Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

太平洋时间2025年8月13日，2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）官网公布了本届大会入选研究摘要的详细信息，复星医药子公司复宏汉霖三款肺癌领域核心创新型产品PD-L1 ADC HLX43、抗EGFR单抗HLX07和抗PD-1单抗H药 汉斯状®的10项肺癌领域研究入选大会口头报告、壁报导览、壁报展示等多个专场，其中包括4项口头报告，2项壁报导览，覆盖非鳞状/鳞状非小细胞肺癌（nsNSCLC/sqNSCLC）及广泛期小细胞肺癌（ES-SCLC）的一线治疗，同时，也探索了免疫联合疗法在脑转移患者、肺癌围术期患者等广泛人群中的治疗潜力。 据GLOBOCAN最新数据显示，肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%[1]。肺癌分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中约85%的肺癌类型为NSCLC。进一步划分，NSCLC又可为鳞状细胞癌（约30%）、肺腺癌（约50%）以及其他癌种。复宏汉霖在肺癌治疗领域持续深耕，从H药引领小细胞肺癌免疫治疗，到HLX43、HLX07等多元管线覆盖非小细胞肺癌多个分子特征，公司已逐步构建差异化、全人群覆盖的产品矩阵。 HLX43是全球首个进入临床II期阶段的PD-L1的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂（CPI）治疗并失败的后线耐药NSCLC患者中，持续表现出高应答率，在特定亚组如EGFR野生型nsNSCLC人群中展现了更为优异的疗效，ORR达47.4%，同时延续了良好的安全性。HLX07是公司自主开发的改良型靶向EGFR的人源化单抗，其联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者中展现出显著的抗肿瘤活性和持久疗效。在中位随访18.6个月时，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。H药为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，迄今已在近40个国家和地区获批上市，覆盖全球近半数人口。在肺癌领域，H药已获批联合化疗用于一线治疗驱动基因阴性的鳞状非小细胞肺癌（sqNSCLC）、非鳞状非小细胞肺癌（nsNSCLC）以及广泛期小细胞肺癌（ES-SCLC）。 重磅口头报告，印证NSCLC疗效 本次大会上，由中国医学科学院肿瘤医院石远凯教授担任牵头主要研究者的H药联合化疗一线治疗晚期非鳞状非小细胞肺癌的III期临床（ASTRUM-002）研究，将以口头汇报的形式首次发布，mPFS显著延长5.4个月，脑转移人群获益明确。同时，多项探索H药免疫联合疗法的IIT研究结果也入选大会简短口头报告（Mini Oral）、壁报导览和壁报展示环节，印证了H药在nsNSCLC脑转移患者、EGFR-TKI耐药和非小肺癌围术期患者中的疗效与安全性，展现在更广泛人群中的治疗潜力。 ASTRUM-002研究是一项三臂、随机、双盲、多中心III期研究，患有局部进展期或转移性非鳞状非小细胞肺癌、不携带EGFR致敏突变和ALK/ROS重排、且无系统性治疗史的患者，按1:1:1比例随机分配接受斯鲁利单抗联合HLX04（贝伐珠单抗）及化疗（卡铂-培美曲塞）、斯鲁利单抗联合化疗或化疗。研究结果表明，斯鲁利单抗联合化疗对比化疗一线治疗晚期非鳞状非小细胞肺癌（NSCLC），中位无进展生存期（mPFS）显著延长（11.0个月 vs. 5.6个月；分层HR=0.55，95%置信区间[CI]：0.43-0.69，P < 0.0001），达到预设的优效标准，且具有良好的安全性，未观察到新的安全性信号。在脑转移患者亚组中，斯鲁利单抗联合化疗组的中位PFS达8.1个月，较对照组延长4.0个月，降低疾病进展或死亡风险49%（HR=0.51, 95%CI：0.30-0.87，P=0.0115）。 一项斯鲁利单抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究。研究共纳入40例未经治疗的伴有脑转移的非鳞状非小细胞肺癌患者，接受斯鲁利单抗联合贝伐珠单抗以及化疗（培美曲塞和卡铂）的一线治疗。中位随访13.3个月，中位颅内无进展生存期（iPFS）为13.1个月，颅内肿瘤客观缓解率（ORR）为84.6%，颅外ORR为64.1%，显示出强大的抗肿瘤活性。研究结果显示，斯鲁利单抗联合贝伐珠单抗和化疗一线治疗伴有脑转移的非鳞状非小细胞肺癌患者表现出有前景的颅内抗肿瘤有效性和可控的安全性。 EGFR高表达肺癌，潜力优势治疗选择 在全球非小细胞肺癌（NSCLC）患者中，EGFR高表达的比例约为40%–89%（取决于病理分型、种族等因素），意味着每年有数百万新发患者属于这一人群[2-4]。尤其是在sqNSCLC患者中，高达89%表现为EGFR高表达[2-3]。复宏汉霖亦积极推进一项创新型抗EGFR单抗HLX07联合斯鲁利单抗的创新疗法用于一线治疗EGFR高表达的sqNSCLC的临床II期研究，以满足该领域的临床未尽之需。这项研究的最新临床数据结果入选本次WCLC大会的壁报展示环节。 HLX10HLX07-sqNSCLC-201研究是一项随机、多中心的二期研究，包括4个部分，评估了HLX07（不同剂量）、斯鲁利单抗和化疗的多种组合。 第3部分评估了三药组合的初步有效性，EGFR高表达（H评分≥150）且无既往系统治疗的患者被随机分为1:1两组，接受静脉注射HLX07 800 mg或1000 mg，联合斯鲁利单抗和化疗。在中位随访18.6个月时，两个剂量组均实现了约七成的客观缓解率（ORR），且中位总生存期（mOS）和持续缓解时间（mDOR）均未达到显示出疗效持久且有进一步改善的潜力，且安全性良好。尤其值得注意的是，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。研究结果显示，HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。 肺癌一线全覆盖，ES-SCLC广获益 复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗。在小细胞肺癌领域，基于国际多中心III期临床ASTRUM-005研究，H药已于中国、英国、德国、新加坡、印度等全球近40个国家和地区获批用于一线治疗广泛期小细胞肺癌（ES-SCLC），该研究结束分析结果已于2025年美国临床肿瘤学会（ASCO）大会上发布，4年OS率达到21.9%。 针对ES-SCLC，H药于全国范围内开展的中国ES-SCLC领域样本量最大的真实世界研究（ASTRUM-005R）最新结果已于2025年欧洲肺癌大会（ELCC）上发布，研究结果显示，中位rwPFS为8.2个月，中位OS达到17.2个月，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充了有力证据。在本届WCLC大会上，该研究中针对PS评分≥2的ES-SCLC患者亚组研究分析数据，以及一项评估在ECOG PS≥2 的ES-SCLC患者人群中的荟萃分析等研究结果将进行发布，展现了免疫联合疗法对于ES-SCLC患者人群的广泛获益。 目前，复宏汉霖正在加速推进H药治疗ES-SCLC的全球开发进程，其中日本的桥接临床试验已完成首例患者入组。同时，公司正在开展一项国际多中心III期临床试验，评估H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的疗效，进一步拓展其在SCLC治疗领域的全球布局。 更多研究完整数据与亮点，敬请关注 WCLC 2025！ 参考文献 [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. [2] Prabhakar CN. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res. 2015;4(2):110-118. doi:10.3978/j.issn.2218-6751.2015.01.01 [3] Karlsen E-A, Kahler S, Tefay J, Joseph SR, Simpson F. Epidermal Growth Factor Receptor Expression and Resistance Patterns to Targeted Therapy in Non-Small Cell Lung Cancer: A Review. Cells. 2021; 10(5):1206. https://doi.org/10.3390/cells10051206 [4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. 关于复宏汉霖 复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，6个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。 复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Ten studies on Henlius' innovative products to be showcased at WCLC 2025, Including Three Oral Presentations On August 13, 2025 (Pacific Time), the World Conference on Lung Cancer (WCLC) 2025 has officially unveiled the list of accepted abstracts. Ten studies on Henlius' innovative PD-L1 ADC HLX43, anti-EGFR mAb HLX07 and anti–PD-1 monoclonal antibody(mAb)HANSIZHUANG(serplulimab) have been selected for multiple sessions, including oral presentations, poster tours, and poster presentations. Among these, 4 will be featured as oral presentations and 2 as poster tours. The selected studies span first-line treatment for non-squamous non–small cell lung cancer (nsNSCLC), squamous non–small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). In addition, innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases. Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases [1]. Lung cancer is classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC making up approximately 85% of all cases. NSCLC can be further divided into sqNSCLC(about 30%), nsNSCLC(about 50%), and other subtypes. HLX43, a broad-spectrum anti-tumor PD-L1 ADC, is the first PD-L1 ADC progressed to phase 2 clinical trial development globally, exhibiting dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. HLX43 exhibits superior efficacy in specific subgroups, with an objective response rate (ORR) of 47.4% in EGFR wild-type non-squamous NSCLC, while maintaining a favorable safety profile. HLX07 is a novel anti-EGFR mAb developed by Henlius, which demonstrated significant anti-tumor activity and durable efficacy when combined with serplulimab and chemotherapy in patients with EGFR high-expression sqNSCLC.  At a median follow-up of 18.6 months, the high dose group  reached a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months. HANSIZHUANG is the world’s first anti–PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for marketing in nearly 40 countries and regions, covering almost half of the global population. HANSIZHUANG has been approved in combination with chemotherapy as a first-line treatment for sqNSCLC, nsNSCLC and ES-SCLC.   Spotlight Oral Presentation: Demonstrating Efficacy in NSCLC In NSCLC, At this year’s WCLC, the Phase III ASTRUM-002 study, led by Professor Yuankai Shi of the Cancer Hospital, Chinese Academy of Medical Sciences, will debut its results in an oral presentation. The study evaluates serplulimab plus chemotherapy as a first-line treatment for advanced nsNSCLC, showing a median progression-free survival (mPFS) of 11.0 months, an improvement of 5.4 months compared to chemotherapy alone, as well as clear benefit in patients with brain metastases. Additionally, multiple investigator-initiated trials (IITs) exploring serplulimab in combination immunotherapy have been selected for Mini Oral presentations, poster tours, and poster presentations. These studies further validate the efficacy and safety of serplulimab in nsNSCLC patients with brain metastases, in EGFR-TKI–resistant cases, and in the perioperative setting for non-small cell lung cancer, underscoring its potential in broader patient populations. The ASTRUM-002 study is a randomized, double-blind, multicentre phase 3 clinical study. Patients with locally advanced or metastatic nsNSCLC without EGFR sensitizing mutations or ALK/ROS rearrangements and no prior systemic therapy were randomized 1:1:1 to receive serplulimab + HLX04 + chemo, serplulimab +chemo, or chemo. The results indicated that serplulimab + chemo  versus chemo as first-line treatment of advanced nsNSCLC significantly prolonged mPFS(11.0 months vs. 5.6 months; stratified HR= 0.55, 95% CI: 0.43-0.69, P < 0.0001), meeting the prespecified superiority criteria, with good safety profile and no new safety signals were observed. In the subgroup of patients with brain metastases, the median PFS in the serplulimab + chemo group reached 8.1 months, an extension of 4.0 months compared with the chemo group, reducing the risk of disease progression or death by 49% (HR = 0.51, 95% CI: 0.30-0.87, P = 0.0115). Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer Form: Oral Session: OA05-lmmunotherapy for Special Populations Abstract Number: 1454 Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences Time: Sunday Sep 7, 2025 4:47 PM-4:57 PM (CEST) A Phase 2 trial evaluated serplulimab plus bevacizumab and chemotherapy in treatment-naïve non-squamous NSCLC with brain metastases. The study enrolled 40 nsNSCLC patients with untreated brain metastases to receive first line treatment of serplulimab combined with bevacizumab, pemetrexed, and carboplatin. The median sPFS was 13.3 months. The intracranial ORR was 84.6%, with a 64.1% extracranial ORR, demonstrating potent antitumor activity. Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting. Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN) Form: Mini Oral Session: MA10-Longer Follow Up and New IO Combinations Abstract Number: 2266 Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center Time: Sep 9,2025 1:02 PM-1:07 PM (CEST) Potential Advantageous Therapy Option for EGFR High-Expression Lung Cancer In patients with NSCLC worldwide, the prevalence of EGFR overexpression is estimated at approximately 40%–89% (depending on histological subtype, ethnicity, and other factors), representing millions of newly diagnosed patients each year [2–4]. Notably, up to 89% of patients with sqNSCLC present with EGFR overexpression [2–3]. Henlius is actively advancing a phase 2 clinical study of HLX07, a novel anti-EGFR mAb developed by Henlius, in combination with serplulimab for the first-line treatment of EGFR high expression sqNSCLC, aiming to address the significant unmet clinical need in this population. Updated data from this study have been accepted for poster presentation at this year’s World Conference on Lung Cancer (WCLC). This randomized, multicenter phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemotherapy. Part 3 explored the preliminary efficacy of the tri-combination regimen in systemic treatment-naïve patients with EGFR overexpression (H-score ≥150), who were enrolled and randomly assigned to group A (n=13) and group B (n=14). Two groups of patients received intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300mg) and chemotherapy. With a median follow-up of 18.6 months, both dose groups achieved an IRRC-assessed confirmed objective response rate (ORR) of around 70%, while the median overall survival (mOS) and median duration of response (mDOR) were not reached, indicating durable responses with the potential for further improvement, alongside a manageable safety profile. Notably, the group B achieved a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months (95% CI 8.1-NE). These results demonstrate encouraging preliminary efficacy  with a manageable safety profile of HLX07 plus serplulimab and chemotherapy as first-line treatment in patients with advanced sqNSCLC, supporting further investigation of this regimen. Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study Form: Poster Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy Abstract Number: 1467 Leading PI: Yilong Wu, Guangdong Provincial People's Hospital Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST) Full coverage of first-line lung cancer treatment, broad benefits in ES-SCLC Henlius continues to expand the layout of serplulimab in the field of lung cancer, achieving full coverage of first-line lung cancer treatment. In small cell lung cancer (SCLC), based on the international multicenter Phase III ASTRUM-005 study, serplulimab has been approved in nearly 40 countries and regions worldwide, including China, the UK, Germany, Singapore, and India, for the first-line treatment of ES-SCLC. The final analysis of this study was released at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showing a 4-year OS rate of 21.9%. For ES-SCLC, the latest results from the largest real-world study in China in this field (ASTRUM-005R) were released at the 2025 European Lung Cancer Congress (ELCC). The study showed a median rwPFS of 8.2 months and a median OS of 17.2 months, providing robust evidence to support serplulimab plus chemotherapy as a first-line treatment for ES-SCLC. At this year’s WCLC, subgroup analysis data from this study in ES-SCLC patients with a PS score ≥2, as well as results from a meta-analysis in ES-SCLC patients with ECOG PS ≥2, will be presented, demonstrating the broad benefits of immunotherapy combinations for ES-SCLC patients. Henlius continues to accelerate the global development of serplulimab for ES-SCLC, with the first patient dosed in the Janpanese bridging study. In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). For more research on data integrity and highlights, please stay tuned for WCLC 2025! 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.

近日，复星医药成功发行全国首单民营医药行业中长期科技创新债券，由招商银行担任牵头主承销商兼簿记管理人，北京银行、浦发银行担任联席承销商，规模10亿元人民币，期限2年，票面利率2.70%。 本期科创债获得了银行理财、保险、外资银行、公募基金、券商自营等各类型金融机构的踊跃认购，与此同时，中债信用增进投资股份有限公司也积极参与本期债券的认购，不仅代表监管部门为本期科创债发行给予大力支持。本期债券募集资金将为复星医药在关键科技创新领域的布局提供有力的资金保障，推动加速创新成果的转化与落地，进一步巩固和提升公司在全球医药健康产业的创新竞争力。 民营经济是社会主义市场经济的重要组成部分，推进中国式现代化的生力军。今年2月召开的民营企业座谈会对当前和今后一个时期促进民营经济健康发展、高质量发展作出全面部署，充分彰显了党中央支持民营经济发展壮大的坚定决心。随后，央行等五部门联合召开金融支持民营企业高质量发展座谈会，强调要协同联动，下大气力解决民企融资难题；今年3月，交易商协会发布《银行间债券市场进一步支持民营企业高质量发展行动方案》。以上举措进一步优化了民营企业债券融资环境。 2025年5月7日，中国人民银行、中国证监会联合发布关于支持发行科技创新债券有关事宜的公告，同日，交易商协会发布了《关于推出科技创新债券，构建债市“科技板”的通知》，提出多项科技创新债券配套支持机制，引导债券资金更加高效、便捷、低成本投向科技创新领域，提升债券市场服务科技创新能力。 在此背景下，复星医药结合自身创新驱动的发展战略，引导债券市场低成本的资金流向生物医药科技前沿领域，既响应了中央的政策号召，同时也大幅降低公司的融资成本，优化债务结构。本次科创债的成功发行，进一步巩固了复星医药在国内创新医药企业的领先地位，同时也为企业实现高质量发展提供了有力支撑。 创立30多年来，复星医药始终以创新为核心发展驱动力，在创新药领域，自2019年以来，复星医药已累计获批12款自主研发、许可引进的创新药和生物类似药，同时成功获得8款创新药物的中国境内商业化权益，涵盖实体瘤、血液瘤、免疫炎症等核心治疗领域。2025年至今，复星医药已有4款产品5项适应症在中国及欧盟等多地获批，包括首个自研小分子创新药复迈宁®（芦沃美替尼片）获批上市，填补罕见肿瘤领域空白；抗PD-1单抗斯鲁利单抗注射液成为欧盟首个获批用于广泛期小细胞肺癌（ES-SCLC）治疗的PD-1单抗，国际化布局取得重要进展。 未来，复星医药将继续深化创新转型，致力于为患者和客户提供更优质、更可及的产品和服务，为股东创造可持续的价值回报。

精彩内容 近日，CDE官网显示，国药集团提交的4类仿制药沙库巴曲缬沙坦钠片、3类仿制药注射用硫酸多黏菌素B上市申请获受理。在中国三大终端六大市场（统计范围详见本文末），沙库巴曲缬沙坦钠片、注射用硫酸多黏菌素B销售额峰值分别超49亿元和18亿元。 来源：CDE官网 沙库巴曲缬沙坦钠片是由沙库巴曲（脑啡肽酶抑制剂）和缬沙坦（血管紧张素Ⅱ受体拮抗剂）组成的复方制剂，目前已纳入国家医保乙类药目录，限制使用范围：①射血分数降低的慢性心力衰竭成人患者；②原发性高血压。 在中国三大终端六大市场，沙库巴曲缬沙坦钠片近年来销售额持续攀升，2024年拿下创新高的超49亿元；2025Q1继续以17.27%的增速增长至约15亿元，为高血压化药TOP1产品。目前该药已有27家企业（本土25家、进口2家）拥有生产批文，石药集团、正大天晴药业、国药集团等60余家企业以新分类提交上市申请，其中有26家已获批上市、视同过评。 近年来中国三大终端六大市场沙库巴曲缬沙坦钠片销售趋势（单位：万元） 来源：米内网格局数据库 注射用硫酸多黏菌素B是一种从多黏芽孢杆菌中分离出的抗菌性多肽，可用于绿脓杆菌及其他假单胞菌引起的创面、尿路以及眼、耳、气管等部位感染，也可用于败血症、腹膜炎等，2022年在中国三大终端六大市场销售额达到峰值超18亿元，随后近三年均有所下滑。 米内网数据显示，目前国内仅有汇宇制药、倍特药业等4家企业的注射用硫酸多黏菌素B获批上市，20余家企业的产品以新分类报产在审，包括齐鲁制药、桂林南药、海南双成药业、福安药业、国药集团等。 注射用硫酸多黏菌素B新分类报产在审情况 来源：米内网中国申报进度（MED）数据库 今年以来，国药集团已有近30款高端仿制药提交上市申请在审，涉及玻璃酸钠滴眼液、酒石酸布托啡诺注射液、硫酸羟氯喹片、莫匹罗星软膏、重酒石酸间羟胺注射液等2024年在中国三大终端六大市场销售额超10亿元的重磅品种，覆盖感觉系统药物、神经系统药物、肌肉-骨骼系统等治疗大类。 资料来源：米内网数据库、CDE官网 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月14日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦