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Shanghai Henlius Biotech

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NMPA Has Accepted The NDA of HLX01(Rituximab Injection) for the Treatment of Rheumatoid Arthritis

Lead Product(s): Rituximab

Therapeutic Area: Immunology Product Name: HLX01

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 17, 2020

Details:

The new drug application (NDA) of HLX01 (rituximab injection) for rheumatoid arthritis (RA) is based on results from the Phase 1 clinical study (HLX01-RA01) and Phase 3 clinical study (HLX01-RA03).

WuXi Biologics

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AB2 Bio and WuXi Biologics Announce Collaboration to Accelerate Commercial-Scale Manufacturing of Tadekinig alfa

Lead Product(s): Tadekinig alfa

Therapeutic Area: Immunology Product Name: r-hIL-18BP

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: AB2 Bio

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration October 29, 2020

Details:

Tadekinig alfa is a novel IL-18 binding protein in pivotal Phase 3 testing for orphan disease IL-18 driven monogenic Hemophagocytic Lymphohistiocytosis (HLH). WuXi Biologics to undertake commercial scale manufacturing to support U.S. market launch.