Core Insights - The company, founded in 2015 by Wu Chenbing, focuses on the development of bispecific antibodies, particularly T cell engagers (TCEs), which are considered next-generation technologies in tumor immunotherapy [3] - The company has developed a proprietary bispecific antibody technology platform and has a pipeline that includes eight investigational drugs, none of which have reached commercialization as of June 2025 [3] - The company faces significant uncertainty in its core business, with low probabilities of success for drug development, particularly in the complex field of oncology [4] Financial Overview - As of the end of 2024, the company has accumulated losses of 2.355 billion yuan, with R&D expenditures of 185 million yuan and 123 million yuan in 2023 and 2024, respectively [4] - The total operating expenses for these two years reached 235 million yuan and 166 million yuan, respectively [4] - The company has raised approximately 234.5 million USD (about 1.577 billion yuan) through six rounds of financing, with a post-money valuation of 492 million USD (about 3.311 billion yuan) [4] IPO Plans - The company plans to use the funds raised from its IPO primarily to advance clinical trials for its core product EMB-01 and key products EMB-06 and EMB-07, as well as other investigational pipelines [5] - Successful listing is crucial for the company not only to secure valuable R&D funding but also to provide an exit channel for early investors and alleviate the pressure from redeemable preferred shares [5]

荃信生物-B(02509)涨超4%，截至发稿，涨4.36%，报19.61港元，成交额309.57万港元。 据悉，QX027N是荃信生物自主研发的长效抗TSLPxIL-13双特异性抗体，2025年11月已获得国家药品监 督管理局药品审评中心的临床试验默示许可（受理号：CXSL2500757，CXSL2500758），拟用于治疗 哮喘及特应性皮炎，现已完成国内I期临床试验首例受试者入组。 消息面上，荃信生物今早宣布，12月19日，荃信生物与Windward Bio附属公司LE2025 Therapeutics AG 就公司自主研发的QX027N达成授权合作。根据协议，LE2025获授予在全球范围（不包括中国内地、台 湾、香港特别行政区及澳门特别行政区）内开发及商业化QX027N的独家权利。作为回报，荃信生物将 有权收取最高7亿美元的付款，包括首付款、Windward Bio的股权、开发及商业里程碑付款，此外，公 司还有权根据QX027N在许可地区的销售净额收取分级特许权使用费。 ...

Core Insights - The article discusses the IPO progress of Aimi Biotech, a pioneer in next-generation bispecific antibodies, focusing on its innovative T cell engagers (TCE) for cancer and autoimmune disease treatment [1][2]. Group 1: Company Overview - Aimi Biotech is at the forefront of the bispecific antibody treatment field, aiming to develop TCEs globally for various cancers and autoimmune diseases [1]. - The company plans to use the net proceeds from the IPO primarily for clinical development of core products, pipeline expansion, and operational funding [1]. - Aimi Biotech has a strong leadership team with extensive industry experience, including founder Dr. Wu Chenbing and Chief Medical Officer Dr. Zhu Yonghong, which supports its strategic execution and technology transfer [2]. Group 2: Technology and Product Pipeline - Aimi Biotech has developed proprietary technology platforms, including FIT-Ig, MAT-Fab, and a CD3 antibody library, which are crucial for advancing bispecific antibody development [2][3]. - The FIT-Ig platform is unique as it does not require amino acid mutations or linker peptides, with clinical projects like EMB-01 and EMB-06 already in advanced stages [3]. - The company has established seven product pipelines covering oncology and immunology, including key products EMB-01 for colorectal cancer, EMB-06 for multiple myeloma, and EMB-07 for lymphoma and solid tumors [2]. Group 3: Market Potential and Collaborations - The global bispecific antibody market is projected to reach $221.8 billion by 2034, with a compound annual growth rate (CAGR) of 32.4% from 2024 to 2034 [1]. - Aimi Biotech has secured multiple licensing agreements since the end of 2023, with a total transaction value exceeding $2.1 billion, ranking second globally in the TCE field [4]. - The company is positioned to accelerate the commercialization of innovative drugs, enhancing its competitive edge in the rapidly growing bispecific antibody and TCE treatment markets [4].

Core Viewpoint - The current focus in the Hong Kong stock market is on innovative drug companies, with limited incremental information available until companies disclose new data. However, there are still opportunities in U.S. biotech research and Hong Kong IPOs, particularly in studying prospectuses and new drug targets like ES014 from Kewang Pharmaceuticals [1]. Group 1: Drug Mechanism and Target - CD39 and CD73 are extracellular nucleotidases that play a critical role in purinergic signaling, catalyzing the hydrolysis of ATP to ADP and AMP, and further to adenosine, which contributes to immune regulation and tumor progression [1][2]. - In the tumor microenvironment (TME), CD39 and CD73 are expressed in various cell types, including tumor cells and immune cells, and they promote immune evasion by catalyzing ATP to adenosine [2]. Group 2: Clinical Data and Drug Development - The monoclonal antibody TTX-030 has shown promise in clinical trials, achieving an objective response rate (ORR) of 61% in a study involving 44 patients with HER2-negative gastric cancer [5]. - Kewang's ES014, a bispecific antibody targeting CD39 and TGFβ, has demonstrated potential in activating immune cells and inhibiting Treg cell differentiation, with a high ORR of 40% in a rare tumor type called desmoplastic tumor (DT) [10][11][12]. Group 3: Market Potential and Future Outlook - There is a significant unmet clinical need for effective treatments in DT, and if Kewang can establish ES014 in this indication, it could solidify the pipeline and potentially expand into larger indications, similar to the development path of other successful drugs [12].

Core Viewpoint - Rongchang Biologics (09995) experienced a significant stock increase, with a rise of over 7% during trading, closing at 81.5 HKD, with a transaction volume of 310 million HKD. This surge is attributed to the presentation of clinical trial data for their PD-1/VEGF bispecific antibody RC148 at the ESMO-IO conference in London, highlighting its promising efficacy in treating non-small cell lung cancer [1][1][1]. Group 1: Clinical Trial Data - The clinical trial data for RC148, presented at the ESMO-IO conference, showed a remarkable overall response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2% when combined with docetaxel at a dosage of 20 mg/kg every three weeks [1][1][1]. - Subgroup analysis revealed that patients with PD-L1 positive status (TPS≥1%) had an ORR of 80%, indicating significant efficacy across different patient groups [1][1][1]. - The median follow-up time for the trial was approximately 7 months, with a median progression-free survival (mPFS) of 8.3 months, further supporting the drug's potential effectiveness [1][1][1]. Group 2: Regulatory Approvals and Market Potential - RC148 received FDA approval to initiate Phase II clinical trials in the United States, marking a significant step in its global clinical development [1][1][1]. - Earlier in August, RC148 was also approved in China for clinical research in monotherapy and combination therapy for advanced solid tumors, showcasing its rapid progress in clinical development [1][1][1]. - The global business development (BD) activity surrounding PD-1/VEGF therapies is intensifying, with companies like Kangfang Biologics and 3SBio already pursuing international licensing agreements, indicating a competitive landscape and potential for RC148 to capitalize on this trend [1][1][1].

消息面上，维立志博-B发布公告，于2025年12月6日至9日，第67届ASH年会在美国佛罗里达州奥兰多召 开。公司自主研发用于治疗复发性╱难治性多发性骨髓瘤("RRMM")的GPRC5D/CD3双特异性抗体LBL- 034在大会首日第一个进行口头报告。 智通财经APP获悉，维立志博-B(09887)涨超3%，截至发稿，涨2.39%，报53.6港元，成交额5125.77万港 元。 LBL-034的I/II期临床研究由北京大学人民医院路瑾教授牵头，在全国17家中心开展，研究证实LBL-034 对RRMM患者(包括具有高危特征的难治亚组)表现出良好的安全性和令人振奋的抗肿瘤活性，展现出同 类最佳治疗潜力。 根据弗若斯特沙利文资料显示，截至2024年11月，LBL-034是全球临床进度仅次于强生、中国临床进度 第一的靶向GPRC5D的CD3 T-cell engager。2024年10月LBL-034获得FDA的孤儿药认定(ODD)，用于治 疗多发性骨髓瘤。 ...

维立志博-B(09887)发布公告，于2025年12月6日至9日，第67届ASH年会在美国佛罗里达州奥兰多召 开。公司自主研发用于治疗复发性╱难治性多发性骨髓瘤("RRMM")的GPRC5D/CD3双特异性抗体LBL- 034在大会首日第一个进行口头报告。 LBL-034的I/II期临床研究由北京大学人民医院路瑾教授牵头，在全国17家中心开展，研究证实LBL-034 对RRMM患者(包括具有高危特征的难治亚组)表现出良好的安全性和令人振奋的抗肿瘤活性，展现出同 类最佳治疗潜力。 LBL-034的主要临床亮点包括： LBL-034剂量递增至1,200μg/kg，未观察到任何剂量限制性毒性(DLT)，未达到最大耐受剂量(MTD)。与 生活质量密切相关不良事件均为1至2级，多数不良事件发生于第一周期，在后续治疗中的发生率显著降 低，不影响治疗连续性。味觉、皮肤和指甲毒性发生率低，且有自愈倾向。 在400至1,200μg/kg剂量范围(n=40)，客观缓解率(ORR)为82.5%，≥完全缓解(CR)为52.5%，≥非常好的部 分缓解(VGPR)为72.5%，微小残留病灶(MRD)阴性率为80.0%。在800μg/kg ...

格隆汇12月7日丨维立志博-B(09887.HK)公告，于2025年12月6日至9日，第67届ASH年会在美国佛罗里 达州奥兰多召开。公司自主研发用于治疗复发性╱难治性多发性骨髓瘤("RRMM")的GPRC5D/CD3双特 异性抗体LBL-034在大会首日第一个进行口头报告。LBL-034的I/II期临床研究由北京大学人民医院路瑾 教授牵头，在全国17家中心开展，研究证实LBL-034对RRMM患者(包括具有高危特征的难治亚组)表现 出良好的安全性和令人振奋的抗肿瘤活性，展现出同类最佳治疗潜力。LBL-034的主要临床亮点包括： LBL-034剂量递增至1,200μg/kg，未观察到任何剂量限制性毒性(DLT)，未达到最大耐受剂量(MTD)。与 生活质量密切相关不良事件均为1至2级，多数不良事件发生于第一周期，在后续治疗中的发生率显著降 低，不影响治疗连续性。味觉、皮肤和指甲毒性发生率低，且有自愈倾向。 在400至1,200μg/kg剂量范围，观察到持续获益趋势，12个月无进展生存期(PFS)率为61.2%(中位随访时 间：9.6个月)。400μg/kg(n=11)中位随访时间已达13.1个月，12个月PFS ...

Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics - **Industry**: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology - **Location**: Boston - **Current Pipeline**: Three drugs in clinical trials, with a fourth drug about to enter the clinic [2][3] Key Points and Arguments Upcoming Milestones - **Tevesemig**: A DLL4 VEGF-A bispecific antibody with a readout on secondary endpoints of progression-free survival (PFS) and overall survival (OS) expected by the end of Q1 2026 [2][3] - **PD-1, PD-L1 Bispecific Antibody**: Observed three responses in the first 15 patients treated in a phase 1 clinical trial, with cohort expansions planned for triple-negative breast cancer and non-small cell lung cancer [2][3][31] - **Fourth Drug**: A novel PD-1 VEGF-A bispecific antibody entering the clinic at the beginning of 2026 [3][4] Clinical Trial Insights - **Tevesemig Efficacy**: In a randomized study, the response rate in the combination arm (including Tevesemig) was more than triple that of the control arm, with a significant reduction in progressive disease incidence (42% in control vs. 16% in combination arm) [5][6][9] - **Survival Data**: Observations indicate fewer deaths than projected, suggesting improved overall survival [7][9][10] Market Opportunity - **Biliary Tract Cancer (BTC)**: Approximately 25,000 patients diagnosed annually in the U.S., with an estimated 15,000 patients eligible for second-line therapy, representing a multi-billion-dollar commercial opportunity [11][14] - **Duration of Therapy**: Current second-line chemotherapy duration is low single-digit months, while Tevesemig showed a median PFS of 9.4 months in a phase 2 study [12][14] Expansion Plans - **Frontline Studies**: Ongoing studies at MD Anderson to evaluate Tevesemig in combination with existing regimens, potentially increasing patient numbers by 50% [15][17] - **Additional Indications**: DLL4 expression is enriched in various malignancies, including hepatocellular, gastric, ovarian, renal cell, and colorectal cancers, indicating further expansion potential [17][18] Commercial Readiness - **Manufacturing Capability**: Compass has developed a robust commercial-ready manufacturing process for Tevesemig [20][21] - **Prescriber Awareness**: Initial pre-commercial work has begun, with plans for a full commercial launch preparation for a potential 2027 launch [20][21] Unique Mechanisms - **PD-1, PD-L1 Bispecific Antibody (8371)**: Utilizes a novel technology called StitchMabs, allowing for unique mechanisms of action, including T cell engagement and PD-1 cleavage [22][25] - **Differentiation**: The drug is positioned to have better PD-1 blockade compared to other molecules in development, with a focus on its unique mechanism [33][34] Other Important Insights - **Clinical Observations**: Notable responses in patients previously treated with other therapies, indicating potential for significant clinical impact [31] - **Future Indications**: Plans to explore additional indications for the PD-1 VEGF bispecific, including gastric cancer, hepatocellular, renal cell, and endometrial cancer [34] This summary encapsulates the critical insights and future directions for Compass Therapeutics as discussed in the conference call.

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