Nanjing Leads Biolabs’ Cancer Antibody LBL-024 Wins FDA Fast Track Status for EP-NEC

The latest update is out from Nanjing Leads Biolabs Co., Ltd. Class H ( (HK:9887) ).

Nanjing Leads Biolabs has announced that its bispecific antibody LBL-024 (Opamtistomig), which targets PD-L1 and 4-1BB, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). The candidate, already in Phase II or registrational trials for non-small cell lung cancer, small cell lung cancer and EP-NEC, is positioned as a potential first-in-class or best-in-class therapy and could become the first approved drug for advanced EP-NEC, complementing prior Breakthrough Therapy and Orphan Drug designations obtained in China and the U.S. This latest regulatory milestone underscores the global potential of LBL-024 as a broad-spectrum cancer therapy, particularly for tumors resistant to existing PD-1/PD-L1 treatments, and strengthens the company’s competitive standing in immuno-oncology while highlighting both the opportunity and development risk for investors.

The most recent analyst rating on (HK:9887) stock is a Buy with a HK$80.27 price target. To see the full list of analyst forecasts on Nanjing Leads Biolabs Co., Ltd. Class H stock, see the HK:9887 Stock Forecast page.

More about Nanjing Leads Biolabs Co., Ltd. Class H

Nanjing Leads Biolabs Co., Ltd. is a China-based biopharmaceutical company focused on innovative oncology therapies, leveraging its proprietary X-body® platform to develop next-generation antibody drugs. Its pipeline centers on immuno-oncology, with a particular emphasis on bispecific antibodies targeting difficult-to-treat solid tumors and indications with high unmet medical need worldwide.

Average Trading Volume: 570,900

Technical Sentiment Signal: Strong Sell

Current Market Cap: HK$10.76B

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