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]

Core Viewpoint - The company, Sichuan Baili Tianheng Pharmaceutical Co., Ltd., has received the acceptance notice for its drug application for Iza-bren, a first-in-class EGFR×HER3 dual antibody ADC, marking a significant milestone in its development process [1][2] Group 1: Drug Development and Approval - Iza-bren is the world's first and only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials [2] - The acceptance of the New Drug Application (NDA) is based on the interim analysis results of the BL-B01D1-303 study [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic nasopharyngeal carcinoma [1] Group 2: Clinical Trials and Breakthrough Designations - 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 designation list by the CDE, and one indication has been included in the priority review list [2] - Additionally, one indication has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) [2]

Core Viewpoint - The company has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC, iza-bren, which is currently in Phase III clinical trials [1][2] Group 1: Drug Development and Approval - The National Medical Products Administration (NMPA) has issued an acceptance notice for the NDA of iza-bren, based on interim analysis results from the BL-B01D1-303 study [1] - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials and is the first of its kind to have its NDA accepted globally [2] - The drug is being tested in over 40 clinical trials for various tumor types in both China and the United States [2] Group 2: Regulatory Status and Designations - Seven indications for iza-bren have been included in the breakthrough therapy designation list by the CDE, with one indication also receiving priority review status [2] - Additionally, one indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [2]

证券代码：688506 证券简称：百利天恒 公告编号：2025-086 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）用于治疗 局部晚期或转移性鼻咽癌的药品上市申请获得受理的公告 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。 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，也是全球首个药品上市申请获得受理的 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 CDE 纳入突破性治疗品种名 单，1 项适应症被 CDE 纳入优先审评品种名单，以及 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。 三、风险提示 近日，四川百利天恒药业股份有限公司（以下简称"公司"）收到国家药品 监督管理局核准签发的《受理通知书》，公司自主研发的全球首创（Fir ...

Core Viewpoint - The National Medical Products Administration (NMPA) has accepted the marketing authorization application for iza-bren, a first-in-class EGFR x HER3 bispecific antibody-drug conjugate developed by Bai Li Tian Heng, marking a significant milestone in the field of targeted therapies [1] Group 1: Company Developments - Bai Li Tian Heng has developed the world's first EGFR x HER3 bispecific antibody-drug conjugate, indicating a pioneering advancement in cancer treatment [1] - The acceptance of the marketing authorization application for iza-bren represents its first indication application successfully accepted by the NMPA [1] Group 2: Industry Implications - The acceptance of the application for iza-bren is a notable event as it is the first new drug application for a targeted EGFR x HER3 bispecific antibody-drug conjugate globally [1]

Group 1 - The report highlights the "engineer dividend" period for China's innovative drug industry, indicating that local innovations have gained full recognition from multinational corporations (MNCs) [4][5][53] - The report emphasizes the strong performance of various Chinese biotech stocks, with notable price increases observed in companies like Rongchang Biopharmaceutical (+199%) and Mawei Biopharmaceutical (+124%) in the A-share market [4][16] - The report identifies a significant increase in the number of first-in-class (FIC) drugs entering clinical trials in China, from only 9 in 2015 to an expected 120 in 2024, with China's global share of FIC drugs exceeding 30% [4][22] Group 2 - The report discusses the leading position of Chinese companies in the antibody-drug conjugate (ADC) sector, with over 50% global pipeline share in key targets such as HER2 and TROP2 [25][32] - It notes that two Chinese ADC drugs have entered the top ten global upfront payment rankings, indicating strong valuation potential for local innovations [30][31] - The report highlights the anticipated growth in bispecific antibodies (bsAbs), with Chinese companies dominating the top five global upfront payments for related assets [37][41] Group 3 - The report recommends several companies with significant global single product potential, including Kolon Biotech and Innovent Biologics, while also highlighting others like 3SBio and BeiGene as companies to watch [6][52] - It emphasizes the potential for substantial global pricing power for assets, particularly for companies like Rongchang Biopharmaceutical and Zai Lab, which are expected to see continued clinical data readouts [6][52] - The report suggests that companies like Innovent Biologics and Rongchang Biopharmaceutical are likely to turn profitable, with expectations of improved financial performance in the coming years [6][52]

Core Insights - Baillie Tianheng has signed a strategic cooperation agreement with Bank of China Sichuan Branch, securing a total credit support of no less than 8 billion RMB to support its development strategy [1] - The company recently announced a collaboration with Bristol-Myers Squibb (BMS) worth 8.4 billion USD, marking the highest single-asset transaction in the global ADC (antibody-drug conjugate) field [1] - Baillie Tianheng is focusing on becoming a leading entry-level multinational pharmaceutical company in oncology within the next five years [4] Financial and Operational Highlights - The company has submitted its prospectus to the Hong Kong Stock Exchange multiple times and has also launched a 3.9 billion RMB private placement plan in A-shares [1] - As of the third quarter of this year, Baillie Tianheng's cash and cash equivalents stood at 5.546 billion RMB, while its R&D expenses have nearly doubled compared to the previous year, reaching 1.772 billion RMB in the first three quarters [9] - The company has 15 innovative drugs in clinical trials, with 3 entering Phase III registration trials, including the drug iza-bren, which is currently undergoing over 40 clinical studies [4][9] Market Position and Future Prospects - The global development of iza-bren has made significant progress, with a recent milestone triggering a payment of 250 million USD under the collaboration agreement with BMS [11] - The increasing interest from multinational pharmaceutical companies in Chinese innovative drug assets is evident, with many global executives visiting China for project collaborations [16] - Morgan Stanley projects that by 2040, drugs from China will account for 35% of the FDA's approved drugs, up from the current 5% [16]

Group 1 - EVE Energy signed a procurement framework agreement with its affiliate, Smoore International, for continuous procurement of battery cells starting from January 1, 2026 [1] - Zhaoyi Information plans to issue H-shares and list on the Hong Kong Stock Exchange [1] - Fuke Environmental announced a change in its stock abbreviation to "Fuke Technology" effective November 26 [1] Group 2 - Dajia Weikang's shareholder and director terminated a share reduction plan ahead of schedule, having reduced 1% of total shares [2] - Aohong Electronics received approval from the China Securities Regulatory Commission for the issuance of convertible bonds [2] - Yingfeng Environment's controlling shareholder plans to issue exchangeable bonds not exceeding 1 billion yuan [2] Group 3 - Longshen Rongfa's subsidiary obtained a renewed drug production license covering various pharmaceutical products [4] - Xinhua News' subsidiary invested 15 million yuan in a fund with a total commitment of 221 million yuan [5] - Guang'an Aizhong appointed two new deputy general managers [6] Group 4 - Fosun Pharma's subsidiary's drug for gastric cancer treatment was included in the breakthrough therapy program by the National Medical Products Administration [7] - Nanjiao Foods reported a significant decline in October net profit due to rising raw material costs [8] - Nanfeng Co. won two nuclear power project bids totaling 928.7 million yuan [10] Group 5 - Puluo Pharmaceutical received a drug registration certificate for its Cefdinir capsules [11] - Liming Co.'s subsidiary received environmental approval for a new pesticide raw material project [12] - Longhua New Materials' expansion project for polyether polyols has commenced trial production [13] Group 6 - Pumen Technology's products received IVDR CE certification from TÜV Rheinland [15] - China Chemical reported new contracts worth 312.67 billion yuan from January to October [18] - China Nuclear Construction achieved new contracts totaling 123.84 billion yuan as of October [19] Group 7 - Changshu Bank's executives plan to purchase at least 550,000 shares of the bank [20] - Shandong Steel's subsidiary is applying for bankruptcy liquidation to focus on core business [21] - Huakang Clean is expected to win a bid for a purification system project worth 176 million yuan [23] Group 8 - Huawu Co. plans to internally transfer subsidiary equity [24] - Tianen Kang's subsidiary received clinical trial acceptance for a new drug [26] - Tianyi Medical's subsidiary obtained a medical device registration certificate for a blood dialysis product [27] Group 9 - Xuelang Environment is facing a pre-restructuring application from creditors [27] - Chitianhua's subsidiary resumed production after passing safety inspections [28] - Huaping Co.'s director plans to reduce 0.03% of company shares [30] Group 10 - Xizhuang Co. plans to establish a wholly-owned subsidiary in Singapore [31] - Ruisheng Intelligent's subsidiary won a 60.23 million yuan ICT project bid [32] - Junyi Digital plans to invest 120 million yuan in Guanghong Precision [33] Group 11 - Fuguang Co.'s controlling shareholder plans to increase holdings between 80 million to 150 million yuan [34] - Ganyue Express reported a 13.68% increase in logistics revenue in October [39] - Jiangsu Sop terminated its 2025 private placement plan [41] Group 12 - Langke Intelligent's shareholders plan to reduce a total of 1.68% of company shares [42] - Yuantong Express reported an 8.97% increase in express product revenue in October [45] - Jinbei Automotive plans to invest 158 million yuan to acquire 52% of Zhongtuo Technology [46]

Core Viewpoint - Sichuan Baile Tianheng Pharmaceutical Co., Ltd. has signed a strategic cooperation agreement with Bank of China Sichuan Branch to establish a long-term comprehensive strategic partnership, which aims to support the company's development in the innovative drug research and industrialization process [2][10]. Group 1: Agreement Details - The strategic cooperation agreement involves a commitment from Bank of China Sichuan Branch to provide a total of no less than 8 billion RMB in comprehensive credit support to the company [8]. - The agreement will facilitate deep cooperation in areas such as capital market operations, cross-border finance, and innovative financial services [9]. - The agreement is effective for five years and will automatically renew unless otherwise agreed upon by both parties [10]. Group 2: Impact on the Company - The signing of this strategic cooperation agreement is expected to accelerate the company's strategic layout in the global biopharmaceutical frontier, particularly in the fields of antibody-drug conjugates (ADC) and multi-specific antibodies [10]. - This partnership is anticipated to provide significant financial support for the company's future development, aligning with the company's development plan and benefiting all shareholders [10].

Key Points - 合富中国's stock will resume trading on November 20 after completing an investigation into unusual trading fluctuations, confirming normal business operations and no undisclosed significant matters [1] - 中金公司 plans to merge with 东兴证券 and 信达证券, leading to a suspension of its A-shares starting November 20 due to uncertainties surrounding the merger [1] - 大为股份 is progressing with the transition from exploration to mining rights for its lithium battery project in Hunan, having received necessary approvals [1] - 燕东微's major shareholders plan to reduce their stakes by up to 2.5% through block trades or centralized bidding from December 11, 2025, to March 11, 2026 [2] - 中水渔业's major shareholder reduced its stake to 5% after selling 258.88 million shares [3] - 韵达股份 reported a slight decline in express service revenue for October 2025, totaling 4.495 billion yuan, a year-on-year decrease of 0.88% [4] - 倍杰特 intends to acquire a 55% stake in 大豪矿业 for 224.8 million yuan [4] - 辰奕智能 plans to acquire a 55% stake in 华泽电子 through cash [4] - 赣粤高速's actual controller will change from the provincial transportation department to the provincial state-owned assets supervision and administration commission [5] - 东软集团 received a notification for a 4.2 billion yuan contract for intelligent cockpit controllers from a major domestic automotive manufacturer [5] - 海正药业's subsidiary plans to invest in a pet prescription food project [5] - 龙利得's controlling shareholder plans to increase its stake by at least 56 million yuan [6] - 新兴装备's shareholders plan to reduce their stakes by up to 3.13% [6] - 普洛药业 plans to repurchase shares worth between 180 million and 360 million yuan [6]