An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer

开始日期2026-02-27

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT07176702

/ Active, not recruiting临床2期IIT

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is an extremely high-mortality malignancy. The chemotherapy regimen of gemcitabine combined with nab-paclitaxel (GEM-NABP) serves as one of the first-line standard therapies for metastatic pancreatic cancer. Given that traditional dual HER2 blockade (pertuzumab + trastuzumab) has demonstrated preliminary efficacy in HER2-expressing solid tumors, the novel clinical strategy of dual HER2 blockade (HLX22 + trastuzumab) combined with GEM-NAP offers the potential to improve outcomes for patients with HER2-positive pancreatic cancer.

开始日期2025-09-30

申办/合作机构

复旦大学附属中山医院

NCT06832202

/ Recruiting临床2期

A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care

This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

开始日期2025-04-16

申办/合作机构

上海复宏汉霖生物技术股份有限公司

100 项与 Dulpatatug 相关的临床结果

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100 项与 Dulpatatug 相关的转化医学

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100 项与 Dulpatatug 相关的专利（医药）

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项与 Dulpatatug 相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Efficacy and Safety of Different Treatment Regimens for Previously Untreated Patients with HER2-positive Advanced Gastric Cancer: A Meta-Analysis of Randomized Controlled Trials

Review

作者: Xu, Shanshan ; Li, Sheng ; Zhang, Zhongliang ; He, Yuqi ; Kang, Qi

OBJECTIVE:

The development of treatments for advanced gastric cancer (AGC) has made significant advances over the past decade. Although clinical trials for novel drugs targeting HER2-positive AGC are ongoing, current clinical management still faces challenges. Therefore, further comparison of the effectiveness of such combination therapies is needed.

METHODS:

comprehensive search was conducted in the PubMed, Embase, and Cochrane databases, with the search cut-off date set to May 2025. Outcomes were evaluated using indicators such as progression-free survival (PFS) and overall survival (OS).

RESULTS:

Our study included only randomized controlled trials comparing combination regimens of targeted and/or immunotherapy, involving 3,231 patients across eight different interventions.The network meta-analysis revealed that no treatment regimen demonstrated a statistically significant improvement in OS or PFS. However, a trend toward improved PFS was observed with HLX22 plus HLX02 and chemotherapy compared to trastuzumab-based chemotherapy, although the difference was not statistically significant (MD=-0.94, 95% CI: -5.26-3.37). Pembrolizumab in combination with trastuzumab and chemotherapy significantly improved the objective response rate (ORR).Cumulative ranking probabilities indicated that trastuzumab plus chemotherapy may be associated with the longest PFS, while chemotherapy alone ranked highest in OS, though all confidence intervals included the null value.

CONCLUSION:

No first-line regimen significantly improved OS or PFS in HER2-positive advanced gastric cancer. However, HLX22-based and immune-combination strategies show potential clinical value-particularly in enhancing ORR-and merit further investigation.

2024-10-01·Med

A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer

Article

作者: Qiu, Meng ; Chen, Ye ; Deng, Jun ; Liu, Zimin ; Huo, Zhibin ; Zhu, Jun ; Cai, Mingquan ; Hou, Xiaoming ; Zhong, Diansheng ; Wang, Jingran ; Lu, Jianwei ; Li, Jin ; Yang, Mudan ; Lu, Linzhi ; Ma, Yuntao ; Li, Wei ; Zhang, Jingdong ; Yang, Futang ; Sun, Guoping ; Yin, Xianli ; Zhang, Yanqiao ; Wang, Qingyu ; Yu, Haoyu ; Pan, Hongming ; Li, Jing ; Li, Ning

BACKGROUND:

Gastric cancer is the fifth most common cancer and the fourth most common cause of cancer death worldwide, yet the prognosis of advanced disease remains poor.

METHODS:

This was a randomized, double-blinded, phase 2 trial (ClinicalTrials.gov: NCT04908813). Patients with locally advanced/metastatic HER2-positive gastric/gastroesophageal junction cancer and no prior systemic antitumor therapy were randomized 1:1:1 to 25 mg/kg HLX22 (a novel anti-HER2 antibody) + HLX02 (trastuzumab biosimilar) + oxaliplatin and capecitabine (XELOX) (group A), 15 mg/kg HLX22 + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were progression-free survival (PFS) and objective response rate (ORR) assessed by independent radiological review committee (IRRC).

FINDINGS:

Between November 29, 2021, and June 6, 2022, 82 patients were screened; 53 were randomized to group A (n = 18), B (n = 17), and C (n = 18). With 14.3 months of median follow-up, IRRC-assessed median PFS was prolonged with the addition of HLX22 (A vs. C, 15.1 vs. 8.2 months, hazard ratio [HR] 0.5 [95% confidence interval (CI) 0.17-1.27]; B vs. C, not reached vs. 8.2 months, HR 0.1 [95% CI 0.04-0.52]). Confirmed ORR was comparable among groups (A vs. B vs. C, 77.8% vs. 82.4% vs. 88.9%). Treatment-related adverse events (TRAEs) were observed in 18 (100%), 16 (94.1%), and 17 (94.4%) patients, respectively. One (5.6%) patient in group C reported a grade 5 TRAE.

CONCLUSIONS:

Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety.

FUNDING:

Shanghai Henlius Biotech, Inc.

2024-05-01·European journal of drug metabolism and pharmacokinetics

A Phase I Clinical Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of GB221 Injection and Trastuzumab (Herceptin®) in Healthy Chinese Adults

Article

作者: Chen, Liming ; Tian, Jingyuan ; He, Jin ; Song, Haifeng ; Wang, Xiaole ; Li, Chen ; Zhan, Yaoxuan ; Li, Xianbo ; Xiao, Shuangshuang ; Hu, Zhiqin ; Zhu, Yu ; Wang, Tenghua ; Liang, Xintong ; Liu, Haiyan ; Ou, Lun ; Li, Yongmei ; Zheng, Qingshan ; Li, Tong ; Fang, Yi ; Wang, Xuan

BACKGROUND AND OBJECTIVE:

GB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the pharmacokinetic, safety, and immunogenicity of GB221 in healthy Chinese adults in comparison to trastuzumab (Herceptin^®).

METHODS:

In this randomized, double-blind, parallel-group phase I clinical trial, 88 subjects were randomized 1:1 to receive a single intravenous infusion (90-100 min) of GB221 or trastuzumab (6 mg/kg). The primary pharmacokinetic parameters-maximum observed serum concentration (C_max), area under the serum concentration-time curve from zero to the last quantifiable concentration at time t (AUC_0-t), and area under the serum concentration-time curve from time zero to infinity (AUC_0-∞)-of GB221 and trastuzumab were compared to establish whether the 90% confidence interval (CI) attained the 80-125% bioequivalence standard. Safety and immunogenicity were also evaluated.

RESULTS:

The GB221 group (n = 43) and the trastuzumab group (n = 44) showed similar pharmacokinetic characteristics. The geometric mean ratios (90% CI) of C_max, AUC_0-t, and AUC_0-∞ between the two groups were 107.53% (102.25-113.07%), 108.31% (103.57-113.26%), and 108.34% (103.57-113.33%), respectively. The incidence of treatment-emergent adverse events (TEAEs) was 83.7% (36/43) of the subjects in the GB221 group and 95.5% (42/44) of the subjects in the trastuzumab group. No subjects withdrew from the trial due to TEAEs, and there were no occurrences of serious adverse events. All subjects tested negative for antidrug antibodies (ADA).

CONCLUSION:

GB221 demonstrated similar pharmacokinetics to trastuzumab and comparable safety and immunogenicity in healthy Chinese adults.

384

项与 Dulpatatug 相关的新闻（医药）

2026-07-31

·搜狐新闻

复星医药子公司复宏汉霖PD-L1 ADC HLX43再拓临床，联合贝伐珠单抗±化...

2026年7月31日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自研的创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43联合贝伐珠单抗及联合/不联合化疗用于晚期/转移性实体瘤治疗的临床研究获中国国家药品监督管理局（NMPA）批准。近年来，多项临床研究结果均证实了 PD-(L)1 抑制剂与抗VEGF 药物（如贝伐珠单抗）存在协同抗肿瘤效应，即 PD-(L)1 抑制剂可通过阻断 PD-(L)1 恢复免疫系统的抗肿瘤作用，抗 VEGF 药物可通过阻断 VEGF 的免疫抑制作用并促进 T 细胞在肿瘤组织中的浸润从而提高前者疗效1。目前，NCCN 指南将“阿替利珠单抗+贝伐珠单抗+含铂双药”作为驱动基因阴性的晚期非鳞状 NSCLC 一线治疗的 1 类推荐。同时，传统拓扑异构酶抑制剂和贝伐珠单抗联合用药的疗效已在临床研究中得到充分验证2-3。现阶段，伊立替康联合贝伐珠单抗方案已被NCCN、CSCO 等国内外权威诊疗指南一致推荐为mCRC 一线、二线标准治疗方案。随着ADC在肿瘤治疗中展现出卓越的临床疗效4，多款不同靶点的ADC 单药联合贝伐珠单抗在实体瘤（含结直肠癌）中展现出良好抗肿瘤活性，且整体安全可控、未出现非预期叠加毒性5-7。基于此，为本研究的联合用药设计提供了临床依据与实践支撑。 HLX43是一款潜在同类最优的广谱抗肿瘤PD-L1 ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。目前，HLX43在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效，尤其在NSCLC的治疗上展现了全人群覆盖的潜力。复宏汉霖正全力推进HLX43的临床开发进程，已累计开展十余项HLX43单药或联合其他产品的临床研究，广泛覆盖宫颈癌（CC）、食管鳞癌（ESCC）、头颈鳞癌（HNSCC）、鼻咽癌（NPC）、结直肠癌（mCRC）、胃癌/胃食管交界部（G/GEJ）癌、胰腺导管腺癌（PDAC）、乳腺癌（BC）等，累计在全球入组患者逾1000例，持续探索和挖掘HLX43在实体瘤中的广谱治疗潜力。单药之外，公司也在积极探索HLX43与其他多元分子如公司自研创新抗EGFR单抗pimurutamab（HLX07）、抗PD-1单抗H药汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）等产品的联合治疗策略，以进一步评估其在更前线治疗及不同联合场景中的应用潜力。贝伐珠单抗是全球首个获批的抗血管生成药物，通过抑制肿瘤新生血管形成，在结直肠癌、肺癌等多种实体瘤治疗中奠定了治疗基石地位8。汉贝泰是由复宏汉霖自主开发的贝伐珠单抗生物类似药，于2021年11月正式获得国家药品监督管理局（NMPA）批准上市。目前，该产品已覆盖多项实体瘤适应症，包括1）转移性结直肠癌，2）晚期、转移性或复发性非小细胞肺癌，3）复发性胶质母细胞瘤，4）肝细胞癌，5）上皮性卵巢癌、输卵管癌或原发性腹膜癌以及6）宫颈癌。此外，汉贝泰还联合汉斯状（抗PD-1单抗）针对多类肿瘤开展肿瘤免疫联合疗法研究。未来，复宏汉霖将继续秉持“以患者为中心”的初心和理念，深耕实体瘤这一重要疾病领域，通过不断挖掘患者未满足的临床需求，持续夯实更多创新分子的差异化布局，为更多肿瘤患者带来高质量、可负担的新型治疗方案。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、5款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）作为全球首个获批一线治疗小细胞肺癌和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球超50个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22（通用名：dulpatatug）正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。 Henlius Announces IND Approval for Its Innovative PD-L1 ADC HLX43 in Combination with Bevacizumab ± Chemotherapy Shanghai, China, July 31, 2026 – Henlius (2696.HK) today announced that the investigational new drug (IND) application for HLX43, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab with or without chemotherapy, for the treatment of advanced/metastatic solid tumors has been approved by China’s National Medical Products Administration (NMPA). In recent years, multiple clinical studies have confirmed the synergistic antitumor effect of PD-(L)1 inhibitors in combination with anti-VEGF agents such as bevacizumab. Specifically, PD-(L)1 inhibitors restore antitumor immunity by blocking the PD-(L)1 pathway, while anti-VEGF agents may enhance the efficacy of the former by reversing VEGF-mediated immunosuppression and promoting T-cell infiltration into tumor tissues.1 Currently, the NCCN Guidelines recommend atezolizumab plus bevacizumab and platinum-based doublet chemotherapy as a Category 1 preferred regimen for the first-line treatment of advanced non-squamous NSCLC with negative driver genes. Meanwhile, the efficacy of conventional topoisomerase inhibitors combined with bevacizumab has been well validated in clinical studies.2-3 To date, the irinotecan plus bevacizumab regimen has been uniformly recommended by authoritative domestic and international guidelines including NCCN and CSCO as a standard first- and second-line treatment for metastatic colorectal cancer (mCRC). With ADC therapies demonstrating compelling clinical efficacy in oncology,4 several ADC monotherapies targeting different antigens, when combined with bevacizumab, have shown promising antitumor activity in solid tumors including colorectal cancer, with a generally manageable safety profile and no unexpected additive toxicities observed.5⁻7 These findings provide a clinical rationale and practical support for further development and application of ADC in combination with antiangiogenic agents. HLX43 is a potentially best-in-class and broad-spectrum PD-L1-targeting ADC that features a dual mechanism of action combining immune checkpoint blockade with payload-mediated cytotoxicity. To date, Preliminary clinical data has indicated a manageable safety profile and encouraging efficacy in various solid tumors, with notable anti-tumor activity observed in various NSCLC patient subgroups. Henlius is currently advancing HLX43's clinical development with significant momentum, having initiated over ten clinical studies evaluating HLX43 as a monotherapy or in combination with other therapies across a broad range of solid tumors, including cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), metastatic colorectal cancer (mCRC), gastric/gastroesophageal junction (G/GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC), and breast cancer (BC), with over 1,000 patients enrolled globally to date. Beyond monotherapy, the Company is actively exploring combination strategies with other proprietary molecules, including the innovative anti-EGFR monoclonal antibody pimurutamab (HLX07) and the anti-PD-1 monoclonal antibody serplulimab (trade name: Hetronifly in Europe), to further evaluate its potential in earlier lines of therapy and various combination settings.返回搜狐，查看更多

2026-07-30

·今日头条

3月盈警，7月盈喜：复星这4个月，卸下了什么，又装上了什么？

资本市场最迷人、也最残酷的规律，永远是预期差。回望过去四个月，港股市场很少有公司的预期反转，比复星国际更具代表性。 3月份，复星国际发布盈警，2025年归母净利润预亏215亿至235亿元。当时的市场一片哗然。质疑声铺天盖地。 "当时他们的质疑声好大，差点就盖过了我的意志。"冒用一句网友的话，来概括一下当时的复星。四个多月后，反转来了。7月29日，复星国际发布正面盈利预告：2026年上半年归母净利润预计约15亿至18亿元，同比增长127%至172%。二级市场对于复星这次的财报盈喜也表达了积极的态度：今天股价应声大涨，早盘最高涨幅超过8%。资金其实早就用真金白银表过态了。3月6日盈警发布后的首个交易日，股价盘中一度杀到3.42港元，恐慌盘蜂拥而出——结果第二个交易日就收了回去，3月9日股价大涨6.7%。此后股价一路爬坡，到发稿前股价为4.79港元，较最低点已经反弹了30%多。参考券商测算每股 NAV 约 18.1 港元，以 4.79 港元股价测算，NAV 折价约 73.5%；对比 3 月低点时期接近 81% 的折价水平，估值折价明显收窄。从账面亏损到盈利15亿+，完成这个反转，复星只用了四个多月。郭广昌在3月31日的业绩发布会上说得很明白：234亿元的减值计提是审慎的会计处理，是"晴天修屋顶"。现在回头看，这句话说的恰逢时宜。 15亿至18亿，数字本身没那么重要。重要的藏在结构里——谁在替复星挣"当下的钱"，谁又在挣"未来的钱"？ 1.医药：创新这口井，越挖越甜这次盈喜的贡献大头，明眼人都能看出来——医药和保险。先说医药。看看整个行业在发生什么。 2026年上半年，中国创新药对外授权共达成81笔合作，交易总额约1100亿美元，已达2025年全年总额的80%。半年干了去年全年八成的活。首付款总额约50亿美元，已占去年全年的七成。"量"和"价"一起涨，创新药出海从"量升"切换到"量价齐升"。数据来源：医药魔方上半年全球医药交易前十大事件中，中国药企独占八席。中国已经是全球创新药交易市场的核心玩家。在这个行业大beta里，复星的alpha是什么？先看数据。复星医药2026年一季度营收100.73亿元，同比增长6.93%；归母净利润8.71亿元，同比增长13.87%；扣非归母净利润5.01亿元，同比增幅高达21.96%。扣非增速远高于营收增速，主业盈利能力在实实在在地改善。再看创新药的兑现节奏。2025年全年，复星医药创新药品收入已达98.93亿元，占营收约24%，同比增长29.59%，占制药业务收入比重提升至33.16%。照这个斜率跑下去，2026年创新药收入剑指百亿上方。进入2026年，创新管线进入密集获批和商业化放量期。一季度，复星医药共有4款创新药品上市申请获受理，14项创新药品临床试验申请获境内外监管机构批准。研发费用提升至8.97亿元，同比增长21.61%。今年6月，复宏汉霖自主研发的H药汉斯状拿下一个里程碑——获国家药监局批准用于胃癌围术期治疗，成为全球首个且唯一获批用于胃癌围术期治疗的抗PD-1单抗，实现了术后免疫单药替代传统辅助化疗。紧接着，汉斯状又获得欧盟委员会批准，用于鳞状非小细胞肺癌一线治疗。7月初，其广泛期小细胞肺癌适应症再获英国NICE推荐，正式纳入英格兰和威尔士NHS报销体系。胃癌围术期、鳞状非小细胞肺癌、广泛期小细胞肺癌——都是大癌种、大适应症。H药已在全球50个国家和地区获批上市，海外利润正在逐步放量。 H药之外，PD-L1 ADC药物HLX43、HER2单抗HLX22正全面推进全球关键性临床研究。HLX22联合HER2 ADC药物HLX87的乳腺癌一线Ⅱ/Ⅲ期临床研究，已完成首例患者给药。复星管线密集兑现的背后，离不开AI在底层驱动。"星图计划"搭建干湿闭环研发体系，新研究员3分钟即可上手。复宏汉霖AI蛋白药物智能设计平台更直接——HLX203仅用3个月将分子亲和力提升20倍，半年落地10个优化项目，全年预计完成20个管线提速。医疗服务端同样在升级：全球患者来华医疗智能服务平台将80%流程交由AI处理，跨国就医从2-5天缩短至1-2小时。研发和临床两端同时提效，复星的创新转化速度已经不是传统节奏。 2.保险：利润底座的弹性，藏不住了先看国内。复星保德信人寿 2026 上半年净利润7.86亿元，超过 2025 全年 6.5 亿元水平，保费保持高速增长，业务维持高续保、低退保特征，合同服务边际持续积累。半年净利润超过全年，半年保费增长44.8%。 2026年上半年整个保险行业保费增速仅3.24%，人身险增速4.32%。复星保德信44.8%的保费增速——碾压级别的表现。更关键的是质量。13个月续保率98.14%，综合退保率仅0.38%，合同服务边际余额已近60亿元。高续保、低退保、大额的价值储备，这就是一台持续产生现金流的永动机。60亿的合同服务边际余额，就是未来利润的"蓄水池"。再看海外。复星葡萄牙保险2025年全年保费收入65.29亿欧元，同比增长5.8%；净利润2.01亿欧元，同比增长15.8%，葡萄牙市场份额28.1%稳居首位。2026年上半年，本土及海外业务均有希望实现两位数增长。政策面同样在助攻。2026年《政府工作报告》首次明确提出"加快发展商业健康保险"，复星联合健康保险连续五年盈利。保险板块的利润释放才刚刚开始。瘦了身、强了体，逻辑在兑现复星过去几年一直在做一件事——"瘦身健体、聚焦主业"。2022年至2024年累计完成资产退出约750亿元，2025年又完成退出超170亿元。瘦身之后是强体。四大核心子公司——复星医药、豫园股份、复星葡萄牙保险、复星旅文——2025年合计收入1282亿元，占集团总收入的74%。2026年上半年，这些核心资产的利润贡献正在加速释放。债务水平持续下降。2025年末，复星国际集团层面有息负债降至899亿元，相较2020年末下降23%。郭广昌给出的中期目标很清晰：逐步恢复百亿利润规模，集团层面回笼600亿资金，总负债降至600亿以下，力争达成投资级评级。 7月30日，复星开盘价4.48港元，距离机构一致目标价7.38港元还有超64%的上行空间，最高看至7.5港元。过去一年股价虽在底部反复，但盈喜后基本面反转信号明确，NAV折价收窄趋势已经开启。只要后续业绩持续验证，估值修复就不是故事，而是正在发生的现实——这个位置，赔率足够舒服。复星自己也在买。自3月30日至7月10日，复星国际累计回购约5341万股，总计约2.16亿港元。真金白银在买，比任何研报都有说服力。基本面的拐点，已经明牌了 3月发盈警时，很多人都在问："复星还能不能站起来？" 现在答案有了——不仅能站起来，而且跑得比之前更快。复星这轮"晴天修屋顶"，修的是过去多元化扩张留下的历史旧账。屋顶修好了，接下来是安心经营、安心发展的日子。从234亿的账面亏损到15亿+的盈利反弹，只用了四个多月。市场给不给估值，那是市场的事。但基本面的拐点，已经明牌了。

2026-07-30

·谈思生物

Biotech大跌74%！核心管线被砍！

说明：欢迎约稿、业务洽谈、媒体合作及行业交流。如需加入行业交流群，或发现内容涉及侵权需修改，请联系小助手微信：Taaslabs18 近日，瑞典Biotech公司Alligator Bioscience发布公告，终止核心候选药物mitazalimab的独立开发，转而将资源重新聚焦于对外授权的HLX22项目。消息发布后，公司股价单日大跌73.6%，盘中一度触及0.0324瑞典克朗的52周低点。 Alligator Bioscience成立于2001年，总部位于瑞典隆德，专注于靶向CD40受体的肿瘤免疫抗体药物研发。其核心管线mitazalimab是一款CD40激动剂单抗，曾在一线转移性胰腺癌的II期临床试验OPTIMIZE-1中展现出显著疗效，一度被公司定位为即将进入III期开发的关键资产。然而，胰腺癌治疗格局的剧变，让这条管线失去了独立推进的商业可行性。Alligator Bioscience在公告中明确指出，RAS(ON)抑制剂等新型靶向疗法近期取得的突破性临床数据，预计将显著重塑该适应症的未来治疗范式，公司无力独自承担mitazalimab重新定位所需的资源投入。在砍掉核心管线的同时，Alligator Bioscience选择将赌注押在HLX22上。HLX22是一款抗HER2单克隆抗体，源自公司与AbClon的合作发现，目前由复宏汉霖进行全球III期临床开发，适应症为一线HER2阳性胃癌及胃食管结合部癌。 HLX22里程碑进展图片来源：药智数据-全球药物分析系统根据协议，Alligator Bioscience有权获得AbClon从复宏汉霖处所得收入的35%，包括里程碑付款和特许权使用费，对应HLX22净销售额约1.5%—2%的有效特许权费率，峰值销售预计可为公司带来每年1.5亿至4.5亿瑞典克朗的收入。为了维持运营至HLX22 III期临床数据读出，Alligator Bioscience宣布启动总额约1.256亿瑞典克朗的配股融资，认购价为每单位0.04瑞典克朗（每股0.02瑞典克朗）。此外，公司还签订了总额1900万瑞典克朗的过桥贷款协议，以解决配股完成前的流动性需求。这一“断臂求生”的背后，是公司极度紧张的财务状况。根据2026年第一季度财报，Alligator Bioscience现金及现金等价物约为3300万瑞典克朗。此次融资完成后，公司计划将团队缩减至监控HLX22项目所需的最低人员配置。截至2026年第一季度，公司全职员工已仅剩11人。从资本市场表现来看，Alligator Bioscience的处境早已岌岌可危。公司2016年11月上市时发行价为每股32.50瑞典克朗，而截至公告发布前，股价已长期在低位徘徊。7月23日暴跌后，股价跌至约0.04瑞典克朗，较IPO价格累计蒸发约99.88%。 Alligator Bioscience的遭遇并非孤例。在创新药研发周期长、投入高、竞争格局瞬息万变的背景下，中小型Biotech公司一旦核心管线遭遇市场格局剧变或临床数据不及预期，往往陷入困境。本文内容来源于官方网站，旨在为大家提供知识共享，不构成任何专业建议。本资料中含少量AI生成内容，同时所涉及的图片、及文字仅供参考，目的是为了将好的内容分享给更多人，版权依旧归原作者所有，若侵犯肖像权或者著作者权等知识产权，请联系我方删除。信息来源：公众号药智网

100 项与 Dulpatatug 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性乳腺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2026-01-23
胃食管交界处癌	临床3期	希腊	上海复宏汉霖生物技术股份有限公司	2024-11-22
HER2阳性胃食管交界处癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2024-11-08
HER2阳性胃癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2024-11-08
胃癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
HER2阳性癌症	临床2期	中国	复旦大学附属中山医院	2025-09-30
转移性胰腺导管腺癌	临床2期	中国	复旦大学附属中山医院	2025-09-30
HER2低表达乳腺癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2025-04-16
HR阳性/HER2低表达乳腺癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2025-03-18
转移性胃癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2021-09-29

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04908813 (HLX22-GC-201, Company_Website) 人工标引	临床2期	HER2阳性胃癌一线 HER2 Positive	62	HLX22+曲妥珠单抗+XELOX	遞構觸構範憲積繭鑰顧(積夢夢蓋襯鬱顧齋積遞) = 糧顧壓齋鬱鬱鏇選範網夢鬱壓網網製鹹鬱簾廠 (憲窪齋憲願鹹齋齋壓築, 16.2 ~ NE) 更多	积极	2025-06-02
				安慰剂+曲妥珠单抗+XELOX	遞構觸構範憲積繭鑰顧(積夢夢蓋襯鬱顧齋積遞) = 繭網鏇襯齋觸顧遞蓋積夢鬱壓網網製鹹鬱簾廠 (憲窪齋憲願鹹齋齋壓築, 5.7 ~ 21.4) 更多
NCT04908813 (ASCO_GI2025) 人工标引	临床2期	HER2阳性胃食管交界处癌 \| HER2阳性胃癌一线 HER2 Positive	62	HLX22 + trastuzumab + XELOX	蓋艱醖衊鹽選顧窪窪積(醖願範網鹽艱積糧願壓) = 膚鬱糧憲鏇選廠夢築範壓鏇齋壓製糧鏇蓋膚範 (襯壓壓鑰夢鑰膚齋鑰淵, 23.49 ~ NE) 更多	积极	2025-01-23
				placebo + trastuzumab + XELOX	蓋艱醖衊鹽選顧窪窪積(醖願範網鹽艱積糧願壓) = 膚製醖選窪膚憲鑰構鏇壓鏇齋壓製糧鏇蓋膚範 (襯壓壓鑰夢鑰膚齋鑰淵, 5.7 ~ 12.7) 更多
NCT04908813 (phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX, Pubmed)	临床2期	HER2阳性胃癌一线 HER2-positive	53	HLX22 + HLX02 + XELOX (25 mg/kg)	廠衊淵積蓋廠餘餘鹹簾(憲積願膚衊鑰壓鬱網艱) = 積範鑰網簾夢網鹽齋網膚築觸餘鹽窪壓齋齋餘 (遞鬱衊繭簾鏇構窪製製 ) 更多	积极	2024-07-01
				HLX22 + HLX02 + XELOX (15 mg/kg)	廠衊淵積蓋廠餘餘鹹簾(憲積願膚衊鑰壓鬱網艱) = 網窪鹽壓繭築鏇範夢淵膚築觸餘鹽窪壓齋齋餘 (遞鬱衊繭簾鏇構窪製製 ) 更多
NCT04908813 (ESMO_GI2024) 人工标引	临床2期	HER2阳性胃食管交界处癌一线 HER2-positive	53	HLX22 25 mg/kg + HLX02 + XELOX (Group A)	鏇醖餘憲繭憲簾壓觸糧(構憲獵衊膚膚膚鏇餘糧) = 醖醖觸願簾簾積艱繭襯鹽鬱網願膚鹽窪糧築壓 (顧鏇齋製鑰衊窪齋鹹選, 6.8 ~ NE) 更多	积极	2024-06-27
				HLX22 15 mg/kg + HLX02 + XELOX (Group B)	鏇醖餘憲繭憲簾壓觸糧(構憲獵衊膚膚膚鏇餘糧) = 築選憲廠鹽遞夢壓憲壓鹽鬱網願膚鹽窪糧築壓 (顧鏇齋製鑰衊窪齋鹹選, 9.9 ~ NE) 更多
NCT04908813 (ASCO_GI2024) 人工标引	临床2期	HER2阳性胃食管交界处癌一线	53	HLX22 25 mg/kg + HLX02 + XELOX	鹽壓簾壓鏇鏇蓋築獵蓋(廠淵築選鑰選膚構鏇鹹) = 繭窪積窪餘餘繭衊蓋壓願簾鹽餘鬱憲製膚鹽製 (範糧築願廠遞獵廠簾艱, 6.8 ~ NE) 更多	积极	2024-01-17
				HLX22 15 mg/kg + HLX02 + XELOX	鹽壓簾壓鏇鏇蓋築獵蓋(廠淵築選鑰選膚構鏇鹹) = 膚範遞艱艱糧淵壓憲壓願簾鹽餘鬱憲製膚鹽製 (範糧築願廠遞獵廠簾艱, 9.9 ~ NE) 更多
CTR20190723 \| NCT03916094 (NEWS) 人工标引	临床1期	实体瘤 her2过表达	-	HLX22	糧夢鏇鑰憲鹽築遞鬱艱(積憲艱壓憲淵築廠壓築) = 獵獵積獵糧製範衊窪餘獵醖範膚鬱襯膚顧糧鏇 (製鑰餘範積蓋艱憲選顧 )	积极	2022-09-30