Key Takeaways:
- China's NMPA accepts YZYBIO-B's new drug application for M701.
- The bispecific antibody targets malignant ascites from epithelial cancers.
- A Phase II trial for M701 in lung cancer has finished enrollment.
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YZYBIO-B's M701 drug application for ascites accepted in China
YZYBIO-B (02496.HK) said its New Drug Application for the bispecific antibody M701 was accepted by China’s National Medical Products Administration (NMPA).
The application covers the treatment of malignant ascites, a complication of advanced epithelial cancers, the company announced in a statement.
The submission is supported by data from a pivotal Phase III clinical trial. YZYBIO-B is also conducting a Phase II trial for M701 in malignant pleural effusion caused by non-small cell lung cancer, which has completed patient enrollment. Detailed efficacy and safety data from the pivotal Phase III study were not disclosed in the announcement.
Acceptance of the application is a key regulatory step that moves YZYBIO-B closer to the potential commercialization of M701. The company's stock (02496.HK) registered no change at HK$0.000, suggesting the news was released after market hours.
Malignant ascites is the abnormal accumulation of fluid in the abdominal cavity as a result of cancer, a condition that often indicates a poor prognosis and significantly impacts patient quality of life.
The formal review by the NMPA represents the next major hurdle for the asset before a potential market launch in China. This regulatory progress significantly de-risks the M701 program and provides a potential catalyst for YZYBIO-B's valuation, pending final approval. Investors will now watch for the NMPA's final decision and any future release of the clinical data.
This article is for informational purposes only and does not constitute investment advice.
