HMPL-523(300mg PO QD)

Phase 3

HUTCHMED (China) Ltd (HMDCF)

00%

What is LOA?

Phase 3

Development Phase

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Dec '26

HMDCFPDUFA$2.5B

Phase 3

FDA PDUFA Date Sovleplenib (priority review)

HMPL-523(300mg PO QD)• Warm Antibody Autoimmune Hemolytic Anemia

Dec 2026~AI-detectedSTALE

Source

00%

Competitive Landscape

0 competitors in Warm Antibody Autoimmune Hemolytic Anemia

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Drug Information

Target Indication

Warm Antibody Autoimmune Hemolytic Anemia

Clinical Trial

NCT05535933

Last updated: 5/19/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Drug Science

Mechanism of action & safety profile

Developer

HMDCF

HUTCHMED (China) Ltd

Biotechnology•North America•NASDAQ

Related Pipeline

HMPL-523Phase 3

Primary Immune Thrombocytopenia (ITP)

HMPL-760Phase 3

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Tumors

Solid Tumors, Adult

Ovarian Cancer

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