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收涨100%!这家0收入创新药企要火?
中国基金报· 2025-07-24 14:47
Group 1 - The core viewpoint of the article highlights the significant market interest in Weili Zhizhi Bo, an unprofitable innovative drug company, which is set to list on the Hong Kong Stock Exchange, with its shares surging 100.14% in dark pool trading before the official listing [2][3]. - Weili Zhizhi Bo plans to issue 32.0544 million shares at an IPO price range of HKD 31.60 to HKD 35.00, with a total fundraising amount of approximately HKD 1.067 billion based on the midpoint of the offering price [2][3]. - The company has attracted a substantial subscription interest, with a financing subscription multiple exceeding 3000 times and total subscription amount reaching HKD 330 billion [2]. Group 2 - Weili Zhizhi Bo's cornerstone investors include prominent firms such as Tencent, E Fund, Zhengxin Valley Capital, and Gao Yi, indicating strong backing from established players in the industry [3]. - The company's core business model focuses on the discovery, development, and commercialization of tumor immunotherapy, with one core product (LBL-024) and 13 other candidate drugs, of which 6 have entered clinical stages [3]. - The company reported a revenue of HKD 8.865 million in 2023, but projected no revenue for 2024 and the first quarter of 2025, with net losses of HKD 362 million, HKD 301 million, and HKD 75.367 million respectively [4].
打新火热!亏损中的创新药企维立志博港股IPO:已获超额认购逾3000倍
Mei Ri Jing Ji Xin Wen· 2025-07-22 11:38
每经记者|黄婉银 每经编辑|魏官红 在香港交易所创纪录地于同日(7月9日)敲响6面铜锣后,港股IPO(首次公开发行)进入短暂的空闲 期,但这并未浇灭投资者的热情。 近期,维立志博-B(HK09887)开启招股,这是一家尚未盈利的生物科技公司。其拟全球发售3205.44 万股(假设未行使调整权及超配权),招股价区间为31.60港元至35.00港元,以每手100股粗略估算,一 手入场费约3535.3港元。 在上述14款候选药物中,6款已成功进入临床阶段,有2款候选药物于3种适应症的Ⅱ期临床试验中获得 概念证明,且其中有1款进展至注册临床试验阶段。 2023年、2024年及2025年前三个月,维立志博亏损额分别为3.62亿元、3.01亿元、7515万元。期间,维 立志博仅在2023年有约887万元的收入,主要是根据百济神州协议,就维立志博所提供的桥接研究服务 而自百济神州收取的款项。 "我们现时并无产品获准进行商业销售,亦未自产品销售产生任何收入。"维立志博公告称。 封面图片来源:每日经济新闻 刘国梅 摄 和IFBH一样,维立志博的基石投资者阵容也较为豪华,包括腾讯、易方达、正心谷资本、上海高毅 等。 《每日经济新 ...
維立志博-B(09887.HK) 7月17日—7月22日招股
Group 1 - The company,维立志博-B, plans to globally offer 32.0544 million shares, with 3.2055 million shares available in Hong Kong and 28.8489 million shares for international offering, along with an over-allotment option of 4.8081 million shares [1] - The subscription period is set from July 17 to July 22, with a maximum offer price of HKD 35.00 per share, and an entry fee of approximately HKD 3,535.30 for 100 shares [1] - The total expected fundraising amount is HKD 1.067 billion, with a net amount of HKD 968 million, which will be used for clinical development, enhancing preclinical assets, expanding existing pipelines, optimizing technology platforms, increasing production capacity, commercialization post-approval, and general corporate purposes [1] Group 2 - The company is a clinical-stage biotechnology firm focused on discovering, developing, and commercializing innovative therapies to address unmet medical needs in oncology, autoimmune diseases, and other significant conditions [1] - Specifically, the company is a leader in next-generation tumor immunotherapy, aiming to advance breakthrough cancer therapies to improve patient outcomes [1] Group 3 - For the fiscal years 2023, 2024, and the first quarter of 2025 ending March 31, the company's net profits were -362 million, -301 million, and -75.367 million respectively, with year-on-year changes of -29.01%, 16.85%, and 12.94% [2]
基石药业-B与Istituto Gentili就舒格利单抗在西欧和英国达成独家战略合作
Zhi Tong Cai Jing· 2025-07-08 00:12
Group 1 - The core point of the news is that 基石药业 has entered into an exclusive strategic partnership with Istituto Gentili for the commercialization of Shugli monoclonal antibody in Western Europe and the UK, covering 23 countries [1][2] - According to the agreement, Gentili will receive exclusive commercialization rights for Shugli in 23 countries, including 18 EEA countries and the UK, Andorra, Monaco, San Marino, and Vatican City [1] - The total transaction amount can reach up to $192.5 million, which includes upfront payments and milestone payments related to registration and sales [1] Group 2 - Shugli is the first PD-L1 monoclonal antibody approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC) in the EU and the UK, with a new indication application for stage III NSCLC already accepted by the European Medicines Agency (EMA) [2] - The partnership with Gentili is seen as an ideal collaboration to accelerate the accessibility of Shugli in the European market, especially in light of the ongoing changes in the US drug pricing system [2] - The company has already established four regional collaborations for Shugli in Europe, the Middle East, Africa, and Latin America, covering over 60 countries and regions, with plans to expand into Southeast Asia and Canada [2]
基石药业-B:目前CS2009在所有已评估的剂量水平上展现出良好的耐受性
Zhi Tong Cai Jing· 2025-07-07 00:26
Core Insights - Company Basilea Pharmaceutica announced the latest clinical progress of CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, with active patient recruitment in Australia and China, and plans to expand to the US for Phase II enrollment [1][2] Group 1: Clinical Trial Progress - The global multi-center Phase I/II clinical study of CS2009 is rapidly enrolling patients, with expectations to exceed 100 patients by the end of the year [1] - The Phase Ia dose-escalation study has completed assessments at four dose levels in patients with advanced solid tumors, with the fourth dose level (20 mg/kg every three weeks) showing no dose-limiting toxicities (DLT) [1] - The study is currently enrolling patients at the fifth dose level (30 mg/kg every three weeks) to observe safety beyond the recommended Phase II dose (RP2D) [1] Group 2: Safety and Efficacy Data - CS2009 has demonstrated good tolerability across all assessed dose levels, with pharmacokinetic (PK) characteristics supporting a three-week dosing regimen [2] - Pharmacodynamic (PD) data confirm that CS2009 triggers PD-1/CTLA-4 blockade, activating T cells and neutralizing VEGFA, with observed anti-tumor activity in "cold tumors" and PD-(L)1 treated patients in the low-dose group [2] - Phase Ia clinical data, including safety, PK, PD, and anti-tumor activity, is expected to be presented at an international academic conference in Q4 2025 [2] Group 3: Future Research Directions - The Phase Ib/II study is anticipated to start in the second half of 2025, focusing on dose expansion and key extension studies [1] - The trial will evaluate the clinical application value of CS2009 in various advanced solid tumors, including but not limited to non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, colorectal cancer, and cervical cancer [2] - The aim is to advance innovative cancer immunotherapy development [2]
迈威生物20250627
2025-06-30 01:02
Summary of the Conference Call for Maiwei Biotech Company and Industry Overview - **Company**: Maiwei Biotech - **Industry**: Biotechnology, specifically focusing on innovative drug development Key Points and Arguments 1. **Strategic Partnerships**: Maiwei Biotech has partnered with Qilu Pharmaceutical for the long-acting white blood cell enhancer, generating 500 million CNY in cash and earning sales commissions, aligning with its strategy to focus on global innovative drugs [2][3] 2. **Sales Performance**: The sales of Dexamethasone (You Song) reached 139 million CNY in 2023, marking a year-on-year increase of over 230%, leading in both hospital and outpatient market shares [2][3] 3. **International Collaboration**: The company has secured a partnership with Calico for the IL-11 project, receiving a $25 million upfront payment, which is expected to enhance its overseas market valuation [2][3] 4. **Clinical Development**: Maiwei Biotech is the first Chinese company to advance IL-11 into clinical trials, having completed Phase I trials in China and Canada, and received IND approval in the U.S. [2][5] 5. **Market Potential**: IL-11 is anticipated to target various indications, including tumors and fibrosis-related diseases, with a focus on age-related conditions such as pulmonary fibrosis and cardiovascular fibrosis [6][9] 6. **Calico's Background**: Calico, founded by Google co-founders, emphasizes longevity and anti-aging drug development, integrating life sciences with AI technology [4][9] 7. **Funding and Support**: Calico receives substantial funding from Google and has a strong partnership with AbbVie, which enhances its research capabilities and clinical development experience [7][11] 8. **Future Clinical Trials**: Maiwei Biotech is preparing for the initial technology transfer and clinical sample preparation to expedite the launch of clinical trials in the U.S. [10] Additional Important Insights 1. **Sales Team Requirement**: The long-acting white blood cell enhancer requires a robust sales team of 500 to 1,000 personnel, making the partnership with Qilu a strategic move [3] 2. **Scientific Basis for IL-11**: The choice of IL-11 for longevity indications is supported by research indicating its significant impact on lifespan in older mice and its association with age-related fibrotic diseases [9] 3. **Regulatory Engagement**: Calico is actively engaging with the FDA regarding longevity-related indications, aligning with U.S. policy trends aimed at improving lifespan [9] 4. **AbbVie’s Role**: AbbVie is deeply involved in the IL-11 project, conducting rigorous due diligence and providing strong endorsement for Maiwei Biotech's data [11][12] This summary encapsulates the strategic direction, financial performance, and collaborative efforts of Maiwei Biotech, highlighting its potential in the biotechnology sector.
医药生物行业:2025ASCO大会国内重点研究总结报告
GF SECURITIES· 2025-06-17 03:19
Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].
八旬医学博士携手伙伴冲刺IPO 维立志博唯一客户递表前终止合作
Mei Ri Jing Ji Xin Wen· 2025-06-13 08:56
Core Viewpoint - The company Nanjing Weilizhibo Biotechnology Co., Ltd. is seeking to go public in Hong Kong, with its founders, Lai Shoupeng and Kang Xiaoqiang, aiming to unlock the identity of "founder of a listed company" after 13 years of entrepreneurship [1][2]. Company Overview - Founded in 2012 by Lai Shoupeng and Kang Xiaoqiang, the company focuses on the discovery, development, and commercialization of innovative therapies for unmet medical needs in oncology and autoimmune diseases [1][2]. - The company has not yet commercialized any products and reported cumulative losses of nearly 500 million yuan from 2023 to March 2025 [1][8]. Financial Background - The company has successfully completed eight rounds of financing, raising approximately 1.084 billion yuan, with notable investors including Enran Venture Capital and Kunming Pharmaceutical Group [4]. - As of March 31, 2025, the company held cash and cash equivalents of 431 million yuan and had interest-bearing bank loans of 255 million yuan [8]. Product Pipeline - Weilizhibo has 14 drug candidates in development, with six in clinical trials, including the core product LBL-024, which targets PD-L1 and 4-1BB and is in the registration clinical trial stage [6][7]. - The global market for 4-1BB antibodies is projected to grow significantly, reaching 17.4 billion USD by 2035 [6]. Collaborations and Partnerships - The company had a collaboration agreement with BeiGene for LBL-007, which was terminated shortly before the updated prospectus was submitted, with no reason provided for the termination [6][8]. - A new partnership with Aditum Bio for the development of a trispecific T cell engager has a potential total value of up to 614 million USD [8]. Leadership and Compensation - Lai Shoupeng serves as Chief Strategic Officer and Executive Vice President, while Kang Xiaoqiang is the Chairman and CEO. Their salaries are comparable to those of executives in innovative drug companies [4][8].
Enhertu联合帕妥珠一线治疗HER2+乳腺癌mPFS超3年
Huachuang Securities· 2025-06-08 12:53
Investment Rating - The report does not explicitly state an investment rating for the industry or specific companies involved in the innovative drug sector. Core Insights - Enhertu combined with pertuzumab shows a median progression-free survival (mPFS) of 40.7 months for HER2-positive metastatic breast cancer, significantly outperforming the standard THP therapy which has an mPFS of 26.9 months [12][14] - The report highlights the increasing sales of Enhertu, projected to reach $3.754 billion in 2024, indicating strong market potential for HER2-targeted therapies [9] - The report emphasizes the importance of ADC (antibody-drug conjugate) technology in enhancing treatment efficacy for various cancers, particularly in combination with immune checkpoint inhibitors [17] Summary by Sections Section 1: Innovative Drug Focus - The report reviews the latest advancements in innovative drugs, particularly focusing on HER2-positive breast cancer treatments and the performance of Enhertu in clinical trials [4][5] Section 2: Clinical Trial Data - The DESTINY-Breast09 trial results indicate that Enhertu combined with pertuzumab significantly reduces the risk of disease progression or death by 44% compared to THP [14] - The overall response rate (ORR) for Enhertu plus pertuzumab is reported at 85.1%, compared to 78.6% for THP, showcasing the superior efficacy of the combination therapy [12][14] Section 3: Market Dynamics - The report outlines the competitive landscape for HER2 ADCs, listing various drugs in different stages of development and their respective companies [18] - It notes that the ADC market is expected to expand significantly, with potential market growth of 100-200% for certain indications due to the integration of ADCs with existing therapies [17] Section 4: Recent Announcements - Recent announcements from companies like 恒瑞医药 and 康宁杰瑞 highlight ongoing clinical trials and new drug applications, indicating a vibrant pipeline in the innovative drug sector [33][34]
8轮融资超10亿,维立志博二次递表,一家Biotech的港股闯关记
Sou Hu Cai Jing· 2025-06-05 09:38
Core Viewpoint - The enthusiasm of mainland companies for listing on the Hong Kong stock market has surged, with 248 out of 450 companies planning to go public, indicating strong interest in the market [1] Company Overview - Founded in 2012, the company focuses on the discovery, development, and commercialization of new therapies for cancer and autoimmune diseases, positioning itself as a leader in next-generation cancer immunotherapy [3][4] - The company has completed 8 rounds of financing, raising a total of 1.084 billion yuan, attracting notable investors such as Enran Venture Capital and Shenzhen Capital Group [3] Product Pipeline - The company has developed 14 candidate drugs, with 6 currently in clinical stages, including its core product LBL-024, which is the first PD-L1/4-1BB bispecific antibody to enter the registration clinical phase globally [7][8] - LBL-024 is expected to become the fourth approved immunotherapy target after PD-1/L1, CTLA-4, and LAG3, with a significant market potential projected to reach $2.9 billion by 2030, growing at a CAGR of 284.9% from 2026 to 2030 [7] Clinical Progress - LBL-024 has received breakthrough therapy designation from the NMPA for treating advanced pulmonary neuroendocrine carcinoma and orphan drug designation from the FDA for neuroendocrine cancer, showcasing its clinical value and development potential [8] Strategic Positioning - The company has established a strong competitive barrier in the TCE field, having developed a proprietary LeadsBodyTM platform and a complete TCE product matrix covering hematological malignancies, solid tumors, and autoimmune diseases [9] - The innovative design of LBL-034, a bispecific TCE targeting GPRC5D and CD3, aims to activate T cells effectively while minimizing risks associated with T cell exhaustion and cytokine release syndrome [9] Innovation and Future Outlook - The company’s advancements in ADC, IO2.0, and TCE platforms highlight its robust research and development capabilities, contributing to a comprehensive innovation ecosystem [10][11] - The current IPO environment emphasizes the importance of companies with innovative potential and solid clinical data, reinforcing the market's focus on firms capable of sustained innovation and value realization [11]