sichuan Kelun-Biotech's trastuzumab botidotin (Shutailai), Lepu Biopharma's becotatug vedotin (Meiyouheng), and — most notably — Sichuan Baili Pharmaceutical/BMS's izalontamab brengitecan (Yizekang), the world's first approved bispecific ADC.

Domestic programs including Innovent Biologics' IBI343, DualityBio's DB-1303, and LaNova Medicines' LM-302 are now in BLA/NDA review alongside their multinational counterparts, underscoring China's growing share of voice in global ADC innovation.

Section 1 — Globally Approved ADC Drugs (23 Total, as of June 30, 2026)

The 23 programs below are listed in chronological order of first global approval. Each entry includes the antibody format, cytotoxic payload class, linker chemistry, drug-to-antibody ratio (DAR), approved indication, and approving authority — the core variables CDMO and CRO partners evaluate when scoping process development and manufacturing support.

Generic Name (Trade Name) Company Target Antibody Payload Linker DAR Indication First Approval
Gemtuzumab ozogamicin (Mylotarg) Pfizer CD33 Humanized IgG4 Calicheamicin (DNA-damaging agent) Cleavable — AcBut 2–3 CD33-positive acute myeloid leukemia (AML) FDA, May 2000; withdrawn June 2010; re-approved September 2017
Brentuximab vedotin (Adcetris) Seagen / Takeda CD30 Chimeric IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 4 Classical Hodgkin lymphoma; peripheral T-cell lymphoma FDA, August 2011
Trastuzumab emtansine (Kadcyla) Genentech (Roche) HER2 Humanized IgG1 DM1 (tubulin inhibitor) Non-cleavable — SMCC 3.5 HER2-positive breast cancer FDA, February 2013
Inotuzumab ozogamicin (Besponsa) Pfizer CD22 Humanized IgG4 Calicheamicin (DNA-damaging agent) Cleavable — AcBut 6 Relapsed/refractory B-cell precursor acute lymphoblastic leukemia EMA, June 2017; FDA, August 2017
Moxetumomab pasudotox (Lumoxiti) AstraZeneca CD22 Murine IgG1 PE38 (protein synthesis inhibitor) N/A N/A Relapsed/refractory hairy cell leukemia FDA, September 2018; withdrawn 2023
Polatuzumab vedotin (Polivy) Genentech (Roche) CD79b Humanized IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 3.5 Diffuse large B-cell lymphoma FDA, June 2019
Enfortumab vedotin (Padcev) Astellas / Seagen Nectin-4 Fully human IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 3.8 Locally advanced or metastatic urothelial cancer FDA, December 2019
Trastuzumab deruxtecan (Enhertu) Daiichi Sankyo / AstraZeneca HER2 Humanized IgG1 Dxd (topoisomerase I inhibitor) Cleavable — GGFG peptide linker 8 HER2-positive breast cancer FDA, December 2019
Sacituzumab govitecan (Trodelvy) Gilead Sciences TROP2 Humanized IgG1 SN-38 (topoisomerase I inhibitor) Cleavable — CL2A 7.6 Metastatic triple-negative breast cancer FDA, April 2020
Belantamab mafodotin (Blenrep) GSK BCMA Humanized IgG1 MMAF (tubulin inhibitor) Non-cleavable — MC 4 Relapsed/refractory multiple myeloma FDA, August 2020; withdrawn November 2022; re-approved October 23, 2025
Cetuximab sarotalocan (Akalux) Rakuten Medical EGFR Chimeric IgG1 IR700 (photosensitizer) N/A 1.3–3.8 Colorectal cancer; head and neck cancer (photoimmunotherapy) PMDA, September 2020
Loncastuximab tesirine (Zynlonta) ADC Therapeutics CD19 Humanized IgG1 PBD dimer (SG3199, DNA-damaging agent) Cleavable — Val-Cit 2.3 Relapsed/refractory large B-cell lymphoma FDA, April 2021
Disitamab vedotin (Aidixi (爱地希)) RemeGen HER2 Humanized IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 4 HER2-positive gastric cancer NMPA, June 2021
Tisotumab vedotin (Tivdak) Seagen / Genmab Tissue factor Humanized IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 4 Recurrent or metastatic cervical cancer FDA, September 2021
Mirvetuximab soravtansine (Elahere) ImmunoGen (now AbbVie) FRα Fully human IgG1 DM4 (tubulin inhibitor) Cleavable — SPDB 3.4 Epithelial ovarian, fallopian tube, or primary peritoneal cancer FDA, November 2022
Sacituzumab tirumotecan (Jiatailai (佳泰莱)) Sichuan Kelun-Biotech TROP2 Fully human IgG1 KL610023 (topoisomerase I inhibitor) Cleavable — CL2A 7.4 Breast cancer; non-small cell lung cancer NMPA, November 2024
Datopotamab deruxtecan (Datroway) Daiichi Sankyo / AstraZeneca TROP2 Humanized IgG1 Dxd (topoisomerase I inhibitor) Cleavable — GGFG peptide linker 4 HR-positive/HER2-negative breast cancer; EGFR-mutant non-small cell lung cancer FDA, January 2025
Telisotuzumab vedotin (Emrelis) AbbVie c-Met Humanized IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 3.1 Previously treated, locally advanced or metastatic non-squamous NSCLC FDA, May 2025
Trastuzumab rezetecan (Aiweida (艾维达)) Hengrui Pharmaceuticals HER2 Humanized IgG1 SHR9265 (topoisomerase I inhibitor) Cleavable — GGFG peptide linker 5.7 Non-small cell lung cancer NMPA, May 2025
Trastuzumab botidotin (Shutailai (舒泰莱)) Sichuan Kelun-Biotech HER2 Humanized IgG1 Duostatin-5 (tubulin inhibitor) Cleavable — Val-Cit 2 Breast cancer NMPA, October 17, 2025
Becotatug vedotin (Meiyouheng (美佑恒)) Lepu Biopharma EGFR Humanized IgG1 MMAE (tubulin inhibitor) Cleavable — Val-Cit 4 Recurrent/metastatic nasopharyngeal carcinoma NMPA, October 30, 2025
Pivekimab sunirine (Decnupaz) AbbVie CD123 Humanized IgG1 DGN549 (IGN-class DNA alkylating agent) Cleavable — Ala-Ala 2 Blastic plasmacytoid dendritic cell neoplasm (BPDCN) FDA, May 27, 2026
Izalontamab brengitecan (Yizekang (宜泽康)) Sichuan Baili Pharmaceutical (SystImmune) / Bristol Myers Squibb EGFR × HER3 (bispecific) Humanized bispecific IgG1* Ed-04 (topoisomerase I inhibitor) Cleavable — tetrapeptide GGFG 8 Recurrent/metastatic nasopharyngeal carcinoma NMPA, June 22, 2026 — world's first approved bispecific ADC

*Global first bispecific ADC.

Section 2 — ADC Drugs in BLA/NDA Review (4 Total, as of June 30, 2026)

Four ADCs are currently under formal regulatory review with FDA or NMPA, targeting B7-H3, CLDN18.2 (two programs), and HER2 — three of which carry Priority Review or equivalent expedited designations.

Generic Name Company Target Payload Linker DAR Indication Regulatory Status / Filing Date
Ifinatamab deruxtecan (I-DXd) Daiichi Sankyo / Merck (MSD) B7-H3 DXd (topoisomerase I inhibitor) Cleavable — tetrapeptide GGFG 4 Extensive-stage small cell lung cancer (ES-SCLC) progressing after platinum-based chemotherapy FDA BLA accepted April 13, 2026; PDUFA date October 10, 2026; Priority Review
Arcotatug tavatecan (IBI343 / TAK-921) Innovent Biologics / Takeda CLDN18.2 Exatecan (topoisomerase I inhibitor) Cleavable — Val-Ala-PABC 3.6 Locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, ≥2 prior systemic therapies NMPA accepted June 4, 2026; Priority Review
Trastuzumab pamirtecan (DB-1303 / BNT323) DualityBio / BioNTech HER2 P1003 / Pamirtecan (topoisomerase I inhibitor) Cleavable — GGFG peptide linker 8 Second-line treatment of HER2-positive unresectable or metastatic adult breast cancer NMPA BLA accepted April 9, 2026
Tecotabart vedotin (LM-302) Sino Biopharmaceutical / LaNova Medicines CLDN18.2 MMAE (tubulin inhibitor) Cleavable — Val-Cit (MC-VC-PABC) 4 CLDN18.2-positive locally advanced or metastatic gastric/
gastroesophageal junction adenocarcinoma
NMPA accepted June 23, 2026; granted Priority Review

Section 3 — AOC Drugs in BLA Review (2 Total, as of June 30, 2026)

Antibody-oligonucleotide conjugates (AOCs) pair an antibody-mediated delivery mechanism with an oligonucleotide payload — in these two programs, a phosphorodiamidate morpholino oligomer (PMO) that induces exon skipping. Both target Duchenne muscular dystrophy (DMD), marking the first time this conjugate class has reached BLA stage and signaling the expansion of "XDC" technology beyond oncology into rare genetic disease.

Generic Name Company Target Payload Linker DAR Indication Regulatory Status / Filing Date
Delpacibart zotadirsen (del-zota) Novartis (formerly Avidity Biosciences) TfR1-mediated delivery × PMO-induced exon skipping Zotadirsen (PMO, phosphorodiamidate morpholino oligomer) Non-cleavable — maleimide 4 Duchenne muscular dystrophy, exon 44-skip-amenable population (DMD44) BLA submitted June 25, 2026; FDA filing review pending; accelerated approval pathway
Zelecinment rostudirsen (DYNE-251) Dyne Therapeutics TfR1-mediated delivery × PMO-induced exon skipping Rostudirsen (PMO, phosphorodiamidate morpholino oligomer) Cleavable — Val-Cit 2 Duchenne muscular dystrophy, exon 51-skip-amenable population (DMD51) BLA submitted May 26, 2026; FDA filing review pending; accelerated approval pathway

Three Trends Defining Global ADCs in H1 2026

1. China-originated ADCs are accelerating internationally

Hengrui, Kelun-Biotech, Lepu Biopharma, and Baili Pharmaceutical have each brought an approved product to market, with Baili/BMS's izalontamab brengitecan (Yizekang) standing out as the world's first approved EGFR×HER3 bispecific ADC — evidence that Chinese innovation has moved from "me-too" to "first-in-class" in at least some programs.

Meanwhile, Innovent's IBI343, DualityBio's DB-1303, and LaNova's LM-302 are progressing through NDA/BLA review, further strengthening China's position in the global ADC competitive landscape.

2. Target and indication coverage keeps expanding

The field is moving outward from classic targets like HER2 and CD30 toward TROP2, c-Met, B7-H3, CLDN18.2, and bispecific combinations such as EGFR×HER3. Indications are expanding in parallel, from established tumor types such as breast cancer and lymphoma into nasopharyngeal carcinoma, small cell lung cancer, and BPDCN.

Most significantly, AOC drugs have reached BLA stage for the first time, extending conjugate technology from oncology into a hereditary rare disease — Duchenne muscular dystrophy — and opening a new chapter for XDC platforms broadly.

3. Technology iteration is shaping the next generation of ADCs

Bispecific ADCs, the broad adoption of topoisomerase I inhibitor payloads (the Dxd class), refined cleavable-linker chemistry, and low-DAR/high-potency payload design (such as a DAR of 2 in some newer programs) are among the innovations pushing the field from "third generation" toward what many now call "next generation" ADCs — with a continued focus on widening the therapeutic window and improving tolerability.

Outlook: What This Means for Sponsors and CDMO Partners

As more ADC and AOC candidates advance through review and into commercialization, competitive advantage in the sector will increasingly hinge on three capabilities: building durable technology differentiation, securing a resilient and scalable supply chain, and compressing the timeline from clinical development to commercial-scale manufacturing.

ChemExpress has built dedicated ADC/XDC CRO-CDMO capabilities spanning payload and linker synthesis, bioconjugation process development, and scale-up manufacturing, and continues to track the global conjugate-drug pipeline closely.

This article is intended as a timely, accurately sourced reference for industry peers — corrections, additional data points, and differing interpretations are welcome.

Frequently Asked Questions

1. How many ADC drugs are approved globally as of 2026?

As of June 30, 2026, 23 antibody-drug conjugates (ADCs) have received regulatory approval globally (including products that were later withdrawn from the market), across targets such as HER2, TROP2, CD30, CD33, BCMA, EGFR, FRα, Nectin-4, c-Met, and CD123.

2. What is the difference between an ADC and an AOC?

An ADC (antibody-drug conjugate) pairs a monoclonal antibody with a small-molecule cytotoxic payload — typically a tubulin inhibitor or topoisomerase I inhibitor — to kill tumor cells. An AOC (antibody-oligonucleotide conjugate) instead links the antibody to an oligonucleotide payload, such as a phosphorodiamidate morpholino oligomer (PMO), and is used to modulate gene expression rather than directly kill cells — for example, inducing exon skipping in Duchenne muscular dystrophy.

3. Which company has the first approved bispecific ADC?

Sichuan Baili Pharmaceutical (in collaboration with SystImmune and Bristol Myers Squibb) received NMPA approval for izalontamab brengitecan (Yizekang) on June 22, 2026, for recurrent/metastatic nasopharyngeal carcinoma — the world's first approved bispecific ADC, targeting both EGFR and HER3.

4. How many China-originated ADC drugs have been approved globally?

As of mid-2026, five China-originated ADCs have reached approval: RemeGen's disitamab vedotin (Aidixi, 2021), Kelun-Biotech's sacituzumab tirumotecan (Jiatailai, 2024) and trastuzumab botidotin (Shutailai, 2025), Hengrui's trastuzumab rezetecan (Aiweida, 2025), Lepu Biopharma's becotatug vedotin (Meiyouheng, 2025), and Baili Pharmaceutical/BMS's izalontamab brengitecan (Yizekang, 2026).

5. What trends are shaping the next generation of ADC drugs?

Three trends stand out in H1 2026: the accelerating international emergence of China-originated ADCs; continued expansion of target and indication coverage (including the first AOC programs to reach BLA stage); and technology iteration — bispecific ADCs, topoisomerase I inhibitor payloads, refined cleavable linkers, and low-DAR high-potency payload designs — aimed at widening the therapeutic window.

6. What is an AOC (antibody-oligonucleotide conjugate) used for?

AOCs use an antibody to deliver an oligonucleotide payload to a specific tissue or cell type — commonly muscle tissue via the transferrin receptor 1 (TfR1) — enabling therapies such as exon-skipping treatments for Duchenne muscular dystrophy that would otherwise be difficult to deliver systemically at an effective dose.

Contact ChemExpress

Whether you are evaluating an ADC candidate, planning an IND-enabling program, selecting a payload-linker platform, or preparing for commercial manufacturing, ChemExpress provides integrated CRO and CDMO solutions spanning discovery, process development, analytical support, CMC, scale-up, and GMP manufacturing.

Our multidisciplinary teams support antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), peptides, oligonucleotides, small molecules, and other emerging therapeutic modalities with flexible development and manufacturing services tailored to each project stage.