Core Viewpoint - Ascentage Pharma-B (06855) saw a significant increase in stock price, opening over 4% higher and reaching a historical high of 90 HKD, with a trading volume of 16.89 million HKD, following the announcement of a global Phase III clinical trial approval for its drug, APG-2575 [1] Group 1: Clinical Development - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (trade name: Lisatuzumab), has received approval from both the FDA and EMA to initiate a global Phase III clinical study (GLORA-4) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients in combination with Azacitidine [1] - GLORA-4 is the second global Phase III study for Lisatuzumab approved by regulatory agencies in Europe and the U.S., which will expedite the drug's market entry [1] - Lisatuzumab is a novel oral Bcl-2 selective inhibitor that selectively inhibits the Bcl-2 protein, restoring the normal apoptosis process in cancer cells to achieve tumor treatment [1] Group 2: Market Position - The product has already been approved for marketing in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone at least one systemic treatment, including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisatuzumab is the first domestically developed original Bcl-2 inhibitor approved for marketing in China and is currently the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS internationally [1]
亚盛医药-B高开逾4% 利生妥治疗中高危MDS III期临床研究获美国FDA和欧洲EMA批准