简评 一、业绩符合预期，核心产品驱动增长 机构：中信建投证券 研究员：贺菊颖/袁清慧/沈毅 核心观点 诺诚健华发布2025 年中期业绩报告。报告期内营业收入7.3 亿元，同比增长74.26%；亏损减少至0.36 亿 元，同比缩窄86.7%。其中核心产品奥布替尼销售收入6.37 亿元，同比增长52.48%。2025 年公司进一步 发展，里程碑事件有望进一步兑现：（1）奥布替尼联合ICP-248 治疗1L CLL/SLL-FDT 的III期临床试验 完成入组；（2）奥布替尼完成自免领域ITP 适应症的III 期临床；（3）首款ADC 药物ICP-B794 完成首 例患者入组，并取得临床PoC。 事件 2025 年8 月20 日公司披露2025 年半年报，2025 年上半年收入同比增长74.3%，达到7.3 亿元；药品收入 上半年同比增长53.5%，达到6.4 亿元；上半年亏损同比降低86.7%，减少至0.36 亿元。 公司2025H1 实现营业收入7.3 亿元，同比增长74.3%，主要归功于核心产品奥布替尼的持续放量以及公 司与Prolium达成授权许可获得的首付款。核心产品奥布替尼销售额6.37亿元，同比增长5 ...

Core Viewpoint - InnoCare Pharma has initiated a registrational trial for mesutoclax, a BCL2 inhibitor, aimed at treating mantle cell lymphoma (MCL) patients previously treated with BTK inhibitors in China [1][3]. Group 1: Product and Mechanism - Mesutoclax is an orally bioavailable BCL2 selective inhibitor that targets the apoptosis pathway, which is crucial in the development of various hematologic malignancies [2]. - The drug has shown potential in treating multiple diseases, including MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS) [2]. Group 2: Clinical Development - The registrational trial is specifically designed to assess the safety and efficacy of mesutoclax in patients with BTKi-treated MCL, which is characterized as an aggressive form of B-cell non-Hodgkin lymphoma with limited treatment options [3]. - InnoCare is advancing clinical trials for mesutoclax across four indications both in China and globally [2]. Group 3: Company Overview - InnoCare is a commercial stage biopharmaceutical company focused on discovering, developing, and commercializing innovative drugs for cancer and autoimmune diseases with unmet medical needs [4]. - The company has established branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [4].

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 Insights - InnoCare reported solid 1Q25 results with revenue reaching RMB381 million, driven by a significant increase in orelabrutinib sales, which rose 89% YoY to RMB311 million [1] - The company expects orelabrutinib sales to be primarily supported by its uptake in marginal zone lymphoma (MZL), projected to account for approximately 50% of sales by year-end 2025 [1] - Management has raised the FY25 sales growth target for orelabrutinib from 30% to over 35% [1] Financial Performance - InnoCare's net income for 1Q25 was RMB14 million, bolstered by strong orelabrutinib sales and an upfront payment of US$8.75 million from out-licensing its CD3/CD20 asset [1] - The product gross margin improved to 88.4%, up from 86.2% in FY24, indicating enhanced manufacturing efficiency [1] - The SG&A ratio declined to 50%, down from 60% in FY24, reflecting better cost discipline [1] - As of 1Q25, InnoCare maintained a robust cash position of RMB7.8 billion, providing ample capital for R&D initiatives [1] Pipeline Development - InnoCare's autoimmune pipeline is viewed as a key growth driver, with orelabrutinib showing strong potential in multiple sclerosis (MS) [1] - Two Phase 3 trials for orelabrutinib in MS are advancing in the US, targeting primary progressive MS (PPMS) and secondary progressive MS (SPMS) [1] - In the oncology sector, InnoCare is progressing with mesutoclax (ICP-248) as a competitive Bcl-2 inhibitor, with a Phase 3 trial ongoing for first-line chronic lymphocytic leukemia (CLL) [2] - Tafasitamab (CD19) is on track for approval in China for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), enhancing the hematology portfolio [2] Strategic Outlook - InnoCare is targeting less crowded indications overseas, including first-line acute myeloid leukemia (AML) and BTK inhibitor-pretreated mantle cell lymphoma (MCL) [2] - The company is advancing its in-house antibody-drug conjugate (ADC) platform, with an IND for a B7-H3-targeting ADC submitted in April 2025 [2] - The significant out-licensing potential across multiple assets, particularly orelabrutinib and ICP-332, is highlighted as a strategic advantage [3]

Investment Rating - The report maintains an investment rating of "Outperform the Market" for the pharmaceutical sector [2][5]. Core Views - The pharmaceutical sector has seen a 0.49% increase this week, outperforming the CSI 300 index by 0.93 percentage points, ranking 9th among 31 first-level industries [8][28]. - The report highlights the positive impact of favorable policies on the pharmaceutical sector, suggesting a gradual recovery in industry sentiment. It recommends focusing on high-quality targets in the formulation sector and emphasizes the potential of innovative therapies and domestic drug replacements [5][28]. Summary by Sections Industry Performance - The pharmaceutical sector's performance this week was a 0.49% increase, with sub-sectors such as pharmaceutical commerce rising by 3.12% and medical services by 1.69%. In contrast, biological products and traditional Chinese medicine II saw declines of 0.87% and 1.01%, respectively [8][28]. Key News - Baiyi Shenzhou's BCL-2 inhibitor "Sonrotoclax" has been submitted for market approval, targeting specific types of lymphoma and leukemia [28][29]. - Merck KGaA announced a $3.9 billion acquisition of SpringWorks, enhancing its portfolio in the oncology space [28][30]. Key Announcements - Baili Tianheng received approval for two Phase II clinical trials for its innovative drug BL-B01D1, aimed at treating recurrent or metastatic cervical cancer and advanced endometrial cancer [32][33].