HUTCHMED (China) Ltd HCM
HUTCHMED (China) Ltd (Nasdaq: HCM) is an oncology drug developer. Its lead program, Savolitinib (ORPATHYS) + osimertinib (TAGRISSO), is in Phase 3 for EGFR-mutated NSCLC with MET overexpression/amplification after EGFR-TKI progression.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Fruquintinib (Fruzaqla / Elunate) | Metastatic colorectal cancer | small molecule | Approved |
| Surufatinib (Sulanda) | Neuroendocrine tumors (China) | small molecule | Approved |
| Savolitinib + osimertinib (SAFFRON; US NDA) | EGFRm NSCLC with MET overexpression/amplification | small molecule | Phase 3 |
| HMPL-A830 (KRAS-EGFR ATTC) | Advanced/metastatic solid tumors (CRC, PDAC, NSCLC) | antibody | Phase 1 |
| HMPL-A251 (ATTC) | Solid tumors | antibody | Phase 1 |
Recent results and decisions
- Nov 5, 2026n/a US FDA grants Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia.
The US Food and Drug Administration has granted Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia.
Filing - Nov 2, 2026accepted European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for ORPATHYS® plus TAGRISSO® in Europe.
the European Medicines Agency (EMA) has validated and accepted for regulatory review the Marketing Authorization Application (MAA) submitted by AstraZeneca, seeking approval for the combination for the treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors
Filing - Oct 29, 2026n/a Sovleplenib granted US FDA Orphan Drug Designation for primary immune thrombocytopenia.
The US Food and Drug Administration ("FDA") has granted Orphan Drug Designation to sovleplenib for the treatment of primary immune thrombocytopenia ("ITP"), an autoimmune disorder that can lead to increased risk of bleeding.
Filing
28 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.