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Disitamab vedotin is a Chinese HER2 ADC approved for gastric and bladder cancer, now in global trials with Pfizer.
Disitamab vedotin is an anti-HER2 antibody (hertuzumab) linked through a cleavable mc-vc-PABC linker to the microtubule inhibitor MMAE, whose membrane permeability lets it kill neighbouring cells with lower HER2 expression. Developed by RemeGen, it was approved in China in 2021 for HER2-positive gastric cancer after two or more lines and for HER2-expressing urothelial cancer after platinum, and is given at 2.0 mg/kg every 2 weeks. A phase 3 trial with toripalimab in first-line HER2-expressing urothelial cancer was positive in 2025, and the FDA granted Breakthrough Therapy designation in HER2-positive urothelial cancer in 2020. Pfizer, via Seagen, holds ex-China rights and is running global trials. Peripheral neuropathy, neutropenia, alopecia and raised transaminases are the main toxicities. It is a Chinese HER2 ADC now heading into global development.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Anti-HER2 (hertuzumab) with MMAE. Connects to HER2.
1.Antibody binds HER2 on the tumour cell surface
Source: www.remegen.com. Doses are for orientation; the current label governs.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: disitamab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2021-08-09 | RemeGen to Pfizer (incl. Seagen) Disitamab vedotin (RC48), HER2 ADC | Licence | $200m | up to $2.4bn | source |
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Breakthrough Therapy designation, HER2+ urothelial cancer source
Conditional approval, HER2+ gastric cancer after ≥2 lines source
HER2-expressing urothelial cancer after platinum source
First-line urothelial cancer with toripalimab, positive phase 3 source
| Region | Year | Indication |
|---|---|---|
| China | 2021 | HER2+ gastric cancer; HER2-expressing urothelial cancer |
| Adverse event |
|---|
| Peripheral neuropathy |
| Neutropenia |
| Alopecia |
| AST/ALT increased |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2021; on the National Reimbursement Drug List | not disclosed | - |
| United States | Investigational (Pfizer; phase 3 in urothelial cancer) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Disitamab vedotin" OR ABSTRACT:"Disitamab vedotin" OR TITLE:"RC48" OR ABSTRACT:"RC48") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Disitamab vedotin, not a curated reading list.
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Pfizer (incl. Seagen).
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Bladder cancer (KEGG map).
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
Shares MMAE, Tubulin inhibitor payloads, Gastric & gastro-oesophageal junction cancer, Antibody-drug conjugate (ADC).
Shares Sequencing HER2 ADCs by payload after T-DXd, HER2, HER2-positive breast cancer, Antibody-drug conjugate (ADC).
Shares RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure, HER2, HER2-positive breast cancer.
Shares Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer, RemeGen.