EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersMouth and Tooth Diseases+ [7]

Active Indication

Metastatic Esophageal Squamous Cell CarcinomaOesophageal squamous cell carcinoma recurrentNasopharyngeal Carcinoma+ [68]

Inactive Indication-

Originator Organization

Systimmune, Inc.

Sichuan Baili Pharmaceuticals Co.,Ltd

Active Organization

Baili Bio Chengdu Pharmaceutical Co. Ltd.

Systimmune, Inc.

Bristol Myers Squibb Co.

+ [3]

Inactive Organization-

License Organization

Sichuan Biokin Pharmaceutical Co., Ltd.

Bristol Myers Squibb Co.

Shanghai Maibang Biotechnology Co. Ltd.

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

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Sequence Code 43254

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Sequence Code 10172664

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Clinical Trials associated with Izalontamab Brengitecan

NCT07382726

/ Not yet recruitingPhase 1IIT

Combination Of Izalontamab Brengitecan And Adagrasib In Advanced KRAS G12Ci-Refractory Non-Small Cell Lung Cancer - The IZA-A Trial

This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't responded to other treatments. The purpose is to see if this combination works better than existing treatments for people whose cancer keeps growing despite KRAS G12C inhibitors.

Start Date01 Jul 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07307053

/ Not yet recruitingPhase 1/2IIT

An Open-Label, Single-Arm, Phase I/II Platform Trial of Innovative Therapies and Technologies Primarily in Rare Tumors in China (PLATFORM2) in Patients With Advanced Solid Tumors

The goal of this Phase I/II observational and interventional platform study is to evaluate the safety and efficacy of multiple types of innovative anti-tumor drugs and new technologies in patients with rare solid tumors. The study utilizes multi-dimensional precision screening (including WES, RNAseq, mIHC, and quantitative proteomics) to match patients with specific sub-protocols.
Key questions it aims to answer:
Assess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.

Start Date01 Jan 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

NCT07100080

/ RecruitingPhase 2/3

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

Start Date05 Nov 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Izalontamab Brengitecan

100 Translational Medicine associated with Izalontamab Brengitecan

100 Patents (Medical) associated with Izalontamab Brengitecan

Literatures (Medical) associated with Izalontamab Brengitecan

01 Jan 2026·Nature Reviews Clinical Oncology

Iza-bren shows promise in recurrent or metastatic nasopharyngeal carcinoma

Article

Author: Romero, Diana

01 Dec 2025·Translational Lung Cancer Research

A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II–IIIB non-small cell lung cancer patients with EGFR mutation

Article

Author: Yang, Wenjie ; Chen, Yue ; Peng, Zhiyu ; Pu, Qiang ; Li, Chuan ; Mei, Jiandong ; Zhang, Benxia ; Gao, Ge ; Liu, Chengwu ; Wang, Yongsheng ; Li, Yanying ; Liu, Lunxu ; Gan, Fanyi

Background:

Current neoadjuvant strategies for resectable epidermal growth factor receptor (EGFR)-mutation non-small cell lung cancer (NSCLC) yield suboptimal pathological responses, highlighting an unmet need for biologically targeted approaches. This study aimed to evaluate the effectiveness and safety of neoadjuvant BL-B01D1, a first-in-class EGFR/human EGFR 3 (HER3) bispecific antibody-drug conjugate combined with aumolertinib, a third EGFR-tyrosine kinase inhibitor, in individuals with resectable stage II-IIIB NSCLC harboring EGFR mutation.

Methods:

This phase II, open-label, non-controlled, single-arm, dose escalation and dose expansion study will recruit 40 stage II-IIIB resectable NSCLC patients with EGFR mutation. The study will evaluate the efficacy and safety of neoadjuvant therapy combining BL-B01D1 with aumolertinib prior to surgery and aumolertinib adjuvant treatment post-surgery. The primary endpoint is pathological complete response and major pathological response at the time of resection. Secondary end points include objective response rate, event-free survival, disease-free survival, overall survival, and R0 resection rate in the neoadjuvant setting. Safety, tolerability and biomarkers will also be assessed.

Discussion:

This protocol describes the methodology of study in order to identify neoadjuvant therapy of BL-B01D1 and aumolertinib for resectable stage II-IIIB NSCLC with EGFR mutation.

Trial Registration:

Clinicaltrials.gov identifier: NCT06951464. Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.

10 Nov 2025·JOURNAL OF CLINICAL ONCOLOGY

Efficacy and Safety of BL-B01D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: A Phase II Clinical Trial

Article

Author: Liu, Nan ; Cao, Manming ; Yu, Zhixian ; Hu, Changlu ; Fu, Bin ; Bian, Xiaojie ; Yin, Huaqi ; Qin, Yang ; Lin, Jing ; Zhu, Hai ; Hu, Bin ; Ye, Dingwei ; Zhang, Qingyun ; Zhang, Xuepei ; Chen, Yu ; Yao, Kai ; Xiao, Sa ; Zhu, Yi ; Wang, Xiaolin ; Sun, Zhongquan ; Yang, Tiejun ; Jiang, Shusuan

PURPOSE:

To evaluate the efficacy and safety of BL-B01D1, a potential first-in-class epidermal growth factor receptor (EGFR)–human EGFR 3 bispecific antibody-drug conjugated (ADC) with Ed-04, in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) refractory to standard or regular therapies.

METHODS:

BL-B01D1-201 is a multicenter, single-arm, phase II study of BL-B01D1 in patients with la/mUC who have progressed on systemic therapy. Patients received BL-B01D1 at a dose of 2.2, 2.5, or 2.75 mg/kg intravenously over approximately 60 minutes on days 1 and 8 once every 3 weeks. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and safety.

RESULTS:

A total of 41 patients were enrolled, 34 in 2.2 mg/kg, four in 2.5 mg/kg, and three in the 2.75 mg/kg group. In the 2.2 mg/kg group, the confirmed ORR was 44.1% (95% CI, 27.2 to 62.1) and the DCR was 88.2% (95% CI, 72.5 to 96.7). Among 15 patients who had received only one previous line of chemotherapy (either platinum-based or ADCs), the confirmed ORR achieved 80% (95% CI, 51.9 to 95.7). With a median follow-up of 10.2 months, the median PFS was 7.3 months (95% CI, 5.5 to 9.8) and the median DOR was 11.3 months (95% CI, 4.3 to not reached). The most common treatment-related adverse events (all grade/≥grade 3) were anemia (88.2%/38.2%), leukopenia (76.5%/38.2%), neutropenia (64.7%/41.2%), thrombocytopenia (64.7%/32.4%), appetite decrease (52.9%/2.9%), and nausea (52.9%/2.9%).

CONCLUSION:

BL-B01D1 showed promising preliminary efficacy and a favorable safety profile at 2.2 mg/kg in patients with la/mUC who had progressed after systemic therapy. These results suggest that BL-B01D1 could be a promising new agent for patients with la/mUC with few treatment options.

News (Medical) associated with Izalontamab Brengitecan

22 Oct 2025

·www.prnewswire.com

Largest Milestone Payment Secured: Biokin, a Rising Chinese Pharmaceutical MNC

BEIJING, Oct. 22, 2025 /PRNewswire/ -- In October 2025, a partnership between Biokin—a rising star in China's innovative pharmaceutical sector—and global pharmaceutical leader BMS triggered a $250 million milestone payment. This is believed to be the largest antibody-drug conjugate (ADC) milestone payment among hundreds of out-licensing deals involving Chinese innovative drugs. Notably, the overall transaction had previously set a record for the total value of a single-drug asset license in China. Continue Reading iza-bren, a potential first-in-class ADC comprised of an EGFR x HER3 bispecific antibody conjugated In recent years, China's dynamic pharmaceutical ecosystem has rapidly emerged as one of the world's leading sources of novel drug molecules. Such collaborations, however, often come with uncertainties in both China and the U.S. Following the $800 million upfront payment received in early 2024, Biokin's partnership with BMS has advanced smoothly once again. This progress has prompted skeptics to recognize iza-bren's blockbuster potential. The momentum behind the collaboration stems from the continued validation of iza-bren's efficacy. At the 2025 World Congress on Lung Cancer (WCLC), after Dr. Fang Wenfeng presented domestic clinical data, a physician from the prestigious MD Anderson Cancer Center in the U.S. approached him, expressing hope the drug would launch in the U.S. as soon as possible. Such a conversation would have been unimaginable in the past. Despite remarkable progress of China's biopharmaceutical industry over the past decade, nearly all first-in-class new drugs still originate from Western countries. While China has accelerated efforts to bring in overseas innovations, it has also strongly supported domestic pharmaceutical companies and clinical systems in pursuing innovation. Dr. Fang works at the renowned Sun Yat-sen University Cancer Center (SYSUCC), where his team has conducted clinical research on iza-bren for several years. In a study of 50 patients with locally advanced or metastatic EGFR-mutated NSCLC—who had received first-line treatment with other drugs but no chemotherapy—iza-bren controlled tumor progression for over a year, nearly doubling the duration achieved by the current global standard of care. More positive data about iza-bren emerged at the 2025 European Society for Medical Oncology (ESMO) Congress in mid-October. For the first time, results from the pivotal Phase III registration trial of this global first-in-class EGFR×HER3 bispecific ADC were reported: the drug achieved a twofold improvement in key efficacy endpoints in third-line or above treatment for nasopharyngeal carcinoma (NPC). The full study results were published in The Lancet, a leading international medical journal. More than 40 clinical studies of iza-bren are currently underway worldwide, including 10 Phase III registration trials in China and 3 key registration studies overseas. Regulators in China and the U.S. have designated some of these studies as "Breakthrough Therapies" to expedite development. The drug is expected to launch first in China in 2026—three years earlier than its planned U.S. launch—marking a milestone moment for China's innovative pharmaceutical sector. Growing industry consensus on iza-bren's blockbuster potential began at the 2023 ASCO Annual Meeting. At the time, Professor Zhang Li from SYSUCC first reported promising efficacy signals of the drug's Phase I trial. Iza-bren's unique bispecific ADC technology and its ability to target two high-value antigens (EGFR and HER3) have endowed it with strong efficacy and broad applicability. This has attracted multinational pharma giants facing looming patent cliffs and eager to expand their ADC portfolios. BMS reached a global co-development and commercialization agreement with Biokin, the developer of iza-bren, at a potential total value of up to $8.4 billion. Biokin distinguishes itself among China's biotech companies with its unconventional approach. It transitioned from a generic drug manufacturer, and its founder, Zhu Yi, holds no medical degrees from Europe or the U.S., nor has he worked at multinational pharmaceutical companies. Over a decade ago—when the Chinese government first began mapping out the blueprint for its innovative drug ecosystem—Zhu made a firm decision to go all-in on innovative drug R&D. In 2014, amid a global downturn in drug development, he established a lean scientific team in Seattle, U.S., marking the start of his drug R&D journey. Zhu fully leveraged the strengths of both the Chinese and U.S. biopharmaceutical ecosystems: in the U.S., he accessed resources that support early-stage innovation; in China, the efficient regulatory system, large pool of engineers, and abundant patient resources enabled the rapid translation of innovative ideas into reality. Zhu negotiated distinctive terms with BMS: beyond the substantial financial offer, he secured overseas R&D and commercialization rights. He firmly believes the latter is essential for Biokin to truly join the ranks of global pharmaceutical companies. The establishment and progress of this ambitious collaboration model have empowered Biokin to send a strong message for China's biotech industry: to become a multinational company within five years. Beyond iza-bren, Biokin also announced clinical trial results for T-bren, its second ADC drug in Phase III, at the ESMO Congress. Targeting common cancers such as lung, gastric, and breast cancer, T-bren also showed strong signals of becoming a best-in-class drug. Additionally, China's CDE recently approved Biokin's first antibody-radionuclide conjugate (ARC) drug to enter clinical trials. Biokin's story has captured the market's attention. On China's mainland stock exchanges, its market value has surged 15-fold in just over two years. Now, Hong Kong's capital market is embracing the company. Amid the hesitation of onlookers, Biokin may well emerge as a global leader in biopharmaceuticals. SOURCE Biokin WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultADCPhase 1License out/in

22 Oct 2025

·www.biospace.com

ADC, Bispecifics and Kinase Blockers Steal the Spotlight at ESMO 2025 in Berlin

The Spree River, Berlin, Germany iStock, TomasSereda Pfizer, Merck, AstraZeneca and Bristol Myers Squibb were among the many biopharmas showing off novel cancer modalities at ESMO, with antibody-drug conjugates, bispecific antibodies and kinase inhibitors demonstrating encouraging efficacy and safety for various cancers. The 2025 congress of the European Society for Medical Oncology came to a close on Tuesday, wrapping up five days of cutting-edge cancer research that pushed the boundaries of the field. Here, BioSpace rounds up the impactful and cutting-edge presentations at ESMO, the ones most likely to push forward patients’ clinical care and the broader biopharma industry. ADC Arena Heats Up Pfizer and Merck made waves in the antibody-drug conjugate sector, joining together to combine the former’s ADC Padcev with the latter’s mega-blockbuster PD-1 inhibitor Keytruda. Interim data from the Phase III EV-303/KEYNOTE-905 trial showed that the combo regimen reduced by 60% the risk of tumor recurrence, progression or death in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin treatment. Padcev plus Keytruda also led to a 50% improvement overall survival versus surgery alone, an effect that was statistically significant. Analysts at Guggenheim Partners wrote in a Tuesday note that these findings point to the “potential to change standard-of-care treatment for cisplatin-ineligible MIBC patients” and are likely to “provide [a] tailwind” for Padcev. Aside from its Padcev partnership, Merck showed work from its ADC alliance with China’s Sichuan Kelun-Biotech, which has the companies working on the anti-TROP2 ADC sacituzumab tirumotecan, being tested for EGFR-mutated non-small cell lung cancer (NSCLC). Results from a Phase III trial, conducted in China , demonstrated a significant 51% reduction in the risk of death or disease progression. Overall survival (OS) outcomes were likewise significant, with the ADC suppressing the likelihood of death by 40% versus pemetrexed plus platinum-based chemotherapy. Also in the TROP2 game is AstraZeneca with its Daiichi Sankyo–partnered ADC Datroway. At ESMO, the companies showed that Datroway resulted in a significant 43% progression-free survival (PFS) improvement in patients with locally recurrent or metastatic triple-negative breast cancer. The partners also presented data for the HER2-targetig ADC Enhertu. In patients with HER2-positive early breast cancer with residual invasive disease, the therapy resulted in a 53% decrease in the likelihood of death or recurrent invasive disease, as compared with Roche’s Kadcyla. Disease-free survival in these patients likewise improved by 53% after Enhertu treatment. Likewise presenting data at ESMO are Bristol Myers Squibb and SystImmune, which are advancing iza-bren, a bispecific ADC targeting both the EGFR and HER3 proteins. Phase I data pointed to “ promising antitumor activity ,” the companies said, with a confirmed response rate of 55% and a median PFS of 5.4 months. As for safety, common side effects were blood-related, including neutropenia, though most were generally manageable and “rarely” necessitated dose reductions. BMS and SystImmune are testing iza-bren for advanced solid tumors, including metastatic or unresectable NSCLC. Bispecifics on the Rise One of the most highly anticipated presentations at ESMO was for Akeso and Summit Therapeutics’ PD-1/VEGF bispecific antibody ivonescimab, which the partners are testing for advanced NSCLC. In the Phase III HARMONi-6 study, patients treated with ivonescimab plus chemotherapy saw a 40% PFS advantage versus those who were treated with BeOne’s PD-1 inhibitor Tevimbra plus chemotherapy. The companies did not release OS data, but analysts at Truist Securities were nevertheless encouraged by the ESMO presentation. The PFS readout, the analysts wrote, “leaves no room for doubts at this juncture, in our view,” for the benefit of ivonescimab as a frontline NSCLC treatment option. Summit, which is in charge of ivonescimab in the U.S., is planning a regulatory filing for the asset by year-end, management said in its Q3 call earlier this week. The company is specifically eyeing an approval for second-line EGFR-mutated NSCLC. Cutting off the Cascade Kinase blockers gained their own head of steam at ESMO. These are drugs that block signaling cascades that otherwise culminate in a tumor’s growth and proliferation. One such asset is zongertinib, developed by Boehringer Ingelheim for HER2-mutant advanced NSCLC. In the Phase Ib Beamion LUNG-1 study, zongertinib resulted in a 77% objective response rate and 96% disease control rate. Of note, 8% of responders showed no detectable signs of cancer in the body after treatment, while 69% reached partial treatment response. While data were not yet mature at the time, Boehringer reported an “encouraging” 79% PFS rate at six months. Going up against Boehringer is Bayer, which is developing its own tyrosine kinase inhibitor sevabertinib, likewise for HER2-mutated NSCLC. Bayer released results from a Phase I/II study, showing that in those who had been previously treated but not with a HER2-targeted agent, objective response rate reached 64% , which lasted for a median of 9.2 months. Meanwhile, in patients who had been exposed to an anti-HER2 ADC, response rate was 38% and lasted for 8.5 months. Bayer also tested sevabertinib in treatment-naive patients, of whom 71% responded to the agent, with a median duration of 11 months. There was action at ESMO for kinase inhibitors beyond NSCLC. Exelixis, for instance, tested its drug zanzalintinib for metastatic colorectal cancer (mCRC), touting a median overall survival of 10.9 months versus 9.4 months in comparators treated with Bayer’s Stivarga. OS estimates for zanzalintinib at 12 and 24 months were 46% and 20%, respectively. Analysts were effusive about these results, with William Blair saying in a Monday note that zanzalintinib set “a new survival bar in the third-line or later mCRC setting.” Exelixis is taking the drug to the FDA with these data and anticipates a filing within the year.

Clinical ResultADCPhase 3Phase 1

21 Oct 2025

·endpoints.news

'Decade of the ADCs' continues as AstraZeneca, Kelun and Merck take the stage at ESMO

Two years ago at the European Society for Medical Oncology’s annual meeting, a prominent oncologist predicted that the 2020s would be the “decade of the ADCs.” There were several high-value ADC-focused deals in 2023 ahead of that meeting, a trend that continued through the rest of 2023 and into 2024. While dealmaking has since slowed, the hype around ADCs has not. They’re still expected to become the backbone of care for many cancers in place of traditional chemotherapy, thanks to their ability to deliver cytotoxic payloads in a more targeted way. And they’re still a hot topic at this year’s meeting in Berlin. We’ve rounded up the most impactful ADC data presented at ESMO this year: AstraZeneca and Daiichi’s Enhertu took center stage at a presidential symposium on Saturday, when the companies shared topline data from the DESTINY-Breast11 trial. The study evaluated the drug, which is the best-selling ADC out of the 17 approved globally, in the potentially “curative” neoadjuvant setting of early breast cancer. In the same session, the companies reported results from a second Phase 3 study called DESTINY-Breast05, which enrolled a slightly more advanced group of early breast cancer patients. They had residual invasive disease after surgery and neoadjuvant treatment, and were at a high risk of disease recurrence. Enhertu cut the risk of recurrence or death in these patients by 53% compared with Roche’s Kadcyla, the standard of care. The readouts “underscore the potential of Enhertu to become a foundational treatment in early-stage breast cancer,” AstraZeneca head of oncology R&D Susan Galbraith said in a release. But Enhertu has competition in China for one of its current indications: previously treated unresectable or metastatic HER2+ breast cancer. Sichuan Kelun-Biotech’s HER2-targeting ADC trastuzumab botidotin clinched an approval in that setting just days ago. That decision was based on data from Kelun’s Phase 3 study, which were presented on Monday. More than 75% of patients who received the China drug saw their tumors shrink compared with 53% of those given Kadcyla. Trastuzumab botidotin also achieved a median progression-free survival of 11.1 months versus 4.4 months for Kadcyla. Meanwhile, Merck said its Kelun-partnered TROP-2-directed ADC called sacituzumab tirumotecan, also known as sac-TMT, reduced the risk of death in a Phase 3 trial in certain previously treated non-small cell lung cancer patients. The study , also conducted in China, enrolled patients with EGFR-mutated NSCLC who had failed on treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. At a median follow-up of 18.9 months, Sac-TMT achieved an 8.3-month median progression-free survival compared to 4.3 months for patients who received chemotherapy. Median overall survival was not reached in the sac-TMT arm at a pre-specified interim analysis, versus 17.4 months in the chemotherapy arm. Merck struck a deal with Kelun for exclusive rights to develop, manufacture and commercialize sac-TMT outside of Greater China. Bispecific approaches were also hot at the confab, including an EGFRxHER3-targeting ADC developed by Bristol Myers Squibb and SystImmune. The companies on Friday shared the first data from a global Phase 1 trial of iza-bren. The 2.5 mg/kg dose produced confirmed responses in 11 out of 20 patients with previously treated EGFR-mutated non-small cell lung cancer. Separate from its work with Daiichi , AstraZeneca has seven in-house ADC assets, including one directed at FRα. In 56 platinum-resistant ovarian cancer (PROC) patients with high FRα expression enrolled in a first-in-human trial, AZD5335 achieved response rates of about 61% among patients who took one of three dose levels. The overall response rate in patients with low FRα expression at those dose levels was almost 48%, according to a congress abstract. Elsewhere in the FRα pipeline , Genmab’s rinatabart sesutecan is already in Phase 3 development. The company previously reported the drug hit a 50% ORR in heavily pretreated advanced endometrial cancer patients enrolled in a Phase 1/2 study. On Saturday, it was revealed that more than 60% of responders maintained their responses for about a year. Eli Lilly’s contender with the same target , known as LY4170156, also had new early-stage data to share. The drug achieved ORRs ranging from 33% to 61% depending on the dose. Lilly’s Phase 1 study was in patients with PROC, according to a congress abstract. Tubulis is also trying to treat PROC with an ADC , albeit with a different target. The biotech’s NaPi2b-directed candidate, TUB-040, attained a 50% confirmed ORR in a first-in-human study. Last week, the company bagged $361 million in a Series C raise, becoming the latest ADC company to pull in big bucks in recent years. Nicole DeFeudis contributed reporting.

Clinical ResultPhase 1Phase 3ADCLicense out/in

100 Deals associated with Izalontamab Brengitecan

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	NDA/BLA	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	20 Jan 2026
Oesophageal squamous cell carcinoma recurrent	NDA/BLA	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	20 Jan 2026
Nasopharyngeal Carcinoma	NDA/BLA	China	Baili Bio Chengdu Pharmaceutical Co. Ltd.	21 Nov 2025
Advanced Urothelial Carcinoma	Phase 3	United States	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	China	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	Japan	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	Argentina	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	Australia	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	Austria	Bristol Myers Squibb Co.	30 Sep 2025
Advanced Urothelial Carcinoma	Phase 3	Belgium	Bristol Myers Squibb Co.	30 Sep 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06304974 (Company_Website) Manual	Phase 3	Esophageal Squamous Cell Carcinoma	-	iza-bren	yapdbmpvsq(nixiduneze) = 经独立数据监查委员会（iDMC）判断，iza-bren在预设的期中分析中达到无进展生存期（PFS）和总生存期（OS）双主要终点。 fhvhgosnab (byorzqrfmr ) View more	Positive	24 Nov 2025
NCT06118333 (BL-B01D1-303, ESMO2025 \| Company_Website \| Lancet \| Pubmed) Manual	Phase 3	Nasopharyngeal Carcinoma	386	Iza-bren 2.5 mg/kgIza-bren 2.5 mg/kg	lpscytrswj(qodqrnrdwz) = gauwmdahgb laanmeurbr (bzopijcypn ) View more	Positive	17 Oct 2025
				Chemotherapy (capecitabine/gemcitabine/docetaxel)	lpscytrswj(qodqrnrdwz) = eqgosohqjk laanmeurbr (bzopijcypn ) View more
NCT05983432 (BL-B01D1-LUNG-101 \| US-Lung-101 study, ESMO 12025 \| ESMO 22025 \| Company_Website) Manual	Phase 1	Solid tumor \| Non-Small Cell Lung Cancer	113	Iza-bren (all doses)	kcnpekqzac(ivvxeyyxle) = ceswgugocw jvutrzwgjo (lazajanwrv ) View more	Positive	13 Oct 2025
				Iza-bren (1.5 mg/kg D1D8 Q3W)	kcnpekqzac(ivvxeyyxle) = ezleierhvs jvutrzwgjo (lazajanwrv ) View more
NCT05990803 \| NCT05803018 (ESMO 12025 \| ESMO 22025) Manual	Phase 1/2	Recurrent ovarian cancer	96	iza-bren	sqwswanljp(tsvzkfrcqt) = fszcfykhii gcdodwdutb (zhxulwgmjg ) View more	Positive	13 Oct 2025
				iza-bren (2.0 mg/kg Q3W)	sqwswanljp(tsvzkfrcqt) = lssopxvucv gcdodwdutb (zhxulwgmjg ) View more
NCT05785039 (BL-B01D1-201, Pubmed \| J Clin Oncol) Manual	Phase 2	Metastatic urothelial carcinoma	41	BL-B01D1 2.2 mg/kg	jxcmjapklt(yjlfxdpxpr) = qwkkncfwed lksgstncxb (miysvjgkiz, 27.2 - 62.1) View more	Positive	08 Oct 2025
				BL-B01D1 2.5 mg/kg	-
NEWS Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation	40	iza-bren 2.5mg/kg +奥希替尼	calqqndfyp(nsmbtpczgk) = bibtdackdt ykosqyqdxg (qikalcemtg ) View more	Positive	11 Sep 2025
WCLC2025 Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer Second line \| Third line EGFR Mutation	172	Iza-Bren (BL-B01D1)	mhpdurrcmr(gktzrruftd) = yovusdbxma fcldzvhfuf (qpnopzlzeh, 5.5 - 9.6) View more	Positive	09 Sep 2025
				Iza-Bren (BL-B01D1) (2.5 mg/kg D1D8 Q3W)	mhpdurrcmr(gktzrruftd) = buggbwarxv fcldzvhfuf (qpnopzlzeh, 5.5 - 9.7) View more
NEWS Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	50	Iza-bren (既往接受过EGFR-TKI但未接受过化疗)	iralftcply(vniygmqtia) = spulkbfgtu iuddaksgtt (vvuskcatmk ) View more	Positive	08 Sep 2025
				Iza-bren (19 缺失突变组)	iralftcply(vniygmqtia) = hegoprdurb iuddaksgtt (vvuskcatmk )
NCT05880706 (WCLC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation (Sensitizing)	154	iza-bren + osimertinib	mmmxlokcsp(rrszkvgagt) = svlvttkbqr yuloifzrza (asqfjjssya ) View more	Positive	08 Sep 2025
				iza-bren + osimertinib (2.2 mg/kg (D1D8 Q3W))	mmmxlokcsp(rrszkvgagt) = tmhmbrtoaz yuloifzrza (asqfjjssya ) View more
NEWS Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	40	iza-bren 2.5mg/kg D1D8 Q3W + 奥希替尼	jzgymorxnc(dssbcgbkip) = kgxtnsvklf zuinnokqsr (lruaeyoptw ) View more	Positive	08 Sep 2025

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis