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 ...

Summary of Zai Jian Pharmaceutical Conference Call Company Overview - Zai Jian Pharmaceutical focuses on dual-antibody platforms and mature products, with innovative potential in dual-antibody drugs like ZG005 and ZG006, and stable income from mature products such as Donafenib and recombinant human thrombin [2][3] Key Points and Arguments Dual-Antibody Platform - ZG006 shows potential in treating small cell lung cancer (SCLC) with an objective response rate (ORR) close to 60% in third-line and above treatments, outperforming Taletmap's 40% [2][5][9] - ZG005, a PD-1-TIGIT dual-antibody, aims to overcome the limitations of TIGIT monoclonal antibodies and has attracted interest from overseas pharmaceutical companies, indicating potential for international development [2][7] Clinical Progress and Market Potential - Zai Jian Pharmaceutical is a leader in dual-antibody drug development, with significant advancements in cervical cancer treatment, showing progression-free survival (PFS) exceeding 11 months, which is significantly better than competitors [2][9] - The dual-antibody platform has internationalization potential, especially after breakthroughs in lung cancer, which may attract collaborations with foreign pharmaceutical companies [2][10] Product Pipeline Characteristics - The product pipeline includes mature products like Donafenib (for liver cancer), recombinant human thrombin (for hemostasis), and Jikaxitini (for myelofibrosis and autoimmune diseases), providing diversified growth drivers [3][4] Future Development Plans - Zai Jian Pharmaceutical plans to complete a business development (BD) transaction for ZG006 by the end of the year, with expectations to achieve this in the first quarter of the following year [11][16] - Preliminary data for liver cancer and pneumonia treatments are expected to be released by the end of this year or early next year, further validating the internationalization capabilities of their products [11][16] Additional Important Insights - The entry of recombinant human thrombin into medical insurance is expected to enhance revenue growth, while Donafenib is projected to achieve over 10% year-on-year growth [12] - Jikaxitini shows promise in treating autoimmune diseases and may gradually replace other treatments like Ruxolitinib [12][13] - Zai Jian Pharmaceutical is focusing on new fields such as liver cancer, bleeding disorders, and immune inflammation, with a strong emphasis on their innovative dual-antibody platform [14] Recent Data and Significance - Recent data from ZG006 in SCLC treatment indicates a median PFS that could significantly outperform Taletmap, which is crucial for market competitiveness [15] - The ORR for ZG005 in first-line liver cancer treatment is also a key focus, as liver cancer progresses rapidly, making ORR a direct indicator of efficacy [15] This summary encapsulates the critical aspects of Zai Jian Pharmaceutical's conference call, highlighting its strategic focus, product pipeline, clinical advancements, and future growth plans.

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 Viewpoint - Zejing Pharmaceutical has confirmed the receipt of a 50 million RMB upfront payment from Merck for exclusive market promotion services, which will be reported as non-current liabilities and amortized over the cooperation period [1] Group 1 - The company has received the first installment of 50 million RMB from ATSA as part of the agreement [1] - This payment is related to exclusive market promotion service authorization and will be treated according to accounting standards [1] - The amount will be reported as non-current liabilities after deducting value-added tax and will be amortized against sales expenses during the cooperation period [1]

Summary of Zai Jian Pharmaceutical Conference Call Company Overview - Zai Jian Pharmaceutical has launched three products: Donafenib, Recombinant Human Thrombin, and Jikaxitinib, with a fourth product (Recombinant Human Thyroid-Stimulating Hormone) expected to be approved by the end of the year. These products and commercial collaborations will provide stable cash flow [2][3][4]. Core Pipeline and Product Development - The core pipeline includes molecules 006 and 005. Molecule 006 shows efficacy and safety in small cell lung cancer and neuroendocrine tumors, while molecule 005 shows preliminary efficacy in cervical cancer and neuroendocrine tumors, with potential for combination therapy [2][5]. - Molecule 006 is the first global tri-antibody targeting DU3 expression in small cell lung cancer, with an overall response rate (ORR) of approximately 60% in Phase II clinical trials, outperforming competitors [2][8]. - Molecule 005 is in Phase II clinical trials, with an ORR of 40.9% and a disease control rate (DCR) of 68.2% in second-line cervical cancer patients [2][13]. Sales and Market Potential - Donafenib is projected to achieve sales of 500 million RMB in 2024, covering 1,100 hospitals and 2,000 pharmacies, and included in 26 authoritative guidelines [2][14]. - The domestic peak sales for the four launched or soon-to-be-launched products are expected to reach 6 billion RMB, contributing approximately 18 billion RMB in market value [4][19]. - The market potential for molecule 006 is estimated at 2 billion RMB domestically and 3 billion USD internationally, contributing about 26 billion RMB in market value [10][19]. Collaborations and Partnerships - Zai Jian has partnered with Merck for the promotion of Recombinant Human Thyroid-Stimulating Hormone, with a total licensing fee of 250 million RMB [4][18]. - The collaboration is expected to enhance Merck's existing business in thyroid treatment, leveraging the new product's ability to artificially elevate TSH levels for diagnosis and treatment [18]. Future Catalysts and Expectations - Key catalysts to watch in the second half of 2025 and into 2026 include data readouts for Jikaxitinib in various indications, further data for molecule 005, and ongoing clinical trials for molecule 006 [20]. - The company is transitioning from a biotech to a biopharma model, with significant developments anticipated in the near future [20]. Conclusion - Zai Jian Pharmaceutical is positioned for growth with a robust pipeline and strategic partnerships, aiming for a market valuation of at least 53 billion RMB based on projected sales from its product portfolio [4][19].

Macro Strategy - The "urban renewal" initiative is expected to achieve a total investment of at least 4.48 trillion yuan during the 14th Five-Year Plan period, averaging nearly 900 billion yuan annually. The main sources of potential demand will come from the renovation of urban villages, old residential areas, and urban infrastructure upgrades [1][18] - The renovation of old residential areas and urban infrastructure is projected to contribute at least 2.35 trillion yuan in new investment during the 14th Five-Year Plan period, supported by over 470 billion yuan in central budget investments and special bonds [1][18] - The urban village renovation is estimated to contribute 2.13 trillion yuan in new investment during the 14th Five-Year Plan period, assuming a "half-demolition, half-renovation" approach for the remaining self-built houses [1][18] Economic Data - The actual GDP growth rate for Q2 was 5.2%, with a cumulative growth of 5.3% for the first half of the year, indicating a strong performance compared to the previous year. However, the nominal GDP growth rate was lower at 3.9% [2][20] - Consumer spending showed a year-on-year increase of 5.0% in the first half, driven by the "old-for-new" policy, while real estate sales showed resilience compared to the previous year [2][20] - Industrial production in June saw a year-on-year increase of 6.8%, supported by strong external demand, particularly in the equipment manufacturing sector [2][21] Company Analysis - Zhongkuang Resources (002738) has adjusted its profit forecast for 2025-2027 due to pressure from falling lithium prices and temporary losses in copper smelting, projecting net profits of 4.0/9.6/19.3 billion yuan [10] - Li Ning (02331.HK) anticipates challenges in sales due to deepening discounts and increased expenses, with revised net profit forecasts of 23.1/26.0/29.3 billion yuan for 2025-2027 [10] - 361 Degrees (01361.HK) is expanding its superstore network and maintaining industry-leading growth, with net profit forecasts of 13.0/14.6/16.2 billion yuan for 2025-2027 [11] - Zhongrong Electric (301031) expects continued high growth in its electric vehicle-related products, projecting net profits of 3.4/4.8/6.3 billion yuan for 2025-2027 [12] - Huanxin Cement (600801) reported a significant increase in Q2 profits, driven by improvements in domestic cement profitability and overseas operations, with revised net profit forecasts of 28.8/32.2/35.6 billion yuan for 2025-2027 [15]

Investment Rating - The report maintains an investment rating of "Leading the Market - A" [9] Core Insights - The report highlights that several newly included innovative drugs in the medical insurance directory are rapidly entering hospitals, with significant growth in the number of drugs entering hospitals by the end of May 2025 compared to April 2025 [2][22] - The report notes that the new drug sector has shown a strong performance, with notable increases in stock prices for companies such as Beihai Kangcheng (114.5%), Frontier Biotech (41.4%), and Junsheng Tai (29.4%) during the week of July 7 to July 13, 2025 [1][18] Summary by Sections Weekly New Drug Market Review - From July 7 to July 13, 2025, the top five companies in the new drug sector by stock price increase were Beihai Kangcheng (114.5%), Frontier Biotech (41.4%), Junsheng Tai (29.4%), Kaituo Pharmaceutical (20.7%), and Yongtai Biotech (20.1%) [1][18] - The top five companies by stock price decrease were Yiming Anke (-19.4%), Shenzhou Cell (-13.4%), Ascentage Pharma (-10.0%), Lepu Biotech (-8.9%), and Rongchang Biotech (-8.8%) [1][18] Key Analysis of the New Drug Industry - The National Medical Insurance Administration updated the hospital admission data for innovative drugs included in the medical insurance directory as of the end of May 2025, indicating rapid hospital admissions for several newly included domestic innovative drugs [2][22] - Notable drugs with fast admission growth included Kangfang Biotech's Cardunilumab and Ivorisumab, Shanghai Yizhong's Paclitaxel Micelle, and Zecjin Pharmaceutical's Recombinant Human Thrombin [2][22] New Drug Approval and Acceptance Status - Four new drug or new indication applications were approved this week, including Ascentage Pharma's Lisatoclax tablets and Zhejiang Tianyuan's quadrivalent influenza virus split vaccine [26][27] - Ten new drug applications were accepted, including Dali Yingjie’s Docetaxel Injection and Zhaoke Pharmaceutical's Atropine Sulfate Eye Drops [26][28] Clinical Application Approval and Acceptance Status - This week, 43 new drug clinical applications were approved, and 20 new drug clinical applications were accepted [4][28]