格隆汇7月31日丨迈威生物(688062.SH)公布，公司收到：1）国家药品监督管理局（NMPA）签发的《受 理通知书》，注射用7MW4911的临床试验申请已获正式受理；2）美国食品药品监督管理局（FDA）出 具的INDAcknowledgementLetter，确认已收到公司就注射用7MW4911递交的IND申请。 7MW4911是基于公司自主知识产权的IDDC?抗体偶联技术平台开发的靶向钙黏蛋白17（CDH17）的创 新抗体偶联药物（ADC）。CDH17作为经泛癌种多组学验证的潜力治疗靶点，在正常组织中局限于肠 上皮基底外侧膜表达，而在结直肠癌、胃癌及胰腺癌等消化道恶性肿瘤中呈现显著过表达，其异常高表 达与肿瘤侵袭转移及不良预后密切相关，为精准干预提供了理想靶点。7MW4911采用高度工程化设 计，整合三大核心元件：具有快速内化特性及跨物种（人/猴）中等亲和力的CDH17高特异性单抗 Mab0727、新型可裂解连接子、以及为克服多药耐药机制设计的专有DNA拓扑异构酶I抑制剂MF-6载 荷。MF-6通过卓越的血浆稳定性、可控的药物释放及强效旁观者效应，显著增强抗肿瘤活性。 ...

Core Viewpoint - Maiwei Biotech (688062.SH) has received regulatory approvals for its innovative antibody-drug conjugate (ADC) 7MW4911, marking a significant step in its clinical development [1] Regulatory Approvals - The company has received a formal acceptance notice from the National Medical Products Administration (NMPA) for the clinical trial application of 7MW4911 [1] - Additionally, the U.S. Food and Drug Administration (FDA) has issued an IND Acknowledgement Letter confirming receipt of the IND application for 7MW4911 [1] Product Development - 7MW4911 is developed based on the company's proprietary IDDC? antibody conjugate technology platform, targeting cadherin-17 (CDH17) [1] - CDH17 is identified as a promising therapeutic target validated by multi-omics across various cancer types, with significant overexpression in colorectal, gastric, and pancreatic cancers [1] - The design of 7MW4911 integrates three core components: a high-specificity monoclonal antibody Mab0727, a novel cleavable linker, and a proprietary DNA topoisomerase I inhibitor MF-6 [1] Mechanism of Action - MF-6 is designed to overcome multi-drug resistance mechanisms, enhancing anti-tumor activity through excellent plasma stability, controllable drug release, and a strong bystander effect [1]

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration, indicating progress in its development of a novel antibody-drug conjugate targeting CDH17, which is overexpressed in various gastrointestinal cancers [1] Group 1: Clinical Development - The injectable 7MW4911's clinical trial application has been officially accepted by the National Medical Products Administration [1] - The U.S. Food and Drug Administration has acknowledged receipt of the IND application for 7MW4911 [1] Group 2: Product Details - 7MW4911 is developed based on the company's proprietary IDDC antibody-drug conjugate technology platform [1] - The drug targets calcium adhesion protein 17 (CDH17), which is significantly overexpressed in colorectal, gastric, and pancreatic cancers [1] - The high expression of CDH17 is closely related to tumor invasion, metastasis, and poor prognosis [1] Group 3: Therapeutic Potential - 7MW4911 demonstrates the potential to be a transformative therapy for advanced gastrointestinal solid tumors through CDH17-mediated selective cytotoxic payload release [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。 自願公告 JSKN003獲美國FDA批准開展一項治療不限HER2表達水平的 PROC的II期臨床研究 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，JSKN003已獲美國（「美國」）食 品藥品監督管理局（「FDA」）批准，在美國開展一項I I期臨床研究（研究編號： JSKN003-202）。JSKN003-202是JSKN003的一項隨機、開放式標籤、多中心的 II期臨床研究，用於治療鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌 （統稱為鉑耐藥卵巢癌，「PROC」），且不限人表皮生長因子受體2（「HER2」）表達 水平。此臨床試驗旨在評估JSKN003在上述人群中的療效和安全性，並確定推薦 III期劑量。此次JSKN003-202獲美國FDA批准，是 ...

Core Viewpoint - Nanjing Valiant BioTech Co., Ltd. is leading in next-generation tumor immunotherapy and has successfully listed on the Hong Kong Stock Exchange, raising up to $189 million through its IPO at a price of HKD 35 per share [1][2][11] Financing and Investment - The IPO attracted cornerstone investors totaling approximately HKD 542 million, including prominent medical funds and long-term institutions such as OrbiMed, TruMed, and domestic public funds like E Fund [2] - The net proceeds from the IPO will be allocated as follows: approximately 65% for clinical development, 15% for preclinical assets and pipeline expansion, 10% for production capacity enhancement, and 10% for working capital and general corporate purposes [2] Company Overview - Established in 2012, the company focuses on discovering, developing, and commercializing new therapies for cancer, autoimmune diseases, and other major diseases [3][10] - The company has developed a diverse product portfolio with 14 innovative candidates, of which 6 are in clinical stages and 4 are leading globally in clinical progress [11] Product Pipeline - The core product LBL-024 is a PD-L1 and 4-1BB bispecific antibody, currently in registration clinical stage, and is the first targeted therapy for the 4-1BB receptor [3][11] - The company has a total of 12 products in its tumor pipeline, including 3 monoclonal antibodies, 5 bispecific antibodies, and 3 antibody-drug conjugates (ADCs) [3] Technological Innovation - The company employs a science-driven R&D approach and has developed proprietary technology platforms such as LeadsBody™ and X-body™ for innovative drug development [4][12] - The LeadsBody™ platform supports the development of bispecific antibodies targeting CD3, optimizing efficacy and safety by minimizing systemic toxicity [4][12] Clinical Development - The company has established comprehensive capabilities across early research, translational medicine, clinical development, and business expansion, enabling efficient drug development processes [10][12] - The company aims to become a comprehensive biotechnology firm, with plans to establish commercial-scale production facilities as clinical assets approach commercialization [10]

Core Viewpoint - The successful IPO of Nanjing Weilizhibo Biotech Co., Ltd. has injected confidence into the biotech sector for future listings in Hong Kong, showcasing strong market performance and investor interest [2][4]. Company Overview - Weilizhibo, established in 2012, focuses on discovering, developing, and commercializing new therapies for cancer and autoimmune diseases, with a strategic emphasis on tumor immunology, T-cell engagers, and antibody-drug conjugates [5]. - The company has a diverse product portfolio with 14 innovative candidates, including 4 core products that are leading in global clinical progress [5]. IPO Details - Weilizhibo's IPO on July 25, 2025, involved the issuance of 36,862,500 H-shares at an offering price of HKD 35.00 per share, raising a total of HKD 1.29 billion [2]. - The company attracted 9 cornerstone investors, collectively subscribing USD 69 million (approximately HKD 541.6 million) [2]. Market Performance - As of 9:50 AM on the listing day, Weilizhibo's share price reached HKD 77.65, reflecting a 121.86% increase from the offering price, with a market capitalization of HKD 14.986 billion [3]. Product Pipeline - The core product LBL-024 is a pioneering dual-specific antibody targeting PD-L1/4-1BB, which has entered the registration clinical stage and is recognized as a breakthrough therapy for neuroendocrine carcinoma by NMPA and granted orphan drug status by the FDA [6]. - LBL-024 is being studied for various cancers, including small cell lung cancer and ovarian cancer, showing promising initial efficacy signals [7]. T-cell Engager Products - Weilizhibo has developed a matrix of 6 differentiated T-cell engager products targeting hematological malignancies, solid tumors, and autoimmune diseases, with several candidates already in clinical research [8]. Use of IPO Proceeds - Approximately 65% of the net proceeds from the IPO will be allocated to clinical development and regulatory affairs for ongoing and planned candidates, while 15% will enhance preclinical assets and expand existing pipelines [9].

Core Viewpoint - Nanjing Weilizhibo Biotechnology Co., Ltd. officially listed on the Hong Kong Stock Exchange on July 25, 2025, with an IPO price of HKD 35 per share, aiming to raise approximately USD 189 million for clinical development and operational enhancements [1][2]. Company Overview - Founded in 2012, Weilizhibo is a clinical-stage biotechnology company focused on discovering, developing, and commercializing new therapies for cancer, autoimmune diseases, and other major diseases [2]. - The company has a diverse product portfolio with 14 innovative candidates, including 4 core products, all of which are leading in global clinical progress within their respective categories [2]. Business Model and Technology Platforms - Weilizhibo's core business model emphasizes self-discovery, development, and commercialization of tumor immunotherapies, focusing on three main areas: IO 2.0, T-cell engagers (TCE), and antibody-drug conjugates (ADC) [2][4]. - The company has developed proprietary technology platforms, including LeadsBody™ and X-body™, which support the development of bispecific antibodies and enhance therapeutic efficacy while minimizing systemic toxicity [4]. Clinical Pipeline and Research Highlights - The company has established a robust pipeline with 12 products targeting tumors, including 3 monoclonal antibodies, 5 bispecific antibodies, and 3 ADCs [2][4]. - LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB, has shown promising results in clinical trials for treating advanced pulmonary neuroendocrine carcinoma, achieving an objective response rate (ORR) of 75% and a disease control rate (DCR) of 92.3% [7][8]. - LBL-024 is the first targeted therapy for the 4-1BB receptor in the registration clinical stage, with potential applications across various cancers, including small cell lung cancer and ovarian cancer [8][10]. Funding Utilization - The proceeds from the IPO will be allocated as follows: approximately 65% for clinical development and regulatory affairs, 15% for enhancing preclinical assets and expanding the pipeline, 10% for capacity enhancement and commercialization, and 10% for working capital and general corporate purposes [1].

Core Viewpoint - The Hong Kong IPO market has experienced its strongest recovery in nearly a decade, with significant increases in both the number of IPOs and the quality of listed companies, driven by improved liquidity, optimized listing regulations, and restored investor confidence [1] Company Overview - Weili Zhibo, known as "China's TCE first stock," is set to officially list on the Hong Kong Stock Exchange on July 25, 2025, with a global offering of approximately 36.86 million shares at a price of HKD 35 per share [1] - The company has attracted significant interest from top-tier domestic and international pharmaceutical investment institutions, with a retail subscription rate of 3,494.8 times, setting a record for the Hong Kong 18A medical innovation sector [1] Market Potential - The global tumor immunotherapy market is projected to reach USD 97.1 billion by 2025, with a compound annual growth rate (CAGR) of 17.3%, potentially growing to USD 216 billion by 2030 [2] - The TCE (T-cell engagers) market is expected to reach CNY 8.3 billion by 2030, with a CAGR of 67.4% from 2024 to 2030, indicating a vast market opportunity [5] Product Pipeline - Weili Zhibo has developed a diverse pipeline of 14 candidate drugs, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and others, with six candidates already in clinical stages [3][4] - The company's core product, LBL-034, has shown promising clinical results, with an objective response rate of 77.8% in trials for relapsed/refractory multiple myeloma [6] Innovation Strategy - The company employs a differentiated innovation strategy focusing on T-cell connectors (TCE), tumor immunotherapy 2.0 (IO 2.0), and ADCs, establishing a globally competitive research and development pipeline [3][11] - LBL-024, a key product in the IO 2.0 field, is the first and only 4-1BB antibody drug to enter the registration clinical stage, targeting various cancers with significant unmet medical needs [9][10] Competitive Advantage - Weili Zhibo's unique technology integration allows it to provide comprehensive solutions for different tumor types, enhancing its ability to address complex clinical challenges [11] - The company's strategic focus on innovation positions it to capitalize on the growing demand for effective cancer treatments, potentially leading to substantial market value growth [12]

Company Overview - BlissBio Inc. (百力司康) submitted its listing application to the Hong Kong Stock Exchange on June 29, 2023 [1] - The company, founded in 2017, is a clinical-stage biopharmaceutical firm focused on developing next-generation antibody-drug conjugates (ADCs) to address unmet needs in cancer treatment [3] - The core product, BB-1701, targets HER2 and is aimed at treating breast cancer, non-small cell lung cancer, and other HER2-expressing cancers [3] Financial Performance - For the fiscal years ending December 31, 2023, and 2024, the company reported revenues of approximately RMB 180.2 million and RMB 22.6 million, respectively [2] - The net losses for the same periods were approximately RMB 206.4 million and RMB 556.6 million, indicating an increase in losses [2] - The gross profit for 2023 was RMB 179.5 million, while for 2024, it was RMB 0.3 million [2] Revenue Sources - The company's revenue primarily comes from providing clinical trial materials and R&D services, as well as milestone payments from collaborations with external companies [4] - Revenue from the top five customers accounted for 100% and 99.9% of total revenue for 2023 and 2024, respectively [4] R&D and Competitive Landscape - The company has a strong ADC candidate pipeline supported by a proprietary technology platform that integrates various advanced techniques for precise ADC design [3] - The internal R&D team consists of 95 members, with about 50% holding PhDs or master's degrees, and an average industry experience of over 10 years [7] - R&D costs for 2023 and 2024 were approximately RMB 144 million and RMB 120 million, respectively, with the core product BB-1701 accounting for 59.3% and 45% of total R&D costs in those years [7] Industry Competition - The ADC industry is characterized by intense competition, with numerous multinational companies and leading biotech firms developing similar ADC drugs [6] - Competitors may have more substantial financial, technical, and resource advantages, potentially allowing them to advance their candidates more rapidly [6] - The company faces procurement concentration risks, with purchases from the top five suppliers accounting for 56.5% and 41.3% of total procurement in 2023 and 2024, respectively [6]

Core Viewpoint - BlissBio Inc. is facing increased uncertainty regarding the global development prospects of its core drug BB-1701 after terminating its collaboration with Eisai, which was previously expected to yield up to $20 billion in potential revenue [2][3][14]. Group 1: Collaboration with Eisai - Two years ago, BlissBio signed a collaboration agreement with Eisai for BB-1701, which included potential milestone payments and revenue sharing, with a total value of up to $20 billion [5][6]. - In April 2023, a strategic clinical trial collaboration was established, allowing Eisai to retain rights for global development outside of Greater China [5][6]. - The collaboration has been pivotal for BlissBio, as Eisai was not only a major client but also a significant shareholder, contributing to the company's financial backing [13][14]. Group 2: Clinical Trial Data and Termination of Collaboration - Recent clinical trial data revealed that Eisai's trial showed an objective response rate (ORR) of only 14.3%, while BlissBio's own trial reported an ORR of 21.4%, raising questions about the competitiveness of BB-1701 [14][15]. - The termination of the collaboration was formalized in May 2025, with Eisai opting not to exercise its strategic rights, which significantly diminishes BlissBio's revenue prospects [14][15]. - The loss of Eisai as a client is expected to severely impact BlissBio's financial situation, with projected revenue from Eisai dropping by 87.65% in 2024 [16]. Group 3: Financial Implications - BlissBio's revenue is projected to plummet from 180 million yuan in 2023 to 22.59 million yuan in 2024, primarily due to the loss of Eisai's contributions [16]. - The company's gross profit is expected to shrink dramatically, leading to a net loss that could expand from 207 million yuan to 557 million yuan [16]. - High R&D expenditures and significant liabilities from investor agreements are contributing to BlissBio's financial distress, with total liabilities reaching 1.76 billion yuan by the end of 2024 [16].