Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

开始日期2025-08-18

申办/合作机构

National Cancer Institute

NCT06806852

/ Not yet recruiting临床1期

A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer.
The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing.
Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site.
Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2025-05-01

申办/合作机构

Boehringer Ingelheim GmbH

NCT06855212

/ Recruiting临床2期IIT

A Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for Head and Neck Squamous Cell Carcinoma

The purpose of the study is to determine if cemiplimab in combination with cetuximab given before their surgery are beneficial and safe in participants with head and neck squamous cell carcinoma (HNSCC).

开始日期2025-03-20

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+2]

100 项与西妥昔单抗相关的临床结果

登录后查看更多信息

100 项与西妥昔单抗相关的转化医学

登录后查看更多信息

100 项与西妥昔单抗相关的专利（医药）

登录后查看更多信息

8,627

项与西妥昔单抗相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Anti-EGFR Rechallenge in Metastatic Colorectal Cancer and the Role of ctDNA: A Systematic Review and Meta-analysis

Review

作者: da Silva, Luís Felipe Leite ; Peixoto, Renata D 'Alpino ; Saldanha, Erick Figueiredo ; da Conceição, Lucas Diniz ; Noronha, Mariana Macambira ; da Silva, Marcos Vinícius Martins Grangeiro

BACKGROUND:

Metastatic colorectal cancer (mCRC) remains a significant clinical challenge. While anti-EGFR inhibitors have improved survival rates, their long-term efficacy is limited by disease progression, which is often associated with the development of acquired resistance mutations. However, some patients may regain sensitivity to anti-EGFR agents after alternative therapies, suggesting a potential benefit for rechallenge strategies. Our study aims to conduct a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of EGFR rechallenge in patients with mCRC.

METHODS:

A systematic search of the MEDLINE, EMBASE, and Cochrane databases was conducted between October 28 and December 24, 2023, to identify clinical trials investigating treatment regimens incorporating panitumumab or cetuximab as a rechallenge strategy. Pooled proportions or hazard ratios (HR) were calculated using a random effects model. Inter-study heterogeneity was assessed using the I².

RESULTS:

Among the 2105 articles identified through the search, 13 met the predetermined inclusion criteria. Of these, 12 were phase II studies, encompassing 92.3% of the patient population. Cetuximab was administered to 302 patients (75.1%), whereas panitumumab was utilized in 100 patients (24.9%).A pooled analysis of eight studies demonstrated an objective response rate of 20.50% (95% CI 7.94 to 33.07) and a disease control rate of 67.35% (95% CI 58.60 to 76.09). The median progression-free survival was estimated at 3.5 months (95% CI 2.68-6.69), with a median OS of 9.8 months (95% CI 6.71-12.89). Patients exhibiting RAS wild-type status in circulating tumor DNA (ctDNA) analysis derived enhanced benefits from anti-EGFR rechallenge (HR: 0.41; 95% CI 0.28-0.60, I² = 60%). Common grade 3 or higher treatment-related adverse events included neutropenia (22.8%) and rash (14.9%).

CONCLUSION:

This meta-analysis underscores the efficacy and safety of anti-EGFR rechallenge as a promising therapeutic approach for a subset of patients afflicted with mCRC. The observed correlation between wild-type RAS status, as determined through ctDNA analysis, and improved OS signals the prospect of precision oncology in guiding treatment decisions.

2025-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Efficacy and safety of PD-1/PD-L1 inhibitors combined with standard of care for locally advanced head and neck squamous cell carcinoma: A meta-analysis of randomized controlled trials

Review

作者: Chen, Long ; Yin, Shi-Hua ; Mo, Dun-Chang ; Peng, Li-Ping ; Zhao, Shi-Jie ; He, Jin-Nian

OBJECTIVES:

Chemoradiotherapy (CRT) or radiotherapy (RT) combined with cetuximab (for cisplatin-ineligible patients) is the standard of care (SoC) for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This study investigates whether adding programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) immune checkpoint inhibitors (ICIs) to standard therapy improves survival in patients with LA-HNSCC.

METHODS:

A comprehensive search of PubMed, Embase, and the Cochrane Library identified randomized controlled trials (RCTs) evaluating PD-1/PD-L1 inhibitors plus SoC compared with SoC alone for LA-HNSCC. The primary endpoints were progression-free survival (PFS), overall survival (OS), locoregional event-free survival (LEFS), and distant metastasis-free survival (DMFS) at the 1-year and 2-year time points, as well as the incidence of grade 3 or higher adverse events (AEs).

RESULTS:

Four RCTs encompassing 1,818 patients met the inclusion criteria. Compared with SoC alone, PD-1/PD-L1 inhibitors combined with SoC did not significantly improve 1-year or 2-year PFS, OS, LEFS, or DMFS (all p > 0.05). Subgroup analyses further showed no survival benefit at 2 years in the ICI + CRT, ICI + RT-cetuximab, anti-PD-1, or anti-PD-L1 subgroups. Additionally, there was no statistically significant difference in the incidence of grade 3 or higher AEs between the combined and SoC-only groups (p = 0.69).

CONCLUSIONS:

These findings suggest that adding PD-1/PD-L1 inhibitors to standard therapy does not enhance 1-year or 2-year survival for patients with LA-HNSCC, and confers a similar severe safety profile.

2025-05-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Synthesis of iron oxide nanocrystals functionalized with hyaluronic acid and 131I-cetuximab for targeted combined (radio-photothermal) treatment of HepG2 cells

Article

作者: El-Shershaby, Hanan M ; Bayoumi, Noha A ; Darwish, Wael M

Surface coating of NIR-plasmonic iron oxide magnetic nanocrystals (Fe₃O₄ MNCs) with natural polysaccharides is a promising strategy for increasing their uptake by cancer cells. In this work, chitosan-coated magnetic nanocrystals (Fe₃O₄@CS MNCs) were prepared and subsequently chemically conjugated with hyaluronic acid (HA). The cellular uptake of MNCs post treatment of HepG2 cells with the synthesized (Fe₃O₄@CS MNCs) and (Fe₃O₄@CS-HA MNCs) was 18.1 ± 0.8 and 25.2 ± 1.3 μg Fe/mL, respectively. The enhancement of MNCs cellular uptake is attributed to HA targeting of the cluster of differentiation 44 (CD44) protein extracellularly expressed on HepG2 cells. In another model, HA was covalently attached to the monoclonal antibody cetuximab. The produced (Fe₃O₄@CS-HA-Cet MNCs) showed the highest cellular uptake (31.4 ± 1.9 μg Fe/mL) via selective binding to the epidermal growth factor receptor (EGFR) overexpressed in HepG2 cells. Consequently, the phototoxicity against HepG2 cells upon near-infrared (NIR) laser light (808 nm, 1.5 W/cm²) at different concentrations of Fe follows the order: (Fe₃O₄@CS-HA-Cet MNCs) > (Fe₃O₄@CS-HA MNCs) > (Fe₃O₄@CS MNCs). For enhancement of the therapeutic efficiency, a combined targeted radio-photothermal candidate was synthesized by radiolabeling the antibody with Iodine-131. The combinatorial model (Fe₃O₄@CS-HA-Cet-¹³¹I MNCs) exhibited the highest toxicity against HepG2 cells upon NIR irradiation due to the synergistic combined radio- photothermal action.

974

项与西妥昔单抗相关的新闻（医药）

2025-03-27

·ir.nanobiotix.com

Nanobiotix Announces First Data From the Completed Dose Escalation Part of a Phase 1 Study Evaluating NBTXR3 (JNJ-1900) as a 2L+ Therapy for Patients With Locally Advanced NSCLC

Data show favorable safety and confirm injection feasibility in 12 patients with locally advanced NSCLC amenable to re-irradiation for whom prior lines of therapy have failed A preliminary review of survival data showed 12-month LPFS of 64% (median 18.6 months) and 12-month OS of 83% (median 30.2 months) The dose escalation part is complete, and 5/12 patients have been injected to date in the ongoing expansion part PARIS and CAMBRIDGE, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering disruptive, nanotherapeutic approaches to revolutionize treatment outcomes for millions of patients, today announced the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") evaluating radiotherapy-activated NBTXR3 (JNJ-1900)1 as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer (“NSCLC”) amenable to re-irradiation. These data will be presented at the 2025 European Lung Cancer Conference by study principal investigator Dr. Saumil Gandhi. ABSTRACT #207P: Phase 1 Study of Reirradiation (“ReRT”) with NBTXR3 (JNJ-1900) for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer (“NSCLC”)Saumil J. Gandhi, MD, PhD, Enoch Chang, MD, Aileen Chen, MD, Stephen G. Chun, MD, Steven H. Lin, MD, PhD, Rachel C. Maguire, BS, Matthew S. Ning, MD, MPH, Julianna K. Bronk, MD, PhD, David Qian, MD, Joe Y. Chang, MD, PhD, James W. Welsh, MD, Zhongxing Liao, MD, Rahul A. Sheth, MD, Roberto F. Casal, MD Locoregional recurrence occurs in 30-40% of patients with locally advanced NSCLC after treatment with definitive chemoradiation. Historically, patients who are amenable to re-irradiation are often limited to palliative doses due to associated toxicities. As such, strategies to enhance the therapeutic ratio of radiotherapy are needed to improve treatment outcomes. “Patients with recurrence after prior radiation therapy for locally advanced lung cancer face limited therapeutic options and significant challenges in achieving durable disease control,” said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at MD Anderson. “These data underscore the need for continued therapeutic innovation for these patients and highlight the potential of NBTXR3 (JNJ-1900) as a novel approach to improving patient outcomes.” Results from the completed dose escalation part of the study demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs), and no Grade 3 or higher SAEs related to NBTXR3. Injection feasibility was confirmed, and the recommended phase 2 dose (RP2D) was established at 33% of gross tumor volume. Promising early efficacy signals were observed. Preliminary review of survival data from 12 patients showed 12-month LPFS of 64% (median 18.6 months) and 12-month OS of 83% (median 30.2 months), further supporting the potential clinical benefit of NBTXR3 (JNJ-1900) in this patient population. “The Nanobiotix team is encouraged by these early findings, which suggest NBTXR3 (JNJ-1900) could offer a new therapeutic option for patients with no alternatives after prior treatments have failed,” said Louis Kayitalire, MD, Nanobiotix Chief Medical Officer. “Notably, these results were observed in patients who resisted prior curative radiation doses and that were treated with JNJ-1900 (NBTXR3) activated by a lower radiation dose. As we advance the study’s expansion phase, we look forward to further evaluating NBTXR3 (JNJ-1900)’s potential to improve patient outcomes.” The expansion phase of the study is ongoing, with 5/12 patients injected to date. About JNJ-1900 (NBTXR3) NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18, 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts 1 Potential first-in-class radioenhancer “NBTXR3” was licensed to Johnson & Johnson by Nanobiotix in 2023 and renamed “JNJ-1900” for the purposes of Johnson & Johnson-led clinical development. Attachment 2025-03-27 -- NBTX -- 1st Data from Ph1 of NBTXR3 in 2nd Line NSCLC -- FINAL

临床结果临床3期临床1期引进/卖出免疫疗法

2025-03-26

·PRNewswire

ANNOUNCEMENT OF ANNUAL RESULTS FOR 2024

Notable Progress in R&D and Commercialization Gross Profit Surging 68% CHENGDU, China, March 26, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announced its audited consolidated results for the year ended December 31, 2024 (the " Reporting Period"). In 2024, the pharmaceutical and healthcare sector experienced significant turbulence amid multiple internal and external shocks. China's biopharmaceutical industry continued to advance through transformation and breakthroughs, with factors such as pharmaceutical innovation, overseas expansion of innovative drugs, a "wave of M&A" in capital market, and the deepening of anti-corruption campaigns in healthcare collectively driving the industry toward steady recovery and innovative development. Adhering to its innovation-driven development strategy, the Company has consistently expanded into new targets, technologies, payloads, and therapeutic areas while continuously unlocking the clinical value of its core programs. From rapid advancement of key projects and sustained exploration of novel technologies to the steady establishment of a commercialization framework and the approval of three innovative drugs for market launch, the Company has achieved new breakthroughs in its "Pin(品)"-shaped strategic operational framework, with business progress yielding highly encouraging results. As of the latest update, the Company is actively developing over 30 drug candidates, including its core product sac-TMT (approved for marketing in China) as well as key products Tagitanlimab and Cetuximab N01. The Company has 11 ADC and novel DC assets at clinical stage or above, Through focused recognition of projects with competitive advantages and market value, along with strategic allocation of existing R&D resources to these prioritized programs, the Company's pipeline mainly consists of oncology drug candidates as well as drug candidates for non-oncology diseases and conditions such as autoimmune, metabolism and other disease areas. Core ADC Programs Advance Rapidly with Enhanced Value Across Innovative Pipeline Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) TNBC. In March 2024, sac-TMT was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. The results from the Phase 3 study of sac-TMT in patients with previously treated locally recurrent or metastatic TNBC were presented at the ASCO Annual Meeting in May 2024. Sac-TMT demonstrated a significant statistically and clinically meaningful improvement in PFS (HR: 0.32, representing a 68% reduction in disease progression risk) and OS (HR: 0.53, representing a 47% reduction in mortality risk). In November 2024, the Company received marking authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT is the first domestically developed ADC with global intellectual property rights to receive complete marketing authorization in China. HR+/HER2- BC. A Phase 3 registrational study for 2L+ HR+/HER2- locally advanced or metastatic BC is in progress. EGFR-mutant NSCLC. In October 2024, the NDA for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA and was included in the priority review and approval process. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Compared with docetaxel, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress. EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT, namely sac-TMT in combination with pembrolizumab (KEYTRUDA®) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress. T rastuzumab Botidotin (HER2 ADC, also known as A166) ( 舒泰萊 ®) In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1. Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ advanced HER2+ BC based on results from the primary analysis, which the Company used to submit an NDA to the NMPA. The Company has also initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC. Other ADCs and Novel Conjugate Drugs SKB315 (CLDN18.2 ADC). SKB315 is configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. The early-stage clinical data of SKB315 demonstrates promising efficacy and acceptable safety profile in GC with mid and high CLDN18.2 expression. The Company is conducting a Phase 1b clinical trial of SKB315. SKB410/MK-3120 (Nectin-4 ADC). SKB410 is a novel Nectin-4 ADC targeting advanced solid tumors and utilizing a differentiated payload-linker strategy. SKB410 has shown promising Phase 1 clinical data. MSD, as the sponsor, has launched the global Phase 1/2 clinical trial of SKB410. SKB571/MK-2750. SKB571 is a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 1 clinical trial in China is ongoing. SKB518, SKB535/MK-6204 and SKB445. SKB518, SKB535 and SKB445 are novel ADC drugs with potential FIC targets. The Phase 1 clinical trials for each of them are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. It was announced on the official website of the NMPA that SKB535 is the first pilot project approved by the NMPA through the optimized clinical trial review scheme for innovative drugs, and the review and approval time is 21 days. SKB500 and SKB501. SKB500 and SKB501 are novel ADC drugs with verified targets but differentiated payload-linker strategies. In November and December 2024, the Company received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA. SKB107. SKB107 is an RDC drug jointly developed by us and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting tumor bone metastasis. In January 2025, an IND application for SKB107 was accepted by the NMPA. Three I nnovative D rugs A pproved for M arket L aunch, M arking a S uccessful C ommercialization M ilestone for the P roduct P ipeline Currently, the Company has received marketing authorization for sac-TMT, tagitanlimab (科泰萊®) and Cetuximab N01 (達泰萊®) and has commenced their commercialization. The Company expects to launch trastuzumab botidotin (舒泰萊®) in the China market and file an NDA for A400 in 2025. Sacituzumab tirumotecan sac-TMT is a China's first domestically developed original TROP2 ADC targeting drug and the first domestically developed ADC to receive complete marketing authorization in China. It provides a novel and superior treatment pathway for Chinese patients with advanced triple-negative breast cancer (TNBC). Tagitanlimab (PD-L1 mAb, also known as A167) (科泰萊®) is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. In December 2024, the Company received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA. Cetuximab N01 (EGFR mAb, also known as A140) (達泰萊®). In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. As demonstrated by a large-scale domestic Phase 3 clinical study conducting a head-to-head comparison of Cetuximab N01 Injection with Cetuximab Solution for Injection (Erbitux®), the Cetuximab N01 combination chemotherapy was clinical equivalent in ORR (Cetuximab N01 vs. Cetuximab Solution for Injection (Erbitux®): 71.0% vs. 77.5%; ORR ratio is 0.93 [95% CI: 0.87, 0.99]), and Cetuximab N01 did not demonstrate any clinically meaningful or statistically significant differences in DoR and PFS compared with Cetuximab Solution for Injection (Erbitux®) (median PFS: 10.9 months vs 10.8 months, HR: 1.03 [95% CI: 0.83, 1.28]; median DoR: 10.2 months vs. 9.5 months). As for safety, this study has sufficiently proven that the Cetuximab N01 combination chemotherapy is comparable in safety, tolerance and immunogenicity compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy. The Company has set up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products and established a departmental structure within the Company, consisting of various departments such as Marketing, Commercial and Marketing Access, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence. The Company will continue to refine our commercialization strategies for each late-stage drug candidate, first prioritizing therapeutic areas with medical needs in China, such as BC, NSCLC and GI cancers, while offering synergistic treatment options enabled by our diverse pipeline to optimize patient outcome. Globally, the Company will continue to pursue a flexible strategy to capture the commercial value in major international market, through forging synergistic license and collaboration opportunities worldwide. Steady Advancement in International Collaboration and Capital Management, with Continuous Refinement of ESG Governance Structure In 2024, the Company upheld its international development strategy and, in collaboration with MSD, promoted multi-dimensional, multi-level, and various forms of interaction and exchange to deepen their strategic partnership. MSD exercised its exclusive option for the SKB571, and several other collaborative pipelines received milestone payments from partners, marking a solid step forward in the cooperation. The Company has entered into license and collaboration agreements with MSD to develop multiple ADC assets for cancer treatment. The Company has granted MSD an exclusive, royalty-bearing and sub-licensable license to develop, use, manufacture and commercialize sac-TMT outside Greater China. The Company retains the right to develop and commercialize sac-TMT within Greater China. As of 4 March 2024, MSD has initiated 12 ongoing Phase3 global clinical studies of sac-TMT as amonotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. In the third quarter of 2024, the Company was informed by MSD regarding an exclusive option to exercise SKB571/MK-2750. MSD has paid US$37.5 million to the Company in connection with the option to exercise, and the Company is eligible to receive further milestone payments conditional upon the achievement of specified development and sales milestones and tiered royalties on net sales of SKB571/MK-2750 if commercialized. Regarding the collaboration with Ellipses Pharma, in March 2024, it was announced that A400/EP0031 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, A400 was cleared by the FDA to progress into Phase 2 clinical development. As of December 31, 2024, a total of 33 clinical sites in the United States, Europe and UAE were set up for A400/EP0031. Regarding the collaboration with Windward Bio, in January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). The Company has received upfront and milestone payments totaling US$147.5 million from partners with regard to multiple collaborated pipelines in 2024 and up to now. During the Reporting Period, the Company maintained a steady and disciplined approach to capital operations. It successfully completed a Hong Kong placement and domestic share issuance, raising US$150 million, providing strong and sustained momentum for its growth. Additionally, the Company continued to improve its ESG governance structure, issuing its first ESG report to reaffirm its commitment to environmental protection, social responsibility, and corporate governance, demonstrating its dedication as a publicly listed enterprise. In 2024, the Company was awarded "Excellence in ESG Governance Performance Award" by Ming Pao, and the Emerging Innovation Power Award from the China National Pharmaceutical Industry Information Center. Outlook In 2025, the Company will continue to deepen its R&D innovation reforms. By focusing on its core strengths, the Company aims to enhance efficiency, strengthen external collaborations, benchmark against the highest industry standards, and improve its scientific decision-making capabilities—thus maintaining and expanding its leading position in pioneering projects and key technology areas such as ADCs. Simultaneously, the Company will cultivate a product market-oriented mindset and, in response to unmet clinical needs, develop innovative drugs with differentiated advantages and international potential. Leveraging big data and artificial intelligence, the Company will further bolster its research capabilities in biology and translational medicine to improve the efficacy and success rate of innovative drug development. In addition, it will intensify international collaboration in innovative drugs, accelerate the cultivation of new competitive advantages, and integrate more deeply into the global innovative drug network to realize greater value for its innovations across broader market. About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDCTM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床3期临床2期临床结果上市批准

2025-03-25

·同写意

距离止亏一步之遥！科伦博泰年报公布

年报季，科伦博泰交出了一份亮眼“成绩单”。昨天（3月24日）晚间，科伦博泰发布了2024年度业绩报告。报告期内，公司营收19.33亿元，同比增长25.5%；毛利12.74亿元，同比增长67.8%；研发支出12.06亿元，同比增长17%；年度亏损2.67亿元，同比减少53.5%；调整后年度亏损1.18亿元，同比减少73.7%；截止2024年12月31日，现金及金融资产30.76亿元，同比增长21.6%。整体来看，科伦博泰的收入结构更趋多元健康，“自主开发+全球授权”模式正在稳步进入兑现期。尽管尚没有成功扭亏，但这一连串数据显示，距离那个节点，科伦博泰已经越来越近了。 1 超30条管线在研，3款产品“上岸” 公开信息显示，科伦博泰目前共有30多款在研管线，涵盖肿瘤、免疫等疾病领域。其中超10款处于临床研究阶段，针对5种适应症的3款产品已成功实现商业化。作为其核心产品，芦康沙妥珠单抗（sac-TMT；佳泰莱®）在乳腺癌、非小细胞肺癌等多个领域均有应用/研发： • 三阴性乳腺癌（TNBC） 2024年11月，sac-TMT获NMPA批准于中国上市，用于治疗既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性TNBC；Sac-TMT是国内首个获得完全批准上市的具有全球知识产权的国产ADC。 2024年3月，获NMPA突破性疗法认定（BTD），用于一线治疗不可手术切除的局部晚期、复发或转移性PD-L1阴性TNBC。已启动1L晚期TNBC的III期注册性临床试验。 • HR+/HER2-乳腺癌（BC）针对2L+局部晚期或转移性HR+/HER2-BC的III期注册性研究正在进行中。 • EGFR突变型非小细胞肺癌（NSCLC） 2025年3月，sac-TMT获NMPA批准上市，用于治疗经EGFR-TKI和含铂化疗后进展的局部晚期或转移性EGFR突变型NSCLC。Sac-TMT成为全球首款在肺癌领域获批上市的TROP2 ADC药物。 2024年10月，针对2L EGFR突变型NSCLC的注册性研究的NDA申请获CDE受理，并纳入优先审评审批程序。 Sac-TMT联合奥希替尼治疗1L EGFR突变的局部晚期或转移性非鳞状NSCLC的III期注册性临床研究正在进行中。 • EGFR野生型NSCLC Sac-TMT联合帕博利珠单抗（可瑞达®）对比帕博利珠单抗一线治疗PD-L1阳性的局部晚期或转移性NSCLC患者的III期注册性研究正在进行中。 Sac-TMT联合帕博利珠单抗对比化疗联合帕博利珠单抗一线治疗PD-L1阴性的局部晚期或转移性非鳞状NSCLC患者的III期注册性研究正在进行中。 • 其他适应症科伦博泰亦正积极探索sac-TMT作为单药疗法及联合其他疗法用于治疗其他实体瘤的可能性，其中包括GC、EC、CC、OC、UC、CRPC及HNSCC。根据年报，科伦博泰的其他关键产品还包括：塔戈利单抗（PD-L1单抗，A167）（科泰莱®），该药物于2024年12月获NMPA批准用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌；2025年1月，A167联合顺铂和吉西他滨用于一线治疗复发或转移性鼻咽癌获NMPA批准上市。塔戈利单抗是全球首个获得批准用于鼻咽癌一线治疗的PD-L1单抗。西妥昔单抗NO1（EGFR单抗，A140）（达泰莱®），2025年2月，A140用于与FOLFOX或FOLFIRI方案联合用于一线治疗RAS基因野生型的转移性结直肠癌获NMPA批准上市。 2 license-out红利持续释放科伦博泰的营收构成中，license-out收入仍是重要支柱。其年度业绩报告显示，其来自许可及合作协议的收入为18.63亿元，而源自药物销售、提供研发服务的收入共计6997.4万元。就源自许可及合作协议的收入而言，默沙东仍然是那个最重要不过的“付款方”。近年来，科伦博泰与默沙东的合作持续深化。年度报告显示，截至2025年3月24日，默沙东已启动十二项sac-TMT作为单一疗法或联合帕博利珠单抗或其他药物用于多种适应症的全球性III期临床研究，研究均由默沙东申办并主导。此外，科伦博泰还与默沙东还在若干ADC资产（包括SKB410/MK-3120、SKB571/MK-2750、SKB535/MK-6204等）中开展合作，不断探索最优ADC管线组合，以期借助不同靶点覆盖更广泛的肿瘤适应症，针对不同靶点的ADC资产应用差异化的载荷－连接子策略，实现更好的疗效及/或差异化的安全性，并凭借不同策略探索ADC的联合用药。由此产生的首付款、特定开发及销售里程碑款项是科伦博泰的重要收益来源，但值得注意的是，科伦博泰并未放弃其在中国本土的权利——在向默沙东授予独家全球许可的同时，科伦博泰保留了为中国内地、香港及澳门研究、开发、制造和商业化若干许可和选择ADC的权利。这种“双循环”的收益结构，能够帮助其在未来实现利益最大化。默沙东之外，科伦博泰还与Ellipses Pharma、Windward Bio等多家公司订立合作及许可协议，进一步开拓其管线潜力及收入来源。例如，2021年3月，科伦博泰与Ellipses Pharma订立合作及许可协定，授予Ellipses Pharma独家、收入分成、付特许权使用费、可转授的许可，用于A400（EP0031）的开发、制造及商业化，许可涵盖除大中华区、朝鲜、韩国、新加坡、马来西亚及泰国外的所有国家和地区。 2024年3月，A400/EP0031获得FDA快速通道资格认定，用于治疗RET融合阳性NSCLC。于2024年4月，A400获FDA批准进入II期临床开发。截至2024年12月31日，共计在美国、欧洲及阿联酋为A400/EP0031设立33个临床试验中心。

优先审批突破性疗法财报临床3期上市批准

100 项与西妥昔单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D03455	西妥昔单抗	L01XC06	DB00002

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
RAS 野生型结直肠癌	澳大利亚	Merck Healthcare Pty Ltd.	2007-09-25
头颈部肿瘤	美国	Eli Lilly & Co.	2006-03-01
转移性结直肠癌	欧盟	Merck Europe BV	2004-06-29
转移性结直肠癌	冰岛	Merck Europe BV	2004-06-29
转移性结直肠癌	列支敦士登	Merck Europe BV	2004-06-29
转移性结直肠癌	挪威	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	欧盟	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	冰岛	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	列支敦士登	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	挪威	Merck Europe BV	2004-06-29
结直肠癌	瑞士	Merck & Co., Inc.	2003-12-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
KRAS G12C突变结直肠癌	临床3期	美国	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	中国	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	阿根廷	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	澳大利亚	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	奥地利	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	比利时	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	巴西	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	加拿大	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	哥伦比亚	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	捷克	Mirati Therapeutics, Inc.	2021-06-24

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00545545 (CTgov)	临床1/2期	复发性结直肠癌 \| 结直肠癌	32	PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)	夢夢醖鏇糧夢築簾齋壓 = 獵夢淵顧餘製醖廠淵窪選窪窪衊願壓網範餘蓋 (觸築夢夢襯夢鏇鏇築獵, 鏇廠醖窪顧鏇窪鏇繭遞 ~ 選遞鑰醖襯繭築鏇壓淵) 更多	-	2025-03-25
				PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)	夢夢醖鏇糧夢築簾齋壓 = 餘願觸構鏇醖夢蓋鹽蓋選窪窪衊願壓網範餘蓋 (觸築夢夢襯夢鏇鏇築獵, 窪壓艱夢範觸構淵鹽齋 ~ 範築鬱齋蓋齋積製構鏇) 更多
NCT03785249 (KRYSTAL-1, ASCO_GI2025) 人工标引	临床1/2期	KRAS G12C突变结直肠癌二线 KRAS G12C	94	Adagrasib + Cetuximab	築壓憲願簾醖夢醖鹽繭(網壓衊鬱憲簾鑰積網鏇) = 繭積夢願窪膚夢憲願窪製淵衊醖衊積壓窪遞夢 (願膚範憲窪選壓壓構餘, 32 ~ 53) 更多	积极	2025-01-23
JPRN-jRCTs061180022 \| NCT02515734 (JACCRO CC-13, ASCO_GI2025) 人工标引	临床2期	RAS 野生型结直肠癌 RAS wild-type	359	m-FOLFOXIRI plus cetuximab	網蓋壓繭鬱衊憲糧衊範(糧鑰醖衊鹽艱蓋糧積淵) = 鹹艱醖淵製鑰淵網願窪糧選齋夢餘顧願築觸觸 (鑰選餘顧膚遞糧鬱構鏇 ) 更多	积极	2025-01-23
				m-FOLFOXIRI plus bevacizumab	網蓋壓繭鬱衊憲糧衊範(糧鑰醖衊鹽艱蓋糧積淵) = 築廠艱製壓鏇夢廠膚願糧選齋夢餘顧願築觸觸 (鑰選餘顧膚遞糧鬱構鏇 ) 更多
NCT04607421 (BREAKWATER, ASCO_GI2025 \| Pubmed \| FDA) 人工标引	临床3期	BRAF V600E突变结直肠癌一线 BRAF V600E	479	Encorafenib + Cetuximab + FOLFOX	積觸鏇夢壓繭艱願膚遞(繭餘膚築選憲觸糧顧遞) = 蓋夢簾顧獵構願鹹夢選鹽蓋選淵獵糧廠夢繭鬱 (鑰餘選壓窪觸壓簾蓋壓, 51.6 ~ 69.5) 更多	积极	2025-01-23
				Standard of Care (chemo with or without bevacizumab)	積觸鏇夢壓繭艱願膚遞(繭餘膚築選憲觸糧顧遞) = 製襯鹽鏇顧鹽襯憲廠繭鹽蓋選淵獵糧廠夢繭鬱 (鑰餘選壓窪觸壓簾蓋壓, 31.3 ~ 49.3) 更多
NEW BEACON (ASCO_GI2025)	临床2期	BRAF V600E突变结直肠癌 BRAF V600E mutated	20	Cetuximab every second week + Encorafenib	網淵鹽觸網餘淵窪遞蓋(糧構憲淵淵膚齋艱鏇廠) = 糧壓餘餘築顧獵齋簾餘觸願壓艱齋淵襯獵築觸 (醖艱鑰膚膚鑰廠鑰繭鹽 )	积极	2025-01-23
NCT04241731 (ESMO_ASIA2024) 人工标引	临床2期	RAS 野生型结直肠癌维持 \| 一线 RAS wild-type	31	Cetuximab plus Raltitrexed	遞鏇願製廠鏇願壓糧鏇(網糧餘夢網製網選構齋) = 築憲淵衊襯鑰鬱觸廠衊築築齋積範鑰窪鑰夢夢 (網艱鬱衊餘鏇構艱齋繭, 3.2 ~ 12.0) 更多	积极	2024-12-07
NCT03258554 (NRG-HN004, Pubmed \| Lancet Oncol) 人工标引	临床2/3期	头颈部肿瘤	186	Durvalumab	顧蓋鬱範夢觸糧繭餘鏇(顧選選衊齋糧構顧顧壓) = The most common grade 3-4 adverse events were dysphagia (26 [22%] of 119 patients in the durvalumab group vs 18 [30%] of 61 patients in the cetuximab group), lymphopenia (33 [28%] vs 20 [33%]), and oral mucositis (13 [11%] vs 11 [18%]). 築製艱衊齋襯淵醖遞鏇 (蓋壓蓋夢鹽鹹顧鹹醖鹹 ) 更多	不佳	2024-12-01
				Cetuximab
SITC2024 人工标引	临床1期	结直肠癌 Proficient DNA Mismatch Repair (pMMR)	15	pre-A+E CBNK cells + cetuximab	窪鹹鏇廠願艱夢衊獵簾(繭遞獵淵鏇淵獵鏇鬱製) = None 簾膚蓋觸夢窪製繭選齋 (鏇鑰鑰遞鏇糧衊壓糧繭 ) 更多	积极	2024-11-05
NCT04717375 (623, SITC2024)	临床1期	实体瘤	76	SAR444881 monotherapy	鑰鹹鬱壓糧範獵糧選願(選餘鹽糧餘襯簾窪鬱憲) = 19% 衊選壓淵積齋醖膚艱餘 (範窪願遞獵選築淵獵淵 ) 更多	积极	2024-11-05
				SAR444881 + pembrolizumab
NCT04117945 (CTgov)	临床2期	大肠腺癌 \| 遗传性非息肉病性结直肠癌1型 \| 转移性结直肠癌	22	Regorafenib (Arm A (Regorafenib))	憲範選簾構膚製繭糧衊(鹹積艱鏇積積齋遞壓壓) = 鹹簾壓選壓鑰積顧憲窪鬱獵觸艱鹽構糧膚網蓋 (鑰鹽窪鑰淵鹹鑰積製餘, 繭廠蓋顧鹽廠簾餘齋艱 ~ 鏇憲鏇憲觸廠憲鹹鏇憲) 更多	-	2024-09-27
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	憲範選簾構膚製繭糧衊(鹹積艱鏇積積齋遞壓壓) = 鹹築觸鑰願齋齋齋襯憲鬱獵觸艱鹽構糧膚網蓋 (鑰鹽窪鑰淵鹹鑰積製餘, 餘齋積顧糧膚願觸遞餘 ~ 齋遞蓋繭廠獵憲範糧廠) 更多