Shares of LEADS BIOLABS-B (09887) surged more than 27% in the morning trading session. At the time of writing, the stock was up 27.40%, trading at HK$63.60 with a turnover of HK$202 million.
On July 10, the company announced that the Biologics License Application (BLA) for its self-developed PD-L1/4-1BB bispecific antibody, Velixicon® (LBL-024), as a monotherapy for the treatment of advanced, previously treated extra-pulmonary neuroendocrine carcinoma (EP-NEC), has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for priority review.
The company stated that this milestone officially locks in the commercialization timeline for Velixicon®, with a clear and expected time for market approval. In parallel, LEADS BIOLABS is actively advancing various pre-launch commercialization preparations to ensure the product can be brought to market promptly upon approval. Analysts have previously noted that, based on the clinical progress of LBL-024, key data for its core indications are expected to be presented at the WCLC and ESMO conferences in September, which could validate its potential value in major disease areas and across tumor types, potentially opening a critical window for business development and overseas partnerships.
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