国投证券股份有限公司 关于四川百利天恒药业股份有限公司 随着公司业务的持续推进，为满足公司及全资子公司发展的资金需求，进一 步拓宽融资渠道，公司及全资子公司拟在 2023 年年度股东大会审议通过的 2024 年度申请综合授信额度基础上增加向金融机构申请不超过人民币 15 亿元的综合 授信额度，授信额度在有效期内可循环使用，并为增加的综合授信额度内的融资 相互提供预计不超过人民币 15 亿元的担保，具体担保金额、担保期限、担保费 率等内容，由公司及被担保人与贷款银行等金融机构在以上额度内共同协商确定， 1 相关担保事项以正式签署的担保文件为准。担保项下银行授信用途和/或涉及项 目，应符合公司经批准的经营计划。 本次增加担保额度是基于目前公司业务情况的预计，为确保公司及全资子公 司生产经营的实际需要，在总体风险可控的基础上在公司合并范围内相互提供担 保。授权期限内，该等担保额度可在被担保人中进行调剂。公司董事会提请股东 大会授权公司管理层在股东大会审议通过之日起至 2025 年 5 月 16 日（前述不超 过 20 亿元担保额度的有效期截止日），根据公司实际经营情况的需要，在上述担 保额度范围内，全权办理提供担保 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-060 四川百利天恒药业股份有限公司 关于增加 2024 年度公司及下属公司向金融机构申请 综合授信额度及担保额度的公告 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。 重要内容提示： ● 本次担保是否有反担保：无 ● 本事项尚需提交公司 2024 年第三次临时股东大会审议。 一、增加申请综合授信额度及担保额度情况概述 （一）已审议通过的申请综合授信额度及担保额度情况 公司于 2024 年 4 月 26 日召开了第四届审计委员会 2024 年第二次会议、第 四届董事会第十四次会议、第四届监事会第十二次会议，审议通过了《关于 2024 年度公司及下属公司向金融机构申请综合授信并提供担保的议案》，同意公司及 全资子公司向金融机构申请不超过人民币 20 亿元的综合授信额度，授信额度在 有效期内可循环使用，并为综合授信额度内的融资相互提供预计不超过人民币 20 亿元的担保额度，有效期为公司 2023 年年度股东大会审议通过后 12 个月内。 上述议案已经公司 2023 ...

Investment Rating - The investment rating for the company is "Outperform the Market" [1] Core Insights - The report highlights significant clinical advancements for the company's drug candidates, particularly BL-B01D1 and BL-M11D1, which are expected to be key catalysts for growth in 2025 [4][5] - The company is projected to achieve a substantial increase in revenue in 2024, with an estimated operating income of 6.213 billion yuan, representing a year-on-year growth of 1005.8% [6][11] - The report anticipates a return to profitability in 2024, with a forecasted net profit of 4.089 billion yuan and an earnings per share (EPS) of 10.20 yuan [6][11] Summary by Sections Clinical Development - Event 1: BMS has updated its clinical advancement plan for BL-B01D1, with expected results from Phase I trials in 2025, which are considered critical milestones [4] - Event 2: The company will present early clinical data for CD33 ADC BL-M11D1 at the 2024 ASH conference, showing promising treatment potential for r/r AML patients [5][8] Financial Forecast - The company is expected to report a net profit of 4.089 billion yuan in 2024, with a projected EPS of 10.20 yuan [6][11] - Revenue is forecasted to increase significantly in 2024, with a total operating income of 6.213 billion yuan [6][11] Market Potential - The report identifies a large unmet clinical need in the r/r AML market, with over 40,000 new cases annually in China and over 20,000 in the U.S. [7] - BL-M11D1 targets CD33, which is expressed in approximately 85-90% of AML patients, indicating a broad potential treatment scope [8]

证券代码：688506 证券简称：百利天恒 公告编号：2024-058 四川百利天恒药业股份有限公司 自愿披露关于 BL-M17D1（ADC）用于治疗晚期实体瘤 患者的 I 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-M17D1（ADC）用于治疗晚期实体瘤患者的 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-M17D1 申请编号：171882 申请人：SystImmune,Inc. 二、其他基本情况 BL-M17D1 是与 BL-B16D1 出自同一新的小分子技术平台、与 BL-B16D1 共 享同一新的"连接子+毒素"平台的 ADC 药物，其适应症为晚期实体瘤。 包括本次 BL-M17D1 新获得 FDA 许可，截至目前，公司共有 6 个项目已获 FDA 许可开 ...

Financial Performance - In the first three quarters of 2024, the company achieved operating revenue of 5.663 billion CNY, a year-on-year increase of 1,399.22% [5] - The net profit attributable to shareholders was 4.065 billion CNY, with a net profit of 4.043 billion CNY after deducting non-recurring gains and losses [5] - The significant revenue growth was primarily due to an irrevocable and non-deductible upfront payment of 800 million USD received from BMS under the BL-B01D1 cooperation agreement [5] Research and Development - R&D investment for the first three quarters of 2024 was 932 million CNY, an increase of 422 million CNY or 80.34% compared to 510 million CNY in the same period of 2023 [6] - The company is conducting 7 Phase III registration clinical trials for BL-B01D1, covering multiple indications including non-small cell lung cancer and esophageal squamous cell carcinoma [8] Collaboration with BMS - In addition to the upfront payment, BMS may pay up to 500 million USD for recent or contingent payments, and up to 7.1 billion USD in milestone payments upon achieving development, registration, and sales milestones [6] - The company has 5 projects approved by the FDA for clinical research in the U.S., including BL-B01D1 and BL-M11D1 [9] Clinical Trial Progress - As of October 2024, BL-B01D1 has been included in the breakthrough therapy designation list for several indications, enhancing its development priority [8] - The GNC platform has developed 4 innovative multi-specific antibody drugs currently in clinical stages, with GNC-038 and GNC-035 undergoing Phase Ib/II clinical studies [10] IPO Progress - The company's Hong Kong IPO project is currently in progress, with further details to be disclosed in future announcements [10]

Financial Performance - The company's revenue for Q3 2024 reached ¥109,832,714.73, representing a 64.78% increase year-over-year[2] - The net profit attributable to shareholders was -¥600,972,496.17 for the quarter, with a year-to-date net profit of ¥4,065,367,515.10, reflecting a significant increase of 1,399.22%[2] - The total operating revenue for the first three quarters of 2024 reached ¥5,662,560,246.21, a significant increase from ¥377,699,836.45 in the same period of 2023, representing a growth of approximately 1398.5%[16] - The net profit for the first three quarters of 2024 was ¥4,065,367,515.10, a turnaround from a net loss of ¥515,105,766.43 in the same period of 2023[17] - The total comprehensive income for the first three quarters of 2024 is CNY 4,080,957,866.61, while it was a loss of CNY 517,514,257.99 in the previous year[18] - Basic and diluted earnings per share for the first three quarters of 2024 are CNY 10.14, compared to a loss of CNY 1.28 per share in the same period of 2023[18] Research and Development - Research and development (R&D) expenses totaled ¥387,170,570.48 for the quarter, up 110.65% compared to the same period last year[3] - R&D expenses accounted for 352.51% of revenue in Q3 2024, an increase of 76.77 percentage points year-over-year[3] - Research and development expenses surged to ¥931,701,202.14 in the first three quarters of 2024, up from ¥509,799,039.53 in 2023, reflecting an increase of approximately 82.7%[17] - The report indicates that the company is actively engaged in research and development of new technologies, although specific advancements were not detailed[12] Assets and Liabilities - Total assets at the end of the reporting period were ¥6,960,162,590.08, a 388.40% increase compared to the previous year[3] - The total assets as of the end of the third quarter of 2024 amounted to ¥6,960,162,590.08, compared to ¥1,425,099,282.62 at the end of the third quarter of 2023, marking an increase of approximately 388.5%[16] - The total liabilities for the company reached ¥2,718,263,644.16, up from ¥1,273,225,982.60 in the previous year, which is an increase of about 113.5%[16] - The total liabilities and shareholders' equity as of September 30, 2024, were not specified but are critical for assessing the company's financial health[14] Cash Flow and Liquidity - The company reported a net cash flow from operating activities of -¥534,191,877.93 for the quarter, primarily due to increased tax payments and R&D investments[5] - Cash inflow from operating activities for the first three quarters of 2024 is CNY 6,151,840,374.07, significantly up from CNY 496,361,943.72 in the previous year[19] - The net cash flow from operating activities for the first three quarters of 2024 is CNY 4,494,488,783.12, compared to a net outflow of CNY 480,074,664.80 in the same period of 2023[19] - The cash and cash equivalents at the end of the period for the first three quarters of 2024 amount to CNY 4,922,577,373.88, compared to CNY 385,356,845.46 at the end of the same period in 2023[20] - The company's cash and cash equivalents reached approximately ¥4.98 billion, a significant increase from ¥403.96 million at the end of 2023, reflecting a growth of over 1,134%[14] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 4,098[7] - The largest shareholder, Zhu Yi, holds 74.35% of the shares, totaling 298,159,400 shares[7] Government Support - The company received government subsidies amounting to ¥705,971.27 during the quarter, contributing to its non-operating income[4] Strategic Direction - The company is focusing on expanding its market presence and developing new products, although specific details were not disclosed in the report[12] - The company plans to continue expanding its market presence and investing in new product development to sustain growth momentum[16] - The company has not reported any significant mergers or acquisitions during the quarter, maintaining its current strategic direction[12] - Future performance guidance was not explicitly provided, but the company remains optimistic about growth prospects based on current trends[12]

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 ...