Market Performance - The pharmaceutical sector experienced a decline of -1.18% on January 15, 2025, underperforming the CSI 300 index by 1.38 percentage points, ranking 25th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, other biological products (-0.04%), hospitals (-0.75%), and medical consumables (-0.77%) performed relatively well, while pharmaceutical distribution (-2.57%), medical devices (-2.51%), and offline pharmacies (-2.11%) lagged behind [1] - Top three gainers included Shanhe Pharmaceutical (+20.01%), Duori Pharmaceutical (+11.48%), and Yahong Pharmaceutical (+7.69%); top three losers were Sunflower (-20.00%), Hongbo Pharmaceutical (-20.00%), and Huaren Health (-19.99%) [1] Industry News - Ipsen announced that the FDA has granted breakthrough therapy designation for its investigational monoclonal antibody IPN60340, which is used in combination with Ven-Aza for the treatment of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable for intensive therapy [2] - The designation is based on data from the Phase 1/2 EVICTION trial, showing that patients receiving the combination treatment had a nearly doubled complete remission rate compared to historical standard treatment data, particularly in subtypes that typically respond poorly to standard treatment [2] - IPN60340 targets BTN3A, a key immune regulatory molecule widely expressed in various cancers, promoting the recognition and elimination of tumor cells by γ9δ2 T cells [2] Company News - Saint Noble Bio (688117) announced an expected net profit attributable to shareholders of 152-190 million yuan for 2025, representing a year-on-year growth of 204.42%-280.53%, with a non-recurring net profit expected to be 149-186 million yuan, reflecting a growth of 226.07%-307.58% [3] - Yipinhong (300723) reported similar profit expectations for 2025, with a net profit forecast of 152-190 million yuan and a non-recurring net profit of 149-186 million yuan, both showing significant year-on-year growth [3] - Chutian Technology (300358) expects to achieve a net profit of 235-300 million yuan for 2025, marking a turnaround from losses in the previous year, with a non-recurring net profit forecast of 135-200 million yuan [3] - Ganli Pharmaceutical (603087) received approval from the Ethiopian National Food and Drug Administration for the registration of its insulin glargine injection and pre-filled pen, allowing for import and sale in Ethiopia [3]

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation for investigational therapy IPN60340 in combination with venetoclax and azacitidine for first-line treatment of unfit acute myeloid leukemia (AML) [1][2] - IPN60340 is a first-in-class monoclonal antibody targeting BTN3A, which is crucial for immune regulation in cancer [1][4] - The designation aims to expedite the development of therapies for serious conditions, highlighting the urgent need for new treatment options in AML [2] Group 1: Breakthrough Therapy Designation - The Breakthrough Therapy Designation is based on promising data from the Phase I/II EVICTION trial, which showed high response rates in patients treated with IPN60340 and Ven-Aza [2][3] - The trial demonstrated a near doubling of complete response rates compared to historical standard care data, particularly in molecular subtypes less responsive to standard treatments [2][3] Group 2: EVICTION Trial Details - The EVICTION trial is a first-in-human study that includes dose-escalation and cohort-expansion phases for patients with advanced cancers, including newly diagnosed AML [3] - The trial aims to evaluate the safety and efficacy of IPN60340 in patients who have exhausted standard treatment options [3] Group 3: Mechanism of Action - IPN60340 is designed to enhance the immune response by promoting the recognition and elimination of tumor cells by γ9δ2 T cells [4] - The therapy targets BTN3A, which is overexpressed in various solid tumors and hematologic malignancies, facilitating the activation of anti-tumor immune responses [4] Group 4: Company Overview - Ipsen is a global biopharmaceutical company focused on developing transformative medicines in oncology, rare diseases, and neuroscience [5] - The company has nearly 100 years of development experience and operates in over 40 countries, bringing medicines to patients in more than 100 countries [5]