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维立志博-B(09887.HK)研究摘要入选第67届ASH年会展示
Ge Long Hui· 2025-11-03 22:45
Core Viewpoint - The company, Valiant Bio-B (09887.HK), announced that five research abstracts have been selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH), highlighting its innovative drug candidates LBL-034 and LBL-076 [1] Group 1: Research Highlights - The clinical study of LBL-034 has been chosen for the first oral presentation on the first day of the conference, showcasing the latest efficacy and safety data for patients with relapsed/refractory multiple myeloma [1] - Multiple research results have been accepted for the 67th ASH meeting, indicating strong recognition from the international academic community regarding the company's research and innovation capabilities [1] Group 2: Company Recognition - The company has consistently presented its innovative drug development results at international platforms such as ASH and the American Society of Clinical Oncology (ASCO) over the years [1]
维立志博-B:1项LBL-034临床研究获选在第67届ASH年会首日作第一个口头报告
Zhi Tong Cai Jing· 2025-11-03 22:44
Core Viewpoint - The company, Valiant Bio-B (09887), announced that five research abstracts have been selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH) [1] Group 1: Company Developments - The company provided further details regarding its innovative drugs LBL-034 and LBL-076, which have multiple research abstracts included in the ASH meeting [1] - One clinical study of LBL-034 has been selected for the first oral presentation on the first day of the conference, showcasing the latest efficacy and safety data for LBL-034 in patients with relapsed/refractory multiple myeloma [1]
维立志博-B(09887):1项LBL-034临床研究获选在第67届ASH年会首日作第一个口头报告
智通财经网· 2025-11-03 22:40
Core Viewpoint - The company, Wuxi Biologics-B (09887), announced that five research abstracts have been selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH) [1] Group 1: Company Developments - The company provided further details regarding its innovative drugs LBL-034 and LBL-076, which have multiple research abstracts included in the ASH conference [1] - One clinical study of LBL-034 has been selected for the first oral presentation on the first day of the conference, showcasing the latest efficacy and safety data for LBL-034 in patients with relapsed/refractory multiple myeloma [1]
维立志博-B(09887) - 自愿公告 - 有关研究摘要入选第67届ASH年会展示的进一步公告
2025-11-03 22:06
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。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 (於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司) (股 份 代 號:9887) 自願公告 有關研究摘要入選第67屆ASH年會展示 的進一步公告 本公告由 南京維立 志博生物科技股份有限公司(「本公司」,連 同 其 附 屬 公 司 統 稱「本集團」)自 願 作 出,以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 茲提述本公司日期為2025年10月9日 的 公 告,內 容 有 關5篇研究摘要入選美國血 液學會(「ASH」)以於其第67屆 年 會 上 展 示。本 公 司 欣 然 提 供 有 關 其 在 研 創 新 藥 LBL-034及LBL-076的 進 一 步 詳 ...
维立志博-B(09887):深度报告:三大技术平台助力,领跑下一代肿瘤免疫
China Post Securities· 2025-10-31 11:26
Investment Rating - The report assigns an "Accumulate" rating for the company, marking its first coverage [1]. Core Insights - The company positions itself as a leader in next-generation tumor immunotherapy, leveraging three major technology platforms to establish a high-quality R&D pipeline [3][12]. - The 4-1BB co-stimulation signal market shows significant potential, with the product LBL-024 demonstrating notable competitive advantages [4][25]. - The TCE technology platform has been validated through clinical data, with LBL-034 showing superior efficacy and safety compared to competitors [5][22]. - The company is currently in the new drug development investment phase, with projected revenues of 175 million, 314 million, and 187 million yuan for 2025, 2026, and 2027 respectively, and expected net losses of 200 million, 99 million, and 262 million yuan [5]. Summary by Sections Section 1: Three Platforms Supporting Next-Generation Tumor Immunotherapy - The company aims to address diseases that current therapies, such as PD-1/PD-L1 antibodies, cannot treat, focusing on cutting-edge targets like 4-1BB and PD-L1 dual targets [3][12]. - The R&D team is robust, with extensive experience in new drug development, and has established a pipeline of 14 new drugs, including 6 in clinical stages and 4 with leading global clinical progress [13][22]. Section 2: 4-1BB Co-Stimulation Signal Market Potential - 4-1BB serves as a co-stimulation immune checkpoint molecule, providing a second signal for T-cell activation [25][31]. - LBL-024, a low-affinity 4-1BB dual antibody, has shown excellent efficacy and safety balance in clinical trials, with significant improvements in overall survival compared to existing treatments [4][35]. Section 3: TCE Technology Platform Validation - The TCE platform, particularly the CD3 TCE drug LBL-034, has demonstrated the ability to conditionally activate T-cells in tumor microenvironments, showing advantages in safety and efficacy over similar products [5][22]. - The company has plans for new generation TCE and TCE ADC platforms, with the CD3/MUC16 TCE positioned among the top globally [5][22].
港股创新药调整期真的来了?维立志博董事长康小强:不会将注意力集中于“追风”
Mei Ri Jing Ji Xin Wen· 2025-10-30 14:37
Core Viewpoint - The article discusses the recent developments of Vili Biotech, a company focused on T-cell engagers (TCE), highlighting its market positioning, clinical advancements, and strategic decisions in the competitive biotech landscape [2][3]. Group 1: Company Overview - Vili Biotech completed its IPO in July 2023, becoming the first TCE-focused company listed in Hong Kong, with a market capitalization of approximately HKD 11.34 billion [2]. - The company has positioned itself in the less mainstream TCE sector, which connects T-cells to cancer cells, despite the associated risks such as cytokine storms and neurotoxicity [2][4]. Group 2: Market Performance - Vili Biotech's stock saw a significant increase of 127% shortly after its IPO, with retail subscriptions reaching a record 3,494.8 times, indicating strong market interest [3]. - The company aims to avoid the "overnight success" narrative, focusing instead on long-term development and the quality of its research pipeline [3]. Group 3: TCE Technology Insights - TCEs are gaining traction in the immunotherapy field, particularly for blood cancers, but are less recognized compared to antibody-drug conjugates (ADCs) [4]. - The first TCE drug to surpass USD 1 billion in sales is Amgen's Blincyto, which targets leukemia, with projected sales exceeding USD 1.2 billion in 2024 [4]. Group 4: Clinical Development - Vili Biotech has six innovative drug candidates in clinical stages, with LBL-024 being the closest to market, targeting advanced neuroendocrine carcinoma [7]. - The company employs a "small to large" clinical strategy, starting with niche indications and expanding to broader cancer types [8]. Group 5: Financial Strategy - The company currently has around RMB 2 billion in funds, sufficient to support its R&D plans for the next 4 to 5 years, with no immediate plans for additional financing [10]. - Vili Biotech emphasizes the importance of financial preparedness in the cyclical biotech industry, having adjusted its fundraising strategy during a downturn in 2021 [10].
港股创新药调整期真的来了? 维立志博董事长康小强:不会将注意力集中于“追风”
Mei Ri Jing Ji Xin Wen· 2025-10-30 14:24
Core Viewpoint - The article discusses the recent developments and market positioning of Weili Zhibo, a biotech company that has recently gone public in Hong Kong, focusing on T-cell engagers (TCE) as a novel cancer treatment approach, amidst a competitive landscape in the innovative drug sector [1][4]. Company Overview - Weili Zhibo completed its IPO in July 2023, becoming the first TCE-focused company listed in China [1]. - The company has gained significant market attention, with retail subscriptions reaching a record 3,494.8 times during its IPO [4]. - The CEO, Kang Xiaoqiang, emphasizes a long-term development strategy over quick fame, focusing on the company's research pipeline and clinical data [4][5]. TCE Technology - TCEs are positioned as a promising alternative to antibody-drug conjugates (ADCs), with the potential to activate T-cells against cancer cells [3][5]. - The first TCE drug to surpass $1 billion in sales is Amgen's Blincyto, which targets leukemia [5]. - TCEs have advantages in terms of lower antigen expression requirements and longer duration of action compared to ADCs [5]. Clinical Development - Weili Zhibo has six innovative drug candidates in clinical stages, with LBL-024 being the closest to market, targeting advanced neuroendocrine carcinoma [8][9]. - The clinical strategy involves starting with niche indications and expanding to larger cancer types, aiming for a broad-spectrum anti-cancer approach [9]. - The company plans to showcase two new blood cancer drugs at the 2025 ASH annual meeting, indicating strong clinical data [6][7]. Market Strategy - The company has opted for a "small first, then large" strategy to address unmet clinical needs in less competitive areas [9]. - Weili Zhibo has secured a global licensing agreement with Dianthus Therapeutics, potentially generating over $10 billion in total transaction value [10]. - The CEO remains cautious about market volatility and emphasizes the importance of having sufficient funds to support R&D for the next 4-5 years [10][11].
港股创新药的调整期真的来了?对话维立志博董事长康小强:不会把注意力集中在“追风”上
Sou Hu Cai Jing· 2025-10-28 13:20
Core Viewpoint - The company, Weili Zhibo, has successfully positioned itself in the T-cell engager (TCE) segment of the biotech industry, which is less mainstream compared to antibody-drug conjugates (ADC), and aims to create real value in innovative drugs rather than chasing trends [5][6][7]. Company Overview - Weili Zhibo completed its IPO on July 25, 2023, becoming the first TCE-focused company listed in China, with significant market interest reflected in a subscription rate of 3494.8 times for retail investors and 40.8 times for institutional investors [5][6]. - The company has a pipeline of six innovative drug candidates, with the closest to market being LBL-024, targeting advanced neuroendocrine carcinoma, expected to submit for approval in Q3 2026 [10][12]. Market Positioning - The TCE technology is gaining traction in the immunotherapy space, particularly for blood cancers, but remains less recognized than ADCs. The company believes that TCEs and ADCs serve different purposes and can coexist in the market [7][8]. - The first TCE drug to surpass $1 billion in sales is Amgen's Blincyto, which highlights the potential of this segment despite the challenges faced by other companies in the field [8]. Clinical Development - Weili Zhibo's LBL-034 has shown promising clinical trial results, achieving a 90% objective response rate in patients with relapsed/refractory multiple myeloma, outperforming the only approved competitor [9][10]. - The company plans to expand its focus from niche indications like neuroendocrine carcinoma to larger cancer types, including small cell lung cancer and non-small cell lung cancer, to create a broad-spectrum oncology portfolio [12][14]. Financial Strategy - The company currently has approximately 2 billion RMB in funds, sufficient to support its R&D plans for the next 4 to 5 years without immediate need for additional financing [16][17]. - Weili Zhibo has engaged in a global licensing agreement with Dianthus Therapeutics, which could yield up to $38 million in upfront payments and over $1 billion in total deal value, indicating a strategic focus on business development [16]. Industry Outlook - The innovative drug market is experiencing a shift towards rational investment, with companies focusing on clinical data and development pipelines rather than speculative trends [6][18]. - The domestic market for innovative drugs in China is expected to grow significantly over the next decade, providing a supportive environment for companies like Weili Zhibo, even amid international challenges [17].
维立志博-B:LBL-024于一线治疗胆道癌II期试验的首例患者用药
Zhi Tong Cai Jing· 2025-10-27 10:15
Core Insights - The company has initiated a Phase II clinical trial for LBL-024, a PD-L1/4-1BB bispecific antibody, for first-line treatment of biliary tract cancer, marking significant progress in expanding the indication for this core product [1] - LBL-024 is the first targeted therapy for 4-1BB receptor to reach the registered clinical stage globally, with potential to become the first approved drug for advanced extra-pulmonary neuroendocrine carcinoma [1] - The drug utilizes the proprietary X-bodyTM platform with an optimal 2:2 structural design, aiming to enhance T-cell activation and synergistically eliminate tumors, showing greater cancer treatment potential compared to PD-1/L1 inhibitors [1] Regulatory Approvals - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial [2] - In October 2024, LBL-024 was granted Breakthrough Therapy Designation (BTD) by NMPA for the treatment of advanced extra-pulmonary neuroendocrine carcinoma [2] - In November 2024, the U.S. Food and Drug Administration (FDA) designated LBL-024 as an Orphan Drug (ODD) for neuroendocrine carcinoma [2]
维立志博-B(09887.HK):LBL-024于一线治疗胆道癌II期试验的首例患者用药
Ge Long Hui· 2025-10-27 10:10
Core Insights - The company announced the successful administration of the first patient in a Phase II clinical trial for LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB for the first-line treatment of biliary cancer, indicating efficient progress in expanding the product's indications [1] - The Phase II clinical study, led by Professor Qian Jian from Zhongshan Hospital affiliated with Fudan University, is being conducted at multiple hospitals across the country to evaluate the efficacy and safety of LBL-024 in treating advanced biliary cancer [1] - LBL-024 is the first targeted therapy for the 4-1BB receptor to reach the registered clinical stage for treating extra-pulmonary neuroendocrine cancer, with potential to become the first approved drug for this indication [1] Regulatory Approvals - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial [2] - In October 2024, the company obtained Breakthrough Therapy Designation (BTD) from NMPA for LBL-024 as a treatment for post-line advanced extra-pulmonary neuroendocrine cancer [2] - In November 2024, the company received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for LBL-024 in treating neuroendocrine cancer [2]