A Randomized, Open-label, Controlled, Multi-Center Phase II/III Study to Assess the Efficacy and Safety of AZD3759 Vs. a Standard of Care EGFR TKI, As First Line Treatment to EGFR Mutation Positive Advanced NSCLC with CNS Metastases

The first-line treatment with single agent AZD3759 results in superior Progression Free Survival (PFS) compared to Standard of Care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI), in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with Central Nervous System (CNS) metastasis

Start Date29 Oct 2018

Sponsor / Collaborator

Alpha Biopharma (Jiangsu) Co., Ltd.

CTR20180609

/ CompletedPhase 2/3

评估 AZD3759 作为一线治疗与EGFR-TKI标准治疗相比，在EGFR突变阳性的晚期NSCLC伴CNS转移患者中的有效性和安全性的II/III期临床研究

[Translation] A phase II/III clinical study to evaluate the efficacy and safety of AZD3759 as first-line treatment compared with standard EGFR-TKI treatment in patients with EGFR mutation-positive advanced NSCLC and CNS metastases

主要目的是通过盲态的独立中心影像审查（BICR），判断作为一线疗法，单独使用AZD3759与EGFR-TKI标准治疗相比，是否能够显著提高研究患者人群的无进展生存期（PFS）。

[Translation]

The main purpose is to determine whether AZD3759 alone as first-line therapy can significantly improve the progression-free survival (PFS) of the study patient population compared with standard treatment with EGFR-TKI through blinded independent central imaging review (BICR).

Start Date18 Oct 2018

Sponsor / Collaborator

AstraZeneca Investment (China) Co. Ltd.

NCT03574402

/ RecruitingPhase 2IIT

An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP)

This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

Start Date09 Jul 2018

Sponsor / Collaborator

Chinese Thoracic Oncology Group

100 Clinical Results associated with Zorifertinib

100 Translational Medicine associated with Zorifertinib

100 Patents (Medical) associated with Zorifertinib

Literatures (Medical) associated with Zorifertinib

01 Jan 2025·Med

First-line zorifertinib for EGFR-mutant non-small cell lung cancer with central nervous system metastases: The phase 3 EVEREST trial

Article

Author: Sun, Ping ; Shi, Jianhua ; Hu, Yanping ; Fan, Yun ; Zhong, Diansheng ; Yang, Tsung-Ying ; Zhou, Jianying ; Wang, Zhen ; Xu, Xinhua ; Yao, Yu ; Guo, Yubiao ; Dong, Xiaorong ; Chen, Yuan ; Cui, Jiuwei ; Wang, Ying ; Zhou, Qing ; Wang, Dong ; Wu, Yi-Long ; Pan, Yueyin ; Lu, Shun ; Yang, Nong ; Li, Gaofeng ; Wang, Jie ; Song, Yong ; Zhu, Bo ; Ahn, Myung-Ju ; Cheng, Ying ; Shim, Byoung Yong ; Wu, Jingxun ; Xia, Bing ; Zhao, Jun ; Zhang, Guojun ; Yu, Yan ; Feng, Jifeng ; Ma, Zhiyong ; Xing, Ligang ; Yang, Cheng-Ta ; Zhuang, Wu ; Li, Juan ; Zhang, Longzhen

BACKGROUNDZorifertinib (AZD3759), an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with high blood-brain barrier penetration capability, demonstrated promising intracranial and systemic antitumor activity in phase 1 and 2 studies in central nervous system (CNS)-metastatic patients.METHODSIn this phase 3 EVEREST trial (ClinicalTrials.gov: NCT03653546), patients with EGFR-sensitizing mutations, advanced treatment-naive non-small cell lung cancer (NSCLC), and non-irradiated symptomatic or asymptomatic CNS metastases were randomized (1:1) to zorifertinib or first-generation EGFR-TKI (gefitinib or erlotinib; control). The primary endpoint was blinded independent central review (BICR)-assessed progression-free survival (PFS) per RECIST1.1.FINDINGSOverall, 439 patients were randomized (zorifertinib n = 220; control n = 219). Most patients had the EGFR L858R mutation (55%) or >3 CNS lesions (54%). Median PFS was significantly longer with zorifertinib versus control (9.6 versus 6.9 months; hazard ratio [HR], 0.719; 95% confidence interval [CI], 0.580-0.893; p = 0.0024). Zorifertinib significantly prolonged intracranial PFS versus control (BICR per modified RECIST1.1: HR, 0.467; 95% CI, 0.352-0.619; investigator per RANO-BM: HR, 0.627; 95% CI, 0.466-0.844). Overall survival (OS) was immature; the estimated median OS was 37.3 months with zorifertinib and 31.8 months with control (HR, 0.833; 95% CI, 0.524-1.283) in patients subsequently treated with third-generation EGFR-TKIs. Safety profiles were consistent with previously reported data for zorifertinib.CONCLUSIONSZorifertinib significantly improved systemic and intracranial PFS versus first-generation EGFR-TKIs; adverse events were manageable. Sequential use of zorifertinib and third-generation EGFR-TKIs showed the potential to prolong patients' survival. The results favor zorifertinib as a novel, well-validated first-line option for CNS-metastatic patients with EGFR-mutant NSCLC.FUNDINGThis work was funded by Alpha Biopharma (Jiangsu) Co., Ltd., China.

01 Jan 2025·Anti-Cancer Drugs

Machine learning-based integration develops a multiple programmed cell death signature for predicting the clinical outcome and drug sensitivity in colorectal cancer

Article

Author: Li, Chunhong ; Liu, Yi ; Tan, Haiyin ; Hu, Jiahua ; Su, Chunchun ; Ou, Minglin ; Hou, Xianliang ; Mao, Yuhua

Tumorigenesis and treatment are closely associated with various programmed cell death (PCD) patterns. However, the coregulatory role of multiple PCD patterns in colorectal cancer (CRC) remains unknown. In this study, we developed a multiple PCD index (MPCDI) based on 19 PCD patterns using two machine learning algorithms for risk stratification, prognostic prediction, construction of nomograms, immune cell infiltration analysis, and chemotherapeutic drug sensitivity analysis. As a result, in the TCGA-COAD, GSE17536, and GSE29621 cohorts, the MPCDI can effectively distinguished survival outcomes in CRC patients and served as an independent factor for CRC patients. We then explored the immune infiltration landscape in two groups using the nine algorithms and found more overall immune infiltration in the high-MPCDI group. TIDE scores suggested that the increased immune evasion potential and immune checkpoint inhibition therapy may be less effective in the high-MPCDI group. Immunophenoscores indicated that anti-PD1, anti-cytotoxic T-lymphocyte associated antigen 4 (anti-CTLA4), and anti-PD1-CTLA4 combination therapies are less effective in the high-MPCDI group. In addition, the high-MPCDI group was more sensitive to AZD1332, Foretinib, and IGF1R_3801, and insensitive to AZD3759, AZD5438, AZD6482, Erlotinib, GSK591, IAP_5620, and Picolinici-acid, which suggests that the MPCDI can guide drug selection for CRC patients. As a new clinical classifier, the MPCDI can more accurately distinguish CRC patients who benefit from immunotherapy and develop personalized treatment strategies for CRC patients.

01 Aug 2024·Combinatorial Chemistry & High Throughput Screening

A Six-gene Prognostic Model Based on Neutrophil Extracellular Traps (NETs)-related Gene Signature for Lung Adenocarcinoma

Article

Author: Long, Xuan ; Guo, Ting ; Yan, Yusheng ; Mo, Guiyan ; Cao, Limin ; Tang, Yuling

Background:Lung adenocarcinoma (LUAD) is one of the most common malignant cancers. Neutrophil extracellular traps (NETs) have been discovered to play a crucial role in the pathogenesis of LUAD. We aimed to establish an innovative prognostic model for LUAD based on the distinct expression patterns of NETs-related genes.Methods:The TCGA LUAD dataset was utilized as the training set, while GSE31210, GSE37745, and GSE50081 were undertaken as the verification sets. The patients were grouped into clusters based on the expression signature of NETs-related genes. Differentially expressed genes between clusters were identified through the utilization of the random forest and LASSO algorithms. The NETs score model for LUAD prognosis was developed by multiplying the expression levels of specific genes with their corresponding LASSO coefficients and then summing them. The validity of the model was confirmed by analysis of the survival curves and ROC curves. Additionally, immune infiltration, GSEA, mutation analysis, and drug analysis were conducted. Silencing ABCC2 in A549 cells was achieved to investigate its effect.Results:We identified six novel NETs-related genes, namely UPK1B, SFTA3, GGTLC1, SCGB3A1, ABCC2, and NTS, and developed a NETs score signature, which exhibited a significant correlation with the clinicopathological and immune traits of the LUAD patients. High-risk patients showed inhibition of immune-related processes. Mutation patterns exhibited variability among the different groups. AZD3759, lapatinib, and dasatinib have been identified as potential candidates for LUAD treatment. Moreover, the downregulation of ABCC2 resulted in the induction of apoptosis and suppression of migration and invasion in A549 cells.Conclusion:Altogether, this study has identified a novel NET-score signature based on six novel NET-related genes to predict the prognosis of LUAD and ABCC2 and has also explored a new method for personalized chemo-/immuno-therapy of LUAD.

News (Medical) associated with Zorifertinib

30 Jan 2023

·www.prnewswire.com

Alpha Biopharma Submits New Drug Application for Zorifertinib, a Next-Generation EGFR-TKI to Treat EGFR-mutated NSCLC Patients with CNS Metastases

SHANGHAI, Jan. 29, 2023 /PRNewswire/ -- Alpha Biopharma, a developer of innovative drugs, announces that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Zorifertinib, a next-generation EGFR-TKI specially designed to treat advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases. Zorifertinib is the first EGFR-TKI to be tested in a prospective, controlled registration clinical study for this difficult-to-treat patient population, and if approved, it will bring a much-needed new treatment option for these patients. Data released by the International Agency for Research on Cancer (IARC) of the World Health Organization (SHO) showed that there were 9.96 million cancer deaths worldwide in 2020, and 1.8 million deaths were from lung cancers, making it the most common cause of cancer deaths. Due to the low CNS penetration rate of most current lung cancer drugs, lung cancers metastasized to the CNS were poorly controlled and have become one of the leading causes of NSCLC patient deaths. Zorifertinib is a next-generation EGFR-TKI targeting sensitive EGFR mutations (exon 19 deletion and exon 21 L858R) designed for complete blood-brain barrier (BBB) permeability. In addition, Zorifertinib is not a substrate for the efflux transporters P-gp and BCRP, which allows it to achieve and maintain effective drug exposure in the brain tissues and the cerebrospinal fluid. The EVEREST study was a multinational, multicenter, randomized, open-label, controlled phase II/III clinical trial designed to evaluate the efficacy and safety of Zorifertinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with CNS metastases. The study was carried out in 55 study sites located in the Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The last patient last visit (LPLV) of the EVEREST study was completed in the third quarter of 2022. Results from the EVEREST study demonstrated that Zorifertinib effectively reduced the risk of disease progression and patient deaths in the target patient population and showed significant efficacy in treating metastatic lesions in the CNS. In addition, Zorifertinib's safety profile is comparable to other approved EGFR-TKI's. The primary resistance mutation at the time of disease progression is the EGFR T790M mutation. Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG) and the leading principal investigator (PI) of the EVEREST study, said, "Clinical results from this high-quality, controlled study demonstrated that Zorifertinib provided consistent and statistically significant benefits to EGFR-mutated NSCLC patients with different levels of CNS metastasis. It could provide a much-needed new treatment option for these difficult-to-treat patients. The development of Zorifertinib represents a great example of a patient-centric, targeted precision approach to address unmet medical needs. Eric Zhang, CEO of Alpha Biopharma, said, "after many years of dedicated research and development, we are very pleased to witness that all pre-clinical and clinical data have demonstrated that Zorifertinib can achieve and maintain high CNS exposures, that it is safe, and it is advantageous in controlling CNS and overall disease progression in this difficult-to-treat population. We look forward to working closely with the regulatory agencies around the world to bring this innovative treatment option to patients in dire need. About Zorifertinib Zorifertinib is a potent, oral, reversible inhibitor of mutated EGFR (Exon19Del and Exon21L858R). EGFR is widely expressed in human epidermal and stromal cells and is highly expressed in various human malignancies, such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis. CNS metastases are common in EGFR-mutated NSCLC patients and are accompanied by a poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into the CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a next-generation EGFR-TKI with full blood-brain barrier penetration targeting advanced NSCLC patients with CNS metastases and EGFR-sensitizing mutations. Zorifertinib is currently under NDA submission and has global patent protection. About Alpha Biopharma Alpha Biopharma is a late-stage biopharmaceutical company focusing on developing new therapies for cancers and other unmet medical needs. The Company has submitted its first NDA submission for its small molecule drug Zorifertinib to treat advanced NSCLC patients with CNS metastases and EGFR sensitizing mutations. In addition, in partnership with leading cell therapy company Wugen, Alpha Biopharma is developing memory NK-cells to treat multiple blood and solid tumors and CAR-T cells to treat T-cell lymphomas. It has initiated an IIT clinical study testing memory NK cells in relapse and recurring AML patients. Alpha Biopharma has assembled an experienced management team with solid capabilities in pre-clinical development, pharmacology, medical sciences, clinical operations, and business development to advance its innovative treatment solutions to the market and improve life quality for cancer patients and commercialization. SOURCE ALPHA BIOPHARMA

Clinical StudyCell Therapy

25 Aug 2022

·www.prnewswire.com

Alpha Biopharma Announces Completion of its EVEREST Phase II/III Clinical Study of Zorifertinib in Non-Small Cell Lung Cancer Patients with Central Nervous System Metastases

SHANGHAI, Aug. 24, 2022 /PRNewswire/ -- Alpha Biopharma, a developer of innovative drugs, announces the completion of last patient last visit (LPLV) in its international, multicenter EVEREST phase II/III clinical study of Zorifertinib, a next-generation EGFR-TKI, in first line patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases. Topline data from this MRCT study are expected around the end of 2022, at which time Alpha Biopharma could submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA). As the international leading principal investigator (PI) of EVEREST study, Professor Yilong Wu, President of the Chinese Thoracic Oncology Group (CTONG), said: "EVEREST study is an international, multicenter, phase II/III randomized clinical study. It is also the only large-scale prospective international multicenter clinical study worldwide for first line EGFRm+ NSCLC patients with CNS metastases to date. It was carried out in 55 study sites located in Chinese mainland, Taiwan, South Korea, and Singapore, with a total enrollment of 492 patients. The clinical and preclinical data of Zorifertinib have shown its high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and similar safety profile as other EGFR-TKI drugs. If approved, it is expected to provide a valuable choice for treatment of EGFRm+ NSCLC patients with CNS metastases. As the name EVEREST suggests, the study sponsor and investigators are dedicated to solving important unmet clinical needs." Professor Jie Wang, Director of Oncology Department of Cancer Hospital Chinese Academy of Medical Sciences, and co-leading PI of EVEREST study, said: "Lung cancer with CNS metastases has always been a challenging problem and leading cause of death for these patients. Zorifertinib is a next-generation, high-potent EGFR-TKI drug targeting sensitive mutations of exon 19 deletion or L858R in EGFR gene with good exposure in CNS lesions. It is not a substrate of efflux transporter P-gp and BCRP, thus not only capable of fully passing through BBB, but also maintaining high drug exposure in the brain tissue and cerebrospinal fluid. It was intentionally designed to optimize its physicochemical and biochemical properties meet the requirements of CNS penetration, which has been proven to be the case in this and prior clinical studies. We look forward to the finale data readout and if positive, a direly needed treatment for these patients." Dr. Ruilin Song, Executive President of China Pharmaceutical Innovation and Research Development Association, said: "In the past three years, the COVID-19 pandemic in some regions of China has brought great challenges to innovative biotech companies. Many clinical study sites faced challenges in terms of regional lockdown, logistics, and clinical operations. However, the clinical development team at Alpha Biopharma and investigators worked together to overcome difficulties to achieve the key milestones of the EVEREST study. They diligently communicated with study sites to come up with solutions, paid full attention to the safety of the subjects and the quality of the trial data while ensuring the uninterrupted treatment of the subjects. In recognizing this pivotal milestone of EVEREST study completion, we would like to express sincere respect for the efforts of all relevant personnel involved in the study and wish Zorifertinib a smooth NDA submission. We are a step closer to bringing new hope to patients with CNS metastases of EGFRm+ NSCLC." About Zorifertinib Zorifertinib is a potent, oral, reversible inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor (EGFR-TKI) activating mutation (L858R and Exon19Del). EGFR is widely expressed in human epidermal cells and stromal cells and is highly expressed in a variety of human malignancies, such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface, accelerate the abnormal growth and division of cells, and eventually lead to tumorigenesis. CNS metastases is common in EGFRm+ NSCLC patients and accompanied with poor prognosis of earlier disease progression, shorter survival, and lower quality of life. The BBB significantly increases the difficulty of drug penetration into CNS, which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a new-generation EGFR-TKI specifically designed to fully penetrate the BBB to target brain metastases. Zorifertinib is in late-stage clinical studies and has global intellectual property protection. About Alpha Biopharma Alpha Biopharma is a late-stage biopharmaceutical company focused on developing potential new therapies for cancer's unmet medical need. Founded in 2017, the Company has advanced its EGFRm+ targeted small molecule drug Zorifertinib to its Phase II/III trial (EVEREST) to treat NSCLC patients with brain metastases. In addition, Alpha Biopharma has initiated an IIT clinical study of an NK cell therapy targeting AML and is developing CAR-T cell therapy that it licensed from Wugen Inc. for the Greater China region. Alpha BioPharma's experienced team, leading clinicians, and collaborators integrate their oncology expertise to find innovative solutions to transform the lives of cancer patients. SOURCE ALPHA BIOPHARMA

Innovative DrugCell TherapySmall molecular drug

100 Deals associated with Zorifertinib

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	CN	Alpha Biopharma (Jiangsu) Co., Ltd.	15 Nov 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	CN	Alpha Biopharma (Jiangsu) Co., Ltd.	15 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 2	CN	Alpha Biopharma (Jiangsu) Co., Ltd.	29 Oct 2018
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 2	TW	Alpha Biopharma (Jiangsu) Co., Ltd.	29 Oct 2018
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 2	KR	Alpha Biopharma (Jiangsu) Co., Ltd.	29 Oct 2018
EGFR-mutated non-small Cell Lung Cancer	Phase 2	KR	AstraZeneca Investment (China) Co. Ltd.	18 Oct 2018
EGFR-mutated non-small Cell Lung Cancer	Phase 2	CN	AstraZeneca Investment (China) Co. Ltd.	18 Oct 2018
EGFR-mutated non-small Cell Lung Cancer	Phase 2	TW	AstraZeneca Investment (China) Co. Ltd.	18 Oct 2018
EGFR-mutated non-small Cell Lung Cancer	Phase 2	SG	AstraZeneca Investment (China) Co. Ltd.	18 Oct 2018
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Discovery	SG	Alpha Biopharma (Jiangsu) Co., Ltd.	29 Oct 2018
EGFR positive non-small cell lung cancer	Discovery	CN	AstraZeneca Investment (China) Co. Ltd.	19 Oct 2017
Advanced Lung Non-Small Cell Carcinoma	Discovery	AU	AstraZeneca PLC	05 Nov 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03653546 (EVEREST, Pubmed \| Med) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line	439	Zorifertinib	(qpdhuryelx): HR = 0.467 (95% CI, 0.352 - 0.619) View more	Positive	01 Oct 2024
				First-generation EGFR-TKI (gefitinib or erlotinib)
NCT03653546 (ASCO 12023 \| ASCO 22023) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation	439	AZD3759 200 mg	(ymkpgucjay) = raojokozel uijbdypxyy (bunpsgsjtk, 8.2 - 9.7) View more	Superior	26 May 2023
				Gefitinib 250 mg or Erlotinib Hydrochloride 150 mg	(ymkpgucjay) = hpekycyqez uijbdypxyy (bunpsgsjtk, 6.3 - 8.0) View more
NCT03574402 (CTONG1702, ESMO_ELCC2023) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutant	30	AZD3759	(xmszebmwkv) = vhnogyoatl bulvddadme (pvkbakttfz ) View more	Positive	31 Mar 2023
NCT02228369 (BLOOM, Pubmed \| Lancet Respir Med) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	67	AZD3759 (dose-escalation)	(vbkllwansc) = led to treatment discontinuation in one (4%) patient treated with 200 mg twice a day (grade 3 increase of alanine aminotransferase and aspartate aminotransferase) and two (13%) patients given 300 mg twice a day (grade 3 diarrhoea [n=1] and grade 3 skin rash [n=1]). ukocgaphkp (vrmgkxhfvt ) View more	Positive	01 Nov 2017
				AZD3759 (dose-expansion)
NCT02228369 (BLOOM, ASCO2017)	Phase 1	Meningeal Leukemia \| EGFR-mutated non-small Cell Lung Cancer	38	AZD3759 200 mg BID	wujfzulacj(djkotyaadc) = 67% (12 out of 18) patients had drug-related dose interruption and/or reduction, however, there were no drug-related discontinuations nwkeiuixzu (azovsjycfk ) View more	Positive	30 May 2017
				AZD3759 300 mg BID
NCT02228369 (BLOOM, ASCO2017)	Phase 1	EGFR positive non-small cell lung cancer \| Advanced Lung Non-Small Cell Carcinoma	38	AZD3759 200 mg BID	terfsngjxg(qsordjvogm) = above pEGFR IC90 hzkoqhndln (oltxgqjmjs ) View more	-	30 May 2017
				AZD3759 300 mg BID

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