在针对NTRK融合基因阳性的晚期实体瘤患者的注册临床试验中，佐来曲替尼展示了卓越的有效性和安 全性，同时可以克服第一代TRK抑制剂的耐药性。 据了解，佐来曲替尼是诺诚健华自主研发的泛TRK抑制剂。佐来曲替尼治疗携带NTRK融合基因的晚期 实体瘤成人和青少年(12周岁≤年龄<18周岁)患者的新药上市申请(NDA)已在中国获受理并纳入优先审 评，佐来曲替尼针对儿童患者(2周岁≤年龄<12周岁)的注册临床试验正在进行中，目标于2025年下半年 提交新药上市申请(NDA)。 诺诚健华联合创始人、董事长兼CEO崔霁松表示："NTRK基因融合在儿童肿瘤中非常常见。佐来曲替 尼纳入'星光计划'是对诺诚健华创新能力的高度认可，我们将加速推进其临床开发，为儿童患者带来更 优治疗方案。" "星光计划"是药审中心为了落实国家药监局"提前介入、一企一策、全程指导、研审联动"的要求，在儿 童药物研发领域开展的一项试点工作，旨在通过申请人填写提交《儿童抗肿瘤药物研发实施框架》的方 式，与药审中心及早进行沟通，获得其抗肿瘤药物在儿童人群研究过程中技术问题的相应指导，并在研 发过程中，与药审中心保持紧密沟通，最终提高儿童抗肿瘤药物的研发效率 ...

来源：市场资讯 （来源：诺诚健华） 诺诚健华（香港联交所代码：09969；上交所代码：688428）今日发布截至2025年6月30日的2025年中期 业绩报告和公司进展。 奥布替尼持续放量助推营收大涨 诺诚健华2025年上半年收入同比增长74.3%，达到7.3亿元 [1]，主要归功于核心产品奥布替尼（商品 名：宜诺凯®）的持续放量以及公司与Prolium达成授权许可获得的首付款。药品收入上半年同比增长 53.5%，达到6.4亿元，主要是源于奥布替尼纳入国家医保后持续放量，尤其是独家适应症边缘区淋巴瘤 惠及更多患者，以及商业化团队执行能力的不断强化。公司上半年亏损同比降低86.7%，减少至0.36亿 元，亏损大幅缩窄是源于营业收入的增加以及成本效率进一步提升。 与此同时，公司 2025 年上半年研发费用同比增加6.9%[2]，达到4.5亿元，研发费用的增加主要是搭建差 异化研发平台和推进更多临床III期项目。 截至2025年6月30日，诺诚健华持有现金及相关账户结余约 76.8亿元。强劲的现金流将有助于公司加速 推进多项III期注册临床试验开发和投资于差异化的ADC及其他管线，致力于为全球患者提供更多更好 的治 ...

Core Viewpoint - 诺诚健华 reported a significant increase in revenue for the first half of 2025, driven by the strong performance of its core product, 奥布替尼, and strategic partnerships, while also improving cost efficiency and reducing losses [2][3]. Financial Performance - The company's revenue for the first half of 2025 reached 730 million yuan, representing a year-on-year growth of 74.3% [2]. - Drug revenue increased by 53.5% to 640 million yuan, primarily due to 奥布替尼's inclusion in the national medical insurance and its expanding patient base [2]. - Losses were reduced by 86.7% to 36 million yuan, attributed to increased revenue and enhanced cost efficiency [2]. Research and Development - R&D expenses rose by 6.9% to 450 million yuan, focusing on building a differentiated R&D platform and advancing multiple Phase III clinical projects [2]. - The company holds approximately 7.68 billion yuan in cash and equivalents, which will support the acceleration of clinical trials and investments in differentiated ADC and other pipelines [2]. Product Pipeline and Innovations - 奥布替尼 was approved for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and is included as a top recommendation in the CSCO lymphoma guidelines [3]. - The CD19 monoclonal antibody, 坦昔妥单抗, was approved for treating relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), marking a significant milestone as the first CD19 monoclonal antibody approved for this indication in China [3]. - The BCL2 inhibitor, Mesutoclax, is advancing in two registration clinical studies and has received Breakthrough Therapy Designation, being the first BCL2 inhibitor in China to achieve this status [3]. - The new generation TRK inhibitor, 佐来曲替尼, has had its NDA accepted in China and is under priority review, with expectations to be the first domestically developed TRK inhibitor approved [3]. Strategic Collaborations - The company has formed strategic partnerships to enhance its global presence, including a licensing agreement with Prolium for the development and commercialization of the CD20×CD3 bispecific antibody ICP-B02 [4]. - The commercial team has shown strong execution capabilities, leading to increased market penetration and revenue growth for 奥布替尼 [4]. Future Growth Plans - The company aims to accelerate innovation, commercialization, and internationalization as part of its 2.0 rapid development phase, with plans to advance multiple innovative drugs for approval in the next three to five years [5]. - The focus will also be on expanding its pipeline in autoimmune diseases and solid tumors, with significant market potential anticipated [9][12].