当前，PD-(L)1抑制剂行业正处于发展转折点。翰思艾泰（3378.HK）以颠覆性创新打破困局，凭借两 款重磅管线HX009、HX044的突破性进展，让CD47强势崛起，正式开启肿瘤免疫治疗的全新篇章。 业内人士指出，在CD47赛道从沉寂到爆发的历史性跨越中，翰思艾泰以前瞻性的机制探索、颠覆性的 分子设计、扎实亮眼的临床数据，构建起不可复制的核心竞争优势。两款重磅管线不仅有效攻克了传统 CD47疗法的毒性痛点，更开辟了免疫检查点联合靶向的全新治疗路径。 作为CD47新机制的开拓者与领航者，翰思艾泰跳出传统"别吃我"信号阻断的单一框架，深度解码CD47 在肿瘤免疫中的核心调控密码。最新顶尖研究证实，CD47不仅是固有免疫的抑制信号，更是驱动T细胞 耗竭、激活肿瘤调节T细胞（Treg）的关键适应性免疫检查点——其高表达与免疫治疗耐药直接相关， 这一重大发现为靶向药物研发点亮了全新航向，而翰思艾泰早已精准布局，抢占技术制高点。 翰思艾泰表示，未来，公司将持续深耕CD47新机制，加速推进更多创新药物的临床转化，以强大的管 线价值赋能行业发展，用顶尖科学力量攻克肿瘤治疗难关，书写免疫治疗的全新传奇。 公司产品HX009 ...

Group 1 - Han's Biopharma (3378.HK) listed on the Hong Kong Stock Exchange on December 23, raising a total of HKD 586 million by offering 18.32 million shares at HKD 32 per share, with a market capitalization of nearly HKD 4.4 billion [1] - Following the IPO, the stock price fell significantly, closing at HKD 17.2 per share, representing a decline of 46.25% and a total market value of HKD 2.343 billion [1] - The company, founded in 2014, focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases, with a pipeline of 10 candidate drugs, including 3 in clinical stages and 7 in preclinical stages [1] Group 2 - The core product, HX009, is a self-developed dual-function antibody fusion protein that has completed Phase I clinical trials in Australia and China, and is currently undergoing Phase Ib/I/IIa clinical trials for advanced melanoma, relapsed/refractory EBV-positive non-Hodgkin lymphoma, and advanced biliary cancer in China [1] - The company also has two other main clinical-stage products: HX301, a multi-target kinase inhibitor in Phase II trials for glioblastoma, and HX044, a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein in Phase I/IIa trials for advanced solid tumors [2] - The founder, Zhang Faming, is a professor and doctoral supervisor at Wuhan University, with a history of entrepreneurship in the innovative drug sector, having established multiple companies in the Wuhan East Lake High-tech Zone, which has a significant number of listed companies in the life and health sector [2]

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 - Hanseata Biotechnology (Wuhan) Co., Ltd. has listed on the Hong Kong Stock Exchange, opening below the issue price and closing with a significant decline of 46.25% from the final offer price [1][6]. Group 1: Listing and Share Details - The total number of shares offered globally was 18,321,000 H-shares, with 1,832,100 shares available for public offering in Hong Kong and 16,488,900 shares for international offering [2]. - The final offer price was set at HKD 32.00 per share, resulting in total proceeds of HKD 586.3 million, with net proceeds amounting to HKD 531.3 million after deducting estimated listing expenses of HKD 55.0 million [6]. Group 2: Use of Proceeds - The net proceeds from the global offering are intended for the research and development of the company's core products (HX009, HX301, and HX044), funding for commercialization and business development activities, and general corporate purposes [6]. Group 3: Financial Performance - The company reported comprehensive losses of RMB 85.2 million for 2023, RMB 116.9 million for 2024, and RMB 48.4 million for the eight months ending August 31, 2025, primarily due to R&D costs and administrative expenses [7][8]. - The total comprehensive loss over the periods mentioned amounted to RMB 289.5 million [8]. Group 4: Cash Flow and Financial Position - The net cash used in operating activities was RMB 52.0 million for 2023 and RMB 104.9 million for 2024, with cash and cash equivalents at the end of the periods being RMB 162.0 million for 2023 and RMB 161.2 million for 2024 [10].

Core Viewpoint - The initial public offering (IPO) of Hansai Aitai-B (03378) experienced a significant decline, with shares dropping nearly 45.5% from the offering price of HKD 32 to HKD 17.44, resulting in a market capitalization of less than HKD 24 billion [1] Company Overview - Hansai Aitai is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates focused on antibody-drug conjugates, bispecific antibodies, and monoclonal antibodies for autoimmune and oncology markets [1] Financial Performance - The company has not recorded any profits during the historical performance period and has incurred operating losses [1] - For the fiscal years ending August 31, 2023, 2024, and the first eight months of 2025, the company reported losses of RMB 85.16 million, RMB 117 million, and RMB 87.44 million, respectively, primarily due to research and development costs and administrative expenses [1]

Core Viewpoint - Hanse Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, marking it as the second company from Wuhan to go public under the HKEX's 18A biotech rules. The company focuses on developing innovative drugs for cancer and autoimmune diseases, addressing unmet medical needs in these areas [3][4]. Group 1: IPO Details - Hanse Aitai issued 18.321 million H-shares at an offering price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion at issuance [3]. - On its first trading day, the opening price was HKD 28.9, and the latest market capitalization was HKD 3 billion [3]. - The company has completed three rounds of financing prior to the IPO, totaling approximately RMB 154 million, with major investors including Betta Pharmaceuticals and Longpan Investment [4]. Group 2: Product Pipeline and R&D Focus - The core product, HX009, is the world's only PD-1/SIRPα dual-function antibody fusion protein, currently in Phase II clinical trials in China after completing Phase I trials in China and Australia [4][20]. - Another innovative product, HX044, has initiated Phase I clinical trials for advanced solid tumors in both China and Australia [4][21]. - The company plans to allocate approximately 35% of the raised funds to advance HX009, 33% to develop HX301 and HX044, and 5% for commercialization preparations [4]. Group 3: Founder's Background and Company Development - Founder Zhang Faming, who has a strong academic and professional background in biochemistry and pharmaceutical development, has previously founded and sold successful biotech companies [10][11]. - Hanse Aitai was established in 2014 and has since focused on developing next-generation immunotherapies, particularly targeting the limitations of existing PD-1 therapies [15][17]. - The company has built a robust R&D team, integrating expertise from various fields to enhance its drug development capabilities [15][20]. Group 4: Market Context and Competitive Landscape - The global PD-1/PD-L1 antibody market is projected to reach USD 53.7 billion by 2024, with expectations to grow to USD 72.5 billion by 2030, highlighting the competitive nature of the immunotherapy sector [25]. - Hanse Aitai's dual-target design for HX044 aims to address the challenges of PD-1 resistance, positioning the company in a competitive landscape with several other firms pursuing similar therapeutic strategies [26][28]. - The company is one of the few globally to have two clinical-stage products targeting the SIRPα pathway, indicating significant long-term collaboration potential [28].

Core Viewpoint - Hansa Biopharma-B (03378) has made its debut on the stock market with an initial share price of HKD 32, issuing 18.321 million shares and raising approximately HKD 531 million, but has seen a decline of 9.69% to HKD 28.9 at the time of reporting [1] Company Overview - Hansa Biopharma is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates targeting autoimmune and oncology markets [1] Product Details - The core product HX009 is a bispecific antibody fusion protein that targets both CD47 and PD-1 [1] - According to a Frost & Sullivan report, HX009's clinical trial progress is leading globally among similar CD47-targeting bispecific antibodies and bifunctional fusion protein products as of the last feasible date [1]

Core Viewpoint - Hantian Aitai-B (03378) has made its debut on the stock market with an initial share price of HKD 32, issuing 18.321 million shares and raising approximately HKD 531 million, but the stock has seen a decline of 9.69% to HKD 28.9 at the time of reporting [1] Company Overview - Hantian Aitai is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with a product pipeline that includes one core product and nine other candidate products [1] - The company has developed three clinical-stage candidates targeting oncology, including the core product HX009 and major products HX301 and HX044, as well as seven preclinical candidates targeting autoimmune and oncology markets [1] Product Details - The core product HX009 is a bispecific antibody fusion protein that targets both CD47 and PD-1 [1] - According to a Frost & Sullivan report, HX009's clinical trial progress is leading globally among similar CD47-targeting bispecific antibody/bifunctional fusion protein products as of the last feasible date [1]

Group 1 - The core viewpoint of the article is that Hanse Aitai-B (03378) has successfully completed its IPO with significant oversubscription, raising substantial capital for its product development [1][2]. - The company has raised HKD 1,472.9 billion in margin financing, with the public offering being oversubscribed by 2,511 times, indicating strong investor interest [1]. - Hanse Aitai plans to issue 18.32 million H-shares, with a public offering accounting for 10% of the total shares, and the share price set between HKD 28 to 32 [1]. Group 2 - The product pipeline includes one core product and nine other candidates, with three clinical-stage candidates targeting oncology, including the core product HX009 [2]. - HX009 is a bispecific antibody fusion protein targeting both CD47 and PD-1, leading in clinical trial progress among similar products globally [2]. - The company reported operating losses during the historical record period, with losses of RMB 85.16 million, RMB 117 million, and RMB 87.44 million for the fiscal years ending August 31, 2023, 2024, and 2025 respectively [2]. Group 3 - The company plans to allocate approximately 35% of the net proceeds from the global offering to the development of its core product HX009, 33% to its main products HX301 and HX044, and 17% to other important products [3]. - Additionally, about 5% of the proceeds will be used for commercialization and business development activities, while 10% will be allocated for working capital and other general corporate purposes [3].

Group 1 - The core viewpoint of the news is that Han's Biotech Company has successfully completed its IPO process, raising significant interest from investors with a substantial oversubscription rate of 2511 times [1] - Han's Biotech plans to issue 18.32 million H-shares, with a public offering accounting for 10% of the total shares, and the share price is set between HKD 28 to 32 [1] - The company has secured cornerstone investments totaling HKD 93.37 million from seven investors, representing 15.93% of the global offering [1] Group 2 - Since 2016, Han's Biotech has developed a product pipeline that includes one core product and nine other candidates, focusing on oncology and autoimmune markets [2] - The core product, HX009, is a bispecific antibody fusion protein targeting CD47 and PD-1, which is reported to be leading in clinical trial progress among similar products [2] - Financially, Han's Biotech has recorded operating losses with no profits during the reporting period, with losses of RMB 85.16 million, RMB 117 million, and RMB 87.44 million for the fiscal years ending August 31, 2023, 2024, and 2025 respectively [2] Group 3 - The company plans to allocate approximately 35% of the net proceeds from the global offering to the research and development of its core product HX009, 33% to its major products HX301 and HX044, and 17% to other important products [3] - Additionally, about 5% of the proceeds will be used for commercialization and business development activities, while 10% will be allocated for working capital and other general corporate purposes [3]