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百利天恒双抗ADC又一上市申请获受理
Huan Qiu Wang· 2026-01-20 10:16
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]
百利天恒BL-B01D1上市申请获受理 系适用于食管癌治疗ADC药物
Zhong Zheng Wang· 2026-01-20 08:00
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 ...
HTI 医药 2026 年 1 月第三周周报:JPM大会落幕,推荐创新药械产业链-20260119
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].
百利天恒:股东OAPIII(HK)Limited拟减持不超1%公司股份
Cai Jing Wang· 2026-01-19 06:10
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]
贵州茅台等191股获推荐 百利天恒目标价涨幅超300%丨券商评级观察
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].
贵州茅台等191股获推荐,百利天恒目标价涨幅超300%丨券商评级观察
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]
1月19日投资避雷针:2400亿PCB龙头四季度业绩低于预期
Xin Lang Cai Jing· 2026-01-19 00:33
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]
国泰海通医药 2026年1月第三周周报:JPM 大会落幕,推荐创新药械产业链-20260118
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical sector [6][26]. Core Insights - The report emphasizes the continuous recommendation of innovative pharmaceuticals and medical devices, highlighting the high growth potential in the sector. It maintains "Overweight" ratings for companies such as Heng Rui Medicine, Hansoh Pharmaceutical, Sanofi, Kelun Pharmaceutical, and Enhua Pharmaceutical. It also recommends Biopharma/Biotech companies like Kelun Biotech, BeiGene, and others, as well as CXO and upstream pharmaceutical companies [6][3]. Summary by Sections 1. Continuous Recommendation of Innovative Pharmaceuticals and Medical Devices - The report highlights the high growth potential of innovative drugs and recommends several companies for investment, including Heng Rui Medicine, Hansoh Pharmaceutical, Sanofi, Kelun Pharmaceutical, and Enhua Pharmaceutical. It also suggests Biopharma/Biotech companies like Kelun Biotech, BeiGene, and others, as well as CXO and upstream pharmaceutical companies [6][7]. 2. A-share Pharmaceutical Sector Performance - In the third week of January 2026, the A-share pharmaceutical sector underperformed the broader market, with the Shanghai Composite Index declining by 0.4% and the SW Pharmaceutical and Biotech index falling by 0.7% [8][11]. 3. Hong Kong and US Market Performance - The Hong Kong pharmaceutical sector performed in line with the market, while the US pharmaceutical sector underperformed. In the same week, the Hang Seng Healthcare index rose by 2.4%, and the S&P 500 healthcare sector fell by 1.1% [19][20].
四川百利天恒药业股份有限公司关于持股5%以上股东减持股份计划公告
Core Viewpoint - The major shareholder OAP III (HK) Limited plans to reduce its stake in Sichuan Baili Tianheng Pharmaceutical Co., Ltd. due to personal funding needs, intending to sell up to 4,128,738 shares, which represents no more than 1.00% of the company's total share capital [1][2]. Shareholder Information - As of the announcement date, OAP III (HK) Limited holds 28,527,171 shares, accounting for 6.91% of the total share capital of the company [1]. - The shares to be sold were acquired prior to the company's initial public offering and have been released from restrictions as of January 8, 2024 [1]. Reduction Plan Details - The reduction will occur through centralized bidding within three months after the announcement, starting fifteen trading days from the disclosure date [1]. - The selling price will be determined based on the market price at the time of the sale, and it will not be lower than the initial public offering price [2]. Compliance and Commitments - OAP III (HK) Limited has no other arrangements regarding the reduction and has made prior commitments regarding its shareholding, including not transferring shares within 12 months of the company's listing [3][4]. - The company has agreed to compensate for any losses incurred due to violations of these commitments [4][5]. Regulatory Compliance - The planned reduction complies with relevant laws and regulations, including the Shanghai Stock Exchange's guidelines for shareholder reductions [8].
百利天恒股东OAP III (HK) Limited拟减持不超1%公司股份
Bei Jing Shang Bao· 2026-01-16 13:20
Core Viewpoint - OAP III (HK) Limited plans to reduce its stake in Baili Tianheng (688506) by selling up to 4.1287 million shares, representing no more than 1% of the company's total share capital, due to its own funding needs [1]. Group 1 - The announcement was made on January 16, indicating the timeline for the share reduction will be within three months after the disclosure, starting fifteen trading days from the announcement date [1]. - The share reduction will be executed through a centralized bidding method [1].