TheraRadar
Page updated Jul 4, 2026 · using data updated on Jun 28, 2026

HER2 family — Platform Heatmap

HER2 mAbs, ADCs, bispecifics, and small-molecule TKIs.

51 drugs
15 indications
171 trials
22 in Phase 3
44 sponsors
Targets: HER2 · HER2 ADC · HER2 bispecific · HER2 mAb · HER2 TKI · HER2 pan-TKI
Beta 40 drugs of 51 15 indications 96 programs mapped curated roster · no per-cell AI classification 5 ⚖ PDUFA-dated ⏰ 16 due ≤6 mo click any cell → asset tearsheet
At a glance

40 drugs target this family across 15 indications (96 drug–indication programs mapped). The most contested indication is Breast (62 programs).

Key findings
  • Class maturity: 7 of 51 drugs map to an approved compound (14%); 44 are NME candidates — mix of label-extension and first-mover bets.
  • Antigen concentration: HER2 (45 drugs, 88%) — dominant target.
  • Indication concentration: Solid (basket) (26 drugs, 51%) — primary deployment target.
  • 14 platform drugs deployed in ≥3 indications (top: trastuzumab deruxtecan (Enhertu) in 9 indications) — broad-applicability bets.
  • Sponsor concentration: Roche / Genentech runs 4 drugs (8%) — leading among 44 sponsors.
  • 25 drugs have hot readouts in next 6 months — class-defining data imminent.
  • 23 drugs have stale trials (overdue without status change) — possible operational issues or class deprioritization.
  • 22 of 51 drugs have reached Ph3 (43%) — class maturity by progression.

Forward catalysts next 18 months⏰ 16 due ≤6 mo⚖ 5 PDUFA-dated

Nearest first. ⚖ Confirmed FDA PDUFA dates (curated calendar, primary sources) and 📅 estimated readouts (ClinicalTrials.gov primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.

Drug × Indication

Each cell = this drug’s most-advanced program in that indication (“all assets against target X”). Click for details. · showing top 40 of 51 drugs by program count — long tail omitted for width, not a data cap.
Ph1 Ph2 Ph3 Ph4 +combo
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Breast
Solid (basket)
Gastric/GEJ
NSCLC
Multi-tumor basket
CRC
Bladder
Biliary
Ovarian
Pancreatic
Cervical
Gynecologic (basket)
Endometrial
Esophageal
Prostate
trastuzumab deruxtecan (Enher…AstraZenecaHER2 ADC
disitamab vedotinRemeGenHER2
BL-M07D1Sichuan BailiHER2
TQB2102Chia Tai Tianqing Pharmaceu…HER2
tucatinib (Tukysa)PfizerHER2 TKI
trastuzumab (Herceptin)Roche / GenentechHER2 mAb
zanidatamabJazzHER2 bispecific
JSKN003Shanghai JMT-BioHER2
T-DM1Roche / GenentechHER2
zongertinibBoehringer IngelheimHER2
KN026Shanghai JMT-BioHER2
HB1801CSPC ZhongQi Pharmaceutical…HER2
BL-M17D1Sichuan BailiHER2
DP303cCSPC ZhongQi Pharmaceutical…HER2 ADC
SHR-A1811Jiangsu HengRui MedicineHER2
IBI354Innovent Biologics (Suzhou)HER2
SSGJ-705Shenyang SunshineHER2
zenocutuzumabMerusHER2
SHR-4602Shanghai HengruiHER2
DB-1303/BNT323DualityBioHER2
neratinib (Nerlynx)Puma BiotechnologyHER2 pan-TKI
A166Sichuan Kelun-Biotech Bioph…HER2
IKS014IksudaHER2
GLSI-100Greenwich LifeSciencesHER2
HLX22Shanghai HenliusHER2
RPH-051R-PharmHER2
HS627BioRayHER2
BCD-178BiocadHER2
MRG002Shanghai MiracogenHER2
BAY2927088 formulation ABayerHER2
TL938Suzhou TeligeneHER2
ARX788AmbrxHER2
SPH5030Shanghai Pharmaceuticals Ho…HER2
ABT-101AnbogenHER2
BAY2927088BayerHER2
ZN-A-1041Roche / GenentechHER2
YH32367Yuhan CorporationHER2
SYS6045CSPC Megalith Biopharmaceut…HER2
HMPL-A251HutchmedHER2
VRN101099VoronoiHER2

Beyond the grid Beta

What the matrix leaves out — rare mechanisms with only one player, small & emerging sponsors, and programs we haven’t classified yet.

White-space indications — a single asset 3 found

Indications where only ONE asset in this family competes — uncrowded ground for a new entrant.
⚡ first-in-class · 🌱 first-in-indication · 🆕 NME candidate · ✅ AI-classified + verified · ⚙️ AI-classified, unverified · first-in-class computed across 1 mapped landscape
More assets in this family (11) — same mechanism, beyond the matrix top 40 by activity
PhaseMechanismCompanyModalityReadoutTrial
Ph1 KJ015 — HER2 Shanghai Bao SC ⏰ 4Q26 NCT07036185
Ph1 MT-304 — HER2 Myeloid IV/SC 1Q27 NCT07334119
Ph1 NVL-330 — HER2 Nuvalent ⏰ 1Q27 NCT06521554
Ph1 ELVN-002 — HER2 Enliven IV/SC ⏰ 1Q27 NCT06328738
Ph1 [177Lu]Lu-ABY-271 — HER2 Affibody Radioligand ⏰ 1Q27 NCT07081555
Ph1 IAM1363 — HER2 Iambic 4Q27 NCT06253871
Ph1 CGT4255 — HER2 Cogent 2Q28 NCT07361562
Ph1 Runimotamab — HER2 Roche / Genentech IV/SC 4Q27 NCT03448042
Ph1 D3L-001 — HER2 D3 Bio (Wuxi) 4Q28 NCT05957536
Ph1 FT825 — HER2 Fate Cell therapy 2Q29 NCT06241456
Ph1 CCT303-406 — HER2 Shanghai PerHum 4Q24 NCT04511871

Frequently asked

Common questions about the HER2 family landscape

What drugs are in the HER2 family class?
51 assets in the HER2 family class are tracked in this platform view, including trastuzumab deruxtecan (Enhertu), disitamab vedotin, and BL-M07D1. The heatmap maps every drug against the indications it is being developed for.
What conditions are HER2 family being developed for?
HER2 family are in clinical development across 15 indications, including Breast, Solid (basket), Gastric/GEJ, NSCLC, and Multi-tumor basket.
How many HER2 family are in late-stage trials?
Of the 51 tracked assets in the HER2 family class, 22 are in Phase 3, developed by 44 sponsors, across 171 mapped trials.
What are the upcoming HER2 family catalysts?
Near-term catalysts in this class include HB1801 (data readout, Jul '26); JSKN003 (data readout, Jul '26); zanidatamab (data readout, Jul '26). Dates combine estimated trial readouts and confirmed FDA decision dates.
How is the HER2 family platform compiled?
Assets are compiled from a curated HER2 family target roster and matched to their ClinicalTrials.gov trials (2008–present). Each cell links to the underlying trial records.
Is the HER2 family heatmap free to use?
Yes — viewing and searching the HER2 family heatmap is free. A TheraRadar Pro subscription adds advanced filters, row/column selection, and one-click export to PowerPoint, PDF, and CSV.
How this is built — methodology & limits

These grids are only as good as the data and the classification behind them — so here is exactly what goes in, what stays out, how every assignment is made, and where the limits are.

Where the data comes from

Every heatmap is built from the public ClinicalTrials.gov registry, via its official API — interventional drug and biologic trials with a start date of 2008 or later. The master index holds over 145,000 trials and is refreshed weekly (see the “updated” date on this page). A disease landscape draws only from the active, Phase 1–3, industry-sponsored slice of that index.

  • In scope: industry-sponsored trials in Phase 1, 2, or 3, with an active status (recruiting, active-not-recruiting, not-yet-recruiting, or enrolling by invitation). Phase 4 sits in the index but is left out of the landscapes.
  • Filtered out: deeply stale programs (a primary completion date more than two years past with no update to completed or terminated); basket trials and incidental mentions (a trial counts toward a disease only when that disease is genuinely the subject of study — not a secondary cohort, an organ-of-origin overlap, or a passing mention); and healthy-volunteer studies.

We do not exclude trials by sponsor geography. Where a sponsor is based in China, the program is flagged on the page rather than hidden, so you can weigh it yourself. An automated test fails the weekly refresh if the underlying index is more than 14 days old, so a published grid is never built on a stale index.

How a trial is matched to a disease

Matching uses a structured medical ontology, not keyword guessing, and is designed so that no trial is ever silently dropped — every trial that clears the filters gets a classification, even if that is just “Other.” It runs as an ordered sequence of steps, stopping at the first that applies:

  1. Healthy-volunteer studies are set aside as non-disease trials.
  2. Ontology match — each tracked disease is linked to its official identifiers in the standard medical taxonomy (MeSH), so a trial can be matched even when its text uses a synonym.
  3. Curated disease patterns — a hand-maintained library of over 150 disease-name patterns covers the more granular indications across oncology, hematology, infectious disease, cardiometabolic, immunology, and neuropsychiatry.
  4. Basket guard — a trial matching four or more distinct diseases, or carrying explicit basket language (“tumor-agnostic,” “all solid tumors,” “pan-cancer”), is grouped into a single advanced-solid-tumor category rather than over-counted across every cancer it touches.
  5. Therapeutic-area roll-up — a trial with no specific match, but which the taxonomy still places under a broad area, is assigned to that area (“Oncology — other,” “Immunology — other,” …), checking cancers first so a site-specific tumor isn’t filed under its anatomical system.

A “drop-if-parent-present” rule keeps a generic name from drowning out a subtype: a trial matching both lupus and lupus nephritis is reported only as lupus nephritis. Internal abbreviations are translated to the plain disease names used across the site (for example, “CRC” becomes “Colorectal Cancer”), and the same classifier is shared by every heatmap, so the same trial always maps to the same disease wherever it appears.

How a drug is matched to its mechanism

Mechanism of action is the hardest part to get right, so it is assigned in layers — leaning on curated and public data first, with AI as a last resort:

  1. Curated rulebook (first). A rulebook we maintain — over 600 drug-to-mechanism rules — is checked first, matching on drug names, trial acronyms, sponsor trial identifiers, and intervention lists. First match wins, which stops a combination trial from being counted several times.
  2. Public molecular-target data. Where no rule applies, each intervention’s target is looked up in a public target database, with verbose or gene-symbol labels normalized into consistent short forms so one target isn’t split across several columns.
  3. Standard-of-care backbones. A small set of rules recognizes common combination scaffolds (checkpoint-inhibitor monotherapy, standard chemotherapy regimens, established standard-of-care agents) so they aren’t mistaken for the experimental arm.
  4. AI as a last resort, then cross-checked. Only for genuinely opaque sponsor code-names that none of the first three steps can resolve do we ask an AI model to propose a mechanism — applied only above a fixed confidence bar, then automatically cross-checked against the sponsor’s own pipeline page. Where AI and the sponsor agree, the program is marked sponsor-verified. Where they contradict, the label is discarded entirely — not shown, not counted.

New mechanism rules are independently double-verified before they’re trusted — a second, adversarial pass set up to disprove the first — and each is checked so it can’t mislabel an unrelated trial. Drugs whose mechanism isn’t publicly disclosed are shown openly as “Emerging — not yet disclosed” rather than guessed at: for a tool meant to support real decisions, “we don’t yet know” is a more trustworthy answer than a confident guess.

Where AI is used — and where it isn’t

The disease and mechanism matching above is driven first by deterministic rules and public ontologies, not AI. AI plays three bounded, disclosed roles: (1) an optional extra check that a trial genuinely studies the disease, on top of the ontology match; (2) inferring a trial’s treatment setting on the competitive grids when the rules don’t cover it, only above a fixed confidence bar; and (3) the last-resort mechanism step above, always cross-checked against the sponsor’s disclosures. Wherever an AI label reaches a cell, the page marks it (⚙️ or ✅) — AI is never the silent, sole source of what you see.

What the on-page markers mean

  • ✅ Sponsor-verified — AI proposed the mechanism and it matched the sponsor’s own pipeline page. High-trust.
  • ⚙️ AI-classified — AI proposed it above the confidence bar but it has not yet been cross-checked against the sponsor. Useful; verify before citing. It never means a person reviewed it.
  • ⚡ First-in-class — the mechanism hasn’t appeared in any other disease landscape we’ve built. This reflects the scope of landscapes published so far (the tooltip lists exactly which were scanned), not an absolute claim about the whole market.
  • 🌱 First-in-indication — the only program competing on that mechanism within this disease.
  • 🆕 NME candidate — the interventions match no drug in our approved-drug index, suggesting a new molecular entity. The index is incomplete — a signal, not a regulatory fact.
  • 🔗 Combination · 👶 Pediatric · 🔥 Hot (readout within six months) · ⏳ Stale (completion date passed but still marked active — often a stalled program).

Sponsor names are resolved through a curated parent/subsidiary map; unrecognized sponsors appear under their raw registry name. The registry records the sponsor at a trial’s inception, so names are as originally filed and may not reflect later acquisitions. To keep large grids legible, mechanisms with a single program are listed separately rather than crowding the main grid, and very small players are listed below it — presentation choices only; nothing is removed from the underlying counts.

How we score programs — “what’s about to move”

Each program carries a 0–100 score that deliberately ranks imminence over raw stage — the most decision-relevant signal on a competitive grid. It is the sum of:

  • Clinical phase — up to 40 points (Phase 3 = 40, Phase 2 = 25, Phase 1 = 10).
  • Readout proximity — up to 60 points (next readout <6 months = 60, 6–12 months = 45, 1–2 years = 30, distant = 5).
  • Stale penalty — the score is halved if a trial is past its expected readout but still listed as active.

Cell colour on the grid is driven by this score, so a Phase 2 program about to read out can — correctly — outrank a dormant Phase 3 one. It answers “what’s about to move,” not just “what’s furthest along.”

What each grid plots

  • Indication landscape — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
  • Company portfolio — one company — diseases (rows) × mechanism (columns): where it is active, and what it is betting on.
  • MOA platform (this page) — one mechanism family — drugs (rows) × diseases (columns): who is working on this class, and where.
  • Competitive landscape — one disease — mechanism (rows) × clinical setting (columns), aggregated across companies; setting columns are tailored per disease (e.g. lines of therapy in oncology; biologic-naïve vs. biologic-experienced in IBD).

What we don’t claim

  • First-in-class is editorial, not absolute — “not seen in the landscapes we’ve built,” not “novel across the industry.”
  • NME candidate is a signal, not a filing — absent from our (incomplete) approved-drug index.
  • Disease matching is automated and not exhaustively validated per disease — ontology and pattern matching can occasionally include or miss a trial.
  • AI-classified mechanisms are machine-proposed — unconfirmed unless they also carry ✅.
  • Sponsor names are as-filed and may lag current ownership.
  • Grids are as fresh as their last rebuild from the weekly index — no faster continuous refresh is claimed.

Data: ClinicalTrials.gov v2 API + FDA Drugs@FDA (approved-drug index). Spot an error? [email protected].

Data: ClinicalTrials.gov · Curated target-family roster · Trials registered 2008 onwards.