9月初，伴随着成都上市公司百利天恒市值飙升，公司实控人朱义的个人财富也来到千亿级别，一度被媒体称为"四川首富"。面对"首富"头衔，朱义淡然表 示，这只是"纸上财富带来的虚名，压力感远强于荣誉感"。而"虚名"之外，大众显然更关心一些实际问题，如百利天恒核心创新药物iza-bren（BL-B01D1） 上市进程、百利天恒在成都新增投资项目、这家成都创新药企迈向跨国药企的步伐……近日，带着这些问题，成都日报锦观新闻记者独家专访了百利天恒创 始人、董事长兼首席科学家朱义。 关于新药： 100%的应答率 有望于2026年6月获批上市 记者：在9月初举行的2025世界肺癌大会（WCLC）上，百利天恒有两项关于核心产品iza-bren（BL-B01D1）的研究入选官方新闻发布计划并进行了口头报 告。iza-bren是凭借什么得到这一殊荣？ 朱义：iza-bren是百利天恒自主研发、全球首创（First-in-class）、新概念（New concept）的双抗ADC，也是全球目前唯一进入III期临床阶段的双抗ADC。在 iza-bren联合奥希替尼一线治疗EGFR突变非小细胞肺癌患者的临床试验中，客观缓解率（ORR）达到了 ...

9月9日，iza-bren (EGFR×HER3双抗ADC) 治疗EGFR突变肺癌的两项研究结果进行了口头报告，"iza- bren (BL-B01D1) 联合奥希替尼治疗局晚期或转移性EGFR突变非小细胞肺癌患者的II期研究"中，ORR 达100%，这是全球首个ORR100%的治疗方案。 9月10日，国家药品监督管理局药品审评中心（CDE）官网公布，由百利天恒自主研发、全球首创 （First-in-class）、新概念（New concept）且唯一进入III期临床阶段EGFR x HER3双抗ADC iza- bren(BL-B01D1)被纳入突破性治疗品种名单，适用于治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性 腹膜癌患者。 9月17日，国家药品监督管理局药品审评中心（CDE），iza-bren (BL-B01D1)拟纳入突破性疗法，用于 既往经含铂化疗及PD-1/PD-L1抑制剂治疗失败的不可手术切除的局部晚期或转移性尿路上皮癌患者的 治疗，这也是BL-B01D1即将在中国获得的第7项突破性疗法。 而在10月，iza-bren相关研究还将登陆于柏林举办的欧洲肿瘤内科学会年会（ESMO），其中，iza- ...

在肿瘤治疗的百年探索史中，很少有一个概念能像"Magic bullets（魔法子弹）"一样承载如此多的想 象。1913年，德国科学家保罗·埃尔利希提出，要找到一种能够精准打击病灶、不伤害正常细胞的理想 药物。一个世纪之后，这一设想在抗体偶联药物（ADC）上逐渐变为现实。 在这股浪潮中，一家中国Biotech的身影格外醒目——百奥赛图。 破解研发痛点：从稳定性到效率 2024年底，百奥赛图与德国Tubulis达成合作，将基于其RenMice®平台授权的抗体序列，与Tubulis专有 连接子与有效载荷技术相结合，共同开发新一代ADC疗法。公司有权获得首付款、里程碑付款及未来 销售分成。这只是其全球布局的一个缩影。 更具代表性的案例来自与IDEAYA Biosciences的合作。IDEAYA在2024年底引进了百奥赛图的B7- H3/PTK7双抗ADC项目IDE034，交易金额接近30亿元人民币。该分子通过百奥赛图独有的RenLite平台 筛选得到，能同时识别B7-H3与PTK7两个靶点，在肺癌、结直肠癌、头颈癌等多种实体瘤中高度共表 达。在临床前研究中，IDE034展现出显著的抑瘤效果，并与IDEAYA的PAR ...

Group 1: Industry Overview - Antibody-drug conjugates (ADCs) are emerging as a prominent sector in the global innovative drug landscape, with a significant increase in clinical trials, reaching 284 in 2024, a year-on-year increase of over 50% [1] - The capital market's enthusiasm for ADCs is reflected in nearly $17.3 billion in licensing deals within just six months [1] - The limitations of single-target ADCs are becoming apparent, with challenges in balancing efficacy and safety, as well as issues related to drug resistance [1] Group 2: Next-Generation Developments - Bispecific antibody-drug conjugates (BsADCs) are viewed as an upgraded version of ADCs, capable of targeting two tumor-related antigens simultaneously, thus enhancing tumor coverage and reducing resistance risks [2] - Over 170 BsADCs are currently in development globally, with 70% originating from Chinese companies, highlighting the growing interest and investment in this area [2] - The collaboration between Baiyoutianheng and BMS, valued at $8.4 billion, underscores the international spotlight on this emerging sector [2] Group 3: Company Insights - Baiyoutianheng - Baiyoutianheng has addressed key challenges in BsADC development, such as molecular stability and complex CMC processes, through its RenLite platform [3] - The company has established a vast library of over one million fully human antibody sequences, allowing for rapid validation of new dual-target combinations [3] - Baiyoutianheng's innovative "antibody shelf" model positions it as a molecular accelerator for global pharmaceutical companies [3] Group 4: Business Model and Financial Performance - Unlike many biotech firms, Baiyoutianheng focuses on an out-licensing strategy, sharing the global innovative drug benefits while maintaining controlled risks [4] - In the first half of 2025, Baiyoutianheng reported revenues of 621 million yuan, a year-on-year increase of 51.5%, and achieved a net profit of 48 million yuan, marking a successful turnaround [4] - The company has signed over 280 antibody molecule transfer or collaboration agreements, with 80 new agreements in the first half of 2025, a 60% increase year-on-year, indicating a shift from a project-based to a platform-based company [4] Group 5: Future Outlook - Baiyoutianheng's evolution from mouse models to antibody molecules and from monoclonal to bispecific ADCs demonstrates a clear and determined growth path [5] - The company's value lies not only in its rich pipeline but also in its sustainable platform capabilities, positioning it well for long-term growth in the ADC sector [5] - As bispecific ADCs are poised to reshape cancer treatment paradigms, Baiyoutianheng's pivotal moment may just be beginning [5]

记者9月23日从百奥赛图获悉，公司授权给美国IDEAYA公司的创新肿瘤药物IDE034研发获得重要进 展，展现出对肺癌、结直肠癌等多癌种的潜在治疗潜力，IDEAYA计划今年四季度在美国提交IDE034的 临床试验申请。 IDE034不是一款普通的抗体偶联药物（ADC）新药，它能够同时识别B7H3与PTK7两个肿瘤标志物， 也就是双靶点协同机制，这意味着它能更精准地锁定肿瘤细胞，提高治疗效果和安全性。IDE034还搭 载百奥赛图专有的新型连接子与载荷平台BLD1102，能与IDEAYA的相关技术形成协同作用，发挥更强 的临床效果。这是百奥赛图与国外公司开展管线授权合作的又一进展。 此前，百奥赛图的B7H3/PTK7全人源双抗ADC管线授权给IDEAYA公司，潜在交易总额近人民币30亿 元。不到一年时间，这条管线就有了快速进展，如果推进顺利，有望成为全球首个进入临床的 B7H3/PTK7双靶点ADC药物。 IDE034由百奥赛图自主研发的RenLite全人抗体共轻链平台筛选获得，这一平台能够有效避免轻重链错 配，提高研发成功率。尤其是在双抗ADC领域，百奥赛图还开发了RenNano平台，可以产生全人纳米抗 体，可 ...

Core Insights - The pharmaceutical industry is currently focused on dual antibodies, ADCs, and nucleic acid delivery systems, with significant data emerging from WCLC regarding dual antibody ADCs [1] - Baiaosaitou has been actively collaborating with various partners, including Merck and Tubulis, to enhance its capabilities in antibody-drug conjugates and nucleic acid delivery [1][4][5] Group 1: Business Model and Strategy - Baiaosaitou has transformed the complex molecular discovery process into a "shelf-style" selection, allowing partners to choose from a vast library of potential drug candidates, significantly reducing time and increasing success rates [2] - The company operates with a dual business model: one focusing on model animals for target humanization and disease modeling, and the other on antibody platforms that continuously produce antibodies for licensing and joint development [3] Group 2: Recent Collaborations and Developments - The collaboration with Merck aims to enhance the delivery of nucleic acid drugs through antibody-conjugated LNPs, potentially benefiting mRNA and siRNA therapies [4] - Tubulis has selected a fully human antibody from Baiaosaitou's RenMice® platform to develop a new generation of ADCs, with Baiaosaitou receiving upfront payments, milestone payments, and sales royalties [5] - IDEAYA's IDE034, developed from the RenLite® platform, targets two tumor-related antigens and is expected to file for IND by Q4 2025, indicating a strong pipeline for dual antibody ADCs [6] Group 3: Market Position and Trends - The global pharmaceutical industry is facing a patent cliff, creating a demand for new pipelines, which aligns with Baiaosaitou's strategy of focusing on molecular discovery and validation tools rather than broad self-research [7] - The shift from single-target competition to multi-target and delivery systems positions Baiaosaitou as a key player in providing reliable molecules and validation tools, establishing itself as a foundational infrastructure in the industry [8]

Core Viewpoint - Iza-bren (BL-B01D1) is a groundbreaking ADC drug developed by the Chinese company BaiLi TianHeng, showing significant potential in treating EGFR-mutant non-small cell lung cancer (NSCLC) and other cancers, with promising clinical trial results that could reshape cancer treatment paradigms globally [1][9][16]. Summary by Sections Clinical Efficacy - In a study involving 50 patients with advanced or metastatic EGFR-mutant NSCLC, 94% experienced tumor shrinkage, with progression-free survival (PFS) exceeding one year, nearly doubling the duration compared to existing treatments [4][14]. - Another study with 38 patients showed that 100% had tumor reductions of over 30% when treated with Iza-bren in combination with the targeted drug Osimertinib, outperforming the best current therapies which have an 86% effective shrinkage rate [5][14]. Drug Development and Market Potential - Iza-bren is the first-in-class dual-target ADC, currently in Phase III clinical trials for multiple cancers, with expectations for a 2026 launch in China [9][18]. - The drug has received breakthrough therapy designations from both the Chinese National Medical Products Administration (NMPA) and the U.S. FDA for several indications, highlighting its potential to address unmet clinical needs [17][18]. Financial Implications - The potential annual sales peak for Iza-bren is estimated at $20 billion, positioning it among the top-selling cancer drugs globally, alongside established products like Merck's Pembrolizumab [25][27]. - Achieving over $20 billion in annual sales would place BaiLi TianHeng among the top pharmaceutical companies worldwide, a significant milestone for a Chinese biotech firm [28][29]. Company Vision and Strategy - BaiLi TianHeng aims to transform into a multinational corporation (MNC) rather than merely a supplier for larger firms, emphasizing the importance of maintaining global rights and pursuing joint development agreements [24][30]. - The company is building a robust pipeline beyond Iza-bren, with several other ADCs in clinical development, indicating a strong commitment to innovation and long-term growth in the biopharmaceutical sector [31][32].

Group 1 - The company, Bai Li Tian Heng (688506.SH), has announced that its self-developed drug, iza-bren (EGFR × HER3 dual antibody ADC), is the first-in-class and new concept therapy that has entered Phase III clinical trials for patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1] - The drug has been included in the list of breakthrough therapies by the National Medical Products Administration's Drug Evaluation Center, and the announcement has recently been made public [1]

Core Viewpoint - The company reported 1H25 results that met expectations, with revenue of 1.412 billion yuan, a year-on-year increase of 37.75%, and a net loss attributable to shareholders of 588 million yuan [1] Group 1: Financial Performance - The company's core product revenue was in line with expectations, with product sales reaching 1.402 billion yuan, a year-on-year increase of 49.2% [1] - The gross margin for products was 79.25%, while the sales and marketing expense ratio decreased by 7.1 percentage points year-on-year to 47.80% [1] Group 2: Product Development and Clinical Trials - The company has established a commercialization team of over 1,000 sales personnel to maximize the domestic commercialization potential of its two core products, AK104 and AK112, which have been included in the national medical insurance directory [1] - The final analysis of the HARMONi-A trial showed statistically significant overall survival (OS) benefits for AK112 in treating 2L EGFRm NSCLC, with an OS hazard ratio of 0.80 [2] - AK112 has 13 ongoing registration/Phase III clinical trials globally, covering indications beyond lung cancer, with 8 trials specifically in the lung cancer field [2] Group 3: Profit Forecast and Valuation - The company maintains its profit forecasts for 2025 and 2026, with an upgraded target price of 225.00 HKD, reflecting an 87.5% increase and a 33.1% upside potential [3]

Group 1 - The core viewpoint of the report is that the company maintains its profit forecasts for 2025 and 2026 for 康方生物 (09926) and has raised the target price by 87.5% to HKD 225.00, indicating a 33.1% upside potential [1] - The company's 1H25 revenue reached CNY 14.12 billion, representing a year-on-year growth of 37.75%, which aligns with the expectations of the analysts [1] - The sales revenue of core products in 1H25 was CNY 14.02 billion, showing a year-on-year increase of 49.2%, with a gross margin of 79.25% [2] Group 2 - The company has established a commercialization team of over 1,000 sales personnel to maximize the domestic commercialization potential of its two core products, AK104 and AK112, which have been included in the national medical insurance catalog [2] - The final analysis of the HARMONi-A trial demonstrated statistically significant overall survival (OS) benefits for AK112 in treating 2L EGFRm NSCLC, with an OS hazard ratio of 0.80 [3] - AK112 has 13 ongoing registration/Phase III clinical trials globally, covering indications beyond lung cancer, with 8 trials specifically in the lung cancer field [4]