DelveInsight’s, “ALK+ NSCLC Pipeline Insight 2025” report provides comprehensive insights about 6+ companies and 7+ pipeline drugs in ALK+ NSCLC pipeline landscape. It covers the ALK+ NSCLC pipeline drug profiles, including clinical and nonclinical stage products. It also covers the ALK+ NSCLC pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the ALK+ NSCLC Pipeline Report
- On 03 September 2025, Pfizer announced a study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.
- On 29 August 2025, Nuvalent Inc. conducted a Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
- On 22 August 2025, Gilead Sciences organized a study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.
- DelveInsight’s ALK+ NSCLC Pipeline report depicts a robust space with 6+ active players working to develop 7+ pipeline therapies for ALK+ NSCLC treatment.
- The leading ALK+ NSCLC Companies such as Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical and others.
- Promising ALK+ NSCLC Pipeline Therapies such as Lorlatinib, XZP-3621, X-396 (ensartinib), Crizotinib, WX-0593, SAF-189s, and others.
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ALK+ NSCLC Emerging Drugs Profile
- SY-3505: Shouyao Holdings
Ficonalkib (SY-3505) is a highly potent, adenosine triphosphate-competitive, CNS-penetrant, 3rd-gen ALK TKI. In vitro kinase assay revealed that ficonalkib exhibits potent inhibition against both wild-type ALK and a diverse spectrum of mutants observed in patients resistant to 1st- and 2nd-gen ALK TKI, including L1196M, G1202R, F1174L, G1269S, and R1275Q20. The drug exhibits high kinase selectivity and has very weak inhibition on tropomyosin receptor kinase (TRK). The drug is currently being evaluated under Phase III clinical trials for the NSCLC Treatment
- APG-2449: Ascentage Pharma
APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development. The updated results at the ASCO indicated favorable safety and promising antitumor activity in NSCLC Patients, and the preliminary efficacy observed in patients who were resistant to second-generation ALK inhibitors was particularly encouraging. APG-2449 is currently being evaluated in Phase I Non-Small Cell Lung Cancer Clinical Trials.
The ALK+ NSCLC Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of ALK+ 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+ NSCLC Treatment.
- ALK+ NSCLC Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- ALK+ 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+ NSCLC market
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ALK+ NSCLC Companies
Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical and others.
ALK-positive Non-Small Cell Lung Cancer Ppeline Report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
- Intra-articular
- Intraocular
- Intrathecal
- Intravenous
- Oral
- Parenteral
- Subcutaneous
- Topical
- Transdermal
ALK+ NSCLC Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
Unveil the future of ALK+ NSCLC Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ ALK+ NSCLC Market Drivers and Barriers
Scope of the ALK+ NSCLC Pipeline Report
- Coverage- Global
- ALK+ NSCLC Companies- Nuvalent, Shouyao Holdings, Xuanzhu Biopharmaceutical, Fochon Pharmaceutical and others.
- ALK+ NSCLC Pipeline Therapies- Lorlatinib, XZP-3621, X-396 (ensartinib), Crizotinib, WX-0593, SAF-189s, and others.
- ALK+ NSCLC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- ALK+ NSCLC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Get the latest on ALK+ NSCLC Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ ALK+ NSCLC Companies, Key Products and Unmet Needs
Table of Content
- Introduction
- Executive Summary
- ALK Positive Non-Small Cell Lung Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- ALK Positive Non-Small Cell Lung Cancer – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- SY-3505: Shouyao Holdings
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Product Name: Company Name
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- APG-2449: Ascentage Pharma
- Drug profiles in the detailed report…..
- Preclinical Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- ALK Positive Non-Small Cell Lung Cancer - Collaborations Assessment- Licensing / Partnering / Funding
- ALK Positive Non-Small Cell Lung Cancer - Unmet Needs
- ALK Positive Non-Small Cell Lung Cancer - Market Drivers and Barriers
- Appendix
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