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 张铃 2025年，明星AI制药公司英矽智能忙着做两件事，一是推进临床管线，在达成全球首个临床阶段药效概念性验证后，进一步验证AI平台跨领域、跨学科的 赋能效应；二是加大BD（商务拓展）力度，希望做出数量更多、范围更广的商业合作，将商业模式打通。 "现在，AI制药到了从技术突破到临床应用的阶段了。"英矽智能联合首席执行官兼首席科学官任峰对经济观察报说。 任峰是拥有近20年经验的药物开发老兵，曾先后在国际制药巨头葛兰素史克和知名合同研究组织（CRO）美迪西（688202.SH）任职。对他来说，从传统制 药到AI制药的赛道转变让梦想近在咫尺：AI提高了药物开发的创新性和创造性，同时大大加快了研发速度。 在制药界，人们用"10年10亿美元"来形容做成一款原研创新药需要付出的成本，AI正 ...

证券研究报告 2025 年 09 月 28 日 湘财证券研究所 行业研究 医疗服务行业周报 恒瑞 ADC 新药海外授权，ADC CDMO 需求不断提升 --医疗服务行业周报 9.22-9.26 相关研究： 核心要点： 本周医药生物下跌 2.20%，涨跌幅排名位列申万一级行业第 24 位 本周申万一级行业医药生物下跌 2.20%，涨幅排名位列申万 31 个一级行业 第 24 位。沪深 300 指数上涨 1.07%，医药跑输沪深 300 指数 3.27 个百分 点。申万医药生物二级子行业医疗服务 II 报收 7150.64 点，下跌 3.99%； 中药 II 报收 6577.59 点，下跌 1.95%；化学制药Ⅱ报收 14307.60 点，下跌 2.44%；生物制品Ⅱ报收 6926.48 点，下跌 1.18%；医药商业Ⅱ报收 5171.98 点，下跌 2.65%；医疗器械 II 报收 6986.59 点，下跌 1.02%。 根据 Wind 数据，从医疗服务板块公司的表现来看，表现居前的公司有： 毕得医药（+10.0%）、皓元医药（+7.4%）、光正眼科（+2.9%）、泰格医药 （+0.9%）、药康生物（-0.8% ...

Investment Rating - The report assigns a "Buy-B" rating to the company, indicating a positive outlook for its stock performance in the next 6-12 months [4]. Core Insights - The company, Bai Li Tian Heng, is positioned as an innovative pharmaceutical enterprise focusing on ADC (Antibody-Drug Conjugates) and multi-antibody therapies. Its core pipeline, the EGFR×HER3 dual antibody ADC, iza-bren, is seen as a potential cornerstone treatment for various tumors, with over 40 ongoing clinical trials globally, including 3 global registration trials and 11 Phase III trials in China. The NDA for nasopharyngeal carcinoma is progressing, with expectations for approval in China by 2026. The drug has shown promising safety and anti-tumor activity across multiple cancer types [4][5]. - The company has licensed iza-bren to BMS, which could trigger up to $500 million in payments, with potential milestone payments reaching $7.1 billion. Additionally, the HER2 ADC, T-Bren, is advancing in 9 Phase III trials for HER2-expressing solid tumors in China and the U.S., showing efficacy in breast cancer [4][5]. - Revenue projections for the company are estimated at 2.251 billion, 2.302 billion, and 2.585 billion yuan for 2025, 2026, and 2027 respectively, with expected net losses of 527 million, 836 million, and 1.004 billion yuan during the same period [4][11]. Financial Data Summary - As of June 30, 2025, the company reported a basic and diluted earnings per share of -2.79 yuan, with a net asset value per share of 6.98 yuan and a return on equity of -39.94% [3]. - The company's revenue for 2023 is reported at 562 million yuan, with a significant projected increase to 5.823 billion yuan in 2024, followed by a decrease to 2.251 billion yuan in 2025. The net profit for 2023 is -780 million yuan, with projections of -527 million yuan in 2025 [11][14]. - The gross margin is expected to remain high, with estimates of 87.9% in 2025, while the net margin is projected to be -23.4% [12][14].

Investment Rating - The report maintains a "Buy" rating for the company with a target price raised from 78.01 HKD to 120.87 HKD per share [6]. Core Insights - The report highlights the impressive performance of HLX43 and HLX07, indicating that HLX43 shows excellent efficacy and safety, while HLX07 may provide new treatment options for first-line sqNSCLC patients [4][5]. Summary by Sections HLX43 Performance - HLX43 demonstrated a 37.0% overall objective response rate (ORR) and an 87.0% disease control rate (DCR) among evaluable patients [3]. - In a subgroup analysis of EGFR wild-type non-squamous NSCLC patients, the confirmed ORR reached 46.7%, indicating that HLX43's anti-tumor activity is not dependent on PD-L1 expression levels [3][4]. - The safety profile of HLX43 is manageable, with the most common grade ≥3 treatment-related adverse events (TRAEs) being anemia and leukopenia, both at 19.6% [4]. HLX07 Performance - HLX07 combined with a PD-1 antibody showed a median progression-free survival (mPFS) of 17.4 months in the high-dose group, significantly exceeding the standard therapy's mPFS of around 7 months [5]. - The safety profile during treatment was reported to be good, with manageable treatment-emergent adverse events (TEAEs) [5]. Financial Projections - The company is projected to achieve total revenues of 58.73 billion, 59.70 billion, and 71.25 billion CNY for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 2.60%, 1.64%, and 19.36% [6]. - Net profits attributable to shareholders are expected to be 8.27 billion, 7.97 billion, and 11.22 billion CNY for the same years [6].

Core Insights - The drug molecule iza-bren (BL-B01D1) has demonstrated unprecedented clinical results in treating advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC), with 94% of patients experiencing tumor shrinkage and a median progression-free survival (PFS) of 12.5 months [4][8][10] - Iza-bren is a first-in-class, innovative dual-target antibody-drug conjugate (ADC) developed by the Chinese company BaiLi Tianheng, which is currently in Phase III clinical trials and has the potential to be a game-changer in cancer treatment [5][12][19] - The drug has received breakthrough therapy designation from both the Chinese National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for multiple indications, indicating its significant clinical value [10][11][12] Company Insights - BaiLi Tianheng has successfully retained substantial global rights while partnering with Bristol-Myers Squibb (BMS) for the development of iza-bren, which was licensed for $8.4 billion, reflecting the drug's high potential value [5][16][18] - The company is positioned to become a major player in the global pharmaceutical market, aiming to achieve annual sales of $20 billion for iza-bren, which would place it among the top pharmaceutical companies worldwide [18][20][22] - BaiLi Tianheng is actively developing additional ADCs and has a robust pipeline, indicating its commitment to innovation and long-term growth in the biopharmaceutical sector [23][24]

Investment Rating - The report assigns an "Accumulate" rating to the company [6]. Core Views - The report highlights the promising potential of the company's drug, Iza-bren, in first-line treatment for EGFRm NSCLC, supported by strong clinical data presented at the WCLC conference [3][17]. - The company is expected to see significant revenue growth in the coming years, with projected revenues of 22.66 billion, 23.35 billion, and 12.01 billion yuan for 2025, 2026, and 2027 respectively [13][14]. - The target price for the company's stock is set at 500.68 yuan, reflecting a substantial upside based on the current market conditions [6]. Financial Summary - Total revenue is projected to decline by 20.1% in 2023, followed by a dramatic increase of 936.3% in 2024, before experiencing a significant drop of 61.1% in 2025 [5]. - The net profit attributable to the parent company is expected to be -780 million yuan in 2023, with a recovery to 3.708 billion yuan in 2024, followed by losses in subsequent years [5]. - The earnings per share (EPS) is forecasted to be -1.95 yuan in 2023, improving to 9.25 yuan in 2024, and then declining again in the following years [5]. Clinical Data Highlights - Iza-bren has shown excellent efficacy in clinical trials, with an overall response rate (ORR) of 83.8% and a disease control rate (DCR) of 96.8% in first-line EGFRm NSCLC patients [18][24]. - The combination of Iza-bren and Osimertinib has demonstrated superior results compared to standard therapies, with a 12-month progression-free survival (PFS) rate of 92.1% [21][30]. - In the second-line treatment for EGFRm NSCLC, Iza-bren has shown an ORR of 57% and a median overall survival (OS) of 20.4 months, indicating strong competitive positioning in the market [34][37]. Market Position and Future Outlook - The report anticipates that the company will initiate several pivotal clinical trials in the next 12-18 months, which could further validate the efficacy of Iza-bren and enhance its market position [3][30]. - The competitive landscape for EGFRm NSCLC treatments is evolving, with Iza-bren positioned as a potential new standard of care based on its clinical performance [32][34].

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].

Core Insights - Iza-bren has demonstrated unprecedented clinical results in treating advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC), with 94% of patients experiencing tumor shrinkage and a median progression-free survival (PFS) of 12.5 months, significantly outperforming existing therapies [1][7] - The drug is a first-in-class dual-target antibody-drug conjugate (ADC) developed by the Chinese company BaiLi Tianheng, which has garnered significant attention and investment from global pharmaceutical giants [5][11] - Iza-bren is currently undergoing over 40 clinical trials across various cancer types in both China and the U.S., with several indications recognized as breakthrough therapies by regulatory authorities [5][8] Company Insights - BaiLi Tianheng has positioned itself as a rising star in the biopharmaceutical industry, with Iza-bren being a cornerstone of its innovative pipeline [9][16] - The company has successfully negotiated a partnership with Bristol-Myers Squibb (BMS) for the co-development of Iza-bren, securing an investment of $8.4 billion, reflecting confidence in the drug's potential [5][11] - BaiLi Tianheng aims to establish itself among the top global pharmaceutical companies, with aspirations to achieve annual sales of $20 billion for Iza-bren, which would place it among the top 20 pharmaceutical companies worldwide [13][14] Industry Insights - ADCs represent the forefront of cancer treatment, and Iza-bren is highlighted as a leading candidate in this category, potentially transforming the treatment landscape for various cancers [5][12] - The global pharmaceutical market is witnessing a shift towards innovative therapies, with ADCs like Iza-bren expected to play a crucial role in addressing unmet clinical needs [8][12] - The success of Iza-bren could pave the way for increased recognition and competitiveness of Chinese biopharmaceutical companies in the global market, challenging the dominance of established multinational corporations [14][16]

Company Overview - Baili Tianheng (688506.SH) recently reached a historical high stock price of 410 CNY per share, with a market capitalization exceeding 164.4 billion CNY [2] - As of September 5, 2023, the stock price closed at 388.02 CNY per share, with a market capitalization of over 150 billion CNY [4] Stock Performance - Since its listing on the Sci-Tech Innovation Board in January 2023 at an initial price of 24.7 CNY per share, Baili Tianheng's stock has increased over 14 times [3] - The stock has shown significant growth, with projected price increases of 37.05% and 102.38% for 2024 and 2025, respectively [4] Major Shareholder - The actual controller, Zhu Yi, holds 74.35% of the shares, with the value of his holdings estimated at approximately 115.69 billion CNY [4] - Zhu Yi's wealth is estimated at 95 billion CNY, making him the richest person in Sichuan province [4] Product Development - Baili Tianheng's drug Iza-bren, a first-in-class dual-specific antibody-drug conjugate (ADC), has been accepted for priority review by the National Medical Products Administration for treating advanced or metastatic nasopharyngeal carcinoma [4][5] - The company has 15 innovative drugs in clinical stages and 2 in IND acceptance stages, with 3 drugs in Phase III clinical trials [6] Industry Context - The ADC sector has become a focal point in cancer treatment, with China emerging as a key player in ADC research and development, accounting for approximately 40% of global ADC pipelines [7] - The market for innovative drug concepts has seen significant growth, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index rising over 100% this year [5]

Core Viewpoint - The article highlights the remarkable rise of Baili Tianheng, a Chinese biopharmaceutical company, which has seen its stock price surge over 1,000% since its IPO, driven by significant licensing deals and a shift towards innovative drug development [3][9][13]. Company Overview - Baili Tianheng's stock reached a historical high of 38.8 yuan, with a market capitalization exceeding 150 billion yuan, marking a more than tenfold increase from its IPO price of 24.70 yuan [3][7]. - The company was founded by Zhu Yi, a Sichuan entrepreneur, who transitioned from traditional pharmaceuticals to innovative drug research, establishing a cash flow system for R&D through previous successes in generic drugs [5][6]. Key Developments - In June 2023, Baili Tianheng's clinical data for its ADC drug BL-B01D1 generated significant interest, leading to a landmark licensing deal with Bristol-Myers Squibb worth approximately 84 billion yuan [9][10]. - The company reported a revenue of 5.823 billion yuan in the previous year, a staggering increase of 936.31%, and turned a profit with a net income of 3.708 billion yuan, a 575.02% year-on-year growth [10]. Market Context - The Chinese biopharmaceutical sector is experiencing a resurgence after a period of downturn, with several companies successfully listing and achieving significant stock price increases [13][14]. - The market is witnessing a shift where innovative drug companies are gaining recognition and valuation, as evidenced by the performance of Baili Tianheng and other firms in the sector [14][15]. Future Outlook - Zhu Yi aims for Baili Tianheng to become a multinational pharmaceutical company within five years, focusing on global commercialization of its products [11]. - Despite the current success, the company faces challenges in sustaining growth due to the high costs and risks associated with innovative drug development [10][12].