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Nanjing Leads Biolabs Wins EU Orphan Drug Status for LBL-024 in Rare Neuroendocrine Cancer

Tip Ranks
Jan 22, 2026 at 01:10 PM
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Nanjing Leads Biolabs Co., Ltd. has received Orphan Drug Designation from the European Commission for its bispecific antibody LBL-024 (Opamtistomig) aimed at treating extrapulmonary neuroendocrine carcinoma (EP-NEC). This designation offers regulatory and commercial benefits, including market exclusivity for 10 years upon approval. LBL-024 is the first therapy targeting 4-1BB to reach the registrational stage for EP-NEC and has shown promising results in trials. Analysts rate the stock (HK:9887) as a Buy with a price target of HK$80.27, and the company focuses on innovative oncology therapies.

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

Nanjing Leads Biolabs Co., Ltd. announced that the European Commission has granted Orphan Drug Designation to its PD-L1/4-1BB bispecific antibody LBL-024 (Opamtistomig) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC), its second orphan designation following one from the U.S. FDA. The designation provides significant regulatory and commercial incentives in the EU, including scientific advice, reduced regulatory fees, access to funding, and 10 years of market exclusivity upon approval, strengthening the global development prospects of LBL-024. LBL-024 is the first 4-1BB–targeting therapy to reach the registrational stage globally for EP-NEC and has shown promising efficacy and safety in Chinese trials as monotherapy and in combination with chemotherapy, with additional encouraging signals across multiple other tumor types, positioning it as a potential first-in-class or best-in-class therapy and the first approved drug for advanced EP-NEC.

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 developing innovative oncology therapies, particularly immuno-oncology drugs. Leveraging its proprietary X-body® platform with full intellectual property rights, the company is advancing bispecific antibody candidates, such as LBL-024 (Opamtistomig), targeting high unmet medical needs across multiple solid tumors including lung, neuroendocrine, biliary tract, ovarian and other cancers.

Average Trading Volume: 551,033

Technical Sentiment Signal: Strong Sell

Current Market Cap: HK$10.44B

See more insights into 9887 stock on TipRanks’ Stock Analysis page.

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