四川百利天恒药业股份有限公司 董事会审计委员会 2023 年度履职报告 根据《上海证券交易所科创板股票上市规则》《上海证券交易所科创板上市 公司自律监管指引第 1 号——规范运作》《公司章程》和《董事会审计委员会工 作制度》等规定，四川百利天恒药业股份有限公司(以下简称"公司")董事会审 计委员会在加强财务报告审计监督、促进内部控制制度建立健全、提高会计信息 质量等方面认真履行了职责,现对 2023 年度履职情况汇报如下: 一、审计委员会基本情况 公司第四届董事会审计委员会由 3 名董事组成，分别为独立董事杨敏先生、 独立董事李明远先生、董事卓识先生，召集人为具有专业会计资格的独立董事杨 敏先生。审计委员会成员的组成及人员结构符合相关法律法规的规定。 二、审计委员会 2023 年度会议召开情况 2023 年度，审计委员会共计召开 8 次会议，主要就公司财务报告、募集资 金使用与管理、审计机构续聘等事宜进行了审议。具体如下： | 召开时间 | 届次 | 议案名称 | 表决情况 | | --- | --- | --- | --- | | 2023/1/13 | 审计委员会 2023 年第一 | 1、《关于使用暂时 ...

国投证券股份有限公司 国投证券股份有限公司（以下简称"国投证券"或"保荐机构"）作为四川百 利天恒药业股份有限公司（以下简称"百利天恒"或"公司"）首次公开发行股 票并在科创板上市持续督导阶段的保荐机构，根据《证券发行上市保荐业务管理 办法》《上市公司监管指引第2号——上市公司募集资金管理和使用的监管要求》 《上海证券交易所科创板股票上市规则》《上海证券交易所科创板上市公司自律监 管指引第1号——规范运作》等有关规定，对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事项进行了审慎核查，具体情况如下： 一、担保情况概述 （一）担保基本情况 为满足公司及全资子公司业务发展的资金需求，结合公司 2024 年度发展计 划，公司及全资子公司拟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总额 不超过人民币 20 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额机构在以上额度内共同协商确定，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 ...

Financial Performance - The company's operating revenue for Q1 2024 reached ¥5,462,123,134.28, representing an increase of 4,325.45% compared to the same period last year[2]. - Net profit attributable to shareholders was ¥5,005,155,365.45, with a basic earnings per share of ¥12.48[2]. - Operating profit for Q1 2024 was ¥5,073,322,380.44, compared to a loss of ¥176,093,605.32 in Q1 2023, indicating a turnaround in profitability[18]. - Net profit for Q1 2024 amounted to ¥5,005,155,365.45, a substantial recovery from a net loss of ¥166,829,778.92 in the same period last year[18]. - Earnings per share for Q1 2024 were ¥12.48, compared to a loss of ¥0.42 per share in Q1 2023, reflecting improved financial performance[19]. - The company reported a tax expense of ¥68,039,298.27 for Q1 2024, compared to a tax benefit of ¥8,593,514.15 in Q1 2023[18]. - Other comprehensive income for Q1 2024 was a loss of ¥1,446,905.08, compared to a loss of ¥3,309,126.89 in Q1 2023, indicating a reduction in negative impacts from other comprehensive items[18]. Assets and Liabilities - Total assets at the end of the reporting period amounted to ¥6,871,302,484.08, a 382.16% increase from the previous year[3]. - The total liabilities as of the end of the reporting period were ¥1,715,720,723.69, up from ¥1,273,225,982.60 in the previous year[15]. - The total current assets reached RMB 6,220,182,105.88, compared to RMB 775,819,668.40 at the end of 2023, indicating a substantial growth[13]. - The total liabilities include a significant rise in contract liabilities, which increased to RMB 358,367,935.32 from RMB 8,671,496.10, indicating a growth of over 4,000%[14]. - Short-term borrowings rose to RMB 375,446,270.22 from RMB 275,117,273.08, representing an increase of about 36.4%[14]. Shareholder Information - The total equity attributable to shareholders increased by 3,294.66% to ¥5,155,581,760.39 compared to the end of the previous year[3]. - The number of ordinary shareholders at the end of the reporting period was 3,070[6]. - The top shareholder, Zhu Yi, holds 74.34% of the shares, amounting to 298,108,880 shares[7]. - Total equity increased to ¥5,155,581,760.39 in Q1 2024, compared to ¥151,873,300.02 in Q1 2023, showing significant growth in shareholder value[15]. Cash Flow - The net cash flow from operating activities was ¥5,378,961,733.25, reflecting significant cash generation during the quarter[2]. - Cash inflow from operating activities in Q1 2024 was ¥5,829,179,801.63, a dramatic increase from ¥141,841,228.05 in Q1 2023[21]. - The net cash flow from investing activities was negative at approximately -$9.18 million, a decline of about $29.20 million year-over-year[22]. - The net cash flow from financing activities was positive at approximately $54.78 million, contrasting with a negative cash flow of about -$57.74 million in the previous period[22]. - The total cash and cash equivalents at the end of the period reached approximately $5.81 billion, an increase from $725.77 million in the previous period[22]. Research and Development - R&D investment totaled ¥248,767,838.91, up 56.52% year-on-year, but the proportion of R&D investment to operating revenue decreased by 124.22 percentage points to 4.55%[2][5]. - Research and development expenses for Q1 2024 were ¥248,767,838.91, up from ¥158,935,991.07 in Q1 2023, indicating a focus on innovation[17]. Market and Future Outlook - The company has not disclosed any new product developments or technological advancements during this reporting period[12]. - There is no indication of market expansion or mergers and acquisitions in the current financial report[12]. - The company has not provided any future outlook or performance guidance in the latest financial disclosures[12].

Profitability and Financial Performance - The company has not achieved profitability as of the reporting period due to high R&D costs and risks associated with the biopharmaceutical industry[4]. - The profit distribution plan for 2023 includes no cash dividends, no stock bonuses, and no capital reserve transfers to increase share capital[7]. - The company's operating revenue for 2023 was ¥561,870,733.49, a decrease of 20.11% compared to ¥703,281,558.80 in 2022[23]. - The net profit attributable to shareholders of the listed company was -¥780,498,884.81, compared to -¥282,379,086.34 in the previous year[23]. - The net cash flow from operating activities was -¥615,351,111.50, worsening from -¥258,649,086.53 in 2022[23]. - The total assets at the end of 2023 were ¥1,425,099,282.62, a decrease of 28.44% from ¥1,991,433,372.18 at the end of 2022[23]. - The net assets attributable to shareholders of the listed company decreased by 83.74% to ¥151,873,300.02 from ¥933,894,287.03 in 2022[23]. - The basic earnings per share for 2023 is -1.95 CNY, a decrease from -0.78 CNY in 2022[25]. - The net profit attributable to shareholders decreased by 498.12 million CNY compared to the previous year, primarily due to increased R&D expenses and decreased total profit[26]. - The weighted average return on net assets was -143.57% in 2023, compared to -148.18% in 2022[25]. Research and Development (R&D) Focus - The company plans to continue advancing its clinical trials for innovative biopharmaceuticals and is focused on sustainable development through talent acquisition[4]. - The company is actively working on its pipeline of innovative drugs, which is expected to enhance its market position in the future[4]. - R&D expenses accounted for 132.81% of operating revenue, an increase of 79.49 percentage points from 53.32% in 2022[25][26]. - The company is focused on the development of new drugs and technologies, including ADC drugs for treating breast cancer[23]. - The company aims to expand its market presence through strategic partnerships and acquisitions in the pharmaceutical sector[23]. - The company is committed to improving drug quality and consistency in line with national standards[23]. - The company plans to enhance its research capabilities in biopharmaceuticals and monoclonal antibodies[23]. - The company has established a comprehensive ADC drug R&D platform, enabling independent development of innovative ADC drugs[36]. - The company has established a complete drug research and development system and a specialized R&D technical team over 20 years of development[62]. - The company emphasizes independent innovation and original research technology accumulation, with R&D teams established in both China and the United States[62]. Clinical Trials and Drug Development - The I phase clinical trial for BL-B01D1 in the treatment of non-small cell lung cancer received FDA approval in July 2023 and is currently enrolling participants[37]. - BL-M07D1 has entered Phase III clinical trials for HER2-positive breast cancer in China, showing strong efficacy signals for other indications as well[39]. - In the U.S., BL-M07D1's Phase I clinical trial for solid tumors received FDA approval in December 2023 and is currently enrolling patients[39]. - SI-B001, a bispecific antibody targeting EGFR and HER3, has entered Phase III clinical trials for non-small cell lung cancer in China[44]. - SI-B003, targeting PD-1 and CTLA-4, is undergoing Phase II clinical trials in head and neck squamous cell carcinoma and non-small cell lung cancer[45]. - GNC-038, a tetravalent antibody, has shown clear efficacy signals in acute lymphoblastic leukemia and non-Hodgkin lymphoma, with multiple clinical studies ongoing[46]. - GNC-039, targeting brain gliomas, has demonstrated clear efficacy signals in its Phase Ia/Ib clinical trials[47]. - The company is advancing multiple projects in clinical trials, including SI-B001 and SI-B003, targeting non-small cell lung cancer and other solid tumors[97]. - The innovative drug BL-B01D1, targeting EGFR×HER3, has entered Phase III clinical trials for multiple cancers, including nasopharyngeal carcinoma and non-small cell lung cancer[115]. Market Position and Strategy - The company is committed to leveraging its existing product resources and continuously launching new products to maintain market advantages[4]. - The company has established a marketing network covering over 200 cities across more than 30 provinces in China, supporting rapid promotion of new drugs[78]. - The company is focusing on the commercialization of its products, with several new drug applications submitted for approval[108]. - The company is strategically positioning itself for future growth by investing in innovative therapies and expanding its market presence[171]. - The company has established a comprehensive procurement management system, ensuring strict compliance with GMP requirements for raw material procurement[64]. - The company is preparing for expected production approvals in 2024 and is actively participating in national and provincial drug procurement initiatives to increase market share[199]. Financial Management and Investments - The company invested a total of 50,786.63 million CNY in fundraising projects, with a usage ratio exceeding 57%[54]. - The company has reported a total investment of 500 million for the C14-24 fat emulsion injection project, with a current investment of 29.72 million and a cumulative investment of 335.22 million[102]. - The company has made significant investments in specific projects, such as SI-B001, with an investment of 10,429.89 million RMB, which accounted for 57.84% of its operating income[184]. - The total investment for the Guanfacine Hydrochloride sustained-release tablets project is estimated at $3.8 billion, with $752.98 million invested this period and a cumulative investment of $4.32 billion[105]. - The company has achieved a significant milestone with the BL-M09D1 project, having invested $435.56 million, also in preclinical research for a Class 1 therapeutic biological product for solid tumors[99]. Regulatory and Compliance - The company has received a standard unqualified audit report from its accounting firm, indicating the reliability of its financial statements[6]. - The company emphasizes the importance of risk awareness in its forward-looking statements regarding future plans and strategies[5]. - The company has not reported any violations of decision-making procedures regarding external guarantees[9]. - The company has established a quality management system to ensure safety and compliance throughout the drug development and production processes[197]. Challenges and Risks - The company faces risks related to ongoing losses and the need for substantial R&D investment, which may impact future profitability[122]. - The company is highly reliant on core technical personnel, and the loss of key employees could hinder R&D and commercialization goals[125]. - Regulatory changes in China's healthcare system may impact the company's operational strategies and compliance costs[129]. - The company reported a significant increase in lung cancer cases in China, rising from 828,000 cases in 2016 to 1,061,000 cases in 2022, reflecting a growth rate of 28.1%[72]. Product Development and Innovation - The company is actively pursuing IND applications for several products, including BL-M14D1 and BL-M17D1, indicating a robust pipeline[172]. - The company is focusing on expanding its product offerings in the anesthesia and sedation market, with multiple products in various stages of development[172]. - The company has developed a stable production process for its injectable drugs, ensuring product quality is consistent with reference formulations[108]. - The company is exploring new therapeutic areas, including treatments for respiratory syncytial virus and anaerobic infections, demonstrating its commitment to addressing unmet medical needs[173].

一、本次授权事项概述 根据《上市公司证券发行注册管理办法》《上海证券交易所上市公司证券发 行上市审核规则》《上海证券交易所上市公司证券发行与承销业务实施细则》等 法律法规和规范性文件的有关规定，四川百利天恒药业股份有限公司（以下简称 "公司"）于 2024 年 4 月 26 日召开第四届董事会第十四次会议，审议通过了 《关于提请股东大会授权董事会以简易程序向特定对象发行股票的议案》，同意 公司董事会提请股东大会授权董事会决定向特定对象发行融资总额不超过人民 币 3 亿元且不超过最近一年末净资产 20%的股票，授权期限为 2023 年年度股东 大会通过之日起至 2024 年年度股东大会召开之日止。上述议案尚需提交公司 2023 年年度股东大会审议通过。 二、本次授权具体内容 证券代码：688506 证券简称：百利天恒 公告编号：2024-019 四川百利天恒药业股份有限公司 关于提请股东大会授权董事会以简易程序向特定对象发行 股票的公告 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。 本次提请股东大会授权事项包括以下内容： ...

四川百利天恒药业股份有限公司 证券代码：688506 证券简称：百利天恒 公告编号：2024-016 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。 自愿披露关于"BL-B01D1+PD-1 单抗±化疗"治疗局部晚期 或转移性非小细胞肺癌获得 II 期临床试验批准通知书的公告 一、《药物临床试验批准通知书》基本情况 产品名称：注射用 BL-B01D1 受理号：CXSL2400112 通知书编号：2024LP00973 申请事项：境内生产药品注册临床试验 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 2 月 7 日受理的注射用 BL-B01D1 符合药品注册的有关要求，同意本品联合 PD-1 单抗±化疗在局部晚期或转移性非小细胞肺癌患者中开展临床试验。 二、药品的其他情况 BL-B01D1 是公司自主研发的全球独家处于临床阶段的可同时靶向 EGFR 和 HER3 的双抗 ADC 药物，EGFR 和/或 HER3 在大多数上皮肿瘤中呈 ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-015 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（EGFR×HER3-ADC）用于治疗局部晚期或转移性鼻咽癌末线患 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 | 年 月 日 2024 2 25 | | 拟定适应症 | 既往经 PD-1/PD-L1 单抗治疗且经至少两线化疗（至少一线含 | | （或功能主治） | 铂）治疗失败的复发性或转移性鼻咽癌患者 | | 理由及依据 | 经审核，本申请符合《药品注册管理办法》和《国家药监局关 | | | 于发布突破性治疗药物审评工作程序（试行）等三个文件的公 | | | 年第 号），同意纳入突破性治疗药物程序。 告》（2020 82 | 一、药品的基本情况 二、药品的其他相关情况 ...

证券研究报告·公司深度研究·药品及生物科技(HS) 百利天恒-U（688506） 首创双抗 ADC，书写全球重磅产品新篇章 2024 年 04月 11日 买入（首次） 证券分析师 朱国广 [Table_EPS] 执业证书：S0600520070004 盈利预测与估值 2021A 2022A 2023E 2024E 2025E zhugg@dwzq.com.cn 营业总收入（百万元） 796.73 703.28 562.00 6,034.00 2,018.00 同比 -21.33% -11.73% -20.09% 973.67% -66.56% 股价走势 归母净利润（百万元） -99.99 -282.38 -272.96 4,933.84 820.07 百利天恒-U 沪深300 1,907.52 同比 -363.82% -182.41% 3.34% -83.38% 77% % 66% 55% 44% EPS-最新摊薄（元/股） -0.25 -0.70 -0.68 12.30 2.05 33% 22% P/E（现价&最新摊薄） - - - 10.51 63.24 11% 0% -11% [关Ta键bl词e_：Ta ...

证券代码：688506 证券简称：百利天恒 公告编号：2024-014 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（EGFR×HER3-ADC）用于 复发性或转移性食管鳞癌 III期临床试验完成首例受试者入组 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。 特此公告。 四川百利天恒药业股份有限公司董事会 2024 年 4 月 10 日 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（EGFR×HER3-ADC）正在开展用于复发性或转移性食管鳞 癌的 III 期临床试验，已于近日成功完成首例受试者入组。现将相关情况公告如下： 一、药品的基本情况 BL-B01D1 是公司自主研发的全球独家处于临床阶段的可同时靶向 EGFR 和 HER3 的双抗 ADC 药物，EGFR 和/或 HER3 在大多数上皮肿瘤中呈高表达， BL-B01D1 单药在多个上皮肿瘤适应症中均表现出强烈的疗效信号，特别是在非小 细胞肺癌、小细胞肺癌、鼻咽癌、食管鳞癌、乳腺癌后线患 ...

上海证券交易所： 国投证券股份有限公司（以下简称"国投证券"或"保荐机构"）作为四川 百利天恒药业股份有限公司（以下简称"百利天恒"或"公司"）首次公开发行 股票并在科创板上市持续督导阶段的保荐机构，根据《证券发行上市保荐业务管 理办法》《上海证券交易所科创板股票上市规则》《上海证券交易所上市公司自律 监管指引第 11 号——持续督导》等有关法律、法规的规定，对公司 2023 年 1 月 6 日（公司上市日）至 2023 年 12 月 31 日期间（以下简称"本持续督导期间"） 的规范运作情况进行了现场检查，现就现场检查的有关情况报告如下： 一、本次现场检查的基本情况 （一）保荐机构 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 2023 年度持续督导工作现场检查报告 （三）现场检查时间 2024 年 3 月 25 日至 2024 年 3 月 28 日，2024 年 4 月 1 日 （四）现场检查人员 柴柯辰、胡园 （五）现场检查内容 公司治理及内部控制、信息披露、独立性、与关联方的资金往来、募集资金 使用情况、关联交易、对外担保、重大对外投资、公司经营状况等。 国投证券股份有限公司 （二）保荐代表 ...