Core Viewpoint - The company Hansai Aitai-B (03378) has received approval from the National Medical Products Administration of China to conduct clinical trials for its innovative drug HX111, which is a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1][4]. Group 1: Stock Performance - The stock price of Hansai Aitai-B increased by nearly 6% during trading, with a current price of 17.60 HKD, reflecting a 2.33% rise and a trading volume of 16.8885 million HKD [1][4]. Group 2: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, with preclinical studies indicating that OX40 is overexpressed in several malignant tumors compared to normal tissues, making it a suitable target for ADC [1][4]. - HX111 is the third first-in-class molecule to advance to clinical development, following the company's previous dual-specific antibody therapies HX009 and HX044 [1][4]. - The company aims to continue its efforts in clinical development to bring more innovative first-in-class drugs to market [1][4].

Core Viewpoint - The company Hansai Aitai-B (03378) has seen a rebound of nearly 6%, with a current increase of 5.12%, trading at HKD 18.08, with a transaction volume of HKD 10.4874 million [1] Group 1: Clinical Development - The company announced that its innovative drug, HX111, has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials within China [1] - HX111 is a first-in-class OX40-targeted antibody-drug conjugate (ADC), which has shown overexpression in several malignant tumors compared to normal tissues during preclinical studies, making it a suitable target for ADC [1] - HX111 is the third first-in-class molecule to advance to clinical development, following HX009 and HX044, both of which are bispecific antibody therapies [1] Group 2: Future Plans - The company aims to continue its efforts in clinical development to bring more novel first-in-class (FIC) drugs to market [1]

Core Viewpoint - The company Hansai Aitai-B (03378) has seen a rebound of nearly 6%, with a current increase of 5.12%, trading at HKD 18.08, and a transaction volume of HKD 10.4874 million [1] Group 1: Clinical Development - The company announced that its innovative drug, HX111, has been approved by the National Medical Products Administration of the People's Republic of China to conduct clinical trials within China [1] - HX111 is a first-in-class OX40-targeted antibody-drug conjugate (ADC), which has shown overexpression in several malignant tumors compared to normal tissues during preclinical studies, making it a suitable target for ADC [1] - HX111 is the third first-in-class molecule to advance to clinical development, following HX009 and HX044, both of which are bispecific antibody therapies [1] Group 2: Future Plans - The company aims to continue its efforts in clinical development to bring more novel first-in-class drugs to market [1]

Core Viewpoint - The company Hansa Biopharma-B (03378) has seen a nearly 6% rebound in its stock price following the approval of its innovative drug HX111 for clinical trials in China by the National Medical Products Administration [1] Group 1: Company Developments - Hansa Biopharma announced that its innovative drug injection HX111 has been approved for clinical trials in China [1] - HX111 is a first-in-class OX40-targeted antibody-drug conjugate (ADC), which has shown overexpression in several malignancies compared to normal tissues, making it a suitable target for ADC [1] - HX111 is the third first-in-class molecule to advance to clinical development, following HX009 and HX044, both of which are bispecific antibody therapies [1] Group 2: Market Reaction - Following the announcement, Hansa Biopharma's stock price increased by 5.12%, reaching HKD 18.08, with a trading volume of HKD 10.4874 million [1]

Core Viewpoint - The company announced that its innovative drug HX111 has been approved by the National Medical Products Administration of the People's Republic of China to conduct clinical trials within the country [1] Group 1: Product Development - HX111 is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] - Preclinical studies indicate that OX40 is overexpressed in several malignancies, including certain lymphomas, compared to normal tissues, making it a suitable target for ADCs like HX111 [1] - OX40 is also overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] Group 2: Mechanism of Action - The elimination of Treg represents a new mechanism of action (MOA) for cancer immunotherapy, which can be achieved through HX111, indicating potential broad cancer application prospects [1] Group 3: Future Development - HX111 is the third first-in-class molecule to advance to clinical development following HX009 and HX044, both of which are bispecific antibody (BsAb) therapies [1] - The company aims to continue its efforts in clinical development to bring more novel FIC drugs to market [1]

Core Viewpoint - Hansa Biopharma-B (03378.HK) has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its innovative drug, HX111, which is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, which shows overexpression in several malignancies, including certain lymphomas, compared to normal tissues, making it a suitable target for ADC therapies [1] - Preclinical studies indicate that OX40 is a tumor-associated antigen (TAA) and is overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] - The mechanism of action (MOA) for HX111 involves the elimination of Tregs, representing a novel approach in cancer immunotherapy with potential applications across various cancers [1] Group 2: Company Strategy - HX111 is the third first-in-class molecule to advance to clinical development following the company's previous dual-specific antibody (BsAb) therapies, HX009 and HX044 [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its innovative drug HX111, a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] - Preclinical studies indicate that OX40 is overexpressed in several malignancies, including certain lymphomas, making it a suitable target for ADCs like HX111 [1] - OX40 is also overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] Group 2: Mechanism of Action - The elimination of Tregs represents a novel mechanism of action (MOA) for cancer immunotherapy, which can be achieved through HX111 [1] - HX111 has potential applications across various cancers due to its unique mechanism [1] Group 3: Future Development - HX111 is the third first-in-class molecule to advance to clinical development following HX009 and HX044, both of which are bispecific antibody therapies [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Hanx Biopharmaceuticals (Wuhan) Co., Ltd. 翰思艾泰生物醫藥科技（武漢）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：3378） 自願公告 獲批准於中華人民共和國開展注射用HX111臨床試驗 本公告由翰思艾泰生物醫藥科技（武漢）股份有限公司（「本公司」）董事（「董事」） 會（「董事會」）自願刊發。 董事會欣然宣佈，由本公司開發的創新藥注射用HX111（「HX111」）已獲中華人民 共和國國家藥品監督管理局批准於中華人民共和國境內開展臨床試驗。 HX111為首創(FIC)OX40靶向抗體偶聯藥物(ADC)。臨床前研究表明，OX40為腫 瘤相關抗原(TAA)，於若干惡性腫瘤（包括部分淋巴瘤）中相較於正常組織呈過度 表達，因而成為如HX111等ADC方式的合適靶點。此外，OX40亦在腫瘤微環境 (TME)中的調節性T細胞(Treg)呈過度表達，而 ...