Investment Rating - The investment rating for the company is "Outperform the Market" and is maintained [1] Core Views - The company is making significant progress in its core pipeline, particularly with the EGFR*HER3 dual antibody ADC BL-B01D1, which has received breakthrough therapy designation for multiple indications in China, indicating strong official support and potential acceleration in clinical development [3] - The company has also received FDA approval to initiate Phase I clinical trials for its CD33 ADC BL-M11D1, suggesting potential opportunities in its other research pipelines [3] - Earnings forecasts indicate a projected net profit of 4.089 billion yuan in 2024, with corresponding EPS of 10.20 yuan, reflecting a significant recovery from previous losses [3] Summary by Sections Investment Rating - The company maintains an "Outperform the Market" rating based on expected stock performance relative to the benchmark index [1] Clinical Development Progress - BL-B01D1 has received breakthrough therapy designation for four indications, with ongoing clinical trials in both China and globally, enhancing its potential for frontline treatment in various cancers [3][5] - The FDA has approved the initiation of Phase I clinical trials for BL-M11D1, expanding the company's clinical portfolio [3][7] Financial Forecasts - Projected revenues for 2024 are expected to reach 6.213 billion yuan, with a significant year-on-year growth of 1005.8% [4] - The company anticipates a net profit of 4.089 billion yuan in 2024, with EPS expected to be 10.20 yuan, indicating a strong recovery trajectory [3][8]

证券代码：688506 证券简称：百利天恒 公告编号：2024-057 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。 近日，四川百利天恒药业股份有限公司（以下简称"公司"）的全资子公司 SystImmune,Inc.收到美国食品药品监督管理局（以下简称"FDA"）的通知， BL-M11D1（CD33-ADC）用于治疗复发或难治性急性髓系白血病患者的 I 期临 床试验申请已获得 FDA 许可，现将相关情况公告如下： 一、本次许可的基本情况 药品名称：BL-M11D1 申请编号：IND171813 申请人：SystImmune,Inc. 四川百利天恒药业股份有限公司 自愿披露关于 BL-M11D1（CD33-ADC）用于治疗复发或 难治性急性髓系白血病患者的 I 期临床试验申请 获得 FDA 许可的公告 包括本次 BL-M11D1 新获得 FDA 许可，截至目前，共有 5 个项目已获 FDA 许可开展临床研究，其他4个分别是：BL-B01D1、BL-M07D1、SI-B001、BL-M05D1 在美国的临床试验。 三、对公司 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-056 四川百利天恒药业股份有限公司 自愿披露关于注射用 BL-B01D1 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患者 纳入突破性治疗品种名单的公告 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。 四川百利天恒药业股份有限公司（以下简称"公司"）自主研发的创新生物药 注射用 BL-B01D1 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 转移性食管鳞癌患者已被国家药品监督管理局药品审评中心（以下简称"药审中心"） 纳入突破性治疗品种名单，近日已完成公示，现将主要情况公告如下： | 药品名称 | 注射用 BL-B01D1 | | | | --- | --- | --- | --- | | 受理号 | CXSL2101249 | | | | 药品类型 | 治疗用生物制品 | | | | 注册分类 | 1 | | | | 申请日期 | 2024 年 月 日 | 8 | 9 | | 拟定适应症 | ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-055 四川百利天恒药业股份有限公司 自愿披露关于注射用 BL-B01D1 用于 EGFR 敏感突变 及 EGFR 野生型非小细胞肺癌患者的 2 项适应症 纳入突破性治疗品种名单的公告 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。 BL-B01D1 是公司自主研发的全球首创也是唯一进入临床阶段的靶向 EGFR× HER3 的双抗 ADC。BL-B01D1 正在中国和美国进行超过 20 项多种肿瘤类型的临床 试验。包括(i)评估 BL-B01D1 单药用于癌症后线治疗的 7 个 III 期临床试验，包括 2 个非小细胞肺癌适应症、1 个小细胞肺癌适应症、2 个乳腺癌适应症、1 个食管鳞癌 适应症、1 个鼻咽癌适应症，(ii)评估其与 PD-(L)1 疗法联用于一线治疗 9 种癌症适 应症（小细胞肺癌、非小细胞肺癌、鼻咽癌、头颈鳞癌、食管癌、胃癌、结直肠癌、 乳腺癌及尿路上皮癌）的 8 个 II 期临床试验，(iii)评估其与 TKI 联用用于肺癌一线 治疗的 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-054 四川百利天恒药业股份有限公司 关于 BL-B01D1 联合用药项目用于治疗晚期实体瘤的 1/2a 期临床试验申请获得 FDA 许可的公告 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。 近日，四川百利天恒药业股份有限公司（以下简称"公司"）的合作伙伴百 时美施贵宝（以下简称"BMS"，纽交所代码：BMY）收到美国食品药品监督 管理局（以下简称"FDA"）的通知，BL-B01D1 联合用药项目用于治疗晚期实 体瘤的 1/2a 期临床试验申请已获得 FDA 许可，现将相关情况公告如下： 一、本次许可的基本情况 药品名称：BL-B01D1 联合用药 适应症：晚期实体瘤 审批结论：FDA 已许可本品开展临床研究 二、药品的基本信息 BL-B01D1 是全球首创也是唯一进入临床阶段的靶向 EGFR×HER3 的双抗 ADC。2023 年 12 月，公司与 BMS 就 BL-B01D1 项目达成独家许可与合作协议， 此项合作可加速推进 BL-B01D1 针对多种恶 ...

Investment Rating - The investment rating for the company is "Outperform the Market" [1] Core Insights - The report highlights the promising data for BL-B01D1 in treating UC, BTC, and ESCC, indicating its potential as a cornerstone drug in these areas [4][6] - The company is expected to achieve significant revenue growth in 2024, with a projected net profit of 4.089 billion yuan, leading to an estimated EPS of 10.20 yuan [5][11] - The report utilizes DCF valuation method, suggesting a reasonable stock price range of 214.73 to 226.83 yuan [4] Financial Performance Summary - The company reported a revenue of 562 million yuan in 2023, with a forecasted increase to 6.213 billion yuan in 2024, representing a year-on-year growth of 1005.8% [5][11] - The net profit for 2023 is projected to be -780 million yuan, with a significant turnaround expected in 2024 to 4.089 billion yuan [5][11] - The gross margin is expected to stabilize around 58.2% in 2024, improving to 70.9% by 2026 [5][11] Clinical Development Insights - BL-B01D1 has shown superior disease control rates (ORR of 40.7% and 6-month PFS rate of 62.4%) compared to other ADCs in late-line treatment for mUC [6][8] - The ongoing global Phase I clinical trial for BL-B01D1 is expected to yield data in 2025, with plans for initiating registration trials in the same year [9][10]

Investment Rating - The report assigns an "OUTPERFORM" rating to Sichuan Biokin Pharmaceutical with a target price of Rmb 226.83 [1][3][55]. Core Insights - Sichuan Biokin Pharmaceutical has transitioned from a focus on generic drugs to innovative drug development, establishing a robust R&D pipeline with significant partnerships, including a global cooperation agreement with BMS for the EGFR*HER3 dual antibody ADC, BL-B01D1, which has a potential total value of $8.4 billion [1][2][66]. - BL-B01D1 is positioned to become a blockbuster anti-tumor drug, demonstrating broad therapeutic potential and advantages in toxicity reduction and treatment range expansion [2][66]. - The company has 11 innovative biological drugs in clinical stages, with 3 in registration clinical stages, showcasing its strong R&D capabilities [1][2][66]. Summary by Sections Company Overview - Sichuan Biokin Pharmaceutical has evolved through three phases: from developing generic drugs to focusing on innovative biological drugs, supported by the establishment of R&D centers in China and the US [8][9]. - The company has developed three core platforms: SEBA dual antibody platform, GNC multi-specific T cell engager platform, and HIRE-ADC platform, which are crucial for its innovative drug development [18][19]. Clinical Pipeline - BL-B01D1 has initiated Phase III clinical trials for multiple indications, including NSCLC, NPC, ESCC, SCLC, and breast cancer, with an NDA application expected by 2026 [2][29][32]. - Other promising drugs in the pipeline include SI-B001, a dual antibody targeting EGFR-HER3, and BL-M07D1, an ADC targeting HER2, both showing strong early clinical data [2][21][39]. Financial Projections - The company is expected to achieve net profits of Rmb 4.09 billion in 2024, with a projected EPS of Rmb 10.20, followed by losses in 2025 and 2026 [3][54]. - The DCF valuation method suggests a target price of Rmb 226.83 per share, indicating significant growth potential as the company enters a high-growth phase [3][55][56].

公司点评 2024 年 09 月 19 日 买入/维持 百利天恒(688506) 目标价: 268.33 昨收盘:164.53 2 线 UC 6 个月 PFS 率 100%，关注年底乳腺癌数据更新 走势比较 (20%) 8% 36% 64% 92% 120% 23/9/18 23/11/3024/2/1124/4/2424/7/624/9/17 百利天恒 沪深300 股票数据 总股本/流通(亿股) 4.01/0.90 总市值/流通(亿元) 659.77/148.82 12 个月内最高/最低价 (元) 215.71/76.32 相关研究报告 《百利天恒深度报告（688506）：厚积 薄发的 ADC 和多抗龙头，携手 BMS 掘金全球市场（2024.08.31）》 证券分析师：周豫 E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：霍亮 E-MAIL：huoliang@tpyzq.com 分析师登记编号：S1190523070002 研究助理：戎晓婕 E-MAIL：rongxj@tpyzq.com 一般证券业务登记编号：S1190123070050 事件： ...

[Table_MainInfo] 公司研究/医药与健康护理/生物科技 证券研究报告 百利天恒-U（688506）公司研究报告 2024 年 09 月 22 日 [Table_InvestInfo] 投资评级 优于大市 首次 覆盖 | --- | --- | |---------------------------------------------------|--------------| | 股票数据 | | | 09 [ Table_StockInfo 月 20 日收盘价（元） ] | 157.99 | | 52 周股价波动（元） | 76.32-215.71 | | 总股本 / 流通 A 股（百万股） | 401/90 | | 总市值 / 流通市值（百万元） 相关研究 | 63354/14290 | 市场表现 [Table_QuoteInfo] -23.86% 3.14% 30.14% 57.14% 84.14% 111.14% 2023/9 2023/12 2024/3 2024/6 百利天恒-U 海通综指 | --- | --- | --- | --- | |------------------- ...

四川百利天恒药业股份有限公司 自愿披露关于 GNC-077 多特异性抗体注射液项目 证券代码：688506 证券简称：百利天恒 公告编号：2024-053 申请人：四川百利药业有限责任公司；成都百利多特生物药业有限责任公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2024 年 7 月 16 日受理的 GNC-077 多特异性抗体注射液临床试验申请符合药品注册的有关 要求，同意开展晚期实体瘤的临床试验。 二、药品的其他情况 GNC-077 是公司依靠全球领先的创新多特异性抗体药物研发平台（GNC 平 台）自主研发的一种创新的多特异性抗体分子，其分子结构包括靶向 T 细胞 CD3 和 T 细胞免疫检查点的抗体结构域，以及靶向肿瘤抗原的抗体结构域。GNC-077 可有效诱导 T 细胞的活化、分化及增殖，并介导活化的 T 细胞特异性靶向杀伤 肿瘤抗原阳性的肿瘤细胞。 治疗晚期实体瘤获得 I 期临床试验批准通知书的公告 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。 四川百利天恒药业股份有限公司（以下简称"公司"） ...