维立志博最初便决定重点解决PD-(L)1等现有疗法不能治疗的 疾病。目前维立志博共有14款候选创新药，其中4款在全球临 床进度前三，有望成为全球first-in-class（同类首创）药 物。 "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 来巨大的经济回报。2024年"K药"的全球销售额约为320.56亿美元，在2023年—2024年，"K药"均蝉联 全球"药王"。 PD-(L)1靶点也成为近年肿瘤治疗领域中最"卷"的赛道之一。在国内，获批的PD-(L)1单抗已经有20款。 然而，在PD-(L)1获批之后，还没有下一款类似的重磅药物获批。同时，PD-( ...

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，也带来巨大的 ...

Group 1 - The Chinese government proposed the establishment of a World Artificial Intelligence Cooperation Organization to promote multilateralism and address the digital divide [2] - The 2025 World Artificial Intelligence Conference emphasized the need for accelerated digital infrastructure development, including clean power and AI standards [3] - Major foreign financial institutions have raised their economic growth forecasts for China following the release of Q2 economic data, with increases ranging from 0.3% to 0.6% [4] Group 2 - The establishment of the China Capital Market Society marks the creation of an official think tank for the capital market, with significant figures from the China Securities Regulatory Commission involved [5] - The stablecoin sector in Hong Kong is gaining attention, with analysts suggesting that clearer regulatory frameworks will drive growth and support the internationalization of the Renminbi [5] - A well-known private equity firm,淡水泉投资, is optimistic about structural investment opportunities in high-quality Chinese assets and the globalization of advantageous industries [5] Group 3 - The World Artificial Intelligence Conference showcased advancements in smart connected vehicles and AI technologies from companies like Alibaba and Baidu [6] - A new action plan for autonomous driving in Shanghai aims for significant milestones by 2027, including L4-level passenger transport and extensive road coverage [6] - The National Cyberspace Administration reported that 474 large models have completed registration, with over 30 billion registered users for these applications [6] Group 4 - The Hong Kong Monetary Authority is prepared to intervene in the currency market if the Hong Kong dollar's exchange rate with the US dollar falls to 7.85 [8] - 华熙生物 addressed false information circulating on social media regarding the company, clarifying the background of the individual responsible for the misinformation [9] - 京东健康 is upgrading its AI medical model system to enhance the coverage of its internet hospital services [9] Group 5 - As of June 30, the total net asset value of public funds in China reached a record high of 34.39 trillion yuan, with bond funds leading the growth [14] - The recent surge in industrial commodity futures prices has prompted exchanges to implement risk control measures to manage trading activity [15]

Summary of Key Points from the Conference Call Company Overview - **Company**: 科伦博泰 (Kelong Botai) - **Core Product**: SKB264, approved for late-stage triple-negative breast cancer (TNBC) and EGFR mutation-positive small cell lung cancer, with three additional indications expected to launch this year [2][6] Industry Insights - **Sales Model**: The company employs a sales model focused on major tertiary hospitals in core cities, with Kelong Pharmaceuticals assisting in penetrating lower-tier markets, while Merck & Co. manages overseas markets [2][5] - **Market Potential**: The domestic peak sales forecast for SKB264 is 7.1 billion RMB, while the overseas peak sales forecast is 7.6 billion USD, indicating significant market potential [3][24] Product Development and Pipeline - **Clinical Trials**: SKB264 has shown significant advantages in TNBC with a progression-free survival (PFS) of 5.7 months and overall survival (OS) of 14.3 months, outperforming chemotherapy [2][16] - **ADC Technology**: The company is advancing its ADC (Antibody-Drug Conjugate) technology, with SKB264 being a modified version of Gilead's SJADC, featuring optimized linkers and ligands to reduce side effects [2][11][12] - **Upcoming Data**: Key clinical data for TNBC and gynecological tumors is expected to be released in 2025 [8] Strategic Partnerships - **Collaboration with Merck**: Merck's involvement is crucial, having acquired multiple ADC projects and showing strong confidence in Kelong Botai's ADC technology [2][3] - **Global Development Focus**: Merck is prioritizing TROP2 ADC, initiating 14 global multi-center clinical trials across various indications, which enhances Kelong Botai's market position [18] Competitive Landscape - **Market Position**: SKB264 is positioned to lead the market due to the failure of competitors' OS data, which has elevated its ranking [24] - **Emerging Competitors**: Other ADCs in development include HER2 and CMET targets, but SKB264's precise patient selection has yielded superior clinical outcomes [15][17] Financial Valuation - **Company Valuation**: The overall company valuation is estimated at 87.8 billion RMB, based on peak sales multiples of approved and clinical-stage products [3][25] Additional Insights - **Team and Management**: The company boasts a strong management team with significant industry experience, contributing to its competitive edge [10] - **Employee Growth**: The commercial team is expected to expand from approximately 360 to 400-500 personnel this year [4] This summary encapsulates the critical aspects of Kelong Botai's current standing, product pipeline, strategic partnerships, and market potential, providing a comprehensive overview for potential investors and stakeholders.

Investment Rating - The report indicates a positive investment rating for the innovative drug sector, particularly highlighting the success of the combination therapy of Bemesumab and Anlotinib in treating NSCLC [8][11]. Core Insights - The report emphasizes the significant progress in the treatment of non-small cell lung cancer (NSCLC) through innovative therapies, particularly the combination of immune checkpoint inhibitors and anti-angiogenic agents, which have shown improved progression-free survival (PFS) rates compared to traditional therapies [7][11]. - The CAMPASS trial demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median PFS to 11.0 months compared to 7.1 months for the control group, marking a notable advancement in first-line treatment options for PD-L1 positive advanced NSCLC [11]. - The report also discusses the ongoing clinical trials and the potential for new drug approvals, indicating a robust pipeline for innovative therapies in the oncology sector [12][47]. Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the latest developments in innovative drugs, particularly in the context of NSCLC treatments and highlights the importance of combination therapies [2][3]. Section 2: Clinical Trial Results - The report details the results of the CAMPASS trial, which compared the efficacy of Bemesumab combined with Anlotinib against Pembrolizumab in treating advanced NSCLC, showcasing a significant improvement in PFS [11][12]. - It also covers the mid-term analysis of the TQB2450-III-12 trial, which further supports the efficacy of the Bemesumab and Anlotinib combination in squamous NSCLC [13]. Section 3: Market Developments - The report notes the recent approvals and submissions for new drug indications, reflecting a dynamic and rapidly evolving market for innovative cancer therapies [45][49]. - It highlights the performance of various biotech companies in the market, indicating significant fluctuations in stock prices and market capitalization [41][43].

Group 1 - The company has established itself as a leading ADC platform and pipeline in China since its inception in 2016, focusing on enhancing its R&D capabilities and drug pipeline [1] - The company has developed three major technology platforms: ADC, large molecule drugs, and small molecule targeted drugs, with OptiDC being one of the first integrated ADC platforms in mainland China, showcasing significant advantages in core component design [1] - The drug pipeline consists of approximately 20 molecules, including at least 11 ADCs and opportunities for I/O + ADC combination therapies, with collaborations with Merck resulting in total transaction values exceeding $10 billion [1] Group 2 - The core product, Lukanasatuzumab, is the second TROP2 ADC approved globally and the first domestically produced TROP2 ADC, demonstrating clear advantages in molecular design and clinical data compared to two other competing products [1] - Merck is rapidly advancing around 14 Phase III studies for Lukanasatuzumab, targeting cancers with significant unmet medical needs, further validating the global clinical and commercial value of the product [1] - The projected peak sales for Lukanasatuzumab are expected to exceed 5 billion RMB in mainland China and 4 billion USD overseas, serving as a key driver for the company's valuation [1] Group 3 - The company is entering a golden period of value realization, with additional product approvals expected by the end of 2024 and early 2025, including PD-L1 and Cetuximab, while HER2 ADC is under review for market approval [2] - The tumor field is gradually forming a comprehensive treatment matrix of I/O + ADC, while the non-tumor field is targeting large patient populations with limited treatment options [2] - The company is at a critical turning point in evolving from a biotech firm to a comprehensive biopharmaceutical platform, with potential operational breakeven expected in two years [2] Group 4 - The company is expected to see rapid revenue growth post-launch of products like Lukanasatuzumab, with projected revenues reaching 2.04 billion RMB, 3 billion RMB, and 4.3 billion RMB in 2025, 2026, and 2027 respectively, corresponding to a 45% CAGR [2] - The CAGR for product sales revenue is anticipated to reach 82% [2] - A target price of 400 HKD has been established based on a DCF valuation model, corresponding to a 5.0x revenue peak sales multiple and a 25% potential upside, with a buy rating assigned [2]

Core Viewpoint - The article highlights the significant milestone of the company starting the Phase III registration clinical trial for Ivosidenib in colorectal cancer (CRC), suggesting it could lead to a transformative impact for the company [3]. Group 1: Colorectal Cancer Overview - Colorectal cancer is the third most common cancer globally, following lung and breast cancer, and is the second leading cause of cancer-related deaths [4]. - The classification of colorectal cancer primarily includes microsatellite instability-high (MSI-H/dMMR) and microsatellite stable (MSS/pMMR), with the latter accounting for approximately 90% of cases [4]. - Prior to the advent of immunotherapy, treatment for metastatic colorectal cancer did not significantly differ between MSI-H and MSS patients, primarily involving VEGF inhibitors and chemotherapy [4]. Group 2: Immunotherapy Efficacy - Immunotherapy, particularly PD-1 inhibitors, has shown significant efficacy in treating MSI-H colorectal cancer, with a median overall survival (OS) of 77.5 months compared to 36.7 months for chemotherapy [5]. - For MSS colorectal cancer, PD-1 inhibitors have demonstrated poor efficacy, with many trials failing to show significant benefits [5][10]. - The combination of PD-1 inhibitors with standard treatments has shown some improvement in overall response rates (ORR) and duration of response (DoR), but overall survival did not improve significantly [9][10]. Group 3: AK112's Potential - AK112 represents a promising advancement in the treatment of MSS colorectal cancer by combining PD-1 and VEGF targeting, potentially enhancing efficacy while reducing side effects [12]. - Initial clinical data for AK112 shows an ORR of 81.8% and a promising progression-free survival (PFS) rate, indicating its potential to outperform existing therapies [14][15]. - The market potential for AK112 in MSS colorectal cancer is substantial, with estimates suggesting a market size of 350-400 billion CNY in China alone, driven by high patient numbers and treatment duration [20]. Group 4: Market Analysis - The colorectal cancer market is expected to be comparable to that of non-small cell lung cancer (NSCLC), with a significant patient population and treatment duration [19]. - In China, the estimated market size for MSS colorectal cancer could reach 150 billion CNY if the company captures a 50% market share [20]. - In the U.S. and other developed countries, the market potential for AK112 could exceed 300 billion USD, reflecting a significant opportunity for the company [22].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index increased by 6.02%, ranking 6th among 31 primary industries, outperforming the CSI 300 index which rose by 3.19% [3][10] - The PE (TTM overall method, excluding negative values) for the pharmaceutical and biotechnology industry as of February 14, 2025, is 26.68x, up from 25.41x in the previous period, indicating an upward valuation trend [12] - The AI medical market in China is projected to grow significantly, with a compound annual growth rate (CAGR) of 43.1%, increasing from 8.8 billion yuan in 2023 to 315.7 billion yuan by 2033 [5] Industry Review - The top-performing sub-industries during the reporting period were hospitals and medical devices, with increases of 14.31% and 12.54% respectively, while blood products and chemical preparations lagged behind with increases of 0.57% and 2.38% [3][10] - A total of 249 out of 501 tracked pharmaceutical and biotechnology companies disclosed their 2024 performance forecasts, with 43 companies expecting significant profit increases of 30% or more [4] Important Industry News - The National Medical Insurance Administration released a list of key tasks for 2025, aiming for 80% of regions to achieve instant settlement with designated medical institutions by the end of the year [15] - The approval of the first domestic biosimilar drug "Westuximab" by Kelun-Botai marks a significant milestone in the industry [22] - Johnson & Johnson received approval for two first-in-class bispecific antibodies, "Reiko" and "Takuiko," expanding its product offerings in the market [28] Investment Recommendations - The rise of AI technology in healthcare is expected to deepen, with over 30 companies accelerating the integration of AI technologies across various applications, including drug development and clinical diagnostics [5] - The acquisition of a 28% stake in Tian Shi Li by China Resources Sanjiu for approximately 6.2 billion yuan is anticipated to enhance market competitiveness and resource integration [38][40]