HK Stock Market Move | ASCENTAGE-B (06855) rose more than 4% during trading, and Nalitrex has been included in the breakthrough therapy category by the CDE for the third time.

ASCENTAGE-B (06855) rose more than 4% during trading hours and at the time of writing, it is up 4.55% at HK$40.25, with a turnover of HK$52.6994 million. On the news front, ASCENTAGE-B announced that their original class 1 new drug Osimertinib (trade name: Nilotinib) has been included in the "Breakthrough Therapy Designation" list by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE). It is used for first-line treatment in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients. It is reported that this is the third time Nilotinib has been included in the CDE breakthrough therapy category. Previously, the drug was included in the breakthrough therapy category in March 2021 and June 2023 for the treatment of first- and second-generation tyrosine kinase inhibitor (TKI) resistant and/or intolerant chronic phase chronic myeloid leukemia (CML-CP) patients; and for patients with succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) who have previously undergone first-line treatment. Nilotinib is a class 1 new drug developed by Ascentage Pharma and is the first third-generation BCR-ABL inhibitor approved for marketing in China. Its commercial promotion in China is jointly managed by Ascentage Pharma and INNOVENT BIO Pharma. As of the date of this announcement, Nilotinib has been approved in China for the treatment of adult patients with CML chronic phase (-CP) and accelerated phase (-AP) who are resistant to any TKI and have the T315I mutation; and for adult patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. All approved indications have been included in the national medical insurance drug list.