A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Surufatinib in Combination With KN046 and AG Regimen Chemotherapy for the First-Line Treatment of Unresectable Advanced Pancreatic Cancer

Advanced pancreatic cancer is a highly aggressive and fatal disease with an extremely low 5-year survival rate. Combined chemotherapy is the mainstay of treatment for patients with unresectable advanced pancreatic cancer, and the combination of nab-paclitaxel and gemcitabine (AG regimen) has been one of the most commonly used regimens for more than a decade. However, chemo-resistance often occurs within half a year and the efficacy remains unsatisfied with an overall survival of only 9
11 months.
Immune checkpoint inhibitors (ICIs) such as anti-PD-1/L1 antibody and anti-CTLA-4 antibody have demonstrated encouraging anti-tumor efficacy in multiple solid tumors including lung cancer, gastric cancer, and esophageal cancer, while obtained controversial results when combined with chemotherapy in pancreatic cancer. Recently, the immune-suppression tumor microenvironment (TME) of pancreatic cancer has been described in several pre-clinical studies, which may explain the resistance against ICIs and chemotherapy.
KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody with innovative designs include a proprietary CTLA-4 domain antibody with a significantly improved safety profile, a bispecific antibody fused with PD-L1 antibody targeting the TME with high PD-L1 expression. Recent clinical studies have shown promising anti-tumor activity of KN046 in pancreatic cancer.
Surufatinib, also known as HMPL-012 or Sulfatinib, is a small molecular tyrosine kinase inhibitor (TKI) targeting the Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor (FGFR) and Colony Stimulating Factor-1 Receptor (CSF-1R), which has a dual mechanism of action of anti-angiogenesis and regulation of immune microenvironment. Previous studies have suggested synergic effect of surufatinib in combination with anti-PD-1 antibodies.
This phase Ib/II clinical trial is intended to investigate the activity and safety of the combination of surufatinib combined with KN046 and the AG regimen chemotherapy as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer.

开始日期2023-11-01

申办/合作机构

复旦大学附属中山医院

[+1]

NCT05985109

/ Recruiting临床2期IIT

A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study

The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.

开始日期2023-10-26

申办/合作机构

北京市肿瘤防治研究所

NCT06099821

/ Recruiting临床2期IIT

A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

开始日期2023-10-25

申办/合作机构

北京肿瘤医院（北京大学肿瘤医院）

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的临床结果

登录后查看更多信息

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的转化医学

登录后查看更多信息

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的专利（医药）

登录后查看更多信息

项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-06-13·CLINICAL CANCER RESEARCH

Safety and Efficacy of KN046 in Combination with KN026 in Patients with Advanced HER2-Positive Breast Cancer: A Phase II Trial

Article

作者: Liu, Jieqiong ; Wang, Xiangcai ; Wang, Xujuan ; Shen, Lin ; Ni, Mingli ; Yang, Hongwei ; Yang, Yaping ; Song, Chuangui ; Zhao, Rusen ; Xu, Ting ; Chen, Lei

Abstract:

Purpose::

In this study, we report the results from a phase II trial assessing the safety and efficacy of KN046 in combination with KN026 in patients with HER2-positive metastatic breast cancer, who had progressed after prior anti-HER2 combination therapies.

Patients and Methods::

Female patients with metastatic HER2-positive breast cancer, who were previously treated with at least one line of HER2-targeted combination therapy, were enrolled from multiple academic hospitals in China to receive KN046 (i.v. 5 mg/kg every 3 weeks) plus KN026 (i.v. 30 mg/kg every 3 weeks) until progression, unacceptable toxicities, or patient withdrawal. Efficacy was evaluated every 6 weeks per RECIST 1.1. The primary endpoint was objective response rate.

Results::

A total of 36 patients with the median age of 53 years were enrolled. Of these 36 patients, 30 (83.3%) received ≥3 lines of HER2-targeted combination therapies in the metastatic setting. Thirty-three patients were evaluable for overall response and all 36 for safety. The objective response rate was 47.2% (95% confidence interval, 30.4–64.5), with two patients achieving complete response. The median progression-free survival was 5.6 months (95% confidence interval, 4.1–13.8). Of the 36 patients, 34 (94.4%) experienced treatment-related adverse events (TRAE) of any grade, and 10 of 36 (27.8%) patients had experienced ≥grade 3 TRAEs. The most common TRAEs were infusion-related reaction (36.1%), rash (16.7%), alanine aminotransferase increased (13.9%), diarrhea (13.9%), and pruritus (13.9%). No treatment-related deaths were observed.

Conclusions::

The combination of KN046 and KN026, as a chemo-free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pretreated patients with advanced HER2-positive breast cancer.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

191

项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的新闻（医药）

2025-09-05

·GlobeNewswire-Health Care

HUTCHMED Highlights Clinical Data to be Presented at the 2025 World Conference of Lung Cancer and the CSCO Annual Meeting 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual Meeting 2025, taking place on September 10-14, 2025 in Jinan, China. Updated analysis from savolitinib’s SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer (“NSCLC”) patients will be presented at WCLC 2025. Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Details of the WCLC 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLCChristina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USAMA03.03Mini Oral: New Advances in Circulating BiomarkersRoom 06Sunday, September 7, 20253:15 - 4:30PM CESTEfficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior ImmunotherapyYongfeng Yu, Shanghai Chest Hospital, Shanghai, ChinaP3.12.48Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Frontline Treatment Duration in MET-Amplified NSCLC After Third-Generation EGFR-TKI Failure: SACHI Study InsightsLijuan Chen, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaP3.12.64Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROsSilvia Novello, University of Turin, San Luigi Hospital, Turin, ItalyPT2.12.04ePoster: Metastatic NSCLC – Targeted TherapyMonday, September 8, 2025INVESTIGATOR-INITIATED STUDIESEfficacy and Safety of Surufatinib, Durvalumab in Combined with Chemotherapy as First-line Treatment of Extensive-stage Small-cell Lung CancerHui Zhang/ Ying Hu, Beijing Chest Hospital, Beijing, ChinaP3.13.22Poster: Small Cell Lung Cancer and Neuroendocrine TumorsTuesday, September 9, 2025 Clinical data of HMPL-653, a novel, selective and potent CSF-1R inhibitor, from a first-in-human Phase I study in patients with tenosynovial giant cell tumor in China will be presented for the first time at the CSCO Annual Meeting 2025. Details of the CSCO Annual Meeting 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES A first-in-human phase I study of HMPL-653, a CSF-1R inhibitor, in patients with tenosynovial giant cell tumorXiaohui Niu25297Oral SessionFriday, September 12, 202515:00 - 15:12PM HKTINVESTIGATOR-INITIATED STUDIES Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm TrialJiwei Huang/ Wei Xue23258Oral SessionThursday, September 11, 202516:50 - 17:15PM HKTFruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trialTianzhu Qiu/ Yanhong Gu23766Oral SessionFriday, September 12, 202511:20 - 12:00 noon HKTFruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trialYongshun Chen22084Poster SessionEfficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical TrialZhiping Li21915AbstractFruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score-matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohortFuxiang Zhou23550AbstractEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armMiaomiao Gou23591AbstractPhase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract CancerMiaomiao Gou23610Oral SessionFriday, September 12, 202516:53 - 16:59PM HKTA single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancerWenquan Wang/ Liang Liu23783Oral SessionThursday, September 11, 202516:20 - 16:35PM HKTUpdated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao22652Poster SessionSurufatinib in patients with soft tissue myeloma who have failed first-line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical studyYuhong Zhou/ Xi GuoP80Poster SessionEfficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S-1) in Advanced Pancreatic Cancer Patients with Liver MetastasisGuanghai Dai/ Ru Jia22309AbstractA Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer: Data UpdateCaixia Wang23679AbstractEfficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinomaXuetao Shi/ Jingtao Zhong24133AbstractEfficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective StudyJiang Long24294Abstract About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib, savolitinib and HMPL-653, the further clinical development for fruquintinib, surufatinib, savolitinib and HMPL-653, its expectations as to whether any studies on fruquintinib, surufatinib, savolitinib and HMPL-653 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib, savolitinib and HMPL-653, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib, savolitinib and HMPL-653 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

临床2期免疫疗法临床结果临床1期上市批准

2025-09-04

·香港证券交易所

自願性公告 - 和黃醫藥將於2025年世界肺癌大會和中國臨床腫瘤學會2025年年會公佈數據

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 HUTCHMED (China) Limited 和黃醫藥（中國）有限公司（於開曼群島註冊成立的有限公司）（股份代號：13）自願性公告和黃醫藥將於2025年世界肺癌大會和中國臨床腫瘤學會2025年年會公佈數據和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「HUTCHMED」）今日宣佈將於2025年9月6日至9日在西班牙巴塞羅那召開的2025年世界肺癌大會（WCLC），以及2025年9月10至14日在中國濟南召開的中國臨床腫瘤學會（「CSCO」）2025年年會上公佈和黃醫藥自主研發的化合物的數項研究的最新及更新後的數據。賽沃替尼用於治療非小細胞肺癌的SACHI研究、SAVANNAH研究以及一項IIIb期驗證性研究的最新分析結果將於 2025年世界肺癌大會公佈。賽沃替尼是一種強效、高選擇性的口服MET酪氨酸激酶抑制劑（「TKI」），由阿斯利康與和黃醫藥共同開發，並由阿斯利康商業化。2025年世界肺癌大會的報告詳情如下： |公司申辦的研究|Col2|Col3| |---|---|---| |SAVANNAH研究: EGFR突變MET過表達和/或擴增的非小細胞肺癌患者中生物標誌物一致性和獲得性耐藥 SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLC|Christina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USA|MA03.03 迷你口頭報告 | Mini Oral: New Advances in Circulating Biomarkers Room 06 2025年9月7日 (星期日) 下午3:15 - 4:30 歐洲中部夏令時間| |賽沃替尼治療既往接受過或未接受過免疫治療的MET外顯子14跳變晚期或轉移性非小細胞肺癌患者的療效與安全性 Efficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior Immunotherapy|虞永峰，上海胸科醫院，中國上海|P3.12.48 海報展示 | Poster: Metastatic NSCLC ‒ Targeted Therapy 2025年9月9日 (星期二)| |第三代EGFR-TKI治療失敗後MET擴增的非小細胞肺癌一線治療持續時間: SACHI研究的洞見 Frontline Treatment Duration in MET-Amplified NSCLC After Third- Generation EGFR-TKI Failure: SACHI Study Insights|陳利娟，鄭州大學附屬腫瘤醫院，河南省腫瘤醫院，中國鄭州|P3.12.64 海報展示 | Poster: Metastatic NSCLC ‒ Targeted Therapy 2025年9月9日 (星期二)| |奧希替尼及賽沃替尼治療EGFR突變伴MET過表達和/或奧希替尼治療後進展的晚期非小細胞肺癌: SAVANNAH研究的患者報告結果 Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROs|Silvia Novello, University of Turin, San Luigi Hospital, Turin, Italy|PT2.12.04 電子壁報 | ePoster: Metastatic NSCLC ‒ Targeted Therapy 2025年9月8日 (星期一)| HMPL-653（一種新型、選擇性、強效的CSF-1R抑制劑）在中國腱鞘巨細胞瘤患者中開展的首個人體I期臨床試驗數據將於2025年CSCO年會上首次公佈。 CSCO 2025年年會報告詳情如下： |研究者發起的研究|Col2|Col3| |---|---|---| |呋喹替尼聯合斯魯利單抗用于一線治療轉移性或不可切除的非透明細胞腎細胞癌: 一項單臂、多中心臨床試驗的最新療效和安全性結果 Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm Trial|黃吉煒/ 薛蔚|23258 口頭報告 | Oral Session 2025年9月11日 (星期四) 下午16:50 - 17:15 中國時間| |呋喹替尼加卡瑞利珠單抗聯合紫杉醇脂質體和奈達鉑作為晚期食道鱗狀細胞癌的一線治療: 一項單臂II期臨床試驗的數據更新 Fruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trial|邱天竹/ 顧艷宏|23766 口頭報告 | Oral Session 2025年9月12日 (星期五) 中午11:20 - 12:00 中國時間| |呋喹替尼聯合化療作為轉移性結直腸癌的二線治療: 一項多中心、開放標籤、II期臨床試驗 Fruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trial|陳永順|22084 壁報交流 | Poster Session| |呋喹替尼聯合特瑞普利單抗和短程放療用於局部晚期直腸癌新輔助治療的II 期臨床試驗: 一項II期臨床試驗的最新療效和安全性結果 Efficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical Trial|李志平|21915 論文摘要 | Abstract| |呋喹替尼聯合化療作為晚期轉移性結直腸癌的一線治療: 利用傾向評分匹配比較前瞻性單臂隊列與回顧性觀察性隊列的療效 Fruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score-matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohort|周福祥|23550 論文摘要 | Abstract| |摘要標題|報告人/ 主要作者|報告詳情| |---|---|---| |呋喹替尼聯合PD-1抑制劑和西達本胺用於治療微衛星穩定型(MSS)轉移性結直腸癌的療效和安全性: 與真實世界貝伐珠單抗聯合抗 PD-1和西達本胺組的比較 Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm|苟苗苗|23591 論文摘要 | Abstract| |索凡替尼聯合吉西他濱和順鉑加度伐利尤單抗/帕博利珠單抗方案治療晚期膽管癌的II期臨床試驗 Phase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer|苟苗苗|23610 口頭報告 | Oral Session 2025年9月12日 (星期五) 下午16:53 - 16:59 中國時間| |索凡替尼聯合KN046和吉西他濱、白蛋白紫杉醇作為不可切除晚期胰腺癌一線治療的單臂、Ib/II期臨床研究 A single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancer|王文權/ 劉亮|23783 口頭報告 | Oral Session 2025年9月11日 (星期四) 下午16:20 - 16:35 中國時間| |索凡替尼聯合動脈栓塞術對比索凡替尼單藥用於治療伴肝轉移的神經內分泌瘤的最新結果: 一項前瞻性、隨機、對照研究 Updated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trial|曹丹|22652 壁報交流 | Poster Session| |索凡替尼治療一線標準化療失敗或安羅替尼治療失敗的軟組織肉瘤患者: 一項多中心、前瞻性、雙隊列、Ⅱ期臨床研究 Surufatinib in patients with soft tissue myeloma who have failed first- line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical study|周宇紅/ 郭曦|P80 壁報交流 | Poster Session| |NASCA方案 (索凡替尼聯合卡瑞利珠單抗、白蛋白結合型紫杉醇和S-1) 治療伴肝轉移的晚期胰腺癌患者的療效和機制研究 Efficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S-1) in Advanced Pancreatic Cancer Patients with Liver Metastasis|戴廣海/ 賈茹|22309 論文摘要 | Abstract| |索凡替尼聯合賽帕利單抗和白蛋白結合型紫杉醇治療晚期三陰性乳癌的 II 期單臂研究: 數據更新 A Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer: Data Update|王彩霞|23679 論文摘要 | Abstract| |索凡替尼聯合吉西他濱與順鉑和免疫檢查點抑制劑用于治療不可切除的局部晚期或轉移性肝內膽管癌的療效與安全性 Efficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma|石學濤/ 鐘敬濤|24133 論文摘要 | Abstract| |索凡替尼治療神經內分泌腫瘤患者的療效和安全性: 一項多中心回顧性研究 Efficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective Study|龍江|24294 論文摘要 | Abstract| 關於和黃醫藥和黃醫藥（納斯達克/倫敦證交所：HCM ；香港交易所：13）是一家處於商業化階段的創新型生物醫藥公司，致力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。自成立以來，和黃醫藥致力於將自主發現的候選藥物帶向全球患者，首三個藥物現已在中國上市，其中首個藥物亦於美國、歐洲和日本等全球各地獲批。欲了解更多詳情，請訪問：www.hutch-med.com或關注我們的LinkedIn專頁。前瞻性陳述本公告包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對呋喹替尼、索凡替尼、賽沃替尼和HMPL-653的治療潛力的預期，呋喹替尼、索凡替尼、賽沃替尼和HMPL-653的進一步臨床研究計劃，對呋喹替尼、索凡替尼、賽沃替尼和HMPL-653的研究是否能達到其主要或次要終點的預期，以及對此類研究完成時間和結果發佈的預期。此類風險和不確定性包括下列假設：入組率、滿足研究入選和排除標準的受試者的時間和可用性；臨床方案或監管要求變更；非預期不良事件或安全性問題；呋喹替尼、索凡替尼、賽沃替尼和HMPL-653（包括作為聯合療法）達到研究的主要或次要終點的療效；獲得不同司法管轄區的監管批准及獲得監管批准後獲得上市許可；呋喹替尼、索凡替尼、賽沃替尼和HMPL-653用於目標適應症的潛在市場，以及資金充足性等。此外，由於部分研究可能依賴於與其他藥物聯合使用，因此此類風險和不確定性包括有關這些治療藥物的安全性、療效、供應和監管批准的假設。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本公告發佈當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會、香港聯合交易所有限公司以及AIM提交的文件。無論是否出現新訊息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本公告所含訊息的義務。醫療信息本公告所提到的産品可能並未在所有國家上市，或可能以不同的商標進行銷售，或用於不同的病症，或採用不同的劑量，或擁有不同的效力。本文中所包含的任何信息都不應被看作是任何處方藥的申請、推廣或廣告，包括那些正在研發的藥物。承董事會命非執行董事兼公司秘書施熙德香港，2025年9月5日於本公告日期，本公司之董事為：主席兼非執行董事：非執行董事：艾樂德博士施熙德女士楊凌女士執行董事：獨立非執行董事：蘇慰國博士莫樹錦教授（首席執行官兼首席科學官）（高級兼首席獨立非執行董事）鄭澤鋒先生言思雅醫生（代理首席執行官兼首席財務官）胡朝紅博士黃德偉先生

CSCO会议临床结果临床3期

2025-08-29

·江苏康宁杰瑞生物制药有限公司

康宁杰瑞公布2025年中期业绩及近期业务进展

2025年8月29日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）公布了截至2025年6月30日的2025年中期业绩和近期业务进展。财务概览 2025年上半年公司实现营业收入319.44百万元人民币，同比增长84.05%。其中归属于本公司的产品收入67.02百万元人民币。 2025年上半年研发开支253.16百万元人民币，同比增长30.14%。 2025年上半年期内利润21.58百万元人民币，2024年同期亏损人民币44.90百万元人民币，同比扭亏为盈。财务状况安全稳健，截至2025年6月30日现金储备为1,644.79百万元人民币。业务摘要产品管线公司依托自主研发的创新技术平台，构建了具有差异化创新和国际竞争力的产品矩阵，覆盖抗体偶联药物（ADC）、双抗及单域抗体等前沿领域：其中1个产品KN035（全球首个皮下注射PD-(L)1抑制剂，恩沃利单抗注射液，商品名：恩维达®）已于2021年在中国获批上市，为患者提供了更为安全和便捷的肿瘤免疫疗法；多个双抗和双抗ADC项目在临床研究阶段，并且快速推进以双抗ADC和双载荷ADC为主的临床前管线。 KN035 恩沃利单抗，恩维达® 一种创新抗肿瘤免疫治疗药物，是全球首个获批上市的皮下注射PD-(L)1抑制剂、中国首个泛瘤种免疫治疗药物、首个国产PD-L1药物。在有效性、安全性、便利性和依从性等方面具有独特优势，尤其适用于体弱、高龄及有静脉输注反应的患者，极大地节省医疗资源。恩沃利单抗共获得国内16部权威指南共识的高度认可；获国家药品监督管理局（NMPA）药品审评中心（CDE）授予突破性疗法认定，用于既往标准治疗失败且无满意替代治疗的高肿瘤突变载荷（TMB-H）不可切除或转移性实体瘤。报告期内主要进展 2025年6月，恩沃利单抗3项单药或联合用药的Ⅱ期临床研究数据在美国临床肿瘤学会（ASCO）年会上以壁报形式发布，同时另有8项研究数据在线发表。 KN026 HER2异二聚体双抗，可同时结合HER2的两个非重叠表位，阻断HER2信号。相比于曲妥珠单抗和帕妥珠单抗联用，KN026针对HER2阳性肿瘤细胞有更强的抑制杀伤；另外KN026对于曲妥珠单抗抗性细胞株也有抑制作用。多项不同阶段临床研究表明，在经过包括抗HER2在内的多线治疗后进展的HER2阳性乳腺癌和胃癌患者中，KN026仍然表现出显著的抗肿瘤活性。KN026联合化疗用于一线标准治疗失败的HER2阳性胃癌（包括胃-食管结合部癌）已获CDE授予突破性疗法认定。报告期内主要进展 2025年1月，KN026联合多西他赛一线治疗HER2阳性复发或转移性乳腺癌的Ⅱ期临床研究结果在Cancer Communications全文发表。 2025年3月，KN026联合KN046治疗除乳腺癌之外的HER2阳性实体瘤的Ⅱ期研究结果在Signal Transduction and Targeted Therapy全文发表。 2025年4月，KN026联合化疗二线及以上治疗HER2阳性胃癌（包括胃食管结合部癌）的Ⅱ/Ⅲ期临床研究完成首次期中分析，达到预先设定的无进展生存期（PFS）的主要终点，具有统计学显著性和临床意义，并具有总生存期（OS）获益趋势。 2025年4月，KN026联合白蛋白结合型多西他赛HB1801一线治疗HER2阳性复发转移性乳腺癌的Ⅲ期临床研究完成全部患者入组。 2025年6月，KN026联合KN046治疗HER2阳性乳腺癌的Ⅱ期研究结果在Clinical Cancer Research全文发表。 KN026联合白蛋白结合型多西他赛HB1801用于HER2阳性早期或局部晚期乳腺癌的新辅助治疗Ⅲ期临床研究正在顺利进行中。报告期后进展 2025年7月，KN026一线治疗HER2阳性胃癌/胃食管结合部癌的Ⅲ期临床研究IND申请获CDE受理。 2025年7月，KN026联合化疗二线及以上治疗HER2阳性胃癌/胃食管结合部癌Ⅲ期临床研究首次期中分析结果数据获欧洲肿瘤内科学会（ESMO）大会接受，将于10月会议期间发布。 2025年预期里程碑 KN026联合化疗二线及以上治疗HER2阳性胃癌/胃食管结合部癌的适应症在国内申报上市。 KN026联合白蛋白结合型多西他赛HB1801用于HER2阳性早期或局部晚期乳腺癌新辅助治疗Ⅲ期临床研究完成全部患者入组。 JSKN003 公司利用领先的糖基定点偶联平台，基于KN026开发的双抗ADC。JSKN003结合肿瘤细胞表面的HER2，通过细胞内吞释放拓扑异构酶Ⅰ抑制剂，进而发挥抗肿瘤作用。较同类ADC药物，JSKN003具有更好的血清稳定性、更强的旁观者杀伤效应，有效地扩大了治疗窗。在中国和澳大利亚进行的多项不同阶段的临床研究显示了JSKN003良好的安全性。在接受过多线抗肿瘤治疗的多种晚期实体瘤患者中，尤其是在铂耐药卵巢癌、HER2表达的乳腺癌以及HER2高表达的其他实体瘤患者中疗效明显。报告期内主要进展 2025年2月，获CDE同意开展JSKN003对比恩美曲妥珠单抗（T-DM1）二线及以上治疗HER2阳性晚期乳腺癌的Ⅲ期临床研究，并于当月完成首例患者给药，目前正在顺利进行中。 2025年2月，JSKN003对比研究者选择化疗治疗铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌的Ⅲ期临床研究完成首例患者给药，目前正在顺利进行中。 2025年3月，JSKN003获CDE突破性疗法认定，用于治疗铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌，且不限HER2表达水平。 2025年6月，JSKN003在澳大利亚Ⅰ期临床研究和中国Ⅰ/Ⅱ期临床研究中治疗非原发性铂难治的铂耐药卵巢癌、多线治疗后进展的HER2阳性乳腺癌以及晚期HER2高表达（IHC 3+）胃肠道肿瘤的疗效与安全性的三项汇总分析结果在2025年ASCO年会上发布。 2025年6月，JSKN003的一项临床前研究结果在RSC Chemical Biology全文发表。 JSKN003治疗不可切除局部晚期或转移性HER2低表达乳腺癌的Ⅲ期临床研究顺利进行中。 JSKN003联合KN026、免疫（IO）及化疗一线和围手术期治疗HER2阳性胃癌/胃食管结合部癌的Ⅱ期临床研究已启动，目前正在顺利进行中。多个探索性Ⅱ期临床研究进行中。报告期后进展 2025年7月，JSKN003获美国食品药品监督管理局（FDA）授予孤儿药资格认定（ODD），用于治疗胃癌及胃食管结合部癌。 2025年7月，JSKN003获FDA批准在美国开展一项Ⅱ期临床研究，用于治疗铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌，且不限HER2表达水平。 2025年7月，JSKN003治疗原发性铂难治卵巢癌和HER2阳性转移性结直肠癌的两项最新临床研究数据，以及对比研究者选择化疗治疗铂耐药卵巢癌的研究设计获ESMO大会接受，将于10月会议期间发布。 2025年预期里程碑 JSKN003对比恩美曲妥珠单抗（T-DM1）二线及以上治疗HER2阳性晚期乳腺癌的Ⅲ期临床研究完成全部患者入组。向CDE申请1项注册临床研究。向CDE申请1项适应症的突破性疗法认定。 JSKN016 公司利用单域抗体发现和糖基定点偶联平台开发的，靶向HER3与TROP2的双抗ADC。TROP2和HER3在多种实体瘤过表达，JSKN016通过结合这两个肿瘤抗原，引起内吞和旁观者效应杀伤肿瘤细胞，比TROP2/HER3单抗ADC有更强的疗效。JSKN016也更能够克服肿瘤异质性导致的耐药。报告期内主要进展 JSKN016单药在HER2阴性乳腺癌中的队列扩展临床研究已完成入组。 2025年3月，JSKN016联合化疗/免疫，一线及后线治疗HER2阴性乳腺癌的Ⅱ期临床研究IND申请获得CDE批准。目前联合化疗后线治疗HER2阴性乳腺癌的剂量优化正在进行中。 JSKN016单药在非小细胞肺癌多个队列中疗效、安全性探索和剂量优化的Ⅱ期临床研究进行中。截至目前EGFR突变的二线和三线队列已完成入组。 2025年3月，JSKN016联合化疗/免疫/TKI，一线及后线治疗非小细胞肺癌的Ⅱ期临床研究IND申请获得CDE批准。截至目前多个队列已完成剂量确认。 JSKN016在中国晚期恶性实体瘤患者中开展的Ⅰ期临床研究顺利进行中。 2025年预期里程碑启动JSKN016联合免疫及化疗一线治疗野生型非小细胞肺癌患者入组。向CDE申请1-2项注册临床研究。向CDE申请1-2项适应症的突破性疗法认定。发布HER2阴性乳腺癌相关临床数据。 JSKN033 公司自主研发的抗体偶联药物和免疫检查点抑制剂的高浓度复方制剂，可皮下注射给药。JSKN033是全球首个进入临床的皮下给药ADC药物。JSKN033将免疫疗法（KN035）与ADC（JSKN003）相结合，极大地提升疗效；同时也提高了安全性和便捷性。报告期内主要进展 2025年1月，JSKN033治疗晚期转移性恶性肿瘤的中国Ⅰ/Ⅱ期临床研究完成首例患者给药。目前已完成爬坡，正在进行队列扩展。该研究为优化创新药临床试验审评审批试点项目。 JSKN033治疗HER2突变/有表达的非小细胞肺癌Ⅱ期临床研究已启动。 JSKN033治疗HER2表达晚期或转移性实体瘤的澳大利亚Ⅰ/Ⅱ期临床研究已完成爬坡。 2025年预期里程碑向CDE申请联合化疗的Ⅱ期临床研究。 JSKN022 一种全球首创的双靶点ADC，同时靶向PD-L1和整合素αvβ6。公司以自主研发的恩沃利单抗（Envafolimab）为基础，创新性地将免疫（IO）机制与ADC技术相结合。该药物采用糖基定点偶联技术，提高了稳定性和均一性。通过可裂解连接子将拓扑异构酶Ⅰ抑制剂T01精准偶联至抗体上，提高疗效。JSKN022有望为PD-1/PD-L1抑制剂耐药或治疗无效的癌症患者提供全新的治疗选择。报告期内主要进展 2025年4月，JSKN022临床前研究数据在2025年美国癌症研究协会（AACR）年会上发布。临床前数据显示，JSKN022在体外和体内模型中，对整合素αvβ6和/或PD-L1表达阳性的肿瘤细胞具有显著的抗肿瘤活性。报告期后进展 2025年8月，JSKN022针对标准治疗失败的晚期实体瘤的Ⅰ期临床研究申请获CDE受理。 2025年预期里程碑 JSKN022针对标准治疗失败的晚期实体瘤的中国Ⅰ期临床研究完成首例患者给药。 KN046 一种双特异性（BsAb）免疫检查点抑制剂，由 CTLA-4与PD-L1单域抗体融合组成，可靶向富集于PD-L1表达的肿瘤微环境。KN046已在中国、美国及澳大利亚开展多项临床研究。报告期内主要进展 2025年2月，KN046联合仑伐替尼治疗晚期不可切除或转移性肝细胞癌的Ⅱ期临床研究结果在Nature Communications全文发表。早期研发公司以糖基定点偶联、连接子载荷、双载荷偶联、双特异性抗体等创新平台技术为基础，开发了具有国际竞争力的ADC、双抗等药物。公司研发的双特异性抗体偶联药物（BADC）和双特异性抗体双毒素偶联药物（BADDC），不仅提高了肿瘤靶向精准性，还有效应对了肿瘤异质性和耐药问题，提供了全新的治疗策略。目前，公司有多个双抗ADC创新分子在临床前开发阶段，将陆续进入临床。 2025年4月，EGFR/HER3双抗双载荷ADC药物JSKN021临床前研究数据在2025年AACR年会上发布。临床前研究表明，JSKN021具有优异的稳定性，其双毒素载荷设计可有效应对肿瘤异质性，肿瘤抑制效果显著优于单载荷ADC。 2025年预期里程碑 JSKN027：向CDE递交IND申请。 JSKN021：申请澳洲Ⅰ期临床研究。生产基地公司产业化基地按照中国国家药品监督管理局（NMPA）、美国食品药品监督管理局（FDA）及欧洲药品管理局（EMA）的GMP标准建设，现有产能满足临床至商业化阶段的规模化生产需求。2024年新建的ADC原液和制剂车间已正式投产。有关上述内容的更多信息，请参阅公司在香港联交所及公司官网上发布的截至2025年6月30日止六个月中期业绩公告。康宁杰瑞是一家以创新驱动、聚焦肿瘤治疗领域的生物制药公司。2019年12月12日，公司在香港联交所主板上市（股票代码：9966.HK）。康宁杰瑞依托自主研发的单域抗体、双特异性抗体、糖基定点偶联、连接子载荷、双载荷抗体偶联及大分子药物高浓度皮下制剂等核心技术平台，构建了具有差异化创新和国际竞争力的产品矩阵，覆盖抗体偶联药物（ADC）、双抗及单域抗体等前沿领域。公司已有1个产品获批上市（恩沃利单抗注射液KN035，商品名：恩维达®，全球首个皮下注射PD-(L)1抑制剂），在肿瘤治疗的便捷性和可及性上做出了重大突破。此外，公司有多个双抗和双抗ADC项目在临床研究阶段，并且快速推进以双抗ADC和双载荷ADC为主的临床前管线。公司已与石药集团、ArriVent、Glenmark等合作方达成多项针对产品或技术平台的战略合作。 “康达病患，瑞济万家”。康宁杰瑞致力于解决未满足的临床需求，不断努力，开发高效、安全、具有全球竞争优势的抗肿瘤药物，以“中国智造”的抗癌方案惠及全球患者。欢迎访问公司网站：www.alphamabonc.com 前瞻性陈述本新闻稿包含与我们未来业务、财务表现和涉及康宁杰瑞未来事件相关的声明，这些声明或构成前瞻性陈述。此类陈述包括预测和估计及关联的基本假设、有关潜在可能性的计划和期望的陈述，以及有关未来活动、运营及表现的陈述。这些陈述或可用诸如"预期"、"期待"、"预计"、"打算"、"计划"、"相信"、"寻求"、"估计"、"将"或类似含义的词语来标识。此类陈述基于康宁杰瑞管理和业务运营的当前某些假设，且受包括但不限于政治、经济、法律环境和商业环境等多种风险和不确定性的影响，康宁杰瑞的实际经营结果、表现或业绩可能较相关前瞻性陈述中明确或暗含的描述呈现（正面或负面）变化。除适用法律的要求外，无论出于新信息、未来事件还是其他原因，康宁杰瑞均无义务公开更新任何前瞻性陈述，且不为无法实现该等前瞻性陈述而承担责任。医药信息声明康宁杰瑞不推荐任何已获批或正在研发的药品/适应症临床使用，本文所包含的任何信息不应被看作是任何药物的申请、推广或广告。

ASCO会议突破性疗法财报抗体药物偶联物临床2期

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的药物交易

登录后查看更多信息

研发状态

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
HER2阳性胃食管交界处癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-10-27
晚期胰腺导管腺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-01-20
晚期非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2021-10-11
鳞状非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2020-09-14
转移性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
转移性微卫星稳定结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
HER2阳性胆道肿瘤	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
HER2阳性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
不能切除的胆道癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
结肠癌肝转移	临床2期	中国	浙江瑞臻医药有限公司	2023-04-27

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


NCT04542837 (Pubmed) 人工标引	临床2期	肝细胞癌	55	KN046 + Lenvatinib	醖襯築積窪網醖選膚願(鹹製選簾範蓋醖醖築製) = 壓鬱襯願艱網壓願廠窪鬱簾淵築憲衊艱願糧網 (鹽選廠顧餘蓋鑰選餘鑰, 31.97 ~ 59.45) 更多	积极	2025-02-07
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥1%))	鑰製廠襯鑰廠顧醖獵膚(膚廠鹽壓齋遞獵醖繭夢) = 繭積淵廠窪獵鬱憲廠醖獵積網觸築襯鹹廠醖觸 (膚齋襯壓鹹觸製糧襯壓, 38.8 ~ 69.6) 更多	积极	2024-12-12
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥50%))	鑰製廠襯鑰廠顧醖獵膚(膚廠鹽壓齋遞獵醖繭夢) = 遞齋獵選繭鹽齋鹽醖餘獵積網觸築襯鹹廠醖觸 (膚齋襯壓鹹觸製糧襯壓, 38.4 ~ 88.2) 更多	积极	2024-12-12
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	KN046+白蛋白紫杉醇+吉西他滨	選衊膚鬱願襯遞壓壓鹽(願願艱齋構築襯選壓膚) = 未达到预设的统计学终点膚構鑰範艱鬱觸選醖蓋 (遞襯鏇製製鏇選積鹹繭 ) 未达到	不佳	2024-05-28
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	安慰剂+白蛋白紫杉醇+吉西他滨		不佳	2024-05-28
NCT04925947 (CTgov)	临床2期	胸腺癌	4	KN046	構襯艱鹹鬱鹽選製鹹淵 = 餘繭齋願廠願糧鏇鹽範鹽鏇築網鏇蓋網憲願糧 (鹹積廠遞獵鹽築鹹獵鹹, 製繭襯衊獵願鹹繭齋醖 ~ 衊衊淵糧構獵選鏇鑰膚) 更多	-	2024-04-16
NCT04054531 (Cell Rep Med) 人工标引	临床2期	转移性非小细胞肺癌一线	-	KN046+chemotherapy	衊顧範觸鏇醖簾窪獵齋(糧鹹壓糧鬱憲積蓋衊鑰) = 網鏇簾繭簾構鏇願網繭醖積範鹽壓膚網廠齋鑰 (觸鏇製繭齋夢繭艱鹽鑰 ) 更多	积极	2024-03-19
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel	觸壓繭膚選範衊膚窪餘(簾窪範網構憲範壓衊遞) = 築窪廠鏇鏇壓壓鏇壓淵餘顧獵構襯襯夢簾簾繭 (觸衊憲範糧鹽鏇鏇簾蓋, 24.4 ~ 65.1) 更多	积极	2024-02-03
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel (PD-L1 positive)	齋餘鹹鏇遞鹽齋顧願廠(醖積築製願製築廠觸醖) = 鬱繭願壓鹽壓蓋觸艱獵淵膚糧製觸艱製鏇築夢 (壓築製築範廠廠餘醖鬱 ) 更多	积极	2024-02-03
NCT03733951 \| NCT03838848 (KN046-201, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	转移性非小细胞肺癌	31	KN046	壓顧蓋壓觸憲壓範獵觸(鬱蓋憲膚網齋膚蓋膚簾) = 憲窪膚糧壓獵範艱鹽範壓積窪餘鏇築範廠積願 (範鹽醖築觸繭積窪範遞, 0.1 ~ 16.7) 更多	积极	2023-10-23
NCT03838848 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	转移性非小细胞肺癌 EGFR L858R \| EGFR Exon 19 Deletion	26	KN046 5 mg/kg + Pemetrexed 500 mg/m2+carboplatin AUC5	構鑰顧淵糧壓夢襯醖顧(窪構顧繭積憲顧鏇築積) = 製衊鬱簾糧壓醖膚鑰繭觸繭鏇齋範積積選憲範 (築選齋願範糧範簾艱獵, 11.6 ~ 47.8) 更多	积极	2023-10-23
NCT05420220 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	非小细胞肺癌一线 PD-L1 expression	22	KN046 5mg/kg + Axitinib 5mg	窪夢鑰憲遞鹽積顧窪夢(選顧顧餘醖餘鏇餘鏇淵) = 蓋壓願淵鹽鏇膚醖積遞選鏇遞糧網製鹽壓鬱繭 (襯網鹽鬱餘鏇窪積構衊 ) 更多	积极	2023-10-23
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046	簾壓製鬱窪繭鏇廠衊齋(獵構膚選膚餘繭積夢襯) = 廠窪夢蓋壓衊膚淵鹽艱窪廠觸餘獵獵繭網願膚 (淵繭膚構願襯鹹糧觸鏇, 6.8 ~ 30.7) 更多	积极	2023-10-21
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046 (PD-L1-positive)	簾壓製鬱窪繭鏇廠衊齋(獵構膚選膚餘繭積夢襯) = 遞鹹願壓構衊鹽鹽衊範窪廠觸餘獵獵繭網願膚 (淵繭膚構願襯鹹糧觸鏇 ) 更多	积极	2023-10-21