公司点评 | 泽璟制药 商业化品种持续放量，在研管线进展顺利 泽璟制药（688266.SH）2025 年半年报点评 摘要内容：公司发布 2025 年半年报，2025 年上半年公司实现营业收入 3.76 亿元（+56.07%），实现归母净利润-7280.35 万元，实现归母扣非净利润-1.03 亿元，亏损同比略有增长。 业绩符合预期，多纳非尼、重组人凝血酶稳健放量。1）多纳非尼片：入院 持续推进，截至 25H1 已入院 1200 余家，覆盖医院 2200 余家、药房 1000 余家。2）重组人凝血酶：纳入 2024 年国家医保目录，截至 25H1 累计准入 医院 590 余家，销量增长明显。3）盐酸吉卡昔替尼片：骨髓纤维化适应症 5 月获国家药监局批准上市，正在积极进行市场推广工作；第二项适应症重 度斑秃的 NDA 申请也于 5 月获受理，即将开展临床核查。4）注射用重组人 促甲状腺激素（rhTSH）：积极推进上市前相关工作，目前已完成发补研究， 正在技术审评阶段；公司 6 月与德国默克瑞士子公司 ATSA 签署服务协议， 授权 ATSA 作为 rhTSH 在中国大陆地区的独家市场推广服务商。 多项潜在重磅管线 ...

半年报披露，盐酸吉卡昔替尼片于2025年5月获得国家药监局批准上市，本次获批的适应症为"用于中危 或高危原发性骨髓纤维化(PMF)、真性红细胞增多症继发性骨髓纤维化(PPV-MF)和原发性血小板增多症 继发性骨纤维化(PET-MF)的成人患者，治疗疾病相关脾肿大或疾病相关症状"。目前，公司积极布局吉 卡昔替尼片的商业化工作，在现有商业化团队核心骨干架构的基础上，新增招聘了擅长血液病领域的市 场、医学和销售推广的优秀人才。 除吉卡昔替尼片治疗骨髓纤维化获批上市外，泽璟制药递交的吉卡昔替尼片治疗重度斑秃的新药上市申 请(NDA)也于2025年5月获得受理，目前即将开展临床核查，这是吉卡昔替尼片第二个申请新药上市的 适应症。 2025年上半年，已有3个新药上市销售的泽璟制药仍处于亏损状况，大幅增加的销售费用是拖累公司业 绩的重要因素。财报数据显示，上半年公司销售费用同比大增75.76%至2.11亿元，占营收56%，其中， 市场推广费1.21亿元。公司表示，市场推广费增长主要系同比新增凝血酶独家市场推广服务费，以及多 纳非尼部分区域市场委托外部推广服务费增长，以及吉卡昔替尼商业化前期市场拓展费用增长所致。 泽璟制药称 ...

公司代码：688266 公司简称：泽璟制药 苏州泽璟生物制药股份有限公司2025年半年度报告摘要 第一节 重要提示 1.1本半年度报告摘要来自半年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规 划，投资者应当到www.sse.com.cn网站仔细阅读半年度报告全文。 1.2重大风险提示 截至2025年6月30日，公司甲苯磺酸多纳非尼片治疗晚期肝癌和进展性、局部晚期或转移性放射性碘难 治性分化型甲状腺癌、重组人凝血酶均已纳入医保目录，盐酸吉卡昔替尼片已获批上市。由于多纳非尼 片仍需持续投入团队扩建和市场拓展等费用、重组人凝血酶和盐酸吉卡昔替尼片获批时间短且尚在市场 准入阶段，以及其它产品还处于上市申请或研发阶段需要较大研发投入，因此公司尚未盈利且存在累计 未弥补亏损。 未来一段时间，公司将存在累计未弥补亏损及可能持续亏损，并将面临如下潜在风险：公司多个产品仍 处于研发阶段，研发支出较大，公司虽有药品获得商业销售批准，但销售收入可能无法弥补亏损，公司 未来一定期间可能无法盈利或无法进行利润分配。公司未来亏损净额的多少将取决于公司药品商业化是 否成功、药品研发项目的数量及相关投入、与该等项目有关的成本 ...

报告期内，公司合计非经常性损益为2983.79万元，其中计入当期损益的政府补助为2281.71万元，其他符合非经常性损益定义的损益项目为1024.23万元，所 得税影响额为-329.53万元。 | 7 I f 4 | | --- | | 1 ⎞ | | 1 1 1 | | . . | | 主要会计数据 | 本报告期 (1-6月) | 上年同期 | | --- | --- | --- | | 营业收入 | 375.650.273.55 | 240.696.731.58 | | 利润总额 | -77.414.988.02 | -79.493.376.06 | | 归属于上市公司股东的净利润 | -72.803.538.99 | -66.536.070.99 | | 归属于上市公司股东的扣除非经常性 损益的净利润 | -102.641.422.42 | -72.371,226.25 | | 经营活动产生的现金流量净额 | -17.020.276.08 | 112,553,063.11 | | | 本报告期末 | 上年度末 | | 归属于上市公司股东的净资产 | 1,176,615,436.44 | 1,253,85 ...

（文章来源：每日经济新闻） 泽璟制药（SH 688266，收盘价：107.99元）8月21日晚间发布公告称，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核准签发的《药物临床试验批准通知书》，注射用 ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验获得批准。 2024年1至12月份，泽璟制药的营业收入构成为：医药制造占比99.73%，其他业务占比0.27%。 ...

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005 combined with JAK inhibitor and chemotherapy for advanced solid tumors [2][5]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized dual-specificity antibody targeting PD-1 and TIGIT, classified as a Category 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3]. - ZG005 works by blocking both PD-1 and TIGIT pathways, enhancing T-cell activation and proliferation, thereby improving the immune system's ability to kill tumor cells [3]. - Hydrochloride JAK inhibitor (previously known as JAK inhibitor) is a new dual inhibitor developed by the company, classified as a Category 1 new drug, with independent intellectual property rights. It is the first domestic JAK inhibitor approved for treating myelofibrosis [4]. Group 2: Clinical Trial and Market Impact - The approval for the clinical trial of injectable ZG005 and JAK inhibitor combined with chemotherapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5]. - The JAK inhibitor is also undergoing multiple key clinical studies for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis, and has received support from national major new drug creation projects [4].

Group 1 - The core point of the article is that Zai Lab has received approval from the National Medical Products Administration for a clinical trial of ZG005 in combination with Jikaxitinib and chemotherapy for advanced solid tumors [2] Group 2 - The clinical trial approval indicates a significant step forward for Zai Lab in its oncology pipeline, potentially enhancing its market position in cancer treatment [2]

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company is recognized as a leading innovator in the pharmaceutical sector, with significant advancements in its drug pipeline and commercialization efforts [7] - The approval of the new drug, Hydrochloride Jikaxitinib Tablets, marks a significant milestone as it is the first domestic JAK inhibitor approved for the treatment of myelofibrosis [7] - The company is expected to achieve substantial revenue growth, with projected revenues of 803 million RMB in 2025, 1.302 billion RMB in 2026, and 1.912 billion RMB in 2027, reflecting growth rates of 50.7%, 62.1%, and 46.9% respectively [6][8] Financial Performance and Forecast - Revenue for 2023 is projected at 386 million RMB, with a growth rate of 27.8% [6] - The company is expected to turn profitable by 2025, with a net profit of 21 million RMB, followed by 336 million RMB in 2026 and 711 million RMB in 2027 [6][8] - Earnings per share (EPS) is forecasted to improve from -1.09 RMB in 2023 to 2.69 RMB in 2027 [6][8] - The company’s return on equity (ROE) is expected to rise significantly, reaching 30.6% by 2027 [6][8]

Investment Rating - The report maintains a "Buy" rating for the company [4][7]. Core Insights - The company has successfully commercialized three key drugs and is on the verge of launching a recombinant human thyroid-stimulating hormone [1][15]. - ZG006, a CD3/DLL3/DLL3 tri-antibody, is in Phase 2 clinical trials and is expected to be the first of its kind to enter Phase 3 trials globally [2][41]. - ZG005, a PD-1/TIGIT dual antibody, shows promising clinical trial results for cervical cancer and is actively expanding into multiple indications [3][31]. Financial Projections - Revenue forecasts for 2025 to 2027 are projected at 820 million, 1.201 billion, and 1.603 billion RMB, respectively, with net profits expected to be -20 million, 121 million, and 282 million RMB [4][6]. - The company is expected to achieve significant revenue growth rates, with a projected increase of 53.81% in 2025 [6]. Key Products Overview - The company has launched three key products: - Tofacitinib tablets for advanced liver cancer and radioiodine-refractory differentiated thyroid cancer, which are included in the national medical insurance directory [17][18]. - Recombinant human thrombin for hemostasis, which has shown clear clinical efficacy [21][30]. - JAK inhibitor JAK2 for myelofibrosis, which has been approved for market and is expanding into other indications [31][33]. Clinical Development Highlights - ZG006 has demonstrated significant anti-tumor activity and safety in small cell lung cancer patients during clinical trials [2][40]. - ZG005 has shown a 40.9% objective response rate in cervical cancer patients who had not previously received immune checkpoint inhibitors [3][34]. Market Potential - The market for recombinant human thrombin is expected to grow alongside the increasing number of surgical procedures in China, projected to reach 12.83 million by 2030 [21][25]. - The myelofibrosis drug market is anticipated to grow significantly, with the market size expected to reach 2.93 billion RMB by 2025 [31][32].

Core Insights - The rare disease drug market in China is rapidly growing, with 55 rare disease drugs approved for market entry and over 210 clinical trials in progress, indicating a significant shift from being a niche market to a major industry segment [1][3][4] - The market is driven by unmet clinical needs, favorable regulatory policies, and an improving medication security system, attracting both domestic and international pharmaceutical companies [1][4][6] Group 1: Market Dynamics - The global rare disease market is projected to reach $300 billion by 2028, accounting for 20% of the global prescription drug market, while China's rare disease drug market is expected to grow from $1.3 billion in 2020 to $25.9 billion by 2030, with a compound annual growth rate (CAGR) of 34.5% [4][6] - As of November 2022, 89 drugs for 45 rare diseases were approved in China, with a notable acceleration in approvals in 2023, including 45 drugs approved and 55 expected in 2024 [3][4] Group 2: Policy Support - The Chinese government has implemented reforms to expedite the approval process for rare disease drugs, including reducing clinical trial requirements and allowing for faster market access [5][6] - Over 90 rare disease drugs have been included in the National Medical Insurance Drug List, enhancing drug accessibility and affordability for patients [6][8] Group 3: Industry Participation - Major international pharmaceutical companies like Pfizer, Roche, Merck, and Novartis are actively entering the Chinese rare disease market, employing strategies that combine in-house development with external partnerships [4][7] - The presence of over 210 clinical trial pipelines for rare disease drugs in China indicates a robust interest from various companies, with nearly 38% in phase III trials [6][8] Group 4: Challenges and Considerations - Despite the promising market, the development of rare disease drugs remains challenging due to high research costs and limited patient pools, making commercial success highly dependent on expanding indications and market access [8][9] - The need for greater public awareness and clinical data on rare diseases poses additional hurdles for drug development and patient management [9][10]