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点击蓝字 关注我们 本 期 看 点 肺癌的分类，按照组织学，可以分为小细胞肺癌（13.9%）；非小细胞肺癌：鳞状细胞癌（24.4%）、腺癌（45.4%）、大细胞癌（1.5%）、其他（如腺鳞癌、肉瘤样癌等）。小细胞肺癌，相较于靶向治疗、免疫治疗进展迅速的非小细胞肺癌，小细胞肺癌一直都是临床难治性瘤种，但SCLC近年来逐步成为创新药物竞逐的热点。 小细胞肺癌的治疗正在经历着变革，迎来了前所未有的快速发展时期，中国研究者做出了突出的贡献，掀起了小细胞肺癌诊疗研究领域的新浪潮。创新型抗肿瘤药物的研发和新的联合策略的探索将带给SCLC治疗格局日新月异的改变，随着分子机制的不断揭示，治疗脆弱点和预测标志物的络绎涌现，SCLC在迈向精准治疗的道路上更进一步，未来有望实现更大的突破。 本期内容 01 百济神州/安进丨塔拉妥单抗 02 小细胞肺癌治疗现状和流行病学 03 国内小细胞肺癌在研态势 04 总结与展望 【01 百济神州/安进丨塔拉妥单抗】 SCLC（小细胞肺癌）研究进展 2025年8月25日，百济神州公告，公司与Royalty Pharma签订了Imdelltra特许权使用费购买协议。 根据协议，Royalty Pharma将在交割时向百济神州的子公司BeOne Medicines I GmbH支付8.85亿美元首付款，购买其在中国以外地区销售的Imdelltra产品的特许权使用费权益。 协议允许卖方在2026年8月25日前出售更多特许权使用费权益（卖出选择权），最高可获得6500万美元额外付款。协议包含惯常的陈述、保证及赔偿条款，并预计首付款将构成公司的一项重大直接财务义务。 2025年7月30日，CDE 官网显示，安进和百济神州联合递交的注射用塔拉妥单抗（DLL3/CD3双抗，Tarlatamab）新适应症上市申请获受理。根据该药的临床试验进度推测，本次申报的适应症为：用于小细胞肺癌患者二线治疗。 截图来自 CDE 官网 在ES-SCLC领域，塔拉妥单抗同样在华申请适应症。 ES-SCLC（广泛期小细胞肺癌）研究进展 2025年4月11日，安进宣布塔拉妥单抗在III期DeLLphi-304研究中达到主要终点。该研究纳入前线铂类化疗后进展的ES-SCLC患者，对比标准治疗（SOC）化疗显示，塔拉妥单抗显著延长总生存期（OS），塔拉妥单抗的中位 OS 为 13.6 个月（vs 8.3 个月），且具有统计学和临床意义。安全性数据与既往研究一致，未出现新的安全性信号。 塔拉妥单抗于2024年5月获FDA加速批准上市，用于铂类化疗后进展的ES-SCLC治疗，成为全球首个靶向DLL3的双抗药物。此次III期数据为其从加速批准转为完全批准提供关键支持。 2025年7月16日，塔拉妥单抗在国内申报上市的首个适应症已在获得 CDE 受理，用于 ES-SCLC 成人患者的三线治疗，且该申请已被纳入优先审评。 国内研发进展 百济神州拥有塔拉妥单抗中国区商业化权益，同步推进多项临床： DeLLphi-305：比较塔拉妥单抗+度伐利尤单抗 vs 度伐利尤单抗维持治疗的III期研究 联合放疗探索：DeLLphi-306研究局限期SCLC放化疗后辅助治疗（NCT05740566） 随着塔拉妥单抗等创新疗法的涌现，ES-SCLC治疗进入精准免疫时代。DLL3靶点的突破不仅为患者提供新选择，更验证了双抗技术在实体瘤治疗中的潜力。 02 小细胞肺癌治疗现状和流行病学 03 国内小细胞肺癌在研态势 普米斯丨PD-L1/VEGF双抗 此外，其他国产双抗也纷纷布局小细胞肺癌，如普米斯的PD-L1/VEGF双抗PM8002。 针对占肺癌病例14%的小细胞肺癌（SCLC），这款中国二期临床试验中展现突破性疗效的药物，已迈入全球三期临床阶段。数据显示，BNT327联合化疗为患者带来16.8个月的中位总生存期（OS），较当前罗氏Tecentriq（12.3个月）和阿斯利康Imfinzi（13个月）的标准疗法显著延长，有望重塑SCLC一线治疗格局。   尽管跨试验对比存在局限性——BioNTech的48例单臂研究与跨国多中心数千人试验的样本差异引发讨论，但其二线治疗数据同样亮眼：65例患者中位OS达14.3个月，未接受免疫治疗人群的缓解持续时间（DOR）更长达11.5个月，超越安进同类药物Imdelltra（9.7个月）。目前，BNT327联合化疗的二线三期试验已在华启动，而全球布局则聚焦一线治疗，覆盖SCLC、非小细胞肺癌及三阴性乳腺癌三大癌种。 正大天晴 广泛期小细胞肺癌（ES-SCLC）一线治疗： 2024年5月，贝莫苏拜单抗注射液联合安罗替尼、依托泊苷及卡铂一线治疗ES-SCLC获国家药监局批准。 在ETER701Ⅲ期研究中，接受该四药联合疗法的患者中位总生存期（OS）达19.3个月，较单纯化疗延长7.4个月，疗效数据亮眼。这是国内首个PD-L1抗体与安罗替尼联合用于ES-SCLC的一线疗法，为该类型患者提供了新的治疗选择。 齐鲁制药丨PD-1/CTLA-4组合抗体 2025年2 月 11 日，药物临床试验登记与信息公示平台官网显示，齐鲁制药登记了一项 QL1706 注射液（艾帕洛利单抗/托沃瑞利单抗，PD-1/CTLA4 混合抗体）单药巩固治疗局限期小细胞肺癌的 III 期临床研究（CTR20250450）。 在齐鲁艾托组合抗体肺癌、宫颈癌、结直肠癌、肝癌、食管癌数据汇总 一文中就QL1706在各个实体瘤领域的研究进展进行过梳理。 04 总结与展望 根据2025年CSCO小细胞肺癌更新可以看出，国产创新药物逐步获得更多认可，也期望后续有更多创新产品重塑小细胞肺癌的治疗格局。 另外，齐鲁 ★

SHANGHAI, Aug. 25, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2025 interim results. In the first half of 2025, Henlius' revenue reached about RMB2.8195 billion, representing an increase of 2.7% YoY. The gross profit of RMB2.1992 billion, up by 10.5% YoY, with a net profit reached RMB390.1 million. Operating cash flow reached RMB770.9 million, with an increase of 206.8% YoY, maintaining a steady positive inflow. Overseas products profits surged over 200%. Cash inflows from BD agreements exceeded RMB 1 billion, surging 280% YoY. As the overseas sales volume of commercialized products continues to rise, the company expects significant growth in overseas revenue and profits for the full year of 2025, with strong momentum likely to continue into 2026. The company remains committed to reinforcing its strategic focus on innovation and globalisation, actively advancing its end-to-end ecosystem to drive sustainable R&D growth with robust growth momentum. During the reporting period, the company invested RMB995.4 million in R&D, with an increase of 21.3% YoY in expensed R&D expenditures, prioritizing preclinical development of differentiated innovative molecules and construction of core innovation platforms. Up to date, Henlius has 6 products launched in China, 4 approved for marketing in overseas markets, benefiting over 850,000 patients and reaching about 60 markets in Asia, Europe, Latin America, North America and Oceania. Meanwhile, the company is expanding its innovation pipeline in disease areas like oncology and autoimmune, advancing a differentiated portfolio of potential best-in-class (BIC) and first-in-class (FIC) candidates. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said "2025 is a pivotal year for Henlius. It is the year we shift into Globalisation 2.0 and step up the pace of innovation. We're strengthening our end-to-end ecosystem and driving overseas revenue growth with global value at scale. Meanwhile, our core innovative products have achieved significant milestones, with the next-generation of high-potential molecules underway. Looking ahead, Henlius will adhere to patient-centricity and accelerate the delivery of superior innovative treatment solutions." Globalisation 2.0: actively advancing the end-to-end ecosystem In the first half of 2025, Henlius' global growth engine was in full swing, with global product revenue exceeding RMB2.5568 billion, representing an increase of 3.1% YoY. Several products are accelerating their expansion into international markets, further improving patient access to essential therapies. The company's core innovative product serplulimab (trade name: HANSIZHUANG in China, Hetronifly® in Europe), the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of small cell lung cancer (SCLC), has recorded a global sales revenue of RMB597.7million during the reporting period. The overseas market expansion of serplulimab has been accelerated in the first half of 2025. It has received approvals in the Europe, Singapore, Malaysia, the United Kingdom and India for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, it has been approved in Indonesia and Thailand for the treatment of squamous non-small cell lung cancer (sqNSCLC). To date, serplulimab has been successfully approved in nearly 40 countries and regions, covering nearly half of the world's population. A head-to-head bridging trial of serplulimab versus first-line standard of care atezolizumab for ES-SCLC in the U.S will also complete patient enrolment soon. The company plans to submit the Biologics License Application (BLA) to the FDA in the first half of 2026. Henlius' core breast cancer product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the "China-developed" mAb biosimilar approved in China, the EU, and the U.S., has recorded a global sales revenue of RMB1.4442 billion in the first half of 2025. During the reporting period, HANQUYOU (trastuzumab) was newly approved in countries including Mexico, bringing its cumulative approvals to over 50 countries and regions worldwide. In the HER2-positive breast cancer segment, Henlius has sequentially combined HANQUYOU (trastuzumab) with HANNAIJIA (neratinib) for extended adjuvant therapy to reduce recurrence risk in early-stage patients. Meanwhile, Henlius' independently developed pertuzumab biosimilar, HLX11, has been accepted for marketing applications by regulatory agencies in China, the U.S., and Europe, and is anticipated to receive approval in th U.S. during the second half of 2025. Focusing on the breast cancer field, Henlius continues to build a comprehensive innovative product portfolio — candidates including Henlius' HLX78 (lasofoxifene), an investigational novel endocrine therapy, the company's novel epitope anti-HER2 mAb HLX22, the next-gen innovative HER2 ADC HLX87, the KAT6A/B inhibitor HLX97 with BIC potential, and the LIV-1 ADC HLX41 are accelerating their research progress. In more disease fields, HLX04-O, a recombinant anti-VEGF humanised mAb injection jointly developed by the company and Essex, for the treatment of wet age-related macular degeneration (wAMD) has been accepted for the New Drug Application (NDA) in China in August 2025. This is the company's first ophthalmic product submitted for marketing approval. The marketing applications for the denosumab biosimilar HLX14, intended for the treatment of osteoporosis and other indications, have been accepted in the U.S., EU, and Canada, with expected approvals in the second half of 2025. In the first half of the 2025, Henlius accelerated the expansion of its core products into major global markets through strategic collaboration, further enhancing the company's international influence and commercial capabilities. The company has entered into agreement with Abbott, granting it exclusive or semi-exclusive licenses for the development and commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets including Asia and Latin America. The company has granted Dr. Reddy's exclusive rights to HLX15, an anti-CD38 mAb, covering a total of 43 countries and regions across the U.S. and Europe. Besides, the company has also entered into an exclusive commercialization and semi-exclusive development collaboration with Lotus for the anti-PD-1 antibody serplulimab in multiple indications in South Korea. Additionally, the company has signed a licensing agreement with Sandoz, granting exclusive commercialization rights for HLX13, an CTLA-4 inhibitor, in the U.S., EU, Japan, Canada, and Australia. In the first half of 2025, leveraging the advanced technologies and extensive resources, the company continued to reinforce its integrated biopharmaceutical platform including R&D, clinical trials, manufacturing, quality management, regulatory affairs, and commercialization. Up to date, the company has submitted over 800 drug registrations, and received more than 600 approvals, covering multiple countries and regions including China, the U.S., the EU, Canada, Indonesia and Japan. It has also conducted MRCTs in the U.S., the EU, Southeast Asia, Japan and other countries and regions, accelerating the globalisation process of its products. During the reporting period, Henlius continues to optimize its production operations and quality management system. The Songjiang Site has once again received the EU GMP Certificate, issued by the Federal Agency for Medicines and Health Products in Belgium, in July 2025. The completion of the Phase 1 of Songjiang Site II in August 2025 has further enhanced the company's production capabilities. Up to now, the company has delivered over 1,150 batches of commercial GMP production, ensuring stable supply to countries and regions including China, Southeast Asia, Europe and Latin America. The company has successfully passed nearly 100 on-site inspections and audits conducted by global regulatory authorities and business partners, and has obtained GMP certifications from China, the EU, the U.S. and multiple PIC/S member countries, including Indonesia and Brazil. Innovation breaks through the growth ceiling In the first half of 2025, the company continued to advance its innovation-driven strategy, accelerating breakthroughs in cutting-edge technology platforms and driving robust growth in its innovative pipeline. Core products such as HLX43, HLX22, and serplulimab have each achieved significant global milestones. HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1 with BIC potential. The results of the phase 1 clinical trial of HLX43 have been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC and thymic squamous cell carcinoma (TSCC). It shows encouraging efficacy in squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative NSCLC patients, indicating its biomarker-independent antitumor potential. Previously, HLX43 has already been approved to conduct phase 2 MRCT in patients with non-small cell lung cancer (NSCLC) in China, the U.S., Japan and Australia, with first patients successfully dosed in both China and the U.S. Simultaneously, as the world's first PD-L1 ADC indicated for thymic carcinoma (TC), HLX43 has received clinical trial approvals for the indication in the U.S. and other regions. A MRCT is planned to be initiated, aiming to fill the therapeutic gap in ADC treatment for this aggressive cancer type. In addition, the company is also accelerating the phase 2 clinical development of HLX43 in various solid tumors, including cervical cancer (CC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC) and gastric/gastroesophageal junction cancer (GC/GEJC). Both monotherapy and combination therapies of HLX43 with other products are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. A phase 3 head-to-head clinical trial of Henlius' novel enpitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy comparing to current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) is steadily progressing. The first patient dosing has been completed in China, the U.S., Japan, Australia, and Korea, regardless of PD-L1 expression, with the aim of overcoming current limitations in first-line treatment of HER2-positive metastatic gastric cancer. Meanwhile, HLX22 has received Orphan Drug Designations from both the U.S Food and Drug Administration (FDA) and the European Commission (EC) in the first half the year for the treatment of gastric cancer, suggesting its significant therapeutic potential. Moreover, the updated data with over two years of follow-up from the phase 2 clinical study (HLX22-GC-201) evaluating HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at the 2025 ASCO Annual Meeting. The study data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up, outperforming previous data and providing solid data foundation for the subsequent phase 3 study. Focusing on lung and gastrointestinal cancer, Henlius is continuously advancing the global clinical development of its self-developed innovative anti-PD-1 mAb serplulimab. In the field of lung cancers, the U.S. and Japanese bridging trial of serplulimab for SCLC, and a phase 3 MRCT of serplulimab combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC) are currently underway in parallel to establish a solid foundation for future overseas regulatory registration, among which the phase 3 MRCT in LS-SCLC has completed the subject enrollment. In the field of gastrointestinal cancers, a phase 3 clinical trial of serplulimab plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the phase 3 MRCT (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) have also completed subject enrollment. During the reporting period, a total of over 20 pivotal studies, investigator-initiated trials (IITs), and real-world studies (RWS) on serplulimab in the fields of lung cancer and gastrointestinal cancer were presented at major international academic conferences such as ASCO GI, ELCC, IGCC, ASCO, and WCLC, and were published in scientific journals including Cancer Immunology, Immunotherapy and Cancer Communications. Among them, the end-of-study analysis of the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC has been first released at the 2025 ASCO Annual Meeting, featuring a four-year OS data of 21.9% and thus validating its long-term survival benefit. While fully leveraging the value of its flagship molecules, the company is actively addressing unmet clinical needs and building an early-stage pipeline of high-potential candidates, creating strong momentum for sustainable, high-quality growth over the medium to long term. During the period, the company continued building and optimizing its competitive R&D platforms, including its ADC platform Hanjugator™ with independent intellectual property, T cell Engager (TCE) platforms, the one-stop drug discovery platform HAI Club, and the independently developed computing platform HAI PBD to enhance R&D capabilities. Meanwhile, building on its core antibody expertise, the company is making ongoing breakthroughs across target coverage and molecular diversity, accelerating multiple candidates toward clinical development, including the potential FIC human sialidase enzyme therapeutic HLX79, HLX701, the novel anti-CD47 SIRPα-Fc fusion protein with good safety profile, anti-PD-L1/VEGF bispecific antibody (BsAb) HLX37, potential BIC KAT6A/B small molecule inhibitor HLX97, TCE platform-derived DLL3xCD3xCD28 TCE HLX3901 and STEAP1xCD3xCD28 TCE HLX3902, Hanjugator™-based EGFRxcMET ADC HLX48, and potential FIC B7H3-sialidase enzyme HLX316. Looking ahead, Henlius will remain committed to its patient-centric mission, accelerate global expansion, drive the efficient implementation of innovation outcomes, and continuously enhance its global product supply as well as quality systems, aiming to bring more high-quality, affordable innovative treatment options to patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 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