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BioWorld - Thursday, July 17, 2025
Home » Topics » Monoclonal antibody, BioWorld Asia

Monoclonal antibody, BioWorld Asia
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China approves Simcere’s suvemcitug for ovarian cancer

July 8, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
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Handshake with digital globe overlay

Abion strikes $1.3B antibody drug deal with unidentified partner

July 1, 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 24, 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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Immuneoncia Kosdaq debut

Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

May 27, 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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Innovent’s IBI-302 meets phase II endpoints in neovascular AMD

May 6, 2025
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration.
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Green approved stamp

Akeso hot with FDA cancer win, nods in China, new data

April 29, 2025
By Randy Osborne
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
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Hand holding elbow

Akeso scores China approval for ebdarokimab in plaque psoriasis

April 22, 2025
By Tamra Sami
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
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More failures for TIGIT: Beigene shutters phase III lung cancer trial

April 8, 2025
By Tamra Sami
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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Leyden Labs raises $70M for intranasal flu drugs, acquires Covbio

March 11, 2025
By Marian (YoonJee) Chu
Leyden Laboratories BV added a fresh $70 million in financing to advance Panflu, its phase II-ready intranasal pan-influenza prophylactic medicine, while acquiring Cov Biotechnology Pte. Ltd. (Covbio) and its zoonotic virus-targeting portfolio to prepare for the next pandemic.
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