编者按：2025年，创新药已成为最具活力与突破性的产业领域之一，也掀起了股市投资热潮。在这股浪 潮之中，一批中国药企正悄然转身——它们不再满足于快速跟进，而是勇敢挺进前沿领域，探索原创研 发的深水区。我们试图探寻，这些企业如何在全球竞合、资本起伏与政策引导的复杂生态中淬炼核心竞 争力，走出一条属于中国的创新突围之路。 经济观察报 记者 刘晓诺 10月6日，诺贝尔生理学或医学奖颁给了三位科学家，他们发现了免疫系统中的调节性T细胞，揭示了 免疫系统如何避免攻击自身组织，为治疗自身免疫疾病和癌症提供了新方向。 "又是免疫治疗得奖。"看到消息后，维立志博-B（09887.HK）创始人、董事长、CEO康小强并不感到 意外，因为肿瘤等很多疾病，都与免疫息息相关。维立志博是一家专注于肿瘤免疫治疗的创新药企，目 前处在临床阶段。 肿瘤免疫疗法自1980年代兴起，其原理是利用并增强人体自身的免疫系统，识别并摧毁癌细胞。2014 年，两款有划时代意义的PD-1免疫检查点抑制剂药物获批，即百时美施贵宝的"O药"与默沙东的"K 药"。 PD-1药物证明了免疫治疗是在化疗、放疗和手术之外的可行治疗思路，展现出更好的疗效和安全性， 也带 ...

Core Viewpoint - The article discusses the innovative strategies and advancements of Weilizhibo, a Chinese biopharmaceutical company focused on cancer immunotherapy, particularly in developing next-generation therapies that address limitations of existing PD-(L)1 treatments [4][5][6]. Group 1: Company Overview - Weilizhibo has 14 candidate innovative drugs, with 4 in the top three of global clinical progress, aiming to become first-in-class drugs [6][7]. - The company was founded by Kang Xiaoqiang and Lai Shoupeng in 2012, focusing on cancer immunotherapy after extensive research in the U.S. [8][9]. Group 2: Market Context - The global market for innovative drugs is rapidly evolving, with significant investment interest, particularly in the field of cancer immunotherapy [4]. - The PD-(L)1 inhibitors have shown a response rate of only about 20%, indicating a substantial unmet need in cancer treatment [6][10]. Group 3: Strategic Focus - Weilizhibo aims to address cancers that do not respond to PD-(L)1 therapies, focusing on alternative immune checkpoint inhibitors like LAG-3 and 4-1BB [10][11]. - The company has developed three core technology platforms: IO2.0, TCE, and ADC, which are expected to define the future of oncology [11][12]. Group 4: Clinical Progress - The PD-L1/4-1BB dual antibody (LBL-024) is currently in Phase III clinical trials and has shown promising results, with an objective response rate of 75% in a recent study [12][19]. - Weilizhibo's GPRC5D/CD3 dual antibody has completed Phase II trials and received orphan drug designation from the FDA, indicating its potential in treating multiple myeloma [19][20]. Group 5: Financial Strategy - Weilizhibo has successfully completed multiple funding rounds, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [15][16]. - The company strategically increased its IPO fundraising target to 189 million USD due to favorable market conditions, resulting in a successful listing on the Hong Kong Stock Exchange [16][17]. Group 6: Future Outlook - The company plans to expand its indications from rare cancers to larger cancer types, with a goal of submitting a biological license application by Q3 2026 [20][21]. - Weilizhibo intends to adopt a light-asset strategy for commercialization, collaborating with CDMOs for production while considering establishing its own facilities in the future [21][22].

Core Insights - The article discusses the rise of innovative drug companies in China, particularly in the field of cancer immunotherapy, as they shift from following trends to pioneering original research and development [2] Company Overview - Leads Biolabs, a Chinese company focused on tumor immunotherapy, is currently in clinical stages and aims to address diseases that existing PD-(L)1 therapies cannot treat [3][5] - The company has 14 candidate innovative drugs, with 4 in the top three of global clinical progress, potentially becoming first-in-class drugs [5] Market Context - The PD-(L)1 target has become highly competitive, with 20 approved monoclonal antibodies in China, yet the response rate for PD-(L)1 monotherapy is only about 20%, leaving a significant portion of patients without effective treatment [4][10] - The global sales of the PD-1 drug "K" reached approximately $32.056 billion in 2024, highlighting the lucrative nature of immunotherapy [3] Strategic Focus - The company has chosen to focus on LAG-3 and other targets instead of PD-(L)1, aiming to develop unique therapies that can address the limitations of existing treatments [10][11] - The company has established three core technology platforms: IO2.0 (4-1BB), TCE (CD3), and ADC (antibody-drug conjugates), which are expected to define the future of oncology [10][16] Clinical Development - The PD-L1/4-1BB dual antibody (code LBL-024) is currently in Phase III clinical trials in China, showing promising results with a 75% objective response rate and a 92.3% disease control rate in a recent study [11][12] - The company plans to submit a biological product license application to the Chinese regulatory authority in Q3 2026, with conditional approval expected by Q2 2027 [17] Financing and IPO - Leads Biolabs has completed 8 rounds of financing, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [13][14] - The company went public in July 2025, initially aiming to raise $100 million but increasing the target to $189 million due to market conditions, achieving a record subscription rate on its first trading day [15] Future Outlook - The company aims to expand its indications from rare cancers to larger cancer types, with plans to target 8 indications this year and 10 next year [17] - The commercialization strategy involves a light asset approach, collaborating with CDMOs for production while considering establishing its own manufacturing base in the future [18]