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Events / Business / Harbour BioMed HBM7004 IND Accepted by NMPA
Business IND application acceptance

Harbour BioMed HBM7004 IND Accepted by NMPA

Analysis based on 7 articles · First reported Jun 10, 2026 · Last updated Jun 10, 2026

Sentiment
60
Attention
4
Articles
7
Market Impact
Direct
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Market Impact

The acceptance of the IND application by the China — National Medical Products Administration (NMPA) of China for HBM7004 is a positive development for Harbour BioMed, potentially leading to increased investor confidence and a rise in its stock price. This regulatory milestone allows Harbour BioMed to advance its oncology therapeutic into clinical trials in China, expanding its market reach and potential revenue streams.

Biotechnology Pharmaceuticals
Event Summary

Harbour BioMed, a global biopharmaceutical company, announced that the China — National Medical Products Administration (NMPA) of China has accepted its Investigational New Drug (IND) application for HBM7004. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using Harbour BioMed's proprietary HBICE platform, designed for the treatment of advanced solid tumors. This acceptance follows a recent IND clearance by the United States — Food and Drug Administration (FDA) and allows Harbour BioMed to proceed with clinical evaluation of HBM7004 in China. Dr. Jingsong Wang, CEO of Harbour BioMed, emphasized that HBM7004 exemplifies the company's strategy to develop differentiated next-generation immunotherapies addressing unmet medical needs in oncology, supported by encouraging preclinical data.

Key Actions
100 China — National Medical Products Administration accepted IND application Harbour BioMed
70 Harbour BioMed developed bispecific antibody
60 United States — Food and Drug Administration cleared IND application Harbour BioMed
Entities Involved
priv
Harbour BioMed
Harbour BioMed's IND application for HBM7004 has been accepted by the China — National Medical Products Administration (NMPA) of China, which is a positive step towards clinical evaluation in China and could enhance its market position in oncology therapeutics.
Importance 100 Sentiment 60
govactor
China — National Medical Products Administration
The China — National Medical Products Administration (NMPA) of China accepted the Investigational New Drug (IND) application for HBM7004, allowing Harbour BioMed to advance its drug towards clinical evaluation in China.
Importance 80 Sentiment 0
cnt
China
China, through its China — National Medical Products Administration (NMPA), is the regulatory authority that accepted the IND application for HBM7004, facilitating its potential clinical development within the country.
Importance 50 Sentiment 0
per
Jingsong Wang
Jingsong Wang, as the Founder, Chairman, and CEO of Harbour BioMed, expressed satisfaction with the NMPA's acceptance of the IND application for HBM7004, highlighting the company's strategy in developing differentiated immunotherapies.
Importance 30 Sentiment 0
govactor
United States — Food and Drug Administration
The United States — Food and Drug Administration (FDA) previously cleared the IND for HBM7004, setting a precedent for the NMPA's acceptance and indicating broader international regulatory progress for the drug.
Importance 20 Sentiment 0
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