Investment Rating - The report maintains a "Buy" rating for Haichuang Pharmaceutical (688302.SH) [3][5] Core Views - The commercialization of HC-1119 (Deunzalutamide) is imminent, with the company actively preparing for market launch and establishing a commercial channel network [5][6] - The company has a robust pipeline with several drugs in clinical trials, including HP518, which is the first oral AR PROTAC drug in clinical trials in China, and HP501, which is advancing in clinical trials for hyperuricemia/gout [6][7] - Revenue projections for 2025 and 2026 are estimated at 163 million and 363 million yuan respectively, driven by the anticipated launch of core products [6][11] Financial Summary - As of June 30, 2024, the company reported a cash balance of 492 million yuan [5] - The company is expected to have no drug sales revenue in 2024, with operating expenses projected to be 57.69 million yuan, a 280% increase year-on-year [5][11] - The net profit for 2024 is projected to be a loss of 234 million yuan, improving to a loss of 167 million yuan by 2026 [11] Pipeline Progress - HC-1119 has completed the necessary reviews for drug registration and is preparing for commercialization [5] - HP518 is currently enrolling patients for clinical trials targeting advanced prostate cancer, with data expected to be presented at major conferences [6] - Other projects include HP501 for hyperuricemia, HP537 for hematological tumors, and HP560 for myelofibrosis, all of which are in various stages of clinical development [6][7]

证券代码：688302 证券简称：海创药业 公告编号：2024-032 会议召开方式：上证路演中心网络文字互动 投资者可于 2024 年 09 月 13 日(星期五)16:00 前通过公司邮箱 ir@hinovapharma.com 进行提问。公司将在说明会上对投资者普遍关注的 问题进行回答。 一、说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2024 年半年度 的经营成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息 披露允许的范围内就投资者普遍关注的问题进行回答。 二、说明会召开的时间、地点 海创药业股份有限公司 关于参加 2024 年半年度科创板制药及生物制品专场 集体业绩说明会的公告 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、准确性和完整性承担个别及连带责任。 重要内容提示： （网址：http://roadshow.sseinfo.com/） 海创药业股份有限公司（以下简称"公司"）已于 2024 年 8 月 24 日 发布公司 2024 年半年度报告，为便于广大投资者更全面深入地了解公司 2024 年半年度经营成果、财 ...

证券代码：688302 证券简称：海创药业 公告编号：2024-028 海创药业股份有限公司 经审议，董事会同意《关于公司<2024 年半年度报告>及其摘要的议案》。 第二届董事会第六次会议决议公告 本公司董事会及董事会全体成员保证信息披露的内容真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏，并对其内容的真实性、准确性和完整 性依法承担法律责任。 一、董事会会议召开情况 海创药业股份有限公司（以下简称"公司"）第二届董事会第六次会议于 2024年8月23日在公司会议室以现场结合通讯表决方式召开，会议通知已于2024 年8月13日以电子邮件等形式送达全体董事。本次会议应到董事7名，实到董事7 名，会议由董事长YUANWEI CHEN（陈元伟）先生主持。本次会议的召集、召开、 议案审议程序符合《中华人民共和国公司法》等有关法律、行政法规、部门规 章、规范性文件和《公司章程》的有关规定，会议决议合法、有效。 二、董事会会议审议情况 具体内容详见公司刊登于上海证券交易所网站（www.sse.com.cn）的《海创 药业股份有限公司 2024 年半年度报告》和《海创药业股份有限公司 2024 年半年 度报告摘要 ...

证券代码：688302 证券简称：海创药业 公告编号：2024-030 海创药业股份有限公司 2024 年半年度募集资金存放与实际使用情况的专项报告 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。 根据《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，海创药业股份有限公司（以下简称"海 创药业"或"公司"）董事会对 2024 年半年度募集资金存放与实际使用情况专项报 告说明如下： 一、募集资金基本情况 根据中国证券监督管理委员会于 2022 年 1 月 28 日印发的《关于同意海创药业 股份有限公司首次公开发行股票注册的批复》(证监许可[2022]250 号)，公司获准 向社会公开发行人民币普通股 A 股 24,760,000 股，每股面值人民币 1.00 元，每股 发行价为人民币 42.92 元，募集资金总额为人民币 1,062,699,200.00 元，扣除发行 费用(不含增值税)人 ...

Financial Performance - The company reported a half-year performance for 2024, covering the period from January 1 to June 30, 2024[6]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion CNY for the first half of 2024, representing a 25% year-over-year growth[10]. - The company's operating revenue for the first half of 2024 was CNY 109.73 million, compared to CNY 0.00 in the same period last year[14]. - The net profit attributable to shareholders was a loss of CNY 100.41 million, an improvement from a loss of CNY 165.20 million year-on-year[14]. - The net cash flow from operating activities was a negative CNY 99.14 million, which is a reduction in outflow compared to the previous year's negative CNY 128.88 million[16]. - The basic earnings per share for the first half of 2024 was -CNY 1.01, an improvement from -CNY 1.67 in the same period last year[15]. - The company reported a net loss of 100.41 million yuan for the reporting period, primarily due to significant R&D expenditures[72]. - The company reported a total revenue of CNY 109,734.51 thousand, with no revenue in the same period last year, indicating a significant increase[92]. - The net loss attributable to shareholders was CNY 100,412.0 thousand, a year-on-year decrease of 39.22%[91]. R&D and Product Development - The company is focused on innovative drug development in cancer and metabolic diseases, utilizing PROTAC technology and deuterated drug platforms[18]. - The company has provided guidance for the second half of 2024, expecting revenue to grow by an additional 20% compared to the first half[10]. - New product development includes the launch of three innovative drugs, with expected market entry by Q4 2024[10]. - The company has developed a product pipeline with 9 investigational products in the fields of cancer and metabolic diseases, with HC-1119 for mCRPC currently under review for market approval in China[19]. - The company is actively engaged in clinical trials for multiple products, including HP518 for hyperuricemia/gout treatment[42]. - The company has established a commercialization strategy that includes a four-pronged approach: medical, market access, sales, and brand building[23]. - The company is investing 100 million CNY in new technology for drug development, aiming to improve efficiency by 40%[10]. - The company has made progress in its R&D projects and is currently in the drug application review phase for its HC-1119 project[15]. - The company has established a full-chain PROTAC technology platform with multiple candidates in clinical and preclinical stages, including HP518 and HP568[68]. Market Expansion and Strategy - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[10]. - The company plans to expand its market presence in Southeast Asia, targeting a 25% market share in the region within the next two years[113]. - A strategic acquisition of a biotech firm was completed, enhancing the company's R&D capabilities and expected to contribute an additional 200 million CNY in revenue by 2025[10]. - The company aims to expand its global market presence through collaborations with well-known international pharmaceutical companies[37]. - The company has established global branches in China, the US, and Australia, enhancing its international clinical development capabilities[61]. Financial Management and Investments - The company has established a fundraising management system to ensure the efficient use of raised funds for project construction, aiming for early production and utilization of these projects[126]. - The total amount of funds raised through the initial public offering (IPO) was ¥1,062,699,200, with a net amount of ¥995,113,315 after deducting issuance costs[138]. - The cumulative investment of raised funds reached ¥798,571,660.35, representing an investment progress of 80.25%[138]. - The company has increased its investment in construction of the R&D production base, with construction in progress valued at CNY 263,781.54 thousand, a 55.59% increase from the previous year[94]. - The company has committed to using raised funds in accordance with the investment plan outlined in the prospectus[139]. Operational Risks and Compliance - The company has outlined various operational risks and corresponding mitigation measures in the report[2]. - The report includes a forward-looking statement risk declaration, indicating that future plans do not constitute a commitment to investors[3]. - The company has not faced any violations in decision-making procedures regarding external guarantees[3]. - The company has not experienced any issues with a majority of directors being unable to ensure the report's authenticity[3]. - The company is exposed to risks related to drug quality control, which could affect its reputation and financial performance[80]. Shareholder Commitments and Governance - The company has committed to not transferring or entrusting the management of shares held before the IPO for 36 months from the listing date, with a gradual reduction allowed thereafter[108]. - The company’s actual controllers have committed to not reducing their holdings until the company achieves profitability, which is expected to be within three complete fiscal years post-IPO[109]. - The company has established a commitment to compensate for any losses incurred due to violations of the share reduction commitments[111]. - The company guarantees that its prospectus and other disclosures do not contain false records or misleading statements, accepting legal responsibility for their accuracy[128]. - The company will take measures to address any failures in fulfilling commitments made during the IPO process, including public explanations and potential compensation for investor losses[128]. Environmental and Social Responsibility - The company promotes a green development philosophy, advocating for paperless offices and resource recycling[106]. - The company invested RMB 7.97 million in environmental protection during the reporting period[105]. - The company has established an environmental protection mechanism and has not faced any environmental pollution incidents during the reporting period[105]. Financial Reporting and Accounting Policies - The financial statements are prepared in accordance with the accounting standards issued by the Ministry of Finance of the People's Republic of China[184]. - The company's accounting policies include provisions for bad debts, inventory measurement, and capitalization of research and development expenses[186]. - The company has assessed its ability to continue as a going concern for the next 12 months and found no significant doubts regarding its sustainability[185]. - The company’s financial reporting adheres to the relevant accounting standards, ensuring accurate representation of financial performance and position[198].

证券代码：688302 证券简称：海创药业 公告编号：2024-029 海创药业股份有限公司 第二届监事会第五次会议决议公告 本公司监事会及全体监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。 一、监事会会议召开情况 海创药业股份有限公司（以下简称"公司"）第二届监事会第五次会议于2024 年8月23日在公司会议室以现场结合通讯表决方式召开，会议通知已于2024年8月13 日以电子邮件等形式送达全体监事。本次会议应到监事3名，实到监事3名，会议由 监事会主席兰建宏先生主持。本次会议的召集、召开、议案审议程序符合《中华人 民共和国公司法》等有关法律、行政法规、部门规章、规范性文件和《公司章程》 的有关规定，会议决议合法、有效。 二、监事会会议审议情况 全体监事对本次监事会会议议案进行了审议，经表决形成如下决议： （一）审议通过《关于公司<2024 年半年度报告>及其摘要的议案》 监事会认为：公司2024年半年度报告及其摘要的编制和审议程序符合相关法律 法规及《公司章程》等内部规章制度的规定；其内容与格式符合相关规定，公允地 反映了公司2024年 ...

证券代码：688302 证券简称：海创药业 公告编号：2024-027 海创药业股份有限公司 自愿披露关于 HP560 片用于治疗骨髓纤维化 （骨髓增殖性肿瘤）的临床试验获得药物 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。 重要内容提示： HP560 片作用机制明确，已有临床前研究结果显示，HP560 片具有良好的 疗效和安全性，有望为骨髓纤维化患者提供一种全新的治疗选择，具有重要的 临床价值。 经查询，截至本公告披露日，国内外均无同类靶点产品获批上市。 三、 风险提示 近日，海创药业股份有限公司（以下简称"公司"）收到中国国家药品监 督管理局药品审评中心核准签发的《药物临床试验批准通知书》，同意HP560片 开展用于治疗骨髓纤维化的临床试验。经查询，截至本公告披露日，国内外均 无同类靶点产品获批上市。 现将相关情况公告如下： | 药品名称 | HP560 片 | | --- | --- | | 剂型 | 片剂 | | 申请事项 | 境内生产药品注册临床试验 | | 申请人 | 海创药业股份有 ...

本次临床试验申请获得FDA批准事项对公司近期业绩不会产生重大影响。由于 医药产品具有高科技、高风险、高附加值的特点，药品前期研发以及产品从研制、 临床试验、报批到投产的周期长、环节多，容易受到一些不确定性因素的影响，公 司将积极推进上述研发项目，并严格按照有关规定及时对项目后续进展情况履行信 息披露义务。敬请广大投资者谨慎决策，注意防范投资风险。 １ HP537片是公司独立自主研发的p300/CBP（E1A-binding protein P300/CREB- binding protein, p300/CBP）抑制剂小分子抗肿瘤药物，HP537片通过结合 p300/CBP溴结构域（bromine domain, BRD）阻断p300/CBP信号通路。p300/CBP参 与细胞周期进展和细胞生长、分化和发展，在肿瘤中高度表达和激活，是肿瘤细 胞生长的关键调控因子。HP537通过抑制p300/CBP酶的活性，从而达到抑制肿瘤细 胞的生长而达到抗肿瘤的效果。HP537片主要用于治疗血液系统恶性肿瘤，包括但 不限于多发性骨髓瘤（multiple myeloma, MM）、非霍奇金淋巴瘤（non-Hodgkin' s ...

证券代码：688302 证券简称：海创药业 公告编号：2024-025 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，海创药业股份有限公司（以下简称"公司"）在研品种HP518片收到美 国食品药品监督管理局（以下简称"FDA"）授予"快速通道认定"（"Fast Track Designation"，以下简称"FTD"）用于治疗雄激素受体（AR）阳性三阴 乳腺癌。目前国内外均无同类靶点产品获批上市。 此前，HP518片已在澳大利亚完成用于治疗转移性去势抵抗性前列腺癌 （mCRPC）的Ⅰ期临床试验，HP518片用于治疗mCRPC的临床试验申请已于2023年1月 获FDA批准，中国Ⅰ/Ⅱ期临床试验申请已于2023年11月获NMPA批准，并于2023年 12月完成首例受试者给药，目前正在入组中。 现将相关情况公告如下： HP518片是海创药业股份有限公司自主研发的蛋白降解靶向联合体 （Proteolysis Targeting Chimera，PROTAC）药物，属于化学药品1类，临床拟 用于治疗mCRPC以及AR阳性三阴 ...

证券代码：688302 证券简称：海创药业 海创药业股份有限公司 投资者关系活动记录表 编号：2024-6-01 特定对象调研 分析师会议 投 资 者 关 □媒体采访 □业绩说明会 系 活 动 类 □新闻发布会 路演活动 □现场参观 别 其他 电话会议 富国基金、嘉实基金、华福证券、国联基金、平安基金、红塔红 土基金、深圳前海云溪基金、华西证券、摩根大通、中信证券、 中信建投证券、隆门创投、华鑫证券、泰康资产、华创证券、中 参 与 单 位 金公司、招商证券、湘财基金、华富基金、德邦证券、新华养老 ...