Core Viewpoint - Valiant Biosciences-B (09887) experienced a significant stock price fluctuation, initially dropping but later increasing by over 5% after the announcement of its core product, LBL-024, receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1 - Valiant Biosciences announced that its core product, LBL-024, has received orphan drug designation from the European Commission, marking an important milestone in its global development process [1] - LBL-024 is currently undergoing Phase II or registration clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC, demonstrating first-in-class (FIC) or best-in-class (BIC) potential [1] - The orphan drug designation provides Valiant with several incentives, including 10 years of market exclusivity and regulatory fee waivers [1] Group 2 - LBL-024 is an antibody that targets both PD-L1 and 4-1BB, showing promising efficacy signals in two clinical trials conducted in China [1] - The company is set to receive approval from the National Medical Products Administration in April 2024 to conduct a single-arm registration clinical trial and has also obtained breakthrough therapy designation for the treatment of advanced extra-pulmonary neuroendocrine carcinoma in October 2024 [1]
港股异动 | 维立志博-B(09887)尾盘涨逾5% 双特异性抗体维利信获欧盟孤儿药认定