ALK-positive NSCLC Pipeline Drugs Analysis Report (2024 Updates): FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight | Pfizer, Xuanzhu Biopharma, Ariad Pharma, Xcovery Holdings

(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, ALK-positive NSCLC pipeline constitutes 6+ key companies continuously working towards developing 8+ ALK-positive NSCLC treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The ALK-positive NSCLC Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.


ALK-positive NSCLC Pipeline Insight, 2024 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the ALK-positive NSCLC Market.


Some of the key takeaways from the ALK-positive NSCLC Pipeline Report:

Companies across the globe are diligently working toward developing novel ALK-positive NSCLC treatment therapies with a considerable amount of success over the years. 

ALK-positive NSCLC companies working in the treatment market are Xuanzhu Biopharmaceutical, Ariad Pharmaceuticals, Pfizer, Xcovery Holdings, Inc., Shanghai Fosun Pharmaceutical, Qilu Pharmaceutical, Pfizer, Hoffmann-La Roche, Sichuan University, Betta Pharmaceuticals, AstraZeneca, and others, are developing therapies for the ALK-positive NSCLC treatment 

Emerging ALK-positive NSCLC therapies in the different phases of clinical trials are- XZP-3621, Brigatinib, Lorlatinib, X-396 (ensartinib), SAF-189s, WX-0593 Tablets, Lorlatinib, Alectinib, Ensatinib, Ensartinib, X-396 capsule, Osimertinib, and others are expected to have a significant impact on the ALK-positive NSCLC market in the coming years.

In May 2024, Pfizer Inc. (NYSE: PFE) today reported longer-term follow-up results from the Phase 3 CROWN trial, which compared LORBRENA® (lorlatinib, a third-generation ALK inhibitor, known as LORVIQUA® in Europe) to XALKORI® (crizotinib) in patients with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). After a median follow-up of five years, the median progression-free survival (PFS) for LORBRENA had not been reached, with a Hazard Ratio (HR) of 0.19 (95% Confidence Interval [CI], 0.13-0.27), indicating an 81% reduction in the risk of disease progression or death compared to XALKORI. Additionally, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years, compared to 8% (3-14) of those treated with XALKORI.

In March 2024, Florida-based biotech company Xcovery has received acceptance from the US Food and Drug Administration (FDA) for its new drug application (NDA) for Bemena (ensartinib) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The FDA will make a decision on the treatment’s approval by December 28, 2024, under the Prescription Drug User Fee Act. Developed jointly by Xcovery and Betta Pharmaceuticals, Bemena is an ALK inhibitor that targets the overactive ALK protein found in certain cancer cells.   

In February 2024, Nuvalent, Inc. (Nasdaq: NUVL), a biopharmaceutical company in the clinical stage dedicated to developing precise therapies for cancer-related kinase targets, has announced the start of the Phase 2 part of its ALKOVE-1 clinical trial. This trial, which is testing NVL-655 in patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors, has proceeded to Phase 2 after reaching an agreement with the US Food and Drug Administration (FDA) on a recommended Phase 2 dose (RP2D) of 150 mg once daily (QD).


ALK-positive NSCLC Overview

ALK-positive non-small cell lung cancer (NSCLC) is a subtype of lung cancer characterized by a specific genetic abnormality.


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Emerging ALK-positive NSCLC Drugs Under Different Phases of Clinical Development Include:

XZP-3621: Xuanzhu Biopharmaceutical

Brigatinib: Ariad Pharmaceuticals

Lorlatinib: Pfizer

X-396 (ensartinib): Xcovery Holdings, Inc.

SAF-189s: Shanghai Fosun Pharmaceutical

WX-0593 Tablets: Qilu Pharmaceutical

Lorlatinib: Pfizer

Alectinib: Hoffmann-La Roche

Ensatinib: Sichuan University

Ensartinib: Betta Pharmaceuticals

X-396 capsule: Betta Pharmaceuticals

Osimertinib: AstraZeneca


ALK-positive NSCLC Route of Administration

ALK-positive NSCLC pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as 







ALK-positive NSCLC Molecule Type

ALK-positive NSCLC Products have been categorized under various Molecule types, such as

Monoclonal Antibody



Small molecule

Gene therapy 


ALK-positive NSCLC Pipeline Therapeutics Assessment

ALK-positive NSCLC Assessment by Product Type

ALK-positive NSCLC By Stage and Product Type

ALK-positive NSCLC Assessment by Route of Administration

ALK-positive NSCLC By Stage and Route of Administration

ALK-positive NSCLC Assessment by Molecule Type

ALK-positive NSCLC by Stage and Molecule Type


DelveInsight’s ALK-positive NSCLC Report covers around 5+ products under different phases of clinical development like

Late-stage products (Phase III)

Mid-stage products (Phase II)

Early-stage product (Phase I)

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration


Further ALK-positive NSCLC product details are provided in the report. Download the ALK-positive NSCLC pipeline report to learn more about the emerging ALK-positive NSCLC therapies


Some of the key companies in the ALK-positive NSCLC Therapeutics Market include:

Key companies developing therapies for ALK-positive NSCLC are – Xcovery, Nuvalent, F. Hoffmann-La Roche, Pfizer, Novartis, TP Therapeutics, Bristol-Myers Squibb, Eli Lilly and Company, Takeda, Beacon Pharma, and others.


ALK-positive NSCLC Pipeline Analysis:

The ALK-positive NSCLC pipeline report provides insights into 

The report provides detailed insights about companies that are developing therapies for the treatment of ALK-positive NSCLC with aggregate therapies developed by each company for the same.

It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for ALK-positive NSCLC Treatment.

ALK-positive NSCLC key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

ALK-positive NSCLC Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. 

Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the ALK-positive NSCLC market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.


Download Sample PDF Report to know more about ALK-positive NSCLC drugs and therapies


ALK-positive NSCLC Pipeline Market Strengths

Premium-price targeted agents with better clinical profile and expansion of therapies in the first-line expected to drive the growth of NSCLC market.

The development of therapies targeting specific mutations are expected to dominate the upcoming market.


ALK-positive NSCLC Pipeline Market Opportunities

Potential for premium pricing of emerging therapies by showing an edge over current therapies.

Uptake of potential emerging therapies with better clinical profile, specificity towards mutations occurs in NSCLC and therapies to overcome resistance expected to be fast.


Scope of ALK-positive NSCLC Pipeline Drug Insight    

Coverage: Global

Key ALK-positive NSCLC Companies: Xuanzhu Biopharmaceutical, Ariad Pharmaceuticals, Pfizer, Xcovery Holdings, Inc., Shanghai Fosun Pharmaceutical, Qilu Pharmaceutical, Pfizer, Hoffmann-La Roche, Sichuan University, Betta Pharmaceuticals, AstraZeneca, and others

Key ALK-positive NSCLC Therapies: XZP-3621, Brigatinib, Lorlatinib, X-396 (ensartinib), SAF-189s, WX-0593 Tablets, Lorlatinib, Alectinib, Ensatinib, Ensartinib, X-396 capsule, Osimertinib, and others

ALK-positive NSCLC Therapeutic Assessment: ALK-positive NSCLC current marketed and ALK-positive NSCLC emerging therapies

ALK-positive NSCLC Market Dynamics: ALK-positive NSCLC market drivers and ALK-positive NSCLC market barriers 


Request for Sample PDF Report for ALK-positive NSCLC Pipeline Assessment and clinical trials


Table of Contents

1. ALK-positive NSCLC Report Introduction

2. ALK-positive NSCLC Executive Summary

3. ALK-positive NSCLC Overview

4. ALK-positive NSCLC- Analytical Perspective In-depth Commercial Assessment

5. ALK-positive NSCLC Pipeline Therapeutics

6. ALK-positive NSCLC Late Stage Products (Phase II/III)

7. ALK-positive NSCLC Mid Stage Products (Phase II)

8. ALK-positive NSCLC Early Stage Products (Phase I)

9. ALK-positive NSCLC Preclinical Stage Products

10. ALK-positive NSCLC Therapeutics Assessment

11. ALK-positive NSCLC Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. ALK-positive NSCLC Key Companies

14. ALK-positive NSCLC Key Products

15. ALK-positive NSCLC Unmet Needs

16 . ALK-positive NSCLC Market Drivers and Barriers

17. ALK-positive NSCLC Future Perspectives and Conclusion

18. ALK-positive NSCLC Analyst Views

19. Appendix

20. About DelveInsight



About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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