Core Viewpoint - The company Baili Tianheng (688506) has received a formal acceptance notice from the National Medical Products Administration (NMPA) for its drug application of the EGFR×HER3 dual antibody ADC (iza-bren), indicating progress towards market approval [1] Group 1: Drug Development and Approval - The drug application (NDA) for iza-bren has been officially accepted based on the interim analysis results from a Phase III clinical trial for esophageal squamous cell carcinoma [1] - The independent data monitoring committee (iDMC) determined that the trial met its primary endpoints of progression-free survival (PFS) and overall survival (OS) during the pre-specified interim analysis [1] - Iza-bren has been included in the priority review list by the NMPA for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]

Core Viewpoint - The company, Baili Tianheng (688506.SH), has received formal acceptance of its New Drug Application (NDA) for its first-in-class EGFR×HER3 dual antibody ADC (iza-bren) from the National Medical Products Administration (NMPA) of China, marking a significant milestone in the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren is the first EGFR×HER3 dual antibody ADC to have its NDA accepted globally [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) in China [1] - Iza-bren is currently undergoing over 40 clinical trials in China and the United States for various tumor types [1] Group 2 - As of now, iza-bren has seven indications included in the CDE's list of breakthrough therapy designations [1] - Two indications have been included in the CDE's priority review list [1] - One indication has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA) [1]

Core Viewpoint - The company has received formal acceptance for the New Drug Application (NDA) of its first-in-class, new concept, and only EGFR×HER3 dual antibody ADC (iza-bren), which is currently in Phase III clinical trials for esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial, as determined by an independent data monitoring committee (iDMC) [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial (study protocol number: BL-B01D1-305) [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]

Core Insights - The National Medical Products Administration (NMPA) has accepted a new drug application for the first-in-class dual antibody ADC drug, iza-bren, developed by BaiLi Tianheng, aimed at treating recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after failure of PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1][2] - The application is based on positive results from a Phase III clinical trial, which met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a pre-specified interim analysis [1] - Esophageal cancer has a significant global burden, with approximately 510,000 new cases and 445,000 deaths annually, and China accounts for about 224,000 new cases, representing 43.8% of the global total [1] Group 1 - Iza-bren has shown anti-tumor activity, safety, and efficacy in a Phase Ib clinical study published in the journal Nature Medicine [2] - Currently, over 40 clinical studies are ongoing for iza-bren in China and the U.S., including 10 registration Phase III studies in China and 3 global pivotal registration studies [2] - Seven indications for iza-bren have been included in the breakthrough therapy designation list by the CDE, and one indication has been designated as breakthrough therapy by the FDA [2] Group 2 - There are currently only 10 new biological drugs approved for esophageal cancer treatment globally, with no ADCs approved yet [3] - If approved, BL-B01D1 will become the first ADC drug for the treatment of esophageal cancer worldwide [3]

2023年12月，百利天恒就公司自主研发的iza-bren(BL-B01D1、EGFR×HER3双抗ADC)项目与BMS(百时 美施贵宝)达成独家许可与合作协议，在全球范围内进行共同开发和商业化。根据合作协议，BMS将向 百利天恒支付8亿美元的首付款，和两笔2.5亿美元的近期或有付款；达成开发、注册和销售里程碑后， 百利天恒将获得最高可达71亿美元的额外付款；潜在总交易额最高可达84亿美元，创下了全球ADC领 域对外授权的单药总价纪录。 第三方医药数据情报分析平台"丁香园Insight数据库"显示，目前全球范围仅有10款生物药新药用于食管 癌治疗，但尚未有ADC获批。如获批准，BL-B01D1将成为全球首个适用于食管癌治疗的ADC药物。 中证报中证网讯(记者吴科任)1月20日，国家药品监督管理局药品审评中心(CDE)官网显示，百利天恒1 类新药注射用药品BL-B01D1上市申请于当日获受理。该药物的适应症为：用于既往经PD-1/PD-L1单抗 联合含铂化疗治疗失败的复发性或转移性食管鳞癌。该适应症此前已被CDE纳入突破性治疗品种名单。 公开信息显示，BL-B01D1(Iza-bren)是一款全球首创双抗ADC ...

Investment Rating - The report maintains an "Outperform" rating for several companies, including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical [6][7]. Core Insights - The annual J.P. Morgan Healthcare Conference concluded successfully, with positive information from global pharmaceutical companies, including new pipeline disclosures and major deals. The report highlights the high prosperity in the innovative drug sector and recommends continuous investment in innovative drugs and the industry chain [25][26]. - The A-Shares pharmaceutical sector underperformed the market in the third week of January 2026, with the Shanghai Composite Index falling by 0.4% and the SW Pharmaceutical and Biological sector declining by 0.7% [8][27]. - The Hong Kong stock pharmaceutical sector performed in line with the market, while the U.S. pharmaceutical sector underperformed. The Hang Seng Healthcare index increased by 2.4%, and the S&P 500 Healthcare Select Sector decreased by 1.1% [28]. Summary by Sections Section 1: Continuous Recommendation of Innovative Drugs and Industry Chain - The report emphasizes the high prosperity of innovative drugs and maintains overweight ratings for key pharmaceutical companies. It also recommends Biopharma/Biotech companies with promising pipelines and volume increases, as well as CXO and upstream companies benefiting from innovation [6][25]. Section 2: A-Shares Pharmaceutical Sector Performance - In the third week of January 2026, the A-Shares pharmaceutical sector's performance was ranked 17th among Shenwan primary industries, with a decline of 0.7%. The medical service sub-sector showed a positive performance of +3.3% [8][12][27]. Section 3: Hong Kong and U.S. Pharmaceutical Sector Performance - The Hong Kong pharmaceutical sector performed similarly to the market, while the U.S. sector underperformed. Notable gainers in the U.S. included MODERNA (+22%) and QUEST DIAGNOSTICS (+9%), while major decliners included BIOGEN (-12%) and BOSTON SCIENTIFIC (-10%) [28].

Core Viewpoint - OAPIII (HK) Limited plans to reduce its stake in Sichuan Baili Tianheng Pharmaceutical Co., Ltd. by up to 4.13 million shares, representing 1% of the company's total share capital, due to its own funding needs [1] Group 1 - OAPIII (HK) Limited currently holds 28,527,171 shares in the company, which accounts for 6.91% of the total share capital [1] - The shares to be sold were acquired prior to the company's initial public offering and will be released from restrictions on January 8, 2024, allowing them to be traded [1]

Group 1: Target Price Increases - The companies with the highest target price increases from January 12 to January 18 are Baili Tianheng, Hunan YN, and Huali Technology, with target price increases of 319.47%, 85.81%, and 58.27% respectively, belonging to the chemical pharmaceuticals, battery, and entertainment products industries [1][2]. Group 2: Broker Recommendations - A total of 191 listed companies received broker recommendations during the same period, with Dongpeng Beverage receiving 9 recommendations, and Pudong Development Bank receiving 8 recommendations [3][4]. - The top recommended companies include Dongpeng Beverage, Pudong Development Bank, and Guizhou Moutai, with respective recommendations from 9, 8, and 7 brokers [3][4]. Group 3: Rating Adjustments - Four companies had their ratings upgraded, including Jiayuan Technology from "Hold" to "Buy" by Tianfeng Securities, and Dike Co. from "Hold" to "Strong Buy" by CMB [5]. - One company, Shaanxi Energy, had its rating downgraded from "Buy" to "Hold" by Guotou Securities [6]. Group 4: First Coverage - During the same period, 60 instances of first coverage were reported, with companies like Chuanjin Nuo and Dongyangguang receiving "Hold" ratings from Guotai Junan Securities [7]. - Other companies receiving first coverage include Qiaoyin Co. with a "Buy" rating from Guosheng Securities, and Yubang Power with a "Buy" rating from Zheshang Securities [7].

Group 1 - The core viewpoint of the article highlights significant target price increases for certain companies, with Baile Tianheng leading at a 319.47% increase, followed by Hunan Yuneng at 85.81% and Huali Technology at 58.27% [1] - The companies with the highest target price increases belong to the chemical pharmaceuticals, battery, and entertainment products industries [1] - A total of 191 listed companies received broker recommendations during the period from January 12 to January 18, with Dongpeng Beverage receiving the most recommendations at 9, followed by Pudong Development Bank with 8, and Chao Hong Ji, Changjiang Electric Power, and Kweichow Moutai each receiving 7 [1]

Economic Information - Several smartphone manufacturers, including Xiaomi, OPPO, vivo, and Transsion, have lowered their annual shipment forecasts, with Xiaomi and OPPO reducing by over 20%, vivo by nearly 15%, and Transsion to below 70 million units [2] - Silver prices have surged over 50% in one month and over 150% in six months, impacting the photovoltaic industry, which consumes a significant amount of silver. The cost of raw materials for solar cells has increased by nearly 20% due to rising silver prices [2] - The company Xibei is expected to incur cumulative losses exceeding 600 million yuan from September 2025 to March 2026, leading to the closure of 102 stores, accounting for 30% of its total outlets [2] Company Alerts - Shenghong Technology anticipates a net profit increase of 260%-295% year-on-year for 2025, although Q4 performance fell short of expectations [4] - Cambridge Technology expects a net profit increase of 51%-67% year-on-year for 2025, with Q4 results also below expectations [4] - Multiple companies, including Weimait and Youyan Silicon, have announced plans to reduce their shareholdings by up to 4.98% and 3% respectively [4][11] Overseas Alerts - The three major U.S. stock indices collectively declined last Friday, with the Nasdaq China Golden Dragon Index dropping by 1.15%. Notable declines were seen in Chinese stocks such as Alibaba and JD.com [5] - The European Union is considering imposing tariffs on U.S. goods worth 93 billion euros in response to U.S. tariffs on eight European countries, which could take effect on February 6 if no agreement is reached [5]