林辰/文 潜在总交易额超20亿美元，在中关村生命科学园深耕10年的诺诚健华，在节后传来重磅消息。其与 Zenas就三款自免管线达成的授权许可合作，刷新了中国自免领域小分子交易记录。这不仅只是奥布替 尼国际化的里程碑，也是中关村生命科学园孵化全球竞争力医药健康产业的又一成果。 另据了解，历经十年，由中国本土科学家及企业自主研发以丁肝为适应症的1类新药立贝韦塔单抗，也 有望在明年第一季度前后获批上市。其背后的华辉安健，亦是中关村生命科学园孵化的立足中国、面向 全球的生物医药企业。 作为昌平"生命谷"核心区域，占地面积7.2平方公里的中关村生命科学园，是北京自贸试验区科技创新 片区的重要组团，也是中关村国家自主创新示范区的重要专业园区。过往数年，这里诞生了中国首 款"十亿美元分子"新药泽布替尼和"国内十亿分子"新药奥布替尼。 从"实验室—共性平台—小试中试—临床应用"，这片"生命谷"的1公里转化圈，正不断缔造医药健康产 业的创新引擎。 治疗慢性丁型肝炎，HH-003注射液有望明年获批上市 2021年，公司A+轮融资引入高瓴资本，老股东汉康资本和经纬中国持续加码。多方加持下，该轮融资 额达到5亿元人民币。与此同时，H ...

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 ...

Core Viewpoint - The company, Innovent Biologics, reported a significant revenue increase driven by the continued growth of its core product, Oubatinib, and strategic partnerships, while also making substantial progress in its clinical pipeline and global expansion efforts [1][3][4]. Financial Performance - For the first half of 2025, the company's revenue grew by 74.3% year-on-year, reaching 730 million RMB, primarily due to the strong sales of Oubatinib and an upfront payment from a licensing agreement with Prolium [1]. - Drug revenue increased by 53.5% year-on-year to 640 million RMB, attributed to Oubatinib's inclusion in the national medical insurance and its expanding patient base [1]. - The company's loss narrowed by 86.7% year-on-year to 36 million RMB, reflecting increased revenue and improved cost efficiency [1]. Research and Development - R&D expenses rose by 6.9% year-on-year to 450 million RMB, focusing on building a differentiated R&D platform and advancing multiple Phase III clinical projects [1][2]. Product Pipeline and Approvals - Oubatinib was approved for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and is included as a Level I recommendation in the CSCO lymphoma treatment guidelines [3]. - Tafasitamab (brand name: Mingnuokai) was approved for treating relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in combination with lenalidomide, marking it as the first CD19 monoclonal antibody approved for this indication in China [3]. - The BCL2 inhibitor, Mesutoclax (ICP-248), 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, Zurletrectinib (ICP-723), has had its new drug application accepted in China and is under priority review, potentially becoming the first domestically developed TRK inhibitor approved for market [3]. Strategic Partnerships and Global Expansion - The company is expanding its global footprint through strategic collaborations, 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 Oubatinib [4]. Leadership in Hematological Oncology - The company is strengthening its leadership position in hematological oncology with Oubatinib, Tafasitamab, and Mesutoclax as cornerstone therapies [5]. - Oubatinib's approval for first-line treatment of CLL/SLL and Tafasitamab's approval for R/R DLBCL enhance the company's product offerings in this field [5]. Autoimmune Disease Pipeline - Oubatinib is being developed as a new treatment option for primary immune thrombocytopenia (ITP), with Phase III clinical trials completed and an application for market approval expected in mid-2026 [11]. - The company is also advancing two TYK2 inhibitors in clinical trials, targeting various autoimmune diseases [12]. ADC Technology Development - The company has developed a differentiated ADC technology platform aimed at creating effective and targeted therapies for cancer treatment [16]. - The first ADC candidate, targeting B7-H3, has received clinical approval and is expected to enter patient trials soon [18][19].

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].