A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer.

开始日期2025-08-17

申办/合作机构

National Cancer Institute

NCT06719973

/ Not yet recruiting临床1期

An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.

开始日期2025-07-01

申办/合作机构

EMD Serono Research & Development Institute, Inc.

[+1]

NCT06760481

/ Not yet recruiting临床1期IIT

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

An open-label, Phase I/Ib study investigating the safety and efficacy of tiragolumab + atezolizumab + RadScopal™ XRT in patients with metastatic solid malignancies.

开始日期2025-06-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与阿替利珠单抗相关的临床结果

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100 项与阿替利珠单抗相关的转化医学

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100 项与阿替利珠单抗相关的专利（医药）

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4,446

项与阿替利珠单抗相关的文献（医药）

2025-08-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Split T7 switch-based orthogonal logic operation of fluorogenic RNA aptamer for small molecules detection

Article

作者: Ying, Zhan-Ming ; Zha, Cheng-Jun ; Liu, Hao ; Peng, Jia-Min ; Su, Mei

Recent advances in fluorescent biosensors have stimulated the development of molecular detection. We herein developed a new orthogonal logic operation of fluorescent biosensor with cell-free to accomplish the detection of atrazine (ATZ) and tetrachlorobiphenyls (PCB77). The transcriptional process to generate fluorescent RNA aptamers (Mango) was controlled by molecules-probe bindings, which regulate split T7 promoter transcription switches ON or OFF. Leveraging the rapid in vitro T7 transcription process and high signal-to-background ratio of the Mango-TO1-Biotin complex, this biosensor demonstrates remarkable sensitivity in detecting ATZ and PCB77, with detection limit of 1.56 pM and 10.2 pM. Moreover, the orthogonality of four logic gates (AND, NOR, INHIBT, NIMPLY) were utilized the ATZ and PCB77 as input to construct, which could be activated by utilizing the target probe-driven association. The output of the fluorescence signal was controlled by split/intact fluorescent RNA aptamer (Mango) to achieve flexible and sensitive orthogonal operations. Significantly, the development of two-input logic gates has enabled the modular detection of various small molecules, offering a promising approach to intelligent multi-input analysis. Predictably, with the advantages of sensitivity, flexibility and easy-to-operate, this orthogonal logic gate platform holds immense potential in small molecules detection.

2025-07-01·Journal of Clinical and Experimental Hepatology

Predictors of Non-response to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma: A Multicentre Real World Study (HCC-AB Study)

Article

作者: Kumar, Guresh ; Arora, Vinod ; Chaubal, Alisha ; Shah, Samir ; Taneja, Sunil ; Choudhury, Ashok ; Kumar, Karan ; Kulkarni, Anand ; Saraswat, Vivek ; Sarin, Shiv K ; Rathi, Sahaj ; Singh, Satender P ; Duseja, Ajay ; Kumar, Ashish ; Nagaraja Rao, P

Background:

The approved immunotherapies for patients with advanced HCC are Atezolizumab and Bevacizumab. However, patients in India present late and healthcare is often available through self-financing. To rationalise the therapy, we conducted a large multicentre study to identify the baseline predictors of non-response to atezolizumab and bevacizumab in advanced unresectable HCC.

Methods:

A dose of atezolizumab 1200 mg and bevacizumab 15 mg/kg was used every 3 weeks from 6 centres across India. A total of 278 patients were screened, and 160 were included in the study. The study included patients with locally advanced metastatic or inoperable hepatocellular carcinoma who were at least 18 years of age and those who received <3 injections were excluded. Fifty-four percent of the included patients were BCLC-B and 46% were BCLC-C. The primary objective was to study overall survival and progression-free survival. While identifying radiological response, objective response rate and adverse effects were secondary objectives.

Results:

The mean age was 61.9 ± 11.7 years, 88% were male, 55% had NASH, 16.3% had hepatitis C, 18.8% had hepatitis B and the rest were alcohol. The mean Model for End-Stage Liver Disease (MELD) is 12.05 ± 4.46, Albumin-Bilirubin Score (ALBI) is -2.04 ± 0.57. Fifty-five percent received first-line and 45% as second/other line therapy. The median overall survival was 10 (95% confidence interval [CI]: 6.1-15.6) months. Progression-free survival was found to be 8 (95%CI: 5.1-14.7) months overall. Eleven (6.9%) achieved complete response, 28 (17.5%) partial response, 33 (20.6%) had stable disease and 88 (55%) had progressive disease. On multivariate analysis, CRP>1 mg/dl (P-0.007), PIVKA-II>400 mAU/mL (P-0.019), AFP>100 ng/ml (P-0.009), presence of diabetes (P-0.042) were associated with non-response to atezolizumab and bevacizumab injection. Fifty-three percent of patients developed any grade of adverse effect, and 20% developed grade 3/4 adverse events amounting to the stoppage of therapy.

Conclusion:

Non-response to atezolizumab and bevacizumab immunotherapy was predicted by CRP>1 mg/dl, PIVKA-II>400mAU/ml, AFP>100 ng/ml and the presence of diabetes.

2025-06-01·JOURNAL OF HAZARDOUS MATERIALS

Co-exposure to enrofloxacin and atrazine enhances the hepatotoxicity in Larimichthys crocea by targeting the hypothalamic–pituitary–thyroid and gut–liver axes

Article

作者: Shi, Xizhi ; Yang, Chenxue ; You, Jinjie ; Liu, Hao ; Sun, Aili ; Song, Suquan ; Zhang, Rongrong ; Zhang, Zeming ; Zhang, Liuquan ; Shi, Qiangqiang ; Wang, Yinan

Enrofloxacin (ENR) and atrazine (ATZ) are common co-contaminants in marine environments. Although the immunosuppressive effects of ENR and the endocrine-disrupting properties of ATZ are well established, the combined effects of these pollutants on hepatotoxicity, particularly concerning the regulation of the hypothalamic-pituitary-thyroid (HPT) and gut-liver axes, remain poorly understood. In this study, Larimichthys crocea was exposed to ENR and ATZ at environmentally relevant concentrations, individually and in combination, to investigate the hepatotoxicity. Liver cell swelling, necrosis, oxidative stress, and elevated liver injury markers were observed, indicating hepatic damage, with co-exposure exacerbating liver injury. Decreased levels of thyrotropin-releasing hormone and thyroid-stimulating hormone, increased triiodothyronine and thyroxine, and altered expression of HPT axis-related genes demonstrated enhanced disruption of the HPT axis under co-exposure, which was strongly associated with oxidative stress and liver dysfunction. Molecular docking confirmed that ENR and ATZ inhibited thyroid hormone binding to target proteins, likely provoking the enhanced hepatotoxicity. Additionally, ATZ significantly intensified the intestinal bacterial disturbances induced by ENR, further aggravating hepatotoxicity through the gut-liver axis. This study is the first to reveal the increased risk associated with ENR and ATZ co-exposure, highlighting the need for attention to such co-contaminants.

2,046

项与阿替利珠单抗相关的新闻（医药）

12 小时之前

·EndPoints

BioNTech details promising mid-stage data for its PD-L1xVEGF in aggressive lung cancer

BioNTech has highly encouraging survival data for its bispecific antibody combining checkpoint blockade with VEGF-A inhibition as a first-line treatment for a serious form of lung cancer. And if the drug can maintain a similar level of efficacy in larger trials in the future, the company believes it could become the standard of care in this setting. The data are an interim cut from an open-label Phase 2 trial in China assessing BioNTech’s bispecific, known as BNT327, plus chemo as a first-line therapy in the most aggressive type of lung cancer — extensive stage small cell lung cancer (ES-SCLC). They were presented Friday at the European Lung Cancer Congress in Paris. At the cut-off date of Dec. 20, 48 patients had undergone at least one tumor evaluation. Among this group, median overall survival (mOS) was not mature, but 72.7% of treated patients survived for one year. “We only had one-third of OS events at the time of data cutoff,” Özlem Türeci, BioNTech’s chief medical officer, told Endpoints News . “With standard of care, the median OS is around 12 months in first-line, and we see a 12-month OS rate of 72%, which means that we most likely will also see a median OS effect once the data is mature.” Another OS cutoff will hit around the end of this year, she said. Leerink analysts wrote in a note last week that the 12-month survival rate is about 20 percentage points above “relevant benchmarks.” In a comparable Phase 3 trial , 45% of ES-SCLC patients taking Keytruda plus chemo lived for a year. In another study, this time for Roche’s PD-1 inhibitor Tecentriq and its VEGF blocker Avastin plus chemo, the one-year survival rate was 56%. The PD-(L)1xVEGF mechanism, as it is known, has been white-hot since May , when Summit Therapeutics announced that its similar bispecific was more effective in non-small cell lung cancer than Merck’s previously unassailable PD-1 blocker Keytruda. In ES-SCLC, however, BioNTech is way out in front as far as PD-(L)1xVEGF bispecifics are concerned. It is the only company conducting “registration-intending advanced clinical trials in small cell lung cancer,” Türeci said. BioNTech also said that progression-free survival (PFS) was 6.9 months in the mid-stage trial for BNT327. According to BioNTech, median PFS in this setting is less than six months with currently available treatment options. Türeci called this “a significant and clinically meaningful increase.” BioNTech’s bispecific yielded a confirmed objective response rate of 85.4%, and 87.5% including unconfirmed responses. A Phase 1b trial for Summit’s bispecific, ivonescimab, paired with chemo in first-line ES-SCLC demonstrated an ORR of 80%. BNT327’s safety looked acceptable, though 86% of patients had a grade 3 or higher treatment-related adverse event. The most common events were neutrophil count decrease (90%), anemia (80%), white blood cell count decrease (76%) and platelet count decrease (62%). There were no treatment-related deaths, but 6% of patients discontinued treatment due to treatment-related events. It’s crucial for BioNTech to ensure the impressive results can be replicated in larger, global studies, since clinical data obtained solely in China is generally not regarded as approvable by US regulators. “There’s no reason why there should be a difference between those data packages” in China-based and global trials, Türeci said. An international Phase 2 trial is currently testing two doses of the bispecific in first- and second-line ES-SCLC. Those data, which could come later this year, are particularly important since they will be the first results from a global trial of BNT327. They should be followed by the first international Phase 3 readout for the asset in 2028, also in ES-SCLC. The latter is using a Tecentriq-chemo regimen, one of the current first-line treatment standards, as its control. To preserve data integrity, no interim cuts from this Phase 3 trial will be released, according to Türeci. The full results could emerge in three years or so, and a successful trial would enable BioNTech to file the drug in Europe and the US. More importantly, Türeci said that if the BNT327 arm beats the Tecentriq arm, BioNTech’s drug could become the front-line therapy of choice in ES-SCLC. BNT327 came from the China-based biotech Biotheus, which BioNTech initially partnered with before buying outright for $800 million in November . If BNT327 does go all the way, this deal will have been a very smart move.

临床结果临床1期临床2期并购临床3期

2025-03-27

·EndPoints

Merck details injectable Keytruda data as it awaits autumn FDA decision

Merck shared Phase 3 data showing that an injectable version of its blockbuster cancer drug Keytruda is comparable to the approved intravenous infusion in lung cancer patients. And it said it’s seeking approval of the injectable for a broad range of cancers. Merck said the FDA has until Sept. 23 to decide whether to approve the subcutaneous injection version of Keytruda. The New Jersey pharma company has also asked European regulators for approval. “In the US, we anticipate the findings will support applications across all solid tumors in adult patients where Keytruda is already indicated. Outside the US, we anticipate findings will support applications across both solid and liquid tumors,” a Merck spokesperson told Endpoints News via email. Keytruda, known generically as pembrolizumab, for the past two years has been the world’s best-selling drug and last year made $29.5 billion. It’s currently approved across over 30 indications to treat a range of cancers. Approval of a new version of the drug could also impact the rollout of biosimilars for Keytruda, for which key patents expire in 2028. Drugmakers including Samsung Bioepsis and Amgen are already studying biosimilars for the drug. In the Phase 3 study, 377 stage 4 lung cancer patients were given either the subcutaneous version of Keytruda plus chemotherapy, or the IV version plus chemotherapy. The primary endpoints of the study measured pharmacokinetic properties and showed that patients would get acceptable levels of the drug with the subcutaneous version as with the intravenous version. The study also showed that response rates and median progression-free survival were similar across the arms. The data were shared at the European Lung Cancer Congress in Paris. In a separate poster presented the the conference, Merck showed that patients who received the injectable version of Keytruda spent 47% less time in treatment rooms — down from around two hours to one hour — and less time in a healthcare facility by 13%. The FDA last year approved subcutaneous injection versions of Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq, two other blockbuster checkpoint inhibitors. Merck could potentially launch the injectable version of Keytruda before the end of this year, CEO Rob Davis said at the JP Morgan Healthcare conference in January, and expects 30% to 40% adoption of the injectable form among patients taking the treatment. Merck’s head of oncology development Marjorie Green told Endpoints in an interview that an injectable version of the drug would provide a faster and easier option for patients, in particular for those who would take Keytruda alongside a pill or by itself. However, Tahir Amin, CEO of the Initiative for Medicines, Access & Knowledge, said that’s a typical pitch from pharmaceutical companies that use product hopping, where they switch patients to a follow-on drug covered by patents that expire even later. While the key patents on Keytruda expire in 2028, Amin says his organization’s research suggests that patent exclusivity could extend as far as 2039 or 2040 with the injectable version of the drug. When Merck’s CEO Davis testified in front of the Senate HELP committee in February 2024, he said , “when the composition of matter patents expire on our drug Keytruda, I fully expect, and I will not try to stop a biosimilar IV version of Keytruda coming on to the marketplace.” Amin noted that Davis specified the IV version of Keytruda in his comments. In addition, the subcutaneous version of Keytruda includes a new active ingredient called berahyaluronidase alfa, which Merck licensed from Alteogen. Merck and another biotech, Halozyme, are currently embroiled in a legal battle over the patents for that technology.

临床3期临床结果上市批准

2025-03-27

·药智网

复宏汉霖赌对了

复宏汉霖越来越稳了。 2024年，公司收入为57.244亿元，同比增长6.1%，净利润8.205亿元，同比增长50.3%。这是继2023年首次取得全年盈利之后，公司连续第二年实现全年盈利。尤为关键的是，公司的盈利质量在同步增强：净利润率达14.3%，同比增长41.6%；现金流创新高，达到12.4亿元。这进一步让市场对其“三级火箭式”增长策略充满期待。复宏汉霖所遵循的三级增长逻辑，本质在于“现金流-差异化-全球化”的螺旋式进阶。短期依靠生物类似药提供稳定现金流，支撑研发投入；中期依靠PD-1等差异化适应症卡位实现价值跃迁，反哺管线升级；长期则依靠ADC等更前沿创新开启第三增长曲线，打开天花板。当下取得的成绩，尤其是2024年财报的公布，表明其第一、二级火箭策略大获成功，且第三级火箭正以“加速度”步入正轨，有望实现价值裂变。创新药企生存不易，而复宏汉霖则用几年时间，趟出了一条Biopharma的成长进阶之路——用行业领先的综合能力赚今天的钱，用差异化的临床策略赚明天的钱，用颠覆性技术赚未来的钱。作为为数不多“站着”穿越周期的中国药企，复宏汉霖这一模式背后蕴含的深意，值得所有企业深入思考与借鉴。 1 第一级火箭：生物类似药构筑现金流护城河在市场认知里，复宏汉霖是生物类似药领域的佼佼者。事实也的确如此，2024年，公司生物类似药总销售额达到35.8亿元，是公司现金流的核心来源之一。这充分体现了复宏汉霖战略的前瞻性。复宏汉霖成立于2010年，当时面临着一个重大机遇：众多重磅生物药专利即将相继到期。从商业逻辑分析，生物类似药领域是难得的机遇。一方面，生物药市场规模极为庞大，单品规模超百亿美金的不在少数；另一方面，尽管生物类似药是“仿制”，但生物药质量控制体系要求颇高，依然能做出差异化。所以，生物类似药市场一旦爆发，抓住机遇的赢家便能收获稳定现金流。事后复盘，复宏汉霖的预测十分精准。当前全球生物类似药整体规模在300亿美元左右，未来十年预期复合增长率有望接近20%。凭借扎实的临床和质量体系，复宏汉霖成功跻身全球TOP行列，实现了从中国走向全球的跨越。以曲妥珠单抗类似药汉曲优为例，其凭借先发及差异化剂型优势，销量持续增长，2024年国内收入达到26.924亿元。同时，汉曲优的全球拓展步伐不断迈进，2024年相继在美国和加拿大获批上市，成为首个在中国、欧盟、美国获批的“中国籍”单抗生物类似药。目前，汉曲优已在全球50+国家和地区获批上市，商业化供货网络拓展至中国、东南亚、北美、欧洲、中东及拉丁美洲等地区，惠及患者超过24万人。考虑到部分市场，尤其是规模最大的美国市场，仍处于放量早期（2024年11月，复宏汉霖完成汉曲优首批美国商业化发货），后续还有显著增量空间。汉曲优是复宏汉霖生物类似药布局的一个缩影。目前，公司已有3款类似药产品在全球获批，且陆续打入高价值市场，规避单一市场不确定性的同时，带来更大增量。比如，地舒单抗生物类似药HLX14已在多个国家获批用于一系列适应症，并且在2024年HLX14的上市申请已获得欧盟EMA和美国FDA受理。地舒单抗是超级重磅炸弹产品，2024年全球销售额逼近70亿美金，并且在2024年才迎来首个生物类似药，竞争格局良好。HLX14的研发进度处于全球第一梯队，因此有望在海外市场为复宏汉霖带来丰厚增量。另外，帕妥珠单抗类似药HLX11的上市申请已获得中国NMPA和美国FDA受理。当下，生物类似药仍是全球核心竞争领域之一，也将持续成为复宏汉霖创造现金流的核心板块。与此同时，基于生物类似药构建的护城河，复宏汉霖在不断拓宽增收途径。 2024年，靶向药奈拉替尼获NMPA批准上市，用于HER2阳性的早期乳腺癌成年患者，在接受含曲妥珠单抗辅助治疗之后的强化辅助治疗。该产品与公司自主研发的曲妥珠单抗汉曲优实现序贯治疗，有望进一步降低HER2阳性早期乳腺癌患者复发风险，为患者提供了全新的治疗选择。这也带来了新的业绩增量。截至目前，汉奈佳已完成全国所有省市的医保准入和招标挂网，2024年3个多月的收入规模达0.453亿元（2024年9月底商业化上市）。由此不难发现，复宏汉霖“现金奶牛”基本盘愈发稳固。而作为第一级火箭的“稳”，自然能驱动第二、三级火箭的“进”。 2 第二级火箭： PD-1差异化撬动价值跃迁尽管复宏汉霖身为生物类似药领域的龙头企业，但其布局远不止于此。从最初规划开始，便遵循“上市一代，布局一代，储备一代”的战略方针。在当时的时间节点下，“上市一代”指的是生物类似药，“布局一代”瞄准的是差异化的PD-1及更多潜在“同类最优”差异化创新管线，“储备一代”则聚焦于更多前沿创新的靶点与技术。目前，复宏汉霖布局的差异化PD-1产品汉斯状已步入收获期。2024年，汉斯状收入规模达13.126亿元，同比增速达17.2%，无论是规模还是增速，均跻身行业TOP行列。这再度彰显了复宏汉霖战略眼光的老到。PD-1领域研发热度极高，相对而言创新风险较低。虽说该领域看似已呈红海态势，但实际上许多适应症尚未得到充分挖掘。通过精准定位差异化的适应症，仍能抢占市场黄金发展窗口。复宏汉霖正是凭借这一策略，让汉斯状后来居上。汉斯状作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，极具突破性。小细胞肺癌患者群体规模较大，约占肺癌患者总数的近20%，然而其治疗手段有限，患者5年总生存率极低。此前，K药、O药等在此领域纷纷折戟，而汉斯状却凭借自身实力成功突围，不仅为小细胞肺癌患者带来了更优的治疗选择，也助力复宏汉霖实现了价值的大幅跃升。当前，汉斯状的增长态势仍在延续，其发展动力主要体现在以下几个方面：第一，前期研发投入正逐步转化为现实成果。比如在2024年12月，汉斯状获批非鳞状非小细胞肺癌（nsNSCLC）新适应症。nsNSCLC患者数量庞大，超50%的肺癌患者属于这一类型，临床需求极为旺盛。抗PD-1单抗联合化疗是一线治疗nsNSCLC的金标准方案，汉斯状的获批，为中国晚期nsNSCLC患者增添了新的用药选择，有助于进一步改善肺癌治疗现状。截至目前，汉斯状已获批用于治疗鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌等适应症，协同效应正在逐步显现。第二，依靠适应症差异化和多维度策略，稳固未来业绩增长。一方面，公司围绕肺癌等大适应症持续深耕。以肺癌领域为例，公司临床布局已全面覆盖肺癌一线治疗。除已获批的sqNSCLC、ES-SCLC和nsNSCLC适应症外，还在全球范围内积极推进一项汉斯状联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验，若试验成功，将进一步巩固其在肺癌领域的“合力”优势。另一方面，公司尝试将在肺癌领域积累的成功经验拓展至消化道肿瘤领域，持续探索结直肠癌、胃癌等疾病的治疗研究。其中，汉斯状联合化疗用于新辅助/辅助治疗胃癌的III期临床研究正在稳步推进，这是国内少有的布局胃癌围手术期的免疫治疗研究，有望让胃癌患者在疾病早期阶段就能从肿瘤免疫疗法中获益。与此同时，汉斯状联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌患者的国际多中心临床研究（ASTRUM-015）已于2024年启动III期临床阶段研究，并在中国、印度尼西亚和日本完成首例受试者给药。汉斯状有望成为全球首个用于治疗non-MSI-H mCRC的抗PD-1单抗，填补该领域一线免疫治疗的临床空白。第三，国际化拓展带来的增量已初步显现。复宏汉霖聚焦肺癌和消化道肿瘤等全球高发癌种，在全球同步开展10余项以汉斯状为核心的免疫联合疗法临床研究，是拥有较多国际临床数据的抗PD-1单抗之一，这使得其海外市场增长潜力巨大。 2024年第一季度，公司高效完成汉斯状首批海外发货，标志着汉斯状成为首个登陆东南亚国家的国产抗PD-1单抗，为全球更多患者带来了新的治疗希望。进入2025年，汉斯状成功打开欧美市场大门。今年2月，汉斯状于欧盟获批上市，用于一线治疗广泛期小细胞肺癌，成为首个且唯一在欧盟获批上市用于ES-SCLC治疗的抗PD-1单抗。欧洲作为仅次于美国的全球第二大医药市场，将为汉斯状带来不可忽视的潜在市场增量。此外，汉斯状治疗SCLC已获得美国FDA孤儿药资格认定，目前公司正在美国积极推进一项汉斯状对比一线标准治疗阿替利珠单抗的头对头桥接试验，为后续汉斯状在美国的上市申报积累数据、奠定基础。作为复宏汉霖的“第二级火箭”，汉斯状的稳定发挥，也为其第三级火箭的腾飞，提供动力。 3 第三级火箭：前沿管线开启创新药“第二曲线” 凭借生物类似药的稳固表现以及PD-1的强劲发力，复宏汉霖成为当下为数不多能够实现自我造血的创新药企。这一突出优势，使其无需依赖外部融资，便能在熊市中维持高强度、快节奏的研发进程。截至目前，公司构建起多元化的创新管线，囊括约50个分子，覆盖单抗、多抗、ADC、融合蛋白和小分子药物等丰富多样的药物形式。值得一提的是，复宏汉霖针对19个产品在全球范围开展30多项临床试验，如此高强度的研发投入，令大多数企业难以企及。而且，其研发速度同样十分可观。以创新型抗HER2单抗HLX22为例，目前，HLX22联合曲妥珠单抗和化疗一线治疗HER2阳性晚期G/GEJ的国际多中心III期临床试验，已相继获得中国、美国、日本、澳大利亚等地的临床试验许可，并完成全球首例患者给药，这个研究也将在亚组中直接头对头对比K药。若试验结果理想，HLX22将开启公司创新药的“第二曲线”。当前，胃癌一直是免疫疗法的一大难题，能够从中获益的患者群体有限。PD-1仅在PD-L1高表达群体中展现出一定疗效，且效果受限，即便是药王K药。在3期KEYNOTE-811试验的中期分析中，K药与罗氏的赫赛汀和化疗联合使用，相较于单独使用赫赛汀-化疗，在HER2阳性PD-L1阳性病例中，将疾病进展或死亡的风险降低了约30%。但从实际情况来看，在PD-L1阴性的一小部分患者中，K药的加入不仅未显示出肿瘤进展的优势，反而可能对患者生命造成损害，研究人员在后续数据中注意到该群体死亡风险增加了41%。这也使得HER2胃癌患者对新的治疗方案需求极为迫切。 HLX22虽在结构上与曲妥珠单抗类似，但其可结合在HER2的亚结构域IV，且结合表位与曲妥珠单抗不重叠，不会产生竞争性结合。因此，当HLX22和曲妥珠单抗联合使用时，两款药物能够同时与HER2结合，进而产生更强的HER2受体阻断效果。早期临床已证实了这一点，2025年3月，HLX22获美国FDA孤儿药资格认定，用于胃癌的治疗。鉴于全球胃癌患者群体庞大且需求未得到充分满足，HLX22有望创造巨大价值。同时，公司还启动了HLX22联合曲妥珠单抗和化疗/联合德曲妥珠单抗的II期临床试验，进一步探索以HLX22为基石的HER2靶向疗法在多项实体瘤中的治疗潜力。此外，复宏汉霖在ADC领域的布局也在加速推进。PD-L1 ADC药物HLX43是全球第二款、国内首款进入临床阶段的靶向PD-L1的ADC产品。从先前数据来看，HLX43杀伤力强大，在抗PD-1/PD-L1单抗耐药的非小细胞肺癌等多个瘤种中疗效显著，且耐受性良好。这也意味着，HLX43有望站在PD-（L）1这一巨人肩膀上起舞。目前，PD-（L）1耐药问题日渐显著，但并未有效对策。近期，复宏汉霖已经启动HLX43在潜在实体瘤适应症中的II期临床试验，HLX43联用H药的ADC免疫联合疗法也已获批开展晚期/转移性实体瘤患者的Ib/II期临床试验，预示着其成为该蓝海市场的有力角逐者，也意味着公司在IO+ADC治疗领域的布局日渐完善，抢先完成对未来的卡位。而从HLX22到HLX43的布局与推进，不仅表明复宏汉霖第三级火箭开始发力，具备层次感的创新梯队正在形成，未来有望形成成果不断档的局面，构建的“研-产-销”飞轮效应日渐显著。 4 结语对于产业界来说，复宏汉霖的崛起并非意料之外。在国内大分子领域，复宏汉霖自创立之初，其核心团队便深植研发基因。也正因如此，通过自主研发打造出一套既有深度又具广度的管线梯队，一切看似水到渠成。然而，复宏汉霖也向市场有力证明，创新药企要迈向成功，单纯依靠技术基因远远不够，商业策略的成功举足轻重。从它所呈现的优异成绩单中，商业策略的关键作用得以充分彰显。不可否认，中国创新药行业的格局始终处于动态变化中。无论对于复宏汉霖，还是整个行业，在技术与商业层面，“边界”仍然还有很大的拓宽空间。衷心期待以复宏汉霖们能够不断书写更多精彩篇章。来源 | 氨基观察（药智网获取授权转载）撰稿 | 蔡九责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

生物类似药财报专利到期抗体药物偶联物上市批准

100 项与阿替利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10773	阿替利珠单抗	L01XC32	DB11595

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期非小细胞肺癌	欧盟	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	冰岛	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	列支敦士登	Roche Registration GmbH	2024-07-25
晚期非小细胞肺癌	挪威	Roche Registration GmbH	2024-07-25
乳腺癌	加拿大	F. Hoffmann-La Roche Ltd.	2024-03-13
肺泡软组织肉瘤	美国	Genentech, Inc.	2022-12-09
PD-L1阳性非小细胞肺癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-05-26
BRAF V600 突变阳性黑色素瘤	美国	Genentech, Inc.	2020-07-30
PD-L1阳性三阴性乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2018-01-19
晚期肝细胞癌	欧盟	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	冰岛	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期肝细胞癌	挪威	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	欧盟	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	冰岛	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	列支敦士登	Roche Registration GmbH	2017-09-20
晚期三阴性乳腺癌	挪威	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	欧盟	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	冰岛	Roche Registration GmbH	2017-09-20
广泛期小细胞肺癌	列支敦士登	Roche Registration GmbH	2017-09-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
结外NK-T细胞淋巴瘤	申请上市	日本	Chugai Pharmaceutical Co., Ltd.	2024-10-31
1型糖尿病	申请上市	中国	Provention Bio, Inc.	2024-08-28
膀胱癌	申请上市	中国	Roche Holding AG	2019-02-25
子宫内膜癌	临床3期	英国	Hoffmann-La Roche, Inc.	2023-10-25
淋巴组织增生性疾病	临床3期	英国	Hoffmann-La Roche, Inc.	2023-10-25
黑色素瘤	临床3期	英国	Hoffmann-La Roche, Inc.	2023-10-25
MSI-H 癌症	临床3期	英国	Hoffmann-La Roche, Inc.	2023-10-25
Turcot综合征	临床3期	英国	Hoffmann-La Roche, Inc.	2023-10-25
肌层浸润性膀胱癌	临床3期	比利时	Hoffmann-La Roche, Inc.	2021-05-03
肌层浸润性膀胱癌	临床3期	中国香港	Hoffmann-La Roche, Inc.	2021-05-03

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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


JPRN-JapicCTI-184038 (WJOG10718L/@ Be Study, ESMO_ELCC2025)	临床2期	PD-L1阳性非鳞状非小细胞肺癌一线 PD-L1 high expression	40	Atezolizumab 1,200 mg + Bevacizumab 15 mg/kg	願糧築觸齋糧鹽範襯廠(築糧簾鹹齋鑰獵構蓋鹹) = 簾餘鬱觸鏇蓋顧觸壓醖鏇獵繭襯觸鑰願構鏇壓 (築膚蓋憲顧製鹹範鹽顧, 4.17 ~ 33.28) 更多	积极	2025-03-26
NCT04920981 (IFCT-1905 CLINATEZO, ESMO_ELCC2025)	N/A	广泛期小细胞肺癌一线	518	atezolizumab (Former smokers)	齋築膚餘齋膚醖鏇鹽製(艱齋醖夢鬱夢醖衊夢獵) = 窪範選鏇壓壓蓋築齋廠願窪網壓衊願簾衊蓋鏇 (憲鹹願襯餘憲積蓋齋積 ) 更多	积极	2025-03-26
NCT04920981 (IFCT-1905 CLINATEZO, ESMO_ELCC2025)	N/A	广泛期小细胞肺癌一线	518	atezolizumab (Current smokers)	齋築膚餘齋膚醖鏇鹽製(艱齋醖夢鬱夢醖衊夢獵) = 網醖鬱膚鑰壓艱鏇廠構願窪網壓衊願簾衊蓋鏇 (憲鹹願襯餘憲積蓋齋積 ) 更多	积极	2025-03-26
NCT03836066 (TELMA, ESMO_ELCC2025)	临床2期	高肿瘤突变负荷肿瘤一线 high tumor mutation burden	38	Atezolizumab plus Bevacizumab	簾鹹糧壓夢構鏇蓋遞築(簾蓋範簾蓋鑰製鹽鹽範) = 齋選範膚願網願簾構網餘襯鬱蓋襯齋願衊壓艱 (襯醖願構鬱構鹽膚鹽構, 38.3 ~ 69.3) 更多	积极	2025-03-26
ESMO_ELCC2025	N/A	广泛期小细胞肺癌一线	45	≥6 cycles of induction chemotherapy	範網夢繭衊餘鹹簾糧憲(鬱築鏇醖鹽鬱憲簾願網) = 鹹築襯襯顧餘淵餘繭構齋築網醖憲廠憲廠餘顧 (製範獵鏇鬱顧選壓鹹窪 ) 更多	积极	2025-03-26
ESMO_ELCC2025	N/A	广泛期小细胞肺癌一线	45	<6 cycles of induction chemotherapy	範網夢繭衊餘鹹簾糧憲(鬱築鏇醖鹽鬱憲簾願網) = 遞顧襯選製鹹壓築壓衊齋築網醖憲廠憲廠餘顧 (製範獵鏇鬱顧選壓鹹窪 ) 更多	积极	2025-03-26
NCT03272217 (CTgov)	临床2期	膀胱尿路上皮癌 \| 不可切除的尿路上皮癌	16	Atezolizumab+Bevacizumab	網餘觸鏇窪蓋艱築壓繭 = 壓獵壓憲築鏇遞餘製壓膚觸獵構廠糧衊衊簾淵 (積廠膚製鹹壓構廠選繭, 願鏇選廠鏇蓋廠遞範憲 ~ 選繭淵膚製廠糧壓餘鬱) 更多	-	2025-03-25
NCT03285763 (TAIL, CTgov)	临床4期	局部晚期非小细胞肺癌	619	Atezolizumab	選齋遞鑰鹽構鏇觸築繭 = 製膚簾壓鬱艱糧憲製糧鑰膚築鬱構憲繭鏇憲鬱 (齋遞醖鏇範構壓淵蓋鏇, 衊糧積淵廠艱製憲餘壓 ~ 顧選鹹餘糧蓋膚壓積繭) 更多	-	2025-03-25
NCT04214418 (MEKiAUTO, CTgov)	临床1/2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 \| 十二指肠肿瘤 \| 大肠腺癌 ... 更多	27	Cobimetinib+Hydroxychloroquine+atezolizumab (Phase 2: Cohort 1)	壓糧網餘襯網衊鏇願網(襯鹹醖壓遞願選顧夢鑰) = 範簾壓襯願選膚願壓觸壓積構齋簾淵糧齋構選 (鑰積窪淵憲艱願壓願顧, 構艱齋憲鹽窪廠繭餘繭 ~ 選夢齋鏇鹹糧繭顧醖鑰) 更多	-	2025-03-25
NCT04214418 (MEKiAUTO, CTgov)	临床1/2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 \| 十二指肠肿瘤 \| 大肠腺癌 ... 更多	27	Cobimetinib+Hydroxychloroquine+atezolizumab (Phase 2: Cohort 2)	壓糧網餘襯網衊鏇願網(襯鹹醖壓遞願選顧夢鑰) = 窪壓膚艱繭積壓繭餘夢壓積構齋簾淵糧齋構選 (鑰積窪淵憲艱願壓願顧, 齋廠醖衊憲範齋遞夢鏇 ~ 鏇範選窪範願鏇齋製蓋) 更多	-	2025-03-25
NCT04710498 (CTgov)	临床2期	晚期皮肤鳞状细胞癌 \| 皮肤鳞状细胞癌	20	Atezolizumab	淵鏇選廠築簾蓋繭願壓 = 顧鬱顧製鑰餘廠餘選觸簾遞憲鏇鹹糧鹽鬱網鬱 (積廠蓋鬱窪鏇遞鏇憲獵, 築窪窪鹽鏇窪願鑰鹹獵 ~ 遞觸餘艱淵膚憲鑰觸構) 更多	-	2025-03-25
NCT04300647 (SKYSCRAPER-04, CTgov)	临床2期	PD-L1阳性宫颈癌	172	atezolizumab (Atezolizumab)	夢衊淵憲糧構顧齋範願 = 選積憲製鏇憲願廠網積製襯糧膚齋憲範餘願鑰 (積選鬱醖觸觸鏇鹽鏇鏇, 鬱憲遞齋鑰憲顧廠獵鹽 ~ 製鑰顧糧窪齋廠夢製糧) 更多	-	2025-03-25
NCT04300647 (SKYSCRAPER-04, CTgov)	临床2期	PD-L1阳性宫颈癌	172	atezolizumab+Tiragolumab (Tiragolumab Plus Atezolizumab)	夢衊淵憲糧構顧齋範願 = 獵築糧獵窪構齋鬱廠築製襯糧膚齋憲範餘願鑰 (積選鬱醖觸觸鏇鹽鏇鏇, 網鑰簾築選膚膚衊壓衊 ~ 獵觸齋鹽選築醖鹹築餘) 更多	-	2025-03-25
NCT04322643 (CTgov)	临床2期	晚期尿路上皮癌 \| 膀胱尿路上皮癌	4	nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	遞壓選觸蓋壓襯繭膚網 = 衊鏇選構簾艱膚獵顧夢淵願醖膚窪繭願觸鑰蓋 (繭顧糧簾網糧網願繭醖, 繭鑰廠廠鹽蓋窪顧獵鹹 ~ 夢夢醖夢繭鬱衊膚齋製) 更多	-	2025-03-25