证券代码：688506 证券简称：百利天恒 公告编号：2025-084 四川百利天恒药业股份有限公司 自愿披露关于 iza-bren（EGFR×HER3 双抗 ADC）用于 复发性或转移性食管鳞癌的 III 期临床试验的期中分析达到 主要终点的公告 Iza-bren 是全球首创（First-in-class）、新概念（New concept）且唯一进入 III 期临床阶段的 EGFR×HER3 双抗 ADC，iza-bren 正在中国和美国进行 40 余项针 对多种肿瘤类型的临床试验。 截至目前，iza-bren 已有 7 项适应症被国家药品监督管理局药品审评中心纳入 突破性治疗品种名单，1 项适应症被美国食品药品监督管理局纳入突破性治疗品种 名单。 二、风险提示 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 四川百利天恒药业股份有限公司（以下简称"公司"）自主研发的全球首创 （First-in-class）、新概念（New concept）且唯一进入 III 期临床阶段的 EGFR× HER3 双抗 ADC（iza-b ...

Core Viewpoint - The company, Baillie Tianheng, announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC (iza-bren) has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma [1] Group 1: Clinical Trial Results - The Phase III clinical trial (study protocol number: BL-B01D1-305) reached the predefined interim analysis, demonstrating positive results for both PFS and OS [1] - This marks the first ADC drug to achieve dual positive results in the treatment of esophageal cancer in a Phase III clinical study globally [1] Group 2: Drug Development and Regulatory Status - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials and is being tested in over 40 clinical trials for various tumor types in China and the United States [1] - As of now, seven indications for iza-bren have been included in the breakthrough therapy designation list by the National Medical Products Administration in China, and one indication has been included by the U.S. Food and Drug Administration [1]

Core Viewpoint - Baili Tianheng's market value has surged due to a high-value licensing agreement with BMS and its technological leadership in the ADC field, indicating potential for global expansion [2] Group 1: Financial Situation - The company is highly dependent on milestone revenues from BMS, with innovative drugs yet to be commercialized, leading to cash flow pressures and a projected funding gap exceeding 4.8 billion yuan over the next three years [3][10] - The company's cash flow is under significant strain due to high global commercialization costs and ongoing R&D expenses, with any issues in clinical trials or financing potentially jeopardizing its goal of becoming an "entry-level multinational pharmaceutical company" [4][29] - Baili Tianheng's IPO was delayed just days before its scheduled launch, a rare occurrence in the pharmaceutical sector, attributed to current market conditions [5][8] Group 2: IPO and Market Dynamics - The company planned to issue 8.6343 million shares at a maximum price of 389 HKD per share, aiming to raise approximately 3.359 billion HKD, but the delay raises concerns about market acceptance and the risk of share price decline [6][7] - The average discount for recent A-share companies listing in Hong Kong is around 20%, with Baili Tianheng's pricing being relatively high, which could deter investors [6][7] Group 3: Dependency on BMS - Baili Tianheng's revenue is heavily reliant on BMS, which accounted for 90% of its income, highlighting the risks associated with such dependency [14] - The company reported a loss of 780 million yuan in 2023, but anticipated a profit of 3.708 billion yuan in 2024 due to an 800 million USD upfront payment from BMS [14] - The reliance on BMS for revenue raises questions about the sustainability of cash flow, especially as the company has yet to commercialize any innovative drugs [16][27] Group 4: R&D and Future Prospects - R&D expenses have significantly increased, reaching 1.772 billion yuan in the first three quarters of 2025, with a 90% year-on-year growth, putting additional pressure on cash flow [16] - The company aims to become an "entry-level multinational pharmaceutical company" by 2029, but this requires over 1 billion USD in capital investment, which is not fully covered by current funding [27][28] - The future success of Baili Tianheng hinges on several critical factors, including the successful clinical progression of BMS projects and the commercialization of its ADC drug [28][29]

Group 1 - The report emphasizes the rapid development of China's innovative pharmaceuticals, highlighting that the number of clinical trials has reached a global leading position, with a significant increase in new drug approvals [3][5][7] - Chinese pharmaceutical companies are transitioning from a "fast follower" to an "innovation leader" model, actively engaging in cutting-edge fields such as ADC, bispecific antibodies, and mRNA vaccines, with a notable increase in the number of products in late-stage development [8][11][18] - The report identifies two main investment directions: the transformation of biotech companies into biopharma and the revaluation of traditional pharmaceutical companies during their innovation transition, suggesting specific companies to watch in both categories [3][4] Group 2 - China's integration into the global innovative drug value chain is deepening, with a growing number of global multi-center clinical trials led by Chinese companies, indicating a shift in the global drug development landscape [3][24] - The report notes that the contribution of Chinese companies to global clinical trials has significantly increased, with a projection of 1,903 innovative drug clinical trials registered in China by 2024 [7][24] - The report highlights the increasing competitiveness of Chinese companies in high-potential therapeutic areas, particularly in oncology, metabolic diseases, and autoimmune diseases, with substantial market shares in these segments [18][19] Group 3 - The report discusses the rising trend of BD (business development) transactions involving Chinese assets, with a notable increase in transaction amounts and numbers, indicating China's growing influence in the global pharmaceutical innovation landscape [33][44] - It highlights that the majority of license-out projects are now in early stages, reflecting the international interest in early-stage Chinese innovations, particularly in oncology and metabolic therapies [39][44] - The report points out that major multinational corporations (MNCs) are increasingly seeking next-generation blockbuster products from China to fill revenue gaps due to impending patent expirations [62][66]

Investment Rating - The report continues to recommend the innovative drug and medical device industry chain, indicating a high level of investment interest in this sector [1][5]. Core Views - The report highlights the high prosperity in innovative drugs, suggesting potential value revaluation for companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical [2][5]. - It emphasizes the importance of Biopharma/Biotech companies with innovative pipelines and performance entering a volume increase phase, including Innovent Biologics, BeiGene, and others [2][5]. - The report also points out the recovery potential for leading medical equipment companies like United Imaging Healthcare, Lepu Medical, and others [2][5]. Summary by Sections A-Shares Performance - In the second week of November 2025, the A-Shares pharmaceutical sector outperformed, with the SW Pharmaceutical and Biological index rising by 3.3% while the SHCOMP fell by 0.2% [2][30]. - The pharmaceutical commerce, chemical raw materials, and chemical preparations sub-sectors showed strong performance, with increases of 5.7%, 5.1%, and 4.4% respectively [2][30]. - Notable stock gains included GDK (+61.6%), HPGC Renmintongtai Pharmaceutical Corporation (+61.1%), and Chengda Pharmaceuticals Co., Ltd. (+58.3%) [2][30]. Hong Kong and U.S. Market Performance - The Hong Kong pharmaceutical sector also outperformed, with the Hang Seng Healthcare index increasing by 6.8% and the Hong Kong Biotechnology index by 7.1% [2][31]. - In the U.S., the S&P Healthcare Select Sector rose by 3.9%, significantly outperforming the S&P 500, which only increased by 0.1% [2][32]. Valuation Metrics - As of November 14, 2025, the premium level of the pharmaceutical sector relative to all A-Shares is at a normal level, with a current relative premium rate of 77.0% [2][15]. - The report provides earnings forecasts and valuation metrics for various companies, indicating expected growth rates and price-to-earnings ratios for the coming years [6][7].

Group 1 - The A-share pharmaceutical index has increased by 3.3% this week and 22.1% year-to-date, outperforming the CSI 300 by 4.4% and 4.5% respectively [1] - The Hang Seng Biotechnology Index has risen by 7.0% this week and 88.8% year-to-date, outperforming the Hang Seng Technology Index by 7.4% and 58.7% respectively [1] - Notable weekly gains in the pharmaceutical sector include: pharmaceutical commerce (+5.7%), chemical pharmaceuticals (+4.5%), traditional Chinese medicine (+4.1%), biological products (+2.7%), medical services (+1.8%), and medical devices (+1.8%) [1] Group 2 - Bai Li Tian Heng focuses on major tumor treatment needs and has developed a global pipeline of innovative candidate drugs, including three platforms: HIRE-ADC, GNC, and HIRE-ARC [2] - As of November 2025, the company has 17 clinical-stage candidate drugs, with 6 undergoing clinical trials in the United States [2] - The pipeline includes izabren (EGFR×HER3 ADC) as a core representative, with 3 global pivotal phase III trials and 10 pivotal phase III trials in China initiated [2] Group 3 - Kolun Pharmaceutical's generic version of Enzalutamide has been approved for market launch, marking it as the first approved generic in China [3] - Jin Fang Pharmaceutical has initiated the first phase III clinical trial for GFH375 (VS-7375), which is the second KRAS G12D inhibitor to enter phase III globally [4] Group 4 - Recommended sub-industry rankings include: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [4] - Specific companies to focus on from the innovative drug perspective include Bai Li Tian Heng, BeiGene, Kolun Botai Biological, Heng Rui Pharmaceutical, and Zai Lab [4] - From the PD1/VEGF dual antibody perspective, recommended companies include Sanofi, Kintor Pharmaceutical, and Rongchang Biopharmaceutical [4]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry, specifically recommending companies like BaiLi Tianheng [1]. Core Insights - The pharmaceutical sector has shown significant performance, with the A-share pharmaceutical index increasing by 3.3% this week and 22.1% year-to-date, outperforming the CSI 300 by 4.4% and 4.5% respectively [4][9]. - BaiLi Tianheng has developed a comprehensive pipeline of innovative drugs targeting major cancer types, with 17 clinical candidates, including 6 in trials in the United States [20]. - The report highlights the approval of the first generic version of Enzalutamide by Kelun Pharmaceutical and the initiation of Phase III trials for a KRAS G12D inhibitor by Jinfang Pharmaceutical [4]. Summary by Sections Industry Performance - The A-share pharmaceutical index has outperformed the CSI 300 index, with significant gains in various sub-sectors, including pharmaceutical commerce (+5.7%) and chemical pharmaceuticals (+4.5%) [4][9]. - Notable stock performances include JinDike (+62%), Renmin Tongtai (+61%), and Chengda Pharmaceutical (+58%) [4][9]. Company Focus: BaiLi Tianheng - BaiLi Tianheng's pipeline includes innovative drug platforms such as HIRE-ADC, GNC, and HIRE-ARC, with a focus on EGFR×HER3 ADC as a cornerstone treatment [20]. - The company has initiated three global pivotal Phase III trials and ten critical Phase III trials in China for its lead candidate, iza-bren [20]. Recommendations - The report suggests a ranking of preferred sub-industries: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [4][9]. - Specific companies to watch include BaiLi Tianheng, BeiGene, Kelun Pharmaceutical, and others in various therapeutic areas such as PD1/VEGF dual antibodies and GLP1 [4][10][11][12][13][14][15].

Core Viewpoint - The company Baili Tianheng (688506.SH) has unexpectedly suspended its Hong Kong IPO just five days before the scheduled listing date due to unfavorable market conditions, despite significant investments in R&D and a strong pipeline of innovative drugs [1][2][4]. Group 1: IPO Suspension Reasons - The decision to pause the IPO is attributed to the current "breaking wave" in the Hong Kong new stock market, where three out of five newly listed stocks in November have already experienced a drop in share price on their first day [4][5]. - Baili Tianheng's initial plan was to issue 8.6343 million shares at a price range of HKD 347.50 to HKD 389.00, but the A-share closing price on the day of the IPO was HKD 370, indicating a potential overvaluation compared to other pharmaceutical companies [4][5]. - The company faced a lack of strong cornerstone investors, with only five investors committing to a total of HKD 249 million, which is only 7.81% of the total fundraising target, contrasting sharply with competitors like Heng Rui Medicine, which secured 43% from cornerstone investors [5][6]. Group 2: Financial Performance and Strategy - Baili Tianheng has invested heavily in R&D, spending CNY 17.72 billion in the first three quarters of 2025, a 90% increase year-on-year, which has led to a net loss of CNY 4.95 billion in the same period [9][10]. - The company recently secured a significant licensing deal with Bristol-Myers Squibb (BMS) for its ADC drug, which generated an upfront payment of USD 800 million and additional milestone payments, resulting in a projected revenue of CNY 58.23 billion for 2024, a staggering increase of 936.31% [9][10]. - The long-term goal of the company is to become an "entry-level multinational pharmaceutical company" by 2029, with the Hong Kong listing aimed at raising funds for global clinical trials and enhancing international visibility [10][12]. Group 3: Market Conditions and Future Outlook - The current market conditions are challenging for innovative drug companies, with investors becoming increasingly selective about unprofitable firms, which has led to a decline in institutional holdings in Baili Tianheng's A-shares [6][12]. - The company’s decision to delay the IPO is seen as a strategic move to avoid "selling itself short" in a down market, with the potential to return to the market when conditions improve [12][13].

Core Viewpoint - The surge in IPO applications from pharmaceutical companies in Hong Kong has created a competitive environment, leading to challenges in securing cornerstone investors and navigating the market dynamics [1][5]. Group 1: IPO Market Dynamics - The Hong Kong IPO market for healthcare has seen a significant recovery, with 23 companies successfully listed this year compared to only 8 last year [1]. - Over 40 healthcare companies have applied for IPOs this year, with 8 applications in just the first half of November [1]. - The competition among companies to attract suitable investors has intensified due to the increasing number of IPO applications [1][5]. Group 2: Specific Company Developments - Bai Li Tianheng's IPO was delayed due to market conditions, with reports suggesting that investor demand did not meet expectations [2][3]. - The company aimed to attract long-term value-focused investors rather than those interested in short-term gains [4]. - The IPO structure includes cornerstone placements, book-building placements, and public offerings, with cornerstone investors playing a crucial role in stabilizing the market perception of the IPO [4]. Group 3: Investor Behavior and Market Trends - Investors are currently more focused on new IPOs due to the significant gains seen in the secondary market this year, leading to a preference for new offerings over existing stocks [5]. - The participation of cornerstone investors has increased, with many successful IPOs this year having multiple cornerstone investors involved [7]. - Despite a recent cooling in the secondary market, the enthusiasm for IPO applications remains high, with expectations for several companies to list in the first quarter of next year [8][9]. Group 4: Future Outlook - The healthcare sector is still attracting attention from both international and domestic investors, with a focus on high-quality investment targets [10]. - The pricing strategy for upcoming IPOs will be critical, as sufficient discounting is necessary to garner investor interest [10].

Core Viewpoint - The article discusses the surge in IPO applications from pharmaceutical companies in Hong Kong, highlighting the competitive landscape and the challenges faced by these companies in securing investors amid a crowded market [3][5][10]. Group 1: IPO Market Dynamics - As of November 14, 2023, 23 healthcare companies have successfully listed on the Hong Kong stock market this year, compared to only 8 in the same period last year [3]. - Over 40 healthcare companies have applied for IPOs in Hong Kong this year, with 8 applications submitted in just the first half of November [3]. - The increase in IPO applications has led to heightened competition among companies to attract suitable investors, resulting in a more complex negotiation landscape between companies and institutional investors [3][5]. Group 2: Case Study of Baillie Gifford - Baillie Gifford's planned global offering was delayed due to market conditions, with reports suggesting that investor demand did not meet expectations [4][5]. - The company aimed to attract long-term value investors rather than those focused on short-term price fluctuations, indicating a strategic approach to its IPO [5][6]. - The IPO process involves cornerstone placements, book-building, and public offerings, with cornerstone investors playing a crucial role in validating the company's value [6]. Group 3: Market Sentiment and Trends - The pharmaceutical sector has seen significant stock price increases this year, leading investors to focus on new IPOs rather than existing stocks [7]. - The introduction of new IPO pricing mechanisms by the Hong Kong Stock Exchange has increased the participation of cornerstone investors in pharmaceutical IPOs [9]. - Despite a recent cooling in the secondary market, the enthusiasm for IPO applications remains strong, with expectations of multiple companies going public in the first quarter of the following year [10][11]. Group 4: Investment Focus Areas - Certain sectors within the pharmaceutical industry, such as siRNA and ADC drugs, are attracting more attention from investors, indicating a trend towards specialized investment opportunities [11]. - The competition among major pharmaceutical companies for acquisitions, particularly in the GLP-1 drug space, has heightened interest in related IPOs [11]. - The article notes that while many IPOs are being pursued, the quality of the offerings and their pricing will be critical in attracting investor interest [13].