5月13日晚间，泽璟制药(688266)发布公告称，已收到国家药品监督管理局核准签发的《受理通知 书》，公司递交的盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请(NDA)获得受理。这是盐酸吉卡昔替 尼片第二个申请新药上市的适应症。 盐酸吉卡昔替尼(曾用名：盐酸杰克替尼)是一种新型的JAK抑制剂，对JAK激酶的四个亚型JAK1、 JAK2、JAK3和TYK2都有显著的抑制作用。吉卡昔替尼能够有效抑制炎症和抑制T细胞过度激活，亦能 显著增加真皮层的厚度和促进毛囊再生，增加毛囊密度。 目前，我国尚无国产JAK抑制剂类药物获批用于治疗重度斑秃，泽璟制药若能成功获批，将填补这一空 白。同时，盐酸吉卡昔替尼片治疗中、高危骨髓纤维化适应症的NDA申请也正在国家药监局审批过程 中。 除已提交上市申请的适应症外，泽璟制药还在积极开展盐酸吉卡昔替尼片用于多个免疫炎症性疾病的临 床研究。其中，治疗重度斑秃的III期临床试验、治疗特发性肺纤维化的II期临床试验已取得成功；针对 中重度特应性皮炎(III期)、强直性脊柱炎(III期)等自身免疫性疾病的临床试验正在进行；用于治疗12岁 及以上青少年和成人非节段型白癜风患者的II/III期临床 ...

| | □特定对象调研 □分析师会议 | | | | --- | --- | --- | --- | | 投资者关系活动类 | □媒体采访 □√业绩说明会 | | | | 别 | □新闻发布会 □路演活动 | | | | | □现场参观 | | | | | □其他 （请文字说明其他活动内容） | | | | 参与单位名称及人 | 投资者网上提问 | | | | 员姓名 | | | | | 时间 | 2025 年 5 月 13 日 (周二) 下午 15:00-17:00 | | | | 地点 | 公司通过全景网"投资者关系互动平台"（https://ir.p5w.net）采用网络 | | | | | 远程的方式召开业绩说明会 | | | | | 1、董事长 屠勇军 | | | | 姓名 | 3、副总经理兼董事会秘书 王艳 | | | | | 4、财务总监 王秀娟 | | | | 投资者关系活动主 | 感谢您的关注！公司 2025 年度 CDMO 业务收入 1.36 | | 亿元，较上年 | | 要内容介绍 | | | | | | 业务市场需求稳定；待产业化的 CDMO 项目受客户机构及项目上市、市 | | | ...

智通财经5月13日电，泽璟制药(688266.SH)公告称，公司收到国家药品监督管理局核准签发的《受理通 知书》，公司递交的盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请（NDA）获得受理。这是盐酸吉 卡昔替尼片第二个申请新药上市的适应症。盐酸吉卡昔替尼是一种新型的JAK抑制剂，对JAK激酶的四 个亚型JAK1、JAK2、JAK3和TYK2都有显著的抑制作用。本次获得NDA受理的适应症是用于治疗重度 斑秃，是盐酸吉卡昔替尼片第二个申请新药上市的适应症。在我国，目前尚无国产JAK抑制剂类药物获 批用于治疗重度斑秃。 泽璟制药：盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理 ...

Financial Data and Key Metrics Changes - The company reported a revenue of $7.3 million for Q1 2025, which remained flat due to a seasonal inventory drawdown despite a 15% growth in patient demand [38][39] - Cost of Goods Sold (COGS) from continuing operations increased to $2.7 million from $1.4 million in Q1 last year, attributed to increased sales of Lactorsi [47] - Research and Development (R&D) expenses decreased by 14% to $24.4 million, reflecting savings from reduced co-development with Junshi [48] - Selling, General and Administrative (SG&A) expenses decreased by 35% to $26 million, primarily due to lower headcount and non-recurring charges from the previous year [48] Business Line Data and Key Metrics Changes - The company is now focused solely on its innovative oncology business, with Lactorsi being the only FDA-approved treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma [6][8] - Lactorsi is projected to grow to approximately $150 million to $200 million annually over the next three years, providing non-dilutive funding for the development pipeline [8][9] - The commercial team has successfully remapped territories and updated customer assignments post-UDENYCA divestiture, with a focus on driving growth in appropriate NPC patients [37][38] Market Data and Key Metrics Changes - The company noted a significant number of patients still receiving non-preferred chemotherapy and off-label immuno-oncology treatments, indicating a market opportunity for Lactorsi [38] - The NCCN guidelines now place Lactorsi in a preferred position for recurrent and metastatic patients, which the company is actively promoting to healthcare providers [38][41] Company Strategy and Development Direction - The company’s strategy is anchored around three core pillars: Lactorsi, CHS-114 (a selective CCR8 cytolytic antibody), and casdosoketogue (an anti-IL-27 antibody) [6][12][13] - The company aims to expand Lactorsi's indications through partnerships and combination therapies, enhancing its market presence and revenue potential [10][11] - The focus on innovative oncology is expected to drive long-term value for shareholders while addressing significant unmet medical needs in cancer treatment [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s ability to navigate recent FDA changes and emphasized the importance of strong development expertise in adapting to regulatory environments [52][56] - The company anticipates that the restructuring of the sales force will lead to accelerated growth in Q2 and beyond, despite transitional challenges faced in Q1 [60][68] - Management highlighted the promising clinical data for CHS-114 and its potential to address PD-1 resistance, which could significantly impact treatment paradigms in oncology [30][36] Other Important Information - The company completed the divestiture of UDENYCA, receiving $483 million in upfront cash and repurchasing $170 million of convertible notes [43][44] - The net cash from these transactions is expected to provide substantial liquidity for ongoing operations and development initiatives [44] Q&A Session Summary Question: What needs to happen for a significant inflection point for Lactorsi? - Management noted that increased awareness among providers and ongoing clinical trials will be crucial for driving adoption and market share [51][56] Question: Can you clarify patient demand for Lactorsi? - Demand is defined as actual patient growth, with a 15% increase in end-user demand reported, indicating strong physician engagement [65][66] Question: Will the Salesforce restructure impact future projections? - The impact of the restructure was primarily felt in Q1, but management expects Q2 and Q3 to be growth periods for the brand [68] Question: Are there any competitor molecules that have proven the efficacy of CCR8 targeting? - Management indicated that while selectivity is a challenge, there are emerging data points suggesting the relevance of CCR8 targeting in certain tumor types [72][75]

内容概要：直接凝血酶抑制剂是一组不需要辅助因子参与直接抑制凝血酶活性的小分子，其既能抑制游 离的也能抑制与血凝块结合的凝血酶。目前，已经上市的凝血酶抑制剂产品有凝血酶抑制剂、来匹卢 定、比伐卢定、希美加群、地西卢定；已进入临床试验的药品有Lu一57291。截止2024年上半年，我国 达比加群酯胶囊在销企业数7家，销售额34083万元；阿加曲班注射液在销企业数15家，销售额14057万 元；注射用比伐芦定在销企业数5家，销售额6467万元。直接凝血酶抑制剂具有既能抑制游离的也能抑 制与血凝块结合的凝血酶，药效学及药动学特征具有可预测性，无血小板减少的危险等突出优点在临床 应用中发挥着重要作用。凝血酶抑制剂行业未来发展趋势将围绕创新药物研发、适应症拓展、生物技术 突破、市场格局重塑等方向展开，将向更安全、更精准、更可及的方向发展。 上市企业：倍特药业(A20284)、津药药业(600488)、苑东生物(688513)、翰森制药（03692.HK）、赛隆 药业(002898)、博瑞医药（688166）、普利制药（300630)、国瑞药业（600511）、石四药集团 （02005.HK）、信立泰（002294） 相关 ...

投资者关系活动记录表 证券代码：002693 证券简称：*ST双成 海南双成药业股份有限公司 编号：2025 -002 | 投资者关系活动类别 | ☐特定对象调研 ☐分析师会议 | | --- | --- | | | ☐媒体采访 业绩说明会 | | | ☐新闻发布会 ☐路演活动 | | | ☐现场参观 | | | ☐其他（请文字说明其他活动内容） | | 参与单位名称及人员姓名 | 线上参与公司2024年度网上业绩说明会的投资者 | | 时间 | 2025年05月09日 15:00-17:00 | | 地点 | 价值在线（https://www.ir-online.cn/）网络互动 | | 上市公司接待人员姓名 | 董事、总经理 Li Jianming | | | 独立董事 肖建华 | | | 财务总监 王旭光 | | | 副总经理、董事会秘书 于晓风 1、公司未来发展方向和业绩增长方面目前有哪些实质性进展 | | | 答:尊敬的投资者，您好。未来公司将以质量为基本要求，做好 研发、销售、生产工作。为了实现上述目标，公司将着重做好以下 | | 投资者关系活动主要内容 | 几个方面工作及进展如下： | | 介 ...

| | 答：感谢您对公司的关注。公司将从以下几方面来提升公司未来的 | | --- | --- | | | 业绩表现。其一，公司将持续推进原料药制剂一体化战略，加大制 | | | 剂新产品的研发投入，并提高其研发和上市效率，不断培育新的业 | | | 务增长点。其二，武汉研发中心去年底已投入使用，公司将利用其 | | | 新增研发资源，加速打造 CDMO 一站式综合服务平台，为公司后续 | | | 发展提供强劲动力。其三，公司将持续开展工艺优化和精益生产活 | | | 动，降低现有产品的生产成本，增强其市场竞争力，提高产能利用 | | | 率。最后，公司将群策群力，通过优化人力资源配置，节约办公和 | | | 差旅费用，适当降低管理费用。 | | | 5.高管您好，请问贵公司本期财务报告中，盈利表现如何？ 谢谢。 | | | 答：感谢您对公司的关注。公司已经公开披露 2024 年度年度报告和 | | | 2025 年一季度报告，业绩情况请参阅公司相关公告。 | | | 6.公司销售费用占比与同行业其他公司相比如何？主要用作何用？ | | | 答：感谢对公司的关注，公司销售费用占比与同行业公司相比，处 | | ...

Group 1 - Roche Pharmaceuticals announced an investment of 2.04 billion RMB to establish a biopharmaceutical production base in Shanghai, aimed at enhancing its supply chain and local production in China, with completion expected in 2029 and production starting in 2031 [1] - Hengrui Medicine's application for the market approval of its CDK4/6 inhibitor, Hydroxyethyl Sulfonate Darsilil Tablets, has been accepted by the National Medical Products Administration, targeting hormone receptor-positive, HER2-negative early or locally advanced breast cancer [2] - Sanyou Medical plans to establish a joint venture with South Korea's CGBio to research innovative cell biological materials in regenerative medicine, marking a significant step in this field [3] Group 2 - ST Kelly has elected a new chairman, Wang Chong, following the recent resignation of both the chairman and the general manager, with the board voting in favor of the appointment [4] - Yunding New Medicine's core product, Naimu Kang, has received full approval from the National Medical Products Administration for treating primary immunoglobulin A nephropathy in adults, becoming the first and only drug in China approved for this indication [5]

近些年，"红斑狼疮"一词频频走进大众视野。如何科学看待这一疾病？常规体检能发现吗？记者采访了 深圳市人民医院风湿免疫科主任医师刘冬舟。 刘冬舟介绍，系统性红斑狼疮（以下简称"红斑狼疮"）是一种累及多系统多脏器的慢性自身免疫病，多 见于育龄期年轻女性。正常情况下，免疫系统会保护自身机体不受病原体伤害，但红斑狼疮患者的免疫 系统出现紊乱，错误地攻击自身健康组织和器官。 "很多人将红斑狼疮理解为一种无法治愈的致命疾病。事实上，虽然目前没有根治方法，但它并不是无 法控制的。"刘冬舟说，随着医学水平的进步，尤其是红斑狼疮生物制剂领域的发展，红斑狼疮患者的 生存率大幅提升，5年生存率可达90%以上，10年生存率也将近90%。患者应树立对疾病治疗的信心， 尽早规范诊疗，有效控制病情。绝大多数患者病情可实现长期缓解，回归正常生活。 刘冬舟表示，红斑狼疮患者的临床表现差异很大，有些患者只累及皮肤、关节，部分患者可能同时累及 肾脏、心脏、肺、脑等多个器官系统，因此须基于患者的临床表现、受累器官系统类型、疾病严重程度 及药物治疗反应等综合考量制定并调整治疗方案，目前仍主要采用激素及传统免疫抑制剂治疗。近几 年，生物制剂在治疗中的地 ...

Skye Bioscience (SKYE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Bernie Hertel - Head IR & CommunicationsPunit Dhillon - President, CEO, Secretary & DirectorChris Twitty - Chief Scientific OfficerKaitlyn Arsenault - Chief Financial OfficerPuneet Arora - Chief Medical Officer Conference Call Participants None - AnalystJay Olson - Managing Director & Senior Analyst - BiotechnologyAlbert Lowe - Senior Research AnalystEdward Tenthoff - Sr. Research AnalystKristen Kluska - AnalystAndy H ...