证券代码：688266 证券简称：泽璟制药 苏州泽璟生物制药股份有限公司 投资者关系活动记录表 编号：2024-008 | --- | --- | --- | |------------|------------------------------------|----------------------------------------------------------------------| | | | | | 投资者关系 | □ | 特定对象调研 √分析师会议 | | 活动类别 | □ | 媒体采访 √业绩说明会 | | | □新闻发布会 □路演活动 | | | | □ | 现场参观 √一对一沟通 | | | □其他 | | | 参与单位 | | 东吴证券、华西证券、平安证券、浙商证券、方正证券、西南证券、信达证 | | 及人员 | | 券、中信证券、民生证券、招商证券、中信建投、中泰证券、天风证券、德邦 | | | | 证券、兴业证券、开源证券、国盛证券、中信资管、金信基金、太平养老、致 | | | 顺投资、 Millennium | 、长盛基金、汇添富基金、汇丰晋信基金、国寿安保基 | | | ...

[Table_Main] 证券研究报告 | 公司点评 泽璟制药(688266.SH) 2024 年 08 月 29 日 | --- | --- | |--------------------------------------------------------|------------------------------| | 泽璟制药（ 买入（维持） | 688266.SH ）：重磅 | | 所属行业：医药生物 / 化学制药 当前价格 ( 元 ) ： 56.30 | 产品将提供增长新动能，创新双 | | | | | 证券分析师 | 三抗进展顺利 | | 周新明 | | 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -11% 0% 11% 23% 34% 46% 泽璟制药 沪深300 | --- | --- | --- | --- | |--------------------------------|----------------|--------------|- ...

[Table_StockInfo] 2024 年 08 月 24 日 证券研究报告•2024 年半年报点评 当前价：56.47 元 泽璟制药（688266）医药生物 目标价：——元（6 个月） 抗体平台优势凸显，吉卡昔替尼上市在即 [Table_Summary 事件：公司发布] 2024半年度报告，报告期内实现营业收入 2.4亿元（+9.4%）， 归属于上市公司的亏损收窄 0.5 亿元。 两款上市品种商业化稳步推进。多纳非尼和重组人凝血酶商业化稳步推进。截 至 2024年 6月 30日多纳非尼已进入医院 1081家、覆盖医院 1844家、覆盖药 房 934家。重组人凝血酶于 2024年 4月实现发货销售，至 2024年公司已收到 合作方支付的独家市场推广权许可费 3.4亿元。 两款产品处于 NDA阶段，循证医学证据充分。吉卡昔替尼的中、高危骨髓纤维 化 NDA 申请已于 2022 年 10月 16 号获得受理，我们预计将于 2024 年下半年 上市。吉卡昔替尼被纳入了原发性骨髓纤维化（PMF）一线分层治疗的 I级推荐， 尤其是在骨髓纤维化（MF）相关贫血患者的一线治疗中，被列为 I 级推荐的首 选。吉卡昔替尼 ...

证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： -15% -4% 8% 19% 31% 43% 23-0823-0923-1023-1224-0124-0224-0324-0424-0524-0624-0724-08 泽璟制药 上证指数 相关研究 1.《泽璟制药-U(688266.SH)：差异 化管线催化不断，销售将迈入高速增 长期》，2024.05.22 公司点评 2024 年 8 月 27 日 泽璟制药-U (688266.SH) 买入（维持） ——收入恢复高增长态势，早研管线稳步推进 投资要点： ➢ 公司事件：泽璟制药发布 2024 年中期业绩公告，24Q2 产品收入恢复高增长态势，亏损大幅 收窄，早期管线积极推进。以下为公司中报业绩要点： ➢ 二季度产品收入恢复高增长，亏损大度收窄： 1）2024 上半年：24H1 收入 2.41 亿元，同比+9.44%。24H1 归母净利润-0.67 亿元，同比 收窄 41.75%。24H1 研发费用 1.81 亿元，同比减少 17.78%。24H1 销售费用 1.20 亿元， ...

Financial Performance - The company has not yet achieved profitability and faces cumulative losses due to significant R&D expenditures and ongoing market expansion efforts[3]. - As of June 30, 2024, the company relies heavily on external financing for working capital, which may pressure its financial status if expenses exceed available funding[3]. - The company achieved operating revenue of CNY 240.70 million in the first half of 2024, representing a year-on-year increase of 9.44% primarily due to increased sales volume of Donafenib tablets[15]. - The net profit attributable to shareholders was a loss of CNY 66.54 million, a reduction in loss of CNY 4.77 million compared to the same period last year[17]. - The net cash flow from operating activities was CNY 112.55 million, mainly due to receiving CNY 280 million from exclusive sales promotion authorization for Zepu Ning[17]. - The company's total assets increased by 7.36% to CNY 3,099.66 million compared to the end of the previous year[15]. - The net assets attributable to shareholders decreased by 4.03% to CNY 1,567.04 million compared to the end of the previous year[15]. - The basic earnings per share for the reporting period was -CNY 0.25, an improvement from -CNY 0.46 in the same period last year[16]. - The company reported a total revenue of 310,566.96 million RMB for the first half of 2024, with a net profit of 15,730.49 million RMB[60]. - The company reported a total comprehensive loss of CNY 47,723,595.11 for the first half of 2024, compared to a total comprehensive loss of CNY 106,113,803.92 in the first half of 2023[165]. Research and Development - Future profitability will depend on the success of drug commercialization, the number of ongoing R&D projects, and related costs[3]. - The research and development expenditure accounted for 75.26% of operating revenue, a decrease of 24.92 percentage points compared to the previous year[16]. - The company has several key drugs under development, including Gecacitinib Hydrochloride Tablets, which have received clinical trial approval from both China and the FDA[14]. - The company is focusing on expanding its product pipeline with multiple investigational new drugs (INDs) currently in clinical trials[14]. - The company is committed to ongoing investment in R&D and commercialization despite the potential for future losses[3]. - The company is actively involved in the research and development of new drugs targeting cancer and autoimmune diseases, responding to the increasing clinical demand[20]. - The company is focusing on developing innovative drugs in oncology, bleeding disorders, and immune-inflammatory diseases, aiming for best-in-class or first-in-class drug development[29]. - The company’s small molecule drug development platform and complex recombinant protein biopharmaceutical platform have made significant progress in new drug development during the reporting period[29]. - The company has received FDA clinical trial approval for multiple investigational drugs, including Jika Xini for severe alopecia areata and myelofibrosis[30]. - The company has established a comprehensive procurement system to manage raw materials and outsourced services, ensuring cost control and efficiency[43]. Market and Competitive Landscape - The Chinese oncology drug market grew from USD 19.9 billion in 2018 to USD 30.9 billion in 2023, with a CAGR of 9.2%[21]. - The market for autoimmune disease drugs in China is projected to grow from USD 2 billion in 2018 to USD 6.1 billion by 2025, with a CAGR of 28.1% from 2022 to 2025[22]. - The company has two domestically developed bispecific antibody drugs approved, with global sales expected to exceed USD 11 billion in 2024, a 37.5% increase from USD 8 billion in 2023[23]. - The company anticipates significant growth in the bispecific antibody market, with projections reaching USD 192.6 billion by 2033[23]. - The competitive landscape includes both approved original drugs and generic alternatives, which may affect market penetration and revenue growth[81]. - The company is focusing on expanding its product pipeline in the oncology sector, driven by increasing patient numbers and supportive government policies[21]. Risks and Challenges - The company has outlined various risks and countermeasures in its report, emphasizing the potential for continued losses[3]. - The company faces risks related to ongoing losses and the inability to predict future profitability due to high R&D expenditures[75]. - The company is experiencing challenges in building a comprehensive marketing team to support its commercialization efforts[76]. - Clinical trial progress may not meet expectations due to challenges in patient recruitment and collaboration with clinical trial institutions[78]. - The company may encounter delays in clinical trials and regulatory approvals, impacting the development timeline of its drug candidates[80]. - The company requires significant funding for ongoing clinical development and commercialization efforts, as current product sales do not meet operational funding needs[82]. - Insufficient operational funding may force the company to delay or cancel research projects, adversely impacting its business[83]. Environmental Compliance - The company has achieved compliance in wastewater discharge, with key pollutants such as COD at 48 mg/L against a limit of 430 mg/L, and NH3-N at 3.79 mg/L against a limit of 35 mg/L[104]. - The company reported that all major pollutants from its emissions met the required standards, including SO2 at 11 mg/L against a limit of 35 mg/L[104]. - The company has established effective pollution prevention facilities to ensure compliance with various environmental standards[107]. - The company has implemented an environmental self-monitoring plan and has contracted a qualified third-party for pollution detection, with all pollutants reported to be within compliance[112]. - There were no administrative penalties imposed on the company during the reporting period for environmental issues[113]. Shareholder and Governance - The company has not distributed dividends or increased capital reserves during the reporting period[100]. - The company’s board of directors and senior management have made commitments to ensure the fulfillment of measures to compensate for any dilution of immediate returns[123]. - The company will ensure compliance with the Shanghai Stock Exchange's regulations regarding share reductions and disclosures[121]. - Major shareholders are committed to supporting the company's development and will not reduce their holdings during the lock-up period[120]. - The company will publicly explain any failure to fulfill commitments and apologize to shareholders if violations occur[123]. Future Outlook - The company provided an optimistic outlook for the second half of 2024, projecting a revenue increase of 10% to 1.32 billion[118]. - New product launches are expected to contribute an additional 200 million in revenue by the end of the year[119]. - The management emphasized a focus on sustainability initiatives, aiming to reduce operational costs by 10% through energy efficiency improvements[119]. - The overall guidance for the fiscal year remains positive, with expected earnings per share (EPS) growth of 12%[117].

证券代码：688266 证券简称：泽璟制药 公告编号：2024-039 苏州泽璟生物制药股份有限公司 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。 一、募集资金基本情况 （一）实际募集资金金额和资金到位时间 1、2020 年首次公开发行 A 股股票募集资金 根据中国证券监督管理委员会 2019 年 12 月 31 日作出的《关于同意苏州泽 璟生物制药股份有限公司首次公开发行股票注册的批复》（证监许可[2019]2998 号），苏州泽璟生物制药股份有限公司（以下简称"公司"）获准向社会公开发行 人民币普通股（A 股）60,000,000 股，每股面值人民币 1 元，发行价格为每股人 民币 33.76 元，募集资金总额为人民币 2,025,600,000.00 元，扣除承销及保荐费 用、发行登记费以及累计发生的其他相关发行费用（共计人民币 117,379,245.32 元，不含税）后，募集资金净额为人民币 1,908,220,754.68 元（以下简称"首发募 集资金 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2024-037 苏州泽璟生物制药股份有限公司 关于自愿披露收到注射用重组人促甲状腺激素 药品注册药学和临床核查通知的公告 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： 近日，苏州泽璟生物制药股份有限公司（以下简称"公司"）收到国家药品 监督管理局药品审评中心（CDE）签发的《国家药监局药审中心关于启动注射用 重组人促甲状腺激素药品注册核查（药学）的通知》（编号：HCY20240566）和 《国家药监局药审中心关于启动注射用重组人促甲状腺激素药品注册核查（临 床）的通知》（编号：HCL20240477），根据《药品注册管理办法》有关规定，国 家药品监督管理局食品药品审核查验中心（CFDI）将对公司申报注册的注射用 重组人促甲状腺激素启动药品注册核查（药学、临床）。 根据相关行政审批程序，药品注册批件的最终审批结果和获批时间尚不确 定，本次收到核查通知对公司近期业绩不会产生重大影响。公司将对该产品注册 的后续进展情况及时履行信息披露义务，敬请广大投资者谨 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2024-036 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG006 获得 FDA 孤儿药 资格认定的公告 注射用 ZG006 是公司及子公司 Gensun Biopharma Inc.通过其双/多特异性抗 体研发平台开发的一个三特异性抗体药物，也是公司第四个同时获得 FDA 和 NMPA 临床试验许可的创新抗体类药物。注射用 ZG006 的注册分类为治疗用生 物制品 1 类，有望成为治疗实体瘤的创新型生物制品。 ZG006 是一种针对 CD3 及两个不同 DLL3 表位的三特异性抗体。ZG006 的 抗 DLL3 端与肿瘤细胞表面不同 DLL3 表位相结合，抗 CD3 端结合 T 细胞。ZG006 衔接肿瘤细胞和 T 细胞，将 T 细胞拉近肿瘤细胞，从而利用 T 细胞特异性杀伤 肿瘤细胞。临床前研究结果显示，ZG006 在小鼠肿瘤模型上具有显著的肿瘤抑制 作用，可以导致显著比例的小鼠肿瘤完全消退，说明 ZG006 具有强效的肿瘤杀 伤作用。ZG006 在非人灵长类动物中显示出毒副作用低等良好的安全性特征。经 查询，ZG006 是全球第一个针对 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2024-035 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG005 与贝伐珠单抗联合用药 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： 苏州泽璟生物制药股份有限公司（以下简称"公司"）于近日收到国家药品监 督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通知书》， 注射用 ZG005 与贝伐珠单抗联合用于晚期肝细胞癌的临床试验获得批准。 本次注射用 ZG005 与贝伐珠单抗联合用于晚期肝细胞癌的临床试验获批事 项对公司近期业绩不会产生重大影响。由于药品的研发周期长、审批环节多、研 发投入大，容易受到一些不确定性因素的影响，敬请广大投资者谨慎决策，注意 防范投资风险。 现将相关情况公告如下： | 药品名称 | 注射用 ZG005 | | --- | --- | | 剂型 | 粉针剂 | | 规格 | 100mg/瓶 | | 申请人 | 苏州泽璟生物制药股份有限公司 | | 申请事项 | 境内生产 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2024-034 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG005 与注射用 ZGGS18 联合 用药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： 现将相关情况公告如下： | 药品名称 | 注射用 ZG005 注射用 | ZGGS18 | | --- | --- | --- | | 剂型 | 粉针剂 | 粉针剂 | | 规格 | 100mg/瓶 | 50mg/瓶 | | 申请人 | 苏州泽璟生物制药股份有限公司 | | | 申请事项 | 境内生产药品注册临床试验 | | | 审批结论 用 | 根据《中华人民共和国药品管理法》及有关规定，经 审查，2024 年 5 月 24 日受理的注射用 ZG005、注射 临床试验申请符合药品注册的有关要求， ZGGS18 | | | | 同意开展 ZG005 联合 ZGGS18 用于晚期实体瘤的临 | | | | 床试验。 | | | 临床试验通知书编号 | 2024LP ...