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Hutchmed

HCM
$2.47BMid Cap

Next catalyst

PDUFADecember 2026

HMPL-523

Warm Antibody Autoimmune Hemolytic Anemia

Source

Get an email about HCM's next catalysts

Track Hutchmed (HCM) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.

Plus 1 more upcoming event in our data (PDUFA date).See the timeline

Catalyst Timeline

2 upcoming, 1 past

PDUFANext

FDA PDUFA Date Sovleplenib (priority review)

December 2026~HMPL-523

For Warm Antibody Autoimmune Hemolytic Anemia. NDA accepted. AI-extracted from: HUTCHMED Announces NDA Acceptance in China with Priority Review Status and Break

Source
PDUFA

FDA PDUFA Date ORPATHYS plus TAGRISSO (standard review)

September 2027~ORPATHYS plus TAGRISSO

For MET-driven EGFR-mutated lung cancer. sNDA submitted. AI-extracted from: HUTCHMED Announces Submission of US NDA for ORPATHYS® plus TAGRISSO® in MET-Driv

Source

Market Overview

Stock performance and key metrics

NASDAQPharmaceutical Preparations🇺🇸North AmericaHONG KONG1.8K employees
Drug Pipeline

Surufatinib with Nab-paclitaxel, and Gemcitabine

Phase 3

Metastatic Pancreatic Cancer

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Phase 3

Metastatic Pancreatic Cancer

HMPL-453

Phase 3

Advanced Intrahepatic Cholangiocarcinoma

fruquintinib+sintilimab

Phase 3

Advanced Renal Cell Carcinoma

HMPL-306 Regimen

Phase 3

Acute Myeloid Leukemia

fruquintinib

Phase 3

Advanced Endometrial Cancer

HMPL-523

Phase 3

Primary Immune Thrombocytopenia (ITP)

HMPL-760

Phase 3

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

sintilimab

Phase 3

Advanced Endometrial Cancer

R-GemOx

Phase 3

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Pamiparib

Phase 2

Ovarian Cancer

HMPL-A251

Phase 2

Solid Tumors, Adult

Tazemetostat

Phase 2

Relapsed/Refractory Follicular Lymphoma With EZH2

HMPL-760 planned dose 2

Phase 2

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Surufatinib

Phase 2

Neuroendocrine Tumors

HMPL-A830

Phase 2

Solid Tumor, Adult

Fruquintinib in Combination with Sintilimab

Phase 2

Advanced Solid Tumor

Surufatinib in combination with Gemcitabine

Phase 2

Solid Tumor

HMPL-A580

Phase 2

Solid Tumors, Adult

HMPL-689

Phase 2

Relapsed/Refractory Lymphoma

HMPL-760 planned dose 1

Phase 2

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

primary immune thrombocytopenia

1 drug in this indication

Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)

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Frequently asked questions

What is in Hutchmed's drug pipeline?→

CatalystAlert tracks 21 drug candidates in Hutchmed's (HCM) pipeline across Phase 3, Phase 2. Its lead program is HMPL-523 (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.

When is Hutchmed's next FDA catalyst?→

Hutchmed's (HCM) next tracked catalyst is a PDUFA date expected December 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.

How do I track HCM biotech catalysts?→

Add HCM to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Hutchmed's live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.

Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply