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BioWorld - Sunday, June 7, 2026
Home » Topics » Monoclonal antibody, BioWorld

Monoclonal antibody, BioWorld
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Enflonsia

ACIP delivers good news for Merck, makes unprecedented precedent

June 26, 2025
By Mari Serebrov
No Comments
Despite the controversies swirling around the June meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the reconstituted committee delivered good news to Merck & Co. Inc. when it voted 5-2 June 26 to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus season.
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Handshake with digital globe overlay

Abion strikes $1.3B antibody drug deal with unidentified partner

June 25, 2025
By Marian (YoonJee) Chu
No Comments
Abion Inc. signed a potential $1.315 billion deal with an anonymous partner June 22, granting the counterparty exclusive global rights to a preclinical claudin 3-targeting monoclonal antibody, ABN-501, and the potential to license four more protein targeting antibodies.
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Keymed launching Stapokibart, advancing pipeline, with $125M raise

June 20, 2025
By Tamra Sami
No Comments
Keymed Biosciences Co. Ltd. has raised HK$982 million (US$125 million) in a placement on the Hong Kong Stock Exchange (HKEX:2162) to commercialize its IL-4Rα monoclonal antibody CM-310 branded as Stapokibart, and to advance its larger pipeline.
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Andembry

New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 17, 2025
By Karen Carey and Tamra Sami
No Comments
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
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Handshake with cityscape

Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

June 10, 2025
By Marian (YoonJee) Chu
No Comments
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
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Enflonsia

Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

June 10, 2025
By Lee Landenberger
No Comments
With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb) will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024.
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Handshake with cityscape

Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

June 5, 2025
By Marian (YoonJee) Chu
No Comments
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
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ASCO 2025: Regeneron, Merck-Gilead drugs drop disease, death rates

June 2, 2025
By Lee Landenberger
No Comments
New and positive phase III cancer data for two monoclonal antibodies from two pharma giants opened the second day of the American Society of Clinical Oncology (ASCO) conference this past weekend.
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ODAC Starglo vote could impact universe of trials

May 22, 2025
By Mari Serebrov
No Comments
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
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Immuneoncia Kosdaq debut

Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

May 21, 2025
By Marian (YoonJee) Chu
No Comments
Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., noted that the funds will support R&D operations until 2026.
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