近日，百利天恒（688506.SH）宣布，其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-bren）在食管鳞癌的III期临床试验（研究方案 编号：BL-B01D1-305）中，经独立数据监查委员会（iDMC）判断，在预设的期中分析中达到无进展生 存期（PFS）和总生存期（OS）双主要终点，适应症为：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。这是全球首个ADC药物在食管癌治疗中取得PFS/OS双阳性结果的III期 临床研究。 BL-B01D1-305研究的期中分析结果表明，iza-bren相比化疗，期中分析达到研究的无进展生存期 （PFS）和总生存期（OS）双主要终点，研究结果具有统计学显著获益和重大临床获益。值得一提的 是，该适应症已被国家药品监督管理局药品审评中心（CDE）纳入突破性治疗品种名单，百利天恒将于 近期向CDE递交上市前沟通交流申请，预计明年国内商业化落地。食管鳞癌市场潜力巨大，中国食管癌 患者占全球53.7%，且晚期食管鳞癌(ESCC)患者5年生存率不足 ...

11月12日，百利天恒在港交所发布公告称，公司股票原定于11月17日上午9时在联交所开始交易。鉴于 现行市况，公司决定全球发售延迟，将不会根据招股章程进行，并将退回香港公开发售的申请股款。 来源：公司公告 延迟全球发售 2024年7月10日，公司向香港联交所递交此次发行上市申请，并于同日在香港联交所网站刊登此次发行 上市的申请资料。按照发行上市的时间安排，公司分别于2025年1月21日、2025年9月29日向香港联交所 分别重新递交本次发行的申请，并于同日在香港联交所网站刊登本次发行的申请资料。 百利天恒11月12日发布公告称，原定于11月7日至12日中午进行的公开招股已停止，将不会根据招股章 程进行全球发售。 对于延迟上市的后续安排，百利天恒宣布，所有公开发售的申请款项将悉数退还，退款安排预计11月17 日完成。公司与包销商相关的协议也不会生效。 公告称，延迟全球发售的决定不影响公司的目前业务。同时，公司及其整体协调人正在审慎评估有关全 球发售及上市的更新时间表。 责任编辑：杨红卜 2024年12月11日，公司收到中国证监会出具的《关于四川百利天恒药业股份有限公司境外发行上市备案 通知书》，中国证监会对公司 ...

公司开发的Iza-bren是全球首创且迄今唯一一款进入III期临床阶段的EGFR×HER3双特异性抗体ADC。 公司致力于解决未被满足的临床需求，在ADC/GNC/ARC等肿瘤大分子治疗领域拥有全球领先的创新研 发、临床开发和生产供应能力。 百利天恒已通过港交所主板上市聆讯，高盛、摩根大通、中信证券为其联席保荐人。 ...

Group 1 - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. is preparing for an IPO in Hong Kong with Goldman Sachs, JPMorgan, and CITIC Securities as joint sponsors [1] - The funds raised from the IPO will be allocated for R&D of candidate biopharmaceuticals outside mainland China, establishing a global supply chain, and operational funding for overseas business [1][2] - The company focuses on innovative biopharmaceuticals and has a leading position in the field of tumor macromolecule therapy, with a core product, iza-bren, being the first of its kind to enter Phase III clinical trials [2] Group 2 - Sichuan Baili Tianheng operates two main business segments: innovative biopharmaceuticals and generic/traditional Chinese medicine, with the former supported by the latter [2] - The company has established dual R&D centers in Seattle, USA, and China, employing a team of 1,360 researchers [2] - As of the latest feasible date, the company has 15 clinical-stage candidate drugs in its innovative pipeline, with iza-bren having submitted a new drug application for nasopharyngeal carcinoma in China [2]

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. is advancing its global strategy in the biopharmaceutical sector, focusing on innovative drug development in oncology, particularly in antibody-drug conjugates (ADC) [3][4][6]. Company Overview - Baili Tianheng is positioned as a comprehensive biopharmaceutical enterprise with a focus on addressing unmet clinical needs in the oncology field, aiming to achieve global commercialization capabilities by 2029 [3][4]. - The company has established a strong research and development (R&D) platform for ADCs, with nine ADC candidates in clinical stages and approximately 70 clinical studies conducted [4][5]. Financial Performance - The company's revenue for the six months ending June 30, 2022, 2023, 2024, and 2025 is projected to be approximately 701.83 million, 560.42 million, 5.82 billion, and 170.41 million RMB, respectively [6][7]. - The company reported losses of approximately 282.38 million, 780.50 million, 3.71 billion, and 1.12 billion RMB for the same periods [6][7]. Strategic Partnerships - Baili Tianheng has entered into a significant global strategic licensing and collaboration agreement with Bristol-Myers Squibb (BMS) for the co-development and commercialization of its ADC, Iza-bren, which is the first and only EGFR×HER3 bispecific ADC in clinical phase III [4][6]. - This partnership is expected to enhance the company's global revenue potential and establish clinical development and commercialization capabilities [6].

Core Viewpoint - The company Baillie Tianheng (688506.SH) has submitted a new IPO application to the Hong Kong Stock Exchange after two previous applications expired, driven by a significant increase in revenue and ongoing funding needs [1][11]. Group 1: Company Overview - Baillie Tianheng was founded in 1996 and is led by Chairman and CEO Zhu Yi, who holds 72.22% of the shares. The company focuses on innovative biopharmaceuticals, particularly in the field of oncology [3]. - The company operates two main business segments: innovative biopharmaceuticals and generic drugs, with a strategy to integrate North American and Chinese advantages to become a multinational pharmaceutical company [4]. Group 2: Financial Performance - In 2024, Baillie Tianheng achieved a revenue of 5.82 billion, marking a growth of over 900% year-on-year. The company reported a net profit of 3.71 billion for the same year [9][10]. - A significant portion (91.6%) of the 2024 revenue came from licensing and collaboration agreements with Bristol-Myers Squibb (BMS), indicating reliance on non-sustainable income sources [10]. Group 3: Research and Development - The company has developed nine ADC innovative drug candidates and is conducting approximately 70 clinical studies, including 16 key registration trials in China and three global trials [6][7]. - Baillie Tianheng's collaboration with BMS on the drug iza-bren is notable, with a total deal value of 8.4 billion, making it the largest single-asset deal in the ADC field to date [7]. Group 4: Funding and Future Plans - The company has raised 3.764 billion through a private placement to accelerate the development of its innovative drug pipeline and expand its product offerings [11]. - A projected funding gap of 4.819 billion is anticipated over the next three years, highlighting the ongoing need for capital to support R&D and operational activities [12].

Core Insights - Bailitianheng has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs, JPMorgan, and CITIC Securities as joint sponsors [1] Company Overview - Bailitianheng is a comprehensive biopharmaceutical company focused on tumor macromolecule therapy (ADC/GNC/ARC) [1] - The company established SystImmune in the United States and successfully developed the world's first EGFR×HER3 bispecific ADC drug, iza-bren (BL-B01D1), which has entered Phase III clinical development [1] Strategic Partnerships - In 2024, Bailitianheng reached a global strategic licensing and collaboration deal with BMS for iza-bren worth up to $8.4 billion, including an upfront payment of $800 million [1] Research and Development Pipeline - The company has established an innovative ADC drug research and development platform with 9 ADC candidates currently in clinical stages [1] - Bailitianheng has built a multispecific T-cell connector platform with 4 GNC innovative drug pipelines [1] - The company has also developed an innovative ARC drug research platform, with the ARC drug BL-ARC001 submitted for IND, which has the potential to become a global first [1]