证券代码：688506 证券简称：百利天恒 公告编号：2025-087 四川百利天恒药业股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 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。 重要内容提示： 投资者可于 2025 年 11 月 28 日（星期五）至 12 月 3 日（星期三）16:00 前 登 录 上 证 路 演 中 心 网 站 首 页 点 击 " 提 问 预 征 集 " 栏 目 （https://roadshow.sseinfo.com/preCallQa）或通过四川百利天恒药业股份有限公司 （以下简称"公司"）邮箱 ir@baili-pharm.com 进行提问。公司将在说明会上对 投资者普遍关注的问题进行回答。 公司已于 2025 年 10 月 27 日发布公司 2025 年第三季度报告，为便于广大投 资者更全面深入地了解公司 2025 年第三季度经营成果、财务状况及发展战略， 公司计划于 2025 年 12 月 4 日（星期四）下午 15:00-16:00 举行 2025 年第三季度 业绩说明 ...

证券日报网讯百利天恒11月25日在互动平台回答投资者提问时表示，截至2025年9月30日，股东户数为 5，979户。 ...

Core Viewpoint - The innovative drug Iza-bren developed by Baillie Tianheng has received formal acceptance for its market application, marking it as the world's first EGFR×HER3 dual-target ADC to enter the III clinical phase, which is expected to accelerate its market launch [2][4]. Group 1: Drug Development and Clinical Trials - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types, specifically targeting locally advanced or metastatic nasopharyngeal carcinoma [2][5]. - The drug has been included in the priority review list by the National Medical Products Administration (NMPA) based on interim analysis results from the BL-B01D1-303 study [4][5]. - Iza-bren has seven indications recognized as breakthrough therapy by the NMPA and one by the U.S. FDA [5]. Group 2: Research and Development Investment - Baillie Tianheng has significantly increased its R&D investment from CNY 196 million in 2020 to CNY 1.443 billion in 2024, with a total of CNY 4.811 billion invested over the past six years [3][9]. - In the first three quarters of 2025, the company’s R&D expenditure reached CNY 1.772 billion, surpassing the total for 2024, reflecting a year-on-year growth of 90.23% [9][10]. - The company employs 1,360 R&D personnel, accounting for 48.16% of its total workforce, with a notable increase in staff with master's degrees or higher [10]. Group 3: Financial Performance and Market Response - Baillie Tianheng's stock price has doubled since the beginning of 2025, with a significant increase from CNY 24.70 per share at the time of its IPO to approximately CNY 384.97 per share by November 2025, representing a cumulative increase of over 14 times [10]. - The company experienced a substantial revenue increase in 2024, reaching CNY 5.823 billion, a 936.31% year-on-year growth, primarily due to a collaboration agreement with Bristol-Myers Squibb [7][10].

Core Insights - The innovation drug sector in China is experiencing a strong upward trend driven by policy, industry dynamics, demand, and globalization, with expectations for continued growth into 2026 [1][2] Group 1: Market Performance - As of November 24, 2025, the CSI Innovation Drug Industry Index rose by 0.82%, with notable increases in stocks such as Zai Lab (up 4.64%) and Kelun Pharmaceutical (up 2.47%) [1] - The index reflects the performance of up to 50 representative listed companies involved in innovative drug research and development [2] Group 2: Regulatory Developments - Baili Tianheng announced that it received a formal acceptance notice from the National Medical Products Administration for its first-in-class EGFR×HER3 dual antibody ADC drug, which is now in Phase III clinical trials [1] Group 3: Industry Outlook - Citic Construction Investment Securities highlights that the Chinese pharmaceutical industry is entering a critical phase of "innovation realization and global layout," supported by population and domestic demand, as well as manufacturing capabilities [2] - The industry is expected to focus on internal supply chain security and compliance while exploring diversified international expansion [2] - The outlook for 2026 includes opportunities from innovation commercialization, global breakthroughs, policy optimization, and industry mergers and acquisitions [2]

Group 1: Industry Highlights - The domestic first large-capacity all-solid-state battery production line has been completed and is currently in small-batch testing, with reports indicating that it will be installed in vehicles by 2027, making 1000 km range for electric vehicles a possibility [4] - The Federal Reserve is managing interest rate cut expectations, with two officials calming the market after a significant drop, indicating a 69% probability of a rate cut in December, leading to a rebound in US stocks [5] - The lithium carbonate futures price has surged recently, prompting CATL to plan the earliest restart of an important lithium mine in Yichun next month, with significant gains in related market concept stocks [5] Group 2: Company Developments - Baillie Tianheng's self-developed dual-antibody ADC drug, iza-bren, has had its market application accepted, aimed at treating locally advanced or metastatic nasopharyngeal carcinoma [7] - Huawei has released Flex:ai AI container software, which utilizes computing power slicing technology to divide a single GPU/NPU computing power card into multiple virtual computing units, enabling simultaneous support for multiple AI workloads [8] - Longxin Storage has launched DDR5 and LPDDR5X memory products, with both product series reportedly ranking at the top tier in terms of speed and capacity in the industry [8] - JinkoSolar's Tiger 3 modules have officially entered mass production, with global orders reaching 15 GW [8] - Chang'an Automobile plans to gradually release prototype vehicles starting next year and will launch its first vehicle-mounted component robot in the first quarter of next year [8] - The company Nenghui Technology signed a contract with Company X for a total estimated price of 10 million yuan for new energy power battery assembly [8] - Guotai Microelectronics' major shareholder and its concerted actors plan to reduce their holdings by no more than 2.24% [8]

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has received the acceptance notice from the National Medical Products Administration for its innovative drug, iza-bren, which is the world's first EGFR×HER3 dual-target ADC entering Phase III clinical trials [1][2] Group 1: Drug Information - The drug name is BL-B01D1/iza-bren, and it is an injectable formulation [1] - The intended indication is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including one line containing platinum, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] - Iza-bren is recognized as a first-in-class and new concept drug, and it is the only EGFR×HER3 dual-target ADC to have its marketing application accepted [2] Group 2: Clinical Trials and Regulatory Status - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [2] - Seven indications for iza-bren have been included in the breakthrough therapy list by the CDE, and one indication has been designated as a priority review product [2]

Suspension - Jiahua Technology is planning to acquire a controlling stake in Shudun Information Technology through a combination of share issuance and cash payment, leading to a stock suspension [1] - Kaizhong Co., Ltd. is planning a private placement to acquire control of Anhui Tuosheng Automotive Parts, resulting in a stock suspension [1] Mergers and Acquisitions - Yingli Co., Ltd. intends to use 66.497 million yuan to purchase 100% equity of Foshan Zhiqiang Optoelectronics, a supplier of PC display module structural components [2] - Aerospace Electric is planning to acquire 32% equity of Hangdian System for 46.5903 million yuan, after which Hangdian System will become a wholly-owned subsidiary [2] - Huaihe Energy plans to conduct a private placement to acquire 89.30% equity of Huainan Mining at a transaction price of 11.694 billion yuan [2] - Jinfeng Technology is in the process of planning a cash acquisition of at least 51% equity in Guangdong Lanyuan Technology [3] Share Buybacks and Equity Transfers - Hesheng New Materials will see a change in controlling shareholder to Moer Zhixin, with the actual controller changing from Zhao Dongming to Xie Haiwen [4] - Zhongwu Drone's Chengdu Industrial Investment plans to transfer 1.5% equity [5] - Changshan Pharmaceutical's shareholder Gao Shuhua intends to transfer 5.0051% equity to Element Fund at a transfer price of 46.25 yuan per share [6] External Investments and Daily Operations - Baili Tianheng's innovative drug, the EGFR×HER3 dual antibody ADC drug iza-bren, has had its market application accepted, marking a global first and unique entry into Phase III clinical trials [7] - Zhongding Co., Ltd. is collaborating with Fourier on humanoid robot-related products to promote the development of components such as harmonic reducers and planetary reducers [7] - JinkoSolar has officially launched mass production of its Tiger Neo 3.0 module, achieving a total of 15GW in signed orders with major distributors [7] - Baicheng Pharmaceutical has reached an exclusive cooperation agreement with Zhongshen Innovation for the Class 1 innovative drug BIOS-0629 project in Greater China, with a milestone payment of 300 million yuan based on R&D milestones [7] - Jindi Co., Ltd. has signed a strategic cooperation intention letter with Dongpei Industrial to collaborate on humanoid robot harmonic reducer assemblies and key components [7] - Nenghui Technology has signed a contract for a "new energy power battery assembly" with Company X, with a total estimated contract value of 10 million yuan [8] - Huibo Pu has been confirmed as the winning bidder for the Naft Khana oilfield restoration project in Iraq, with a contract amount of 225 million USD, approximately 1.596 billion yuan [8] - Guangdong Construction has won the EPC project for the Yuejianke·Zhongshan Smart Gathering Project, with a bid price of 416 million yuan [8] - Dajin Heavy Industry has signed a contract for a European offshore wind farm project, with a total contract amount of approximately 1.339 billion yuan [9] - Aerospace Development's subsidiary, Hangtian Tianmu, plans to publicly list for capital increase [10]

Group 1: Major Announcements - Jiahua Technology plans to acquire controlling stake in Shudun Technology through a combination of share issuance and cash payment, leading to a potential major asset restructuring, with stock suspension starting from November 24, 2025, for up to 5 trading days [2] - China Merchants Bank's wholly-owned subsidiary, China Merchants Financial Asset Investment Co., has received approval to commence operations with a registered capital of 15 billion yuan, focusing on market-oriented debt-to-equity swaps and equity investment pilot projects [3] - CITIC Bank's wholly-owned subsidiary, Xinyin Financial Investment Co., has also been approved to start operations with a registered capital of 10 billion yuan, targeting strategic emerging industries and specialized sectors for market-oriented debt-to-equity swaps and equity investments [4] Group 2: Stock Performance and Risks - Zhongshui Fishery's stock has seen a significant price increase followed by a potential decline, with a rolling P/E ratio of 77.53 and a P/B ratio of 13.48, indicating substantial deviation from industry averages and raising concerns over irrational trading behavior [5] - Caixin Development's stock has also experienced a price deviation exceeding 20%, with uncertainty surrounding the bankruptcy restructuring of its controlling and indirect controlling shareholders, which may affect the company's control dynamics [6] Group 3: Acquisitions and Strategic Moves - Zhongjin Lingnan has acquired minority stakes in its subsidiaries, purchasing 4.2095% of Zhongjin Copper for 242 million yuan and 10.3333% of Zhongjin Rongsheng for 365 million yuan, among other transactions, resulting in full ownership of Zhongjin Copper [7] - Baili Tianheng's drug application for Iza-bren, a first-in-class treatment for advanced or metastatic nasopharyngeal carcinoma, has been accepted by the National Medical Products Administration [8] - Jinfut Technology is planning to acquire at least 51% of Guangdong Lanyuan Technology through cash payment, which is expected to enhance the company's profitability and risk resistance [9] - Qingmu Technology's subsidiary plans to acquire control of Vitalis for 150 million Norwegian kroner (approximately 106 million yuan), aiming to strengthen its position in the health and nutrition supplement market [12] - Zhongding Co. is entering a strategic partnership with Fourier for humanoid robot components, enhancing its product development capabilities [11] Group 4: Leadership Changes - Guiguan Network's chairman Chen Yu has resigned due to work changes, with a new candidate recommended to take over the chairman role [13] Group 5: Shareholding Changes - Shen Shui Haina's shareholder plans to reduce holdings by up to 1% within three months, while other shareholders of Guangli Micro plan to reduce holdings by up to 2.2359% [14][15] - Andar Intelligent's shareholder intends to reduce holdings by up to 2.7401% within three months [16] Group 6: Contracts and Orders - Nenghui Technology has signed a contract for a new energy power battery assembly with an estimated total price of 100 million yuan [17] - Jinko Solar has achieved cumulative orders of 15GW for its Tiger Neo3.0 module, which has a production efficiency exceeding 24.8% and a maximum power output of 670W [18]

Investment Rating - The report indicates a neutral investment rating for the pharmaceutical industry, suggesting it is expected to perform in line with the overall market [24]. Core Insights - The pharmaceutical sector experienced a decline of 6.9% this week, underperforming compared to the Shanghai Composite Index, which fell by 3.9% [3][5]. - The overall valuation of the pharmaceutical sector stands at 28.9 times earnings, ranking it 10th among 31 primary sectors [5][12]. - Key events include the acceptance of a new drug application for 百利天恒's drug iza-bren, which showed promising results in clinical trials for nasopharyngeal cancer [9]. - 泽璟制药's ZG006 received FDA orphan drug designation for treating neuroendocrine cancer, demonstrating significant efficacy and safety in clinical trials [10]. - 盟科药业 decided to terminate its stock issuance plan due to disagreements among major shareholders, which may impact its operational stability [11]. Market Performance Summary - The pharmaceutical index ranked 26th among 31 sub-industries this week, with various segments showing declines, including raw materials (-8.6%) and chemical preparations (-6.8%) [3][5]. - The report highlights a focus on innovative drug sectors and medical devices, recommending specific companies for investment [2].

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its self-developed EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China [1] Group 1: Product Development - Iza-bren is the world's first-in-class and new concept EGFR×HER3 dual antibody ADC, and it is the only one that has entered Phase III clinical trials globally [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various types of tumors [1] Group 2: Regulatory Milestones - As of now, Iza-bren has seven indications included in the CDE's list of breakthrough therapy products and one indication included in the priority review list by CDE [1] - Additionally, one indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]