High-dose furmonertinib in combination with chemotherapy for the first-line treatment of treatment of EGFR mutant NSCLC with CNS metastasis : an open-label, single-arm study

Start Date16 May 2024

Sponsor / Collaborator

Anhui Provincial Hospital

NCT06394674 / RecruitingPhase 2IIT

A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Start Date01 May 2024

Sponsor / Collaborator

Shanghai Changhai Hospital

[+6]

NCT06319950 / Not yet recruitingPhase 2IIT

High-dose Furmonertinib Versus Osimertinib as First-line Treatment in Advanced EGFR Mutation-positive NSCLC Patients With Brain Metastases: a Multi-center, Randomized, Controlled, Prospective, Phase II Clinical Trial

The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis.

Start Date01 Apr 2024

Sponsor / Collaborator

Taizhou Hospital of Zhejiang Province

100 Clinical Results associated with Alflutinib Mesylate

100 Translational Medicine associated with Alflutinib Mesylate

100 Patents (Medical) associated with Alflutinib Mesylate

Literatures (Medical) associated with Alflutinib Mesylate

01 May 2024·Recent patents on anti-cancer drug discovery

Pulmonary Adenocarcinoma Patient with Complex Mutations on EGFR Benefits from Furmonertinib after Acquiring Gefitinib Resistance: A Case Report

Author: Lin, Ling ; Wu, Guixian ; Huang, Jing ; Chen, Qian ; Lv, Dongqing

Background::

A 62-year-old woman was diagnosed with pulmonary adenocarcinoma with stage IV. Genetic testing at the initial treatment showed EGFR L858R positive. After being treated with gefitinib, persistent 2 years disease progression occurred due to drug resistance. The genetic testing showed that EGFR L858R was eliminated, while a rare rare complex mutation of L861Q/G719X appeared. After 160 mg furmonertinib was treated for 1 month, the primary tumor regressed and the intracranial lesions disappeared. The patient has achieved progression-free survival (PFS) for more than 20 months.

Case Presentation::

Conclusion::

Pulmonary adenocarcinoma with rare rare complex mutations in EGFR induced by gefitinib resistance and disease progression might benefit from furmonertinib treatment.

01 Jan 2024·JTO clinical and research reports

The Impact of On-Target Resistance Mediated by EGFR-T790M or EGFR-C797S on EGFR Exon 20 Insertion Mutation Active Tyrosine Kinase Inhibitors

Article

Author: Rangachari, Deepa ; Shaffer, William ; Viray, Hollis ; Kobayashi, Susumu S ; VanderLaan, Paul A ; Kobayashi, Ikei S ; Costa, Daniel B

Introduction:

Mechanisms of resistance to EGFR exon 20 insertion mutation active inhibitors have not been extensively studied in either robust preclinical models or patient-derived rebiopsy specimens. We sought to characterize on-target resistance mutations identified in EGFR exon 20 insertion-mutated lung cancers treated with mobocertinib or poziotinib and evaluate whether these mutations would or would not have cross-resistance to next-generation inhibitors zipalertinib, furmonertinib, and sunvozertinib.

Methods:

We identified mechanisms of resistance to EGFR exon 20 insertion mutation active inhibitors and then used preclinical models of EGFR exon 20 insertion mutations (A767_V769dupASV, D770_N771insSVD, V773_C774insH) plus common EGFR mutants to probe inhibitors in the absence/presence of EGFR-T790M or EGFR-C797S.

Results:

Mobocertinib had a favorable therapeutic window in relation to EGFR wild type for EGFR exon 20 insertion mutants, but the addition of EGFR-T790M or EGFR-C797S negated the observed window. Zipalertinib had a favorable therapeutic window for cells driven by EGFR-A767_V769dupASV or EGFR-D770_N771insSVD in the presence or absence of EGFR-T790M. Furmonertinib and sunvozertinib had the most favorable therapeutic windows in the presence or absence of EGFR-T790M in all cells tested. EGFR-C797S in cis to all EGFR mutations evaluated generated dependent cells that were resistant to the covalent EGFR tyrosine kinase inhibitors mobocertinib, zipalertinib, furmonertinib, sunvozertinib, poziotinib, and osimertinib.

Conclusions:

This report highlights that poziotinib and mobocertinib are susceptible to on-target resistance mediated by EGFR-T790M or -C797S in the background of the most prevalent EGFR exon 20 insertion mutations. Furmonertinib, sunvozertinib, and to a less extent zipalertinib can overcome EGFR-T790M compound mutants, whereas EGFR-C797S leads to covalent inhibitor cross-resistance-robust data that support the limitations of mobocertinib and should further spawn the development of next-generation covalent and reversible EGFR exon 20 insertion mutation active inhibitors with favorable therapeutic windows that are less vulnerable to on-target resistance.

29 Dec 2023·Medicine

First report of furmonertinib as a first-line treatment in advanced lung adenocarcinoma patients harboring EGFR exon 20 insertion mutations after the kinase domain αC-helix: Two case reports and a literature review

Review

Author: Zhang, Xiao ; Zhao, Jiuzhou ; Jiao, Shuyue ; Liu, Xiao ; Tang, Hong ; Zhu, Hui ; Zhang, Jianwei ; Zhang, Jianbo ; Han, Huan

Rationale::

Many studies have shown that first- and second-generation epidermal growth factor receptor tyrosine kinase inhibitors are less effective in patients with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. The efficacy of third-generation epidermal growth factor receptor tyrosine kinase inhibitors is still under investigation. Although new targeted tyrosine kinase inhibitors and monoclonal antibody-based agents have made significant advances in the treatment of epidermal growth factor receptor exon 20 insertion (EGFR ex20ins) mutation, the efficacy of these novel agents is not quite satisfactory. Platinum- and pemetrexed-based chemotherapy remains the standard first-line treatment for patients harboring EGFR ex20ins mutation.

Patient concerns::

We report for the first time 2 Chinese patients diagnosed with advanced lung adenocarcinoma with EGFR ex20ins mutations after analysis of the αC-helix sequence by next-generation sequencing. Both patients were treated with furmonertinib as the first-line therapy.

Interventions::

The first case included a 38-year-old female who had an EGFR ex20ins mutation (p.S768_D770dupSVD). After 1 month of treatment with furmonertinib, her symptoms of pain and cough were significantly alleviated. She achieved a partial response according to response evaluation criteria in solid tumors.[1] The final progression-free survival was 8.13 months. The second case included a 40-year-old male who had an EGFR ex20ins mutation (p.N771_P772insVal). He had a good response to furmonertinib and exhibited stable disease according to response evaluation criteria in solid tumors with a progression-free survival of 10.90 months.

Outcomes::

Both patients experienced significant improvement in symptoms and prolonged survival after furmonertinib was used as first-line treatment. Side effects were limited but manageable.

Conclusion::

The present study indicates that furmonertinib may be a first-line treatment option for patients with non-small cell lung cancer harboring EGFR ex20ins mutation.

News (Medical) associated with Alflutinib Mesylate

05 Jun 2024

·www.globenewswire.com

ArriVent Announces a Multi-Target ADC Collaboration with Alphamab

Collaboration will leverage Alphamab’s antibody drug conjugate (“ADC”) research and discovery platform and ArriVent’s global development and commercialization expertise Upfront and milestone payments to Alphamab worth up to $615.5 million for potential ADCs SUZHOU, China and NEWTOWN SQUARE, Pa., June 05, 2024 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc., (“ArriVent”) a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the Company has entered into a collaboration agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Alphamab”), a wholly owned subsidiary of Alphamab Oncology, to discover, develop and commercialize novel antibody drug conjugates (“ADCs”) for the treatment of cancers. “This exciting collaboration strengthens and complements our pipeline with the potential to add multiple innovative new ADC programs and exemplifies our strategic model of identifying and developing potential first-and best-in-class product candidates from across the globe,” said Bing Yao, Chairman and Chief Executive Officer of ArriVent. “We look forward to complementing the research and discovery capabilities of Alphamab with our global drug development and commercialization expertise to address the unmet needs of cancer patients.” “ArriVent shares our passion for developing differentiated, clinically valuable, and globally competitive new drugs,” said Ting Xu, Ph.D., Founder, Chairman, and CEO of Alphamab Oncology. “This collaboration, based on Alphamab’s proprietary and clinically validated glycan-conjugation platform, combined with ArriVent’s deep knowledge in oncology and extensive development experience, provides us with the opportunity to work together to deliver important new oncology therapeutics to patients.” Under the agreement, both companies will leverage Alphamab’s proprietary linker-payload platform and glycan-conjugation technology to identify novel ADCs for oncology indications. The agreement gives ArriVent exclusive rights to develop and commercialize ADCs globally, except greater China, which includes outside of mainland China, Hong Kong, Macau and Taiwan where Alphamab retains the right to develop and commercialize the ADCs. The terms of the agreement include combined upfront and potential milestone payments to Alphamab of up to $615.5 million in aggregate for the potential programs, based on the achievement of certain regulatory, development, and sales milestones. In addition, Alphamab is entitled to receive tiered sales royalties from ArriVent for each ADC product. About ArriVent ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. About Alphamab OncologyAlphamab Oncology is a leading biopharmaceutical company in China with a fully integrated proprietary biologics platform in bispecific and protein engineering. The Alphamab Oncology’s highly differentiated inhouse pipeline consists of monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates in staggered development status in oncology, including, among others, one approved for marketing by the National Medical Products Administration of China and three in late clinical stage. Alphamab Oncology has developed various technologies and platforms of antibody-based therapies for oncology treatment and expertise in this regard. Benefitting from the proprietary protein engineering platforms and structure-guided molecular modeling expertise, Alphamab Oncology is able to create a new generation of multi-functional biological drug candidates that could potentially benefit patients globally. Forward-Looking StatementsThis press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding ArriVent’s ability to discover develop, and commercialize ADCs in collaboration with Alphamab, the potential milestone payments and tiered sales royalty payments to Alphamab, if any, the potential for such ADCs to help to address the unmet needs of cancer patients, the timing, progress and results of pre-clinical studies and clinical trials for any such ADCs, including our product development plans and strategies, ArriVent’s clinical programs, future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in ArriVent’s annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on March 28, 2024, and its other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. Contact for Investors & Media:Argot Partners212.600.1902ArriVent@argotpartners.com

ADCLicense out/in

05 Jun 2024

·firstwordpharma.com

ArriVent bulks out ADC portfolio via $615M Alphamab deal

ArriVent BioPharma teamed up with Jiangsu Alphamab Biopharmaceuticals on Wednesday to develop antibody-drug conjugates (ADCs) for cancer, the Pennsylvania-based biotech’s second deal focused on the modality.Alphamab will use its linker-payload platform and glycan-conjugation technology to identify ADCs for ArriVent, who will have exclusive, ex-China development and commercialisation rights to the candidates. The Chinese biotech stands to receive $615.5 million, which comprises an upfront payment and potential milestones, in addition to tiered royalties.The deal “strengthens and complements our pipeline with the potential to add multiple innovative new ADC programmes and exemplifies our strategic model of identifying and developing potential first-and best-in-class product candidates from across the globe,” said ArriVent CEO Bing Yao.The agreement will help add fresh early-stage candidates to ArriVent’s pipeline, which consists mainly of EGFR inhibitor firmonertinib. The oral small molecule is in three trials for various EGFR-mutated non-small-cell lung cancers. ArriVent has one existing ADC deal, though details are scarce. The company is working with Aarvik Therapeutics to develop a therapy for solid tumours with improved activity and safety over single target bivalent ADCs, and a lead candidate is expected to be selected in late 2024 or early 2025.The biotech made its public debut in January, raising $175 million in the year’s second IPO.

ADCIPO

22 May 2024

·www.globenewswire.com

Predicine to Present 9 Liquid Biopsy Studies at ASCO 2024

HAYWARD, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc. A leading precision oncology company, announced today that it will present data from 9 ctDNA studies at ASCO 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and drug resistance mechanism studies. The forthcoming data represents significant potential for the practical application of Predicine’s cutting-edge liquid biopsy technology in personalized cancer care, clinical trials, and Companion Diagnostic (CDx) development. Numerous studies to be unveiled at the conference emphasize the distinct advantages of personalized PredicineBEACON™ and methylation-based PredicineALERT™ MRD underscoring the clinical utility of Predicine’s liquid biopsy portfolio in biomarker discovery, therapy selection, MRD monitoring, and drug resistance mechanism analyses. Predicine Oral Presentation PresenterTitle Product Saturday, June 1 | 1:30 pm – 4:30 pm Jian LiA phase 1 study of the small-molecule PD-L1 inhibitor INCB099280 in select advanced solid tumors: Updated safety, efficacy, and pharmacokinetics (PK) results.PredicineCARE™ Full List of Predicine PresentationsAbstract Poster TitleProductSaturday, June 1 | 9:00 am – 12:00 pm2053352Glioma monitoring via longitudinal intracranial cerebrospinal fluid cell-free DNA.PredicineCARE™PredicineSCORE™ Sunday, June 2 | 9:00 pm – 12:00 pm260887Clinical utility of an ultra-sensitive ctDNA NGS assay for the detection and monitoring in HR-positive, HER2-negative breast cancer.PredicineCARE™ Ultra e16604-Non-invasive detection of urothelial carcinoma through ensembled methylation profiles and fragmentomic patterns in urinary cell-free DNA.PredicineEPIC™ e16602-Real-world study of urine-based NGS liquid biopsy in organ preservation therapy of muscle-invasive bladder cancer (MIBC).PredicineBEACON™PredicineALERT™ e12654-Prognostic significance of ctDNA mutation analysis in patients with HER2-positive breast cancer undergoing neoadjuvant chemotherapy.PredicineBEACON™e13076-Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST).PredicineCARE™ Monday, June 3 | 1:30 pm – 4:30 pm8587451High-dose furmonertinib in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A real-world study.PredicineEPIC™4600295Tumor fraction and copy number burden from urinary cell-free tumor DNA (utDNA) to predict minimal residual disease prior to repeat-transurethral resection in high-risk non-muscle invasive bladder cancer (HR-NMIBC).PredicineBEACON™ Visit Predicine Booth #14105 at ASCO 2024! Participate in conversations surrounding these groundbreaking studies and explore collaboration opportunities. Our liquid biopsy solutions are designed to be accessible and affordable for global clinical trials, CDx development, and patient testing across the US, EU, China, and the rest of world. Click here to arrange an in-person meeting with the Predicine team at ASCO booth #14105 or click here to schedule an online meeting. To learn more about Predicine, please see our corporate brochure, product portfolio, and visit our website. About Predicine Predicine is a leading molecular insights company committed to advancing precision medicine in oncology. Predicine has developed a proprietary cell-free DNA and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The Predicine portfolio comprises state-of-the-art blood, urine, and tissue-based Next-Generation Sequencing (NGS) assays designed for harmonized global use in research, clinical development, companion diagnostic (CDx) development, and patient testing. With operational hubs in Silicon Valley, Houston, Chicago, and Shanghai, Predicine collaborates with leading biopharma companies, institutions, and governments in personalized healthcare on a global scale. For more information, please visit us on http://www.predicine.com and follow us on LinkedIn or Twitter (X). Contact Information:Predicine, Inc.media@predicine.com

Phase 1ASCO

100 Deals associated with Alflutinib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB16087

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	CN	Shanghai Allist Pharmaceuticals Co., Ltd.	28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	CN	Shanghai Allist Pharmaceuticals Co., Ltd.	03 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	US	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	JP	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	AU	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	FR	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	NL	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
Non-squamous non-small cell lung cancer	Phase 3	ES	Shanghai Allist Pharmaceuticals Co., Ltd.	18 May 2023
EGFR positive non-small cell lung cancer	Phase 3	CN	Shanghai Allist Pharmaceuticals Co., Ltd.	30 May 2019
metastatic non-small cell lung cancer	Phase 3	CN	Shanghai Allist Pharmaceuticals Co., Ltd.	30 May 2019
Adenocarcinoma of Lung	Phase 2	-	Shanghai Allist Pharmaceuticals Co., Ltd.	01 Aug 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 1	US	Arrivent BioPharma, Inc.Startup	30 Jun 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03787992 (FURLONG, Literature) Manual	Phase 3	EGFR positive non-small cell lung cancer First line EGFR Mutation	257	Furmonertinib 80 mg	araexqcfhp(etqbzpfsjk) = yeveiquypv wrtegsruyu (llxxqntxjn )	Positive	17 Jun 2024
				gefitinib	-
ChiCTR2300072092 (ASCO2024) Manual	Not Applicable	Metastatic Malignant Neoplasm to the Leptomeninges \| EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	48	Furmonertinib 240mg	mhmakqgfak(jqvzmbucnk) = zzlwxaspfz ncdmxgmwpi (syyuyjkklz, 5.481-11.386) View more	Positive	24 May 2024
ChiCTR2300072092 (ASCO2024)	Not Applicable	Metastatic Malignant Neoplasm to the Leptomeninges \| EGFR-mutated non-small Cell Lung Cancer	48	Furmonertinib 240mg	ynmozevadr(ngpxrkygzc) = uuocvoakxr nfrhgtetxw (sgdzvwydpe, 5.481 - 11.386) View more	Positive	24 May 2024
ASCO2024	Not Applicable	-	-	Furmonertinib 240 mg	qjjeaedolf(czrcxefzbd) = The most common AEs were rash, diarrhea and decreased appetite. However, most AEs were grade 1-2. fegaradqyz (ndtowuxcwv ) View more	-	24 May 2024
				Furmonertinib 160 mg
NCT05607550 (FURMO-004, ASCO2024)	Phase 3	Non-Small Cell Lung Cancer First line EGFR exon 20 insertion mutations	375	Furmonertinib 160 mg QD	htyctftnko(zmpaovmhtj) = pefultlxvx xfljvuaqmu (omfgtierxr ) View more	Positive	24 May 2024
				Furmonertinib 240 mg QD	htacqocmxj(syivxnflce) = akjcghrtgr lgdaciedxp (qqtficqihz )
NCT05607550 (FURMO-004, AACR2024)	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR exon 20 insertion mutation	375	Furmonertinib 160 mg QD	jugkqdnmkf(sadmsmhkch) = rxoqjbmsim lpzeovwngm (pewiypozkf ) View more	Positive	05 Apr 2024
				Furmonertinib 240 mg QD	jugkqdnmkf(sadmsmhkch) = komipejyby lpzeovwngm (pewiypozkf ) View more
NCT05364073 (FURTHER, AACR2024)	Phase 1	EGFR-mutated non-small Cell Lung Cancer First line EGFR ex20ins mts \| PACC mts	-	Furmonertinib	zpzdtmkwcc(cysqvotimj) = gkeplifnnz uocjimbutc (hevjohrpev )	-	05 Apr 2024
ESMO_ELCC2024 Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	31	Furmonertinib	hzxmvsydyg(cqvyppwufd) = mxpftgdmqy meuepkazip (ufvlwgexyq ) View more	Positive	22 Mar 2024
ESMO_ELCC2024 Manual	Not Applicable	EGFR ex20ins mutation in non-small cell lung cancer EGFR Exon 20 Insertion	48	furmonertinib (80 mg)	ubugjtavzi(pavxkixpcy) = sbfipqodxb tafhtoumum (kpwsbephtg ) View more	Positive	22 Mar 2024
				furmonertinib (160 mg)	ubugjtavzi(pavxkixpcy) = rzaognuzne tafhtoumum (kpwsbephtg ) View more
ESMO_ELCC2024 Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	43	Furmonertinib	ssjzpzcmtb(mjqllvmzsp) = tlizeodvcv olamadminn (yerzidvuzn ) View more	Positive	20 Mar 2024

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