ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases+ [3]

Active Indication

ALK positive Non-Small Cell Lung CancerNon-small cell lung cancer stage IIIBBrain metastases+ [2]

Inactive Indication

metastatic non-small cell lung cancerReactive oxygen species 1 positive non-small cell lung cancer

Originator Organization

Xcovery, Inc.

Active Organization

Betta Pharmaceuticals Co., Ltd.

Xcovery Holding, Inc.

Inactive Organization

MedImmune LLC

License Organization

Eversana Life Science Services LLC

Betta Pharmaceuticals Co., Ltd.

Xcovery Holding, Inc.

Drug Highest PhaseApproved

First Approval Date

China (17 Nov 2020),

ALK positive Non-Small Cell Lung Cancer

RegulationPriority Review (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC26H29Cl4FN6O3

InChIKeyIERUINQRGJAECT-ISUJJMBGSA-N

CAS Registry2137030-98-7

Clinical Trials associated with Ensartinib Hydrochloride

NCT07354061

/ RecruitingPhase 1/2IIT

A Single-arm, Multicenter Clinical Study of Ensartinib Combined With Chemotherapy as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer (NSCLC) (TD-ENSEMBLE Study)

The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are:
* Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment?
* What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants.
Participants will:
* Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles).
* Undergo surgical resection within 4 weeks after completing neoadjuvant therapy.
* Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years).
* Be monitored for adverse events and survival outcomes.

Start Date25 Mar 2026

Sponsor / Collaborator

Tangdu Hospital

NCT07448116

/ RecruitingPhase 1/2

A Multi-cohort, Open-label Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Combination With Ensartinib Hydrochloride in Patients With Advanced Solid Tumors.

This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the anti-EGFR/c-Met bispecific antibody MCLA-129 in combination with Ensartinib hydrochloride in patients with advanced solid tumors.

Start Date31 Jan 2026

Sponsor / Collaborator

Betta Pharmaceuticals Co., Ltd.

ChiCTR2500115167

/ RecruitingPhase 4IIT

Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star)

Start Date01 Jan 2026

Sponsor / Collaborator

Jiangsu Cancer Hospital

100 Clinical Results associated with Ensartinib Hydrochloride

100 Translational Medicine associated with Ensartinib Hydrochloride

100 Patents (Medical) associated with Ensartinib Hydrochloride

175

Literatures (Medical) associated with Ensartinib Hydrochloride

31 Dec 2026·Lung Cancer Management

Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China

Article

Author: Zhu, Fanfan ; Li, Hongchao ; Xue, Jing ; Le, Hannah ; Duan, Jia ; Hu, Bingqi ; Li, Dingsiman ; Rifi, Nada ; Dong, Peng ; Luan, Luan

AIM:

To estimate brain metastases (BM) management costs in Chinese ALK+ advanced non-small-cell lung cancer (NSCLC) patients receiving first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).

METHODS:

A survey of 105 clinical experts across 23 Chinese regions evaluated healthcare resource utilization (HCRU). Total annual costs with TKIs were calculated by weighting the management costs of patients with and without BM using the cumulative incidence rate (CIR) of BM from ALK-TKI clinical trials.

RESULTS:

First-year management cost averaged ¥24,974 per-patient without BM versus ¥89,859 per-patient with BM, saving ¥64,885. Subsequent years saved ¥33,231. Applying 12-month CIR of BM, the annual costs per-patient were ¥26,791 for 1 L lorlatinib versus ¥46,516 for crizotinib in the intention-to-treat (ITT) population. Subgroup analysis showed annual costs of ¥25,623 per-patient with lorlatinib in those without BM and ¥29,775 in those with BM. Alectinib's and brigatinib's costs were ¥31,073 and ¥32,760 respectively, using the 12-month CIR of BM. Lorlatinib's cost savings increased progressively over 1-4 years. Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials.

CONCLUSION:

Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.

01 Sep 2026·VALUE IN HEALTH

Cost-Effectiveness Analysis of the Five First-line Treatment Regimens for ALK-positive NSCLC in China: An Economic Evaluation Based on Network Meta-Analysis

Article

Author: Cai, Bikun ; Liu, Yuhang ; Hu, Shuangshuang ; Zeng, Guihao ; Ou, Jing ; Zhang, Hui

BACKGROUND:

With multiple first-line treatment options now available for advanced ALK-positive non-small cell lung cancer (NSCLC), clinicians and patients face significant challenges in selecting the optimal therapeutic strategy. This study aims to evaluate the cost-effectiveness of five tyrosine kinase inhibitors (TKIs) as first-line therapies from the perspective of the Chinese healthcare system.

METHODS:

Using crizotinib as a common comparator, we performed indirect comparisons across five ALK-TKIs by reconstructing survival data and applying fractional polynomial models to estimate time-varying hazard ratios. A partitioned survival model was developed to assess cost-effectiveness. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were conducted to evaluate model robustness. Primary outcomes included total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). The willingness-to-pay (WTP) threshold was set at $27,906.00/QALY.

RESULTS:

Compared to crizotinib, the ICERs for lorlatinib, alectinib, ensartinib, brigatinib, and iruplinalkib were $4,674.43/QALY, $5,361.28/QALY, $199,751.00/QALY, -$29,623.06/QALY, and $4,652.70/QALY, respectively. Iruplinalkib yielded the highest QALY gain, while brigatinib was associated with the lowest total cost. DSA identified utility values and drug prices as key drivers of the ICERs. At a WTP threshold of $27,906/QALY, PSA indicated that iruplinalkib had the highest probability (75.70%) of being cost-effective.

CONCLUSION:

For patients with advanced ALK-positive NSCLC in China, lorlatinib, alectinib, brigatinib, and iruplinalkib are cost-effective compared to crizotinib, with the exception of ensartinib. Among these, iruplinalkib is the most cost-effective TKI for first-line treatment, followed by lorlatinib.

01 Aug 2026·VIRUS RESEARCH

Repurposing ALK inhibitors as influenza and corona virus antivirals targeting lymphocyte tyrosine kinase (LTK)

Article

Author: Våtsveen, Thea Kristin ; Farhan, Hesso ; Munthe, Ludvig ; Tjärnhage, Elias ; Nemazee, David ; Grodeland, Gunnveig ; Raki, Melinda

The development of effective antiviral drugs for pandemic scenarios is a significant challenge, particularly due to the rapid emergence of drug-resistant viral strains and a paucity of drugs that have broad efficacy across viral families. A promising strategy is so called host-targeted therapeutics which inhibit host-mechanisms that viruses rely on instead of viruses themselves. LTK, an endoplasmic reticulum-resident kinase, plays a crucial role in ER-to-Golgi trafficking, a process exploited by many viruses during their life cycle, and is therefore a potential candidate for host-targeted antiviral therapeutics. LTK is highly homologous to ALK, a tyrosine kinase that can be aberrantly expressed by cancer cells, and importantly, LTK, but not ALK, is expressed in the lung and small intestine. We here repurposed ALK-inhibitors that also inhibit LTK, and investigated if this inhibition could reduce viral load and serve as a new class of antiviral drug. In vitro, influenza and SARS-CoV-2 viruses could be inhibited by the LTK inhibitors ceritinib, crizotinib, entrectinib, ensartinib, brigatinib, and alectinib, but not lorlatinib. Importantly, the repurposed ALK-inhibitors crizotinib, brigatinib, and ceritinib also gave some protection in mice against lethal viral challenges with influenza and SARS-CoV-2, respectively. The study highlights the potential of LTK inhibition as target for a new class of host-targeted antivirals therapeutics.

News (Medical) associated with Ensartinib Hydrochloride

21 Sep 2026

·firstwordpharma.com

Novo's Frehemgo, Incyte's Povofortay among key CHMP nods in September

The EMA's drug advisory panel backed a dozen new medicines for approval at its September meeting, including Novo's Frehemgo (denecimig) for haemophilia A, Incyte's Povofortay (povorcitinib) in severe hidradenitis suppurativa (HS) and two therapies for ovarian cancer.Among the more closely watched decisions announced Friday, the agency's Committee for Medicinal Products for Human Use (CHMP) recommended Frehemgo for the routine prophylaxis of bleeding episodes in patients with haemophilia A, regardless of inhibitor status. The decision was supported by findings from the FRONTIER programme, in which Frehemgo significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment. The next-generation factor VIIIa mimetic bispecific antibody, previously known as Mim8, has also shown comparable effectiveness in children.The drug's dosing flexibility – it can be given once-monthly, once every two weeks, or once-weekly via single-use pre-filled pens – could be a possible key differentiator (see — KOL Views Q&A: Novo Nordisk’s denecimig may struggle to displace entrenched Hemlibra in haemophilia A). A similar application for Frehemgo is under review in the US.On Friday, Novo also received a positive CHMP opinion to expand use of Sogroya (somapacitan) to include children living with idiopathic short stature with persistent growth disturbance. The once-weekly, long-acting human growth hormone analogue is already authorised in the EU for the treatment of growth hormone deficiency in adults and in children ages 3 years and older.Povofortay nears first OKMeanwhile, the positive opinion for Povofortay moves Incyte's oral JAK1 inhibitor one step closer to securing its first approval. CHMP's decision covers the treatment of active moderate-to-severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.The submission is supported by findings from the Phase III STOP-HS1 and STOP-HS2 studies, which both met their primary endpoints by demonstrating significant reductions in abscess and nodule count. Longer-term results presented at this year's American Academy of Dermatology (AAD) meeting showed that up to 57% of HS patients taking Povofortay achieved ≥75% reduction in inflammatory lesions after one year in the trials.A filing in this indication is also under review in the US, while Incyte is planning applications in vitiligo based on data released earlier this year. Pair of ovarian cancer drugsIn ovarian cancer, CHMP backed the approval of drugs with two different mechanisms of action: Corcept Therapeutics' selective glucocorticoid receptor modulator Lifyorli (relacorilant) and IMPACT Therapeutics' oral PARP1/2 inhibitor Sepalna (senaparib).Lifyorli's positive opinion is for use in combination with nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The drug, which was approved earlier this year in the US, is seen as an advancement in ovarian cancer treatment. Deanna Gerber, an assistant professor of obstetrics and gynaecology at Weill Cornell Medicine, previously told FirstWord that Lifyorli is "going to be the next big thing" in the field (see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The recommendation was based on clinical data including from the Phase III ROSELLA trial, in which patients given Lifyorli plus nab-paclitaxel achieved improved progression-free and overall survival compared to nab-paclitaxel alone, without an increase in adverse events.The EMA panel also endorsed Sepalna as a maintenance treatment for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The decision was supported by findings from the Phase III FLAMES study, in which Sepalna reduced the risk of disease progression of death by 57% compared to placebo when used as first-line maintenance monotherapy in a broad patient population with advanced ovarian cancer.Sepalna is already approved in China in the ovarian cancer maintenance setting, while IMPACT recently out-licensed certain rights to the drug to Pharmanovia, including in the EU.Other new drugs recommended for approval at CHMP's latest meeting include Xcovery's Gevalka (ensartinib) for adults with ALK-positive advanced non–small-cell lung cancer, AstraZeneca's Klygefa (gefurulimab) for generalised myasthenia gravis, Sanofi's rabies vaccine VaxRabeo, and Zealand Pharma's Zeydovio (glepaglutide) for the treatment of short bowel syndrome.

Clinical ResultPhase 3Drug Approval

21 Sep 2026

·www.fiercepharma.com

Europe's CHMP endorses slew of new medicines, including new offerings from Novo and AZ

European drug regulators just wrapped another stack of reviews , and the EU bloc now has a sizeable list of likely new treatments to show for it. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has signed off on eight new medicines, two biosimilars and two generics, while also recommending label extensions for 11 other therapies. Among the most notable developments is a positive recommendation for Novo’s Frehemgo, also known as denecimig, to treat or prevent bleeding episodes in adults and children with hemophilia A. Novo is positioning the drug as a next-generation factor VIIIa mimetic. The bispecific antibody works by binding Factor IXa and Factor X to increase thrombin production and improve clotting. Frehemgo is in direct competition with Roche’s blockbuster and current market leader Hemlibra, which made 4.8 billion Swiss francs ($5.81 billion) in sales last year. The CHMP recommendation comes just days after Frehemgo’s first approval in Saudi Arabia and makes way for a possible approval from the European Commission in the coming weeks. It’s a welcome win for Novo after suffering a string of late-stage disappointments in its cardiovascular pipeline amid mounting competition in metabolic medicine markets. The Danish drugmaker expects an initial launch of Frehemgo by years' end, with a broader rollout in early 2027. AstraZeneca’s rare disease business Alexion also snagged a recommendation from the CHMP, setting up dual-binding nanobody C5 inhibitor Klygefa for a formal approval from the EC. Klygefa, also known as gefurulimab, received the CHMP go-ahead as a treatment for adult patients with generalized myasthenia gravis (gMG), a chronic autoimmune disease marked by muscle weakness caused by the immune system’s attack on the connection points between the nerves and muscles. The treatment marks AstraZeneca’s continued investment in the C5 inhibitor class after Soliris and Ultomiris. But unlike those earlier infused drugs, Klygefa is a self-administered injection, offering patients more control and flexibility. If approved, Europe will be Klygefa’s second approval after Japan earlier this month and it will be the first dual-binding nanobody C5 inhibitor approved for gMG patients. Beyond those meds, new offerings from SFL Pharmaceuticals, Corcept, Incyte Biosciences and Sanofi also made the cut at CHMP this week. SFL scored double with a positive recommendation for both Gevalka and Sepalna. Gevalka was recommended in adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, a version of the disease more common in young patients who have never smoked. And Sepalna was recommended as a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube, or primary perineal cancer. Corcept’s Lifyorli, meanwhile, snagged a recommendation as a combo treatment with chemotherapy for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Incyte Biosciences’ Povofortay will take a positive review to the European Commission for acne inversa. And rounding out the list of endorsements was Sanofi’s rabies vaccine VaxRabeo. Alfasigma’s Jyseleca, AstraZeneca and Daiichi Sankyo's Enhertu, Merk & Co.'s Keytruda, Novartis’ Cosentyx, Leo’s Anzupgo, and Roche’s Ocrevus, among others, took positive opinions for their proposed label expansions. In a setback for MaaT Pharma, the CHMP elected—after reexamination—to uphold its decision to recommend against Xervyteg as a treatment for acute graft-versus-host disease, a life-threatening condition in which donor bone marrow or stem cells attack the patient. The agency maintained that MaaT’s single-arm trial did not show a sufficient benefit-risk profile. In response, the pharma proposed a phase 3 trial evaluating Xervyteg against a best available therapy to satisfy regulator concerns. All CHMP recommendations now head for the European Commission for final sign-off.

Drug ApprovalPhase 3Clinical Result

09 Jul 2026

·www.prnewswire.com

Groundbreaking Achievement: Study of Ensartinib as Postoperative Adjuvant Therapy Published in The New England Journal of Medicine

HANGZHOU, China, July 8, 2026 /PRNewswire/ -- On July 8, the study of Betta's ensartinib as postoperative adjuvant therapy for patients with stage IB–IIIB (T3N2M0) ALK-positive non-small cell lung cancer (NSCLC), known as the ELEVATE study, was published online in full in The New England Journal of Medicine (NEJM; Impact Factor 84.5), a world-leading medical journal. The study provides important evidence for adjuvant therapy of ALK-positive NSCLC worldwide and has the potential to change current clinical practice. Continue Reading Lung cancer is the most common and deadliest malignancy both globally and in China. According to the statistical report issued by the National Cancer Center, in 2022, there were an estimated 1.06 million new cases of lung cancer and 733,300 related deaths in China. Of patients with lung cancer, NSCLC accounts for up to 85%. Approximately 5-7% of patients with NSCLC have ALK-positive disease. Although some patients with ALK-positive NSCLC are diagnosed at an early or intermediate stage amenable to surgical resection, they still face high risks of recurrence and death, and traditional postoperative adjuvant chemotherapy offers modest benefits. Therefore, reducing the risk of recurrence and prolonging survival after surgery remains an urgent unmet clinical need. The ELEVATE study directly addresses this unmet need. In the ELEVATE study, a total of 274 patients from 56 medical centers across China were randomly assigned at a 1:1 ratio to receive oral ensartinib or placebo following complete surgical resection and any planned adjuvant chemotherapy. It is a phase 3, multicenter, randomized, placebo-controlled, double-blind registration study in the field of ALK-TKI adjuvant therapy for ALK-positive lung cancer. The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37). Dr. Ding Lieming, Chairman and CEO of Betta Pharmaceuticals, stated: "The publication of the ELEVATE study in NEJM represents high recognition from the international medical community of the scientific value and clinical significance of this research. It is not only an important milestone for Betta but also a landmark achievement showcasing Chinese clinical oncology research on the global academic stage, with the potential to change postoperative adjuvant treatment strategies for patients with ALK-positive lung cancer. The marketing application for the adjuvant indication of ensartinib has already been accepted in China. Moving forward, we will continue to focus on unmet clinical needs, deepen independent innovation, and accelerate the development of more innovative products with core competitiveness and global impact, benefiting more patients." It is known that ensartinib is a novel, potent, and highly selective next-generation ALK inhibitor. It is an innovative drug developed independently and wholly owned by Betta Pharmaceuticals and its subsidiary Xcovery. Its first-line and second-line indications have already been approved in China, offering good accessibility and a favorable safety profile, and it has received the First Prize for Scientific and Technological Progress in Zhejiang Province. In December 2024, ensartinib was approved for marketing in the United States and subsequently included in the NCCN Guidelines for Non-Small Cell Lung Cancer. Marketing authorization applications in other overseas markets, including the European Union, are progressing. SOURCE Betta Pharmaceuticals 21% more press release views with Request a Demo

Phase 3Drug ApprovalClinical ResultCSCO

100 Deals associated with Ensartinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11356	-	L01XE L01E	DB14860

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	China	Betta Pharmaceuticals Co., Ltd.	17 Nov 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Solid Neoplasm	Phase 2	China	Betta Pharmaceuticals Co., Ltd.	31 Jan 2026
Non-small cell lung cancer stage IIIB	Phase 2	China	Betta Pharmaceuticals Co., Ltd.	15 Jan 2025
Brain metastases	Phase 2	China	Betta Pharmaceuticals Co., Ltd.	21 Mar 2019
Reactive oxygen species 1 positive non-small cell lung cancer	Phase 2	China	Betta Pharmaceuticals Co., Ltd.	29 May 2018
Uveal Melanoma	Phase 2	United States	Xcovery Holding, Inc.	10 Jan 2018
Advanced Malignant Solid Neoplasm	Phase 2	United States	Xcovery Holding, Inc.	01 Jun 2012
metastatic non-small cell lung cancer	Phase 1	China	Betta Pharmaceuticals Co., Ltd.	06 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03213652 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Refractory Central Nervous System Lymphoma \| Ependymoma ... View more	13	Computed Tomography+Ensartinib	mqzgwteofw = pingsqrmso pqvujwjofx (kspsgqwsyk, nzetguvcma - oacguugmvq) View more	-	06 Oct 2026
NCT06780839 (WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	70	Ensartinib	ufxpuxmzst(lqbwywyzwn) = jfrudxcydy rkujjebdfy (toicynlptl, 67.9 - 84.9)	Positive	12 Sep 2026
NCT02767804 (eXALT-3, WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK+	290	Ensartinib 225 mg	ggkcxkloxw(jjzvjyvpbk) = cdqgysryif ufjbmsfkbg (xlsjqgpskq, 50.9 - NE) View more	Positive	12 Sep 2026
NCT02767804 (eXALT-3, WCLC2026)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK+	290	Crizotinib 250 mg	ggkcxkloxw(jjzvjyvpbk) = abxmksmjrp ufjbmsfkbg (xlsjqgpskq, 38.0 - NE) View more	Positive	12 Sep 2026
WCLC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer ALK-positive	7	Ensartinib combined with anlotinib	kzelmnjcta(bfzjrhjolo) = lhxxxactsa dlivlavwkf (uqnppqipcq, 42.1 - 99.6) View more	Positive	12 Sep 2026
NCT05380024 (NEOEAST, WCLC2026)	Phase 2	ALK positive Non-Small Cell Lung Cancer Neoadjuvant ALK+	10	Ensartinib 225 mg	bhuwafgioo(lvqgeeuyom) = zgwezpavjk iywncfrhjf (efpqdfvluk ) View more	Positive	12 Sep 2026
NCT05341583 (ELEVATE, Pubmed \| N Engl J Med)	Phase 3	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	274	Ensartinib 225 mg	bhcefssxyz(jjgpzyibqy) = sypcbmccky xszolobzta (kypxocrmin ) View more	Positive	09 Jul 2026
NCT05341583 (ELEVATE, Pubmed \| N Engl J Med)	Phase 3		274	Placebo	bhcefssxyz(jjgpzyibqy) = nhvjaifmcu xszolobzta (kypxocrmin ) View more	Positive	09 Jul 2026
EBMT2026	Not Applicable	ALK-positive anaplastic large cell lymphoma	9	Ensartinib alone	imvytjhnib(txozxiolee) = svnxowlorf asujnfmysf (ffqtotgbun ) View more	Positive	22 Mar 2026
NCT05341583 (ELEVATE, ESMO2025)	Phase 3	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK+	274	Ensartinib 225 mg	rwkbmhidfe(tmccymbtxy) = zwoymrmbjb wwwxlqlxia (kcmabqvvez ) View more	Positive	17 Oct 2025
NCT05341583 (ELEVATE, ESMO2025)	Phase 3	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK+	274	Placebo	rwkbmhidfe(tmccymbtxy) = buasoqkfyd wwwxlqlxia (kcmabqvvez ) View more	Positive	17 Oct 2025
WCLC2025	Not Applicable	ALK positive Non-Small Cell Lung Cancer Neoadjuvant	9	Ensartinib (monotherapy or combination with chemotherapy)	goauzkomox(spzciuprxw) = mifefviesr nynvrjiczn (dwfwyuurea ) View more	Positive	09 Sep 2025
NCT05341583 (BTP-42338, Corporate Publications) Manual	Phase 3	Small Cell Lung Cancer \| Non-Small Cell Lung Cancer Adjuvant ALK Positive	-	Ensartinib	ayjhptkbpg(lqhkpiwbmo) = 具有显著统计学意义和重要临床获益 xgybmffyeh (ntmxunipdm ) Met	Positive	25 Aug 2025
NCT05341583 (BTP-42338, Corporate Publications) Manual	Phase 3		-	placebo		Positive	25 Aug 2025

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