Company

Product

Description

Indication

Status

Date


Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J.

Lenvima (lenvatinib)

Kinase inhibitor

Unresectable hepatocellular carcinoma

Approved in China for use as a single agent in patients who have not received prior systemic therapy

9/5/18

Hutchison China Meditech Ltd., of London

Elunate (fruquintinib)

Oral, small-molecule VEGFR1, 2,3 inhibitor

Metastatic colorectal cancer

Approved by China's National Medical Products Administration for use in patients who have failed at least 2 prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan, with or without prior use of anti-VEGF or anti-EGFR therapies

9/5/18

Innovent Biologics Inc., of Suzhou, China

IBI-188

Fully human anti-CD47 monoclonal antibody

Tumors

China's National Medical Products Administration cleared the IND; firm plans to launch trials in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer

9/10/18

Mabspace Biosciences Co. Ltd., of Suzhou, China

MSB-0254

VEGFR2 antibody

Gastric, non-small-cell, colorectal and hepatocellular cancers

Submitted IND application to the National Medical Products Administration of China

9/6/18

Sihuan Pharmaceutical Holdings Group Ltd., of Beijing

Degludec

Long-acting recombinant insulin analog

Diabetes mellitus

National Medical Products Administration of China greenlighted trials

9/6/18

Vertex Pharmaceuticals Inc., of Boston

Orkambi (lumacaftor/ivacaftor)

CFTR corrector/CFTR potentiator

Cystic fibrosis

Finalized agreement with Australian government allowing for reimbursement for patients, 6 and older, with CF who have 2 copies of the F508del mutation in the CFTR gene

9/4/18


Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

 

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