ALK+ NSCLC Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

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.

Discover the latest drugs and treatment options in the ALK+ NSCLC Pipeline. Dive into DelveInsight's comprehensive report today! @ ALK+ NSCLC Pipeline Outlook- https://www.delveinsight.com/sample-request/alk-positive-non-small-cell-lung-cancer-alk-nsclc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Key Takeaways from the ALK+ NSCLC Pipeline Report
• In May 2025, Shenzhen TargetRx Inc. announced a Phase II studyaims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced NSCLC. The primary purpose of this study is to evaluate the efficacy profile of TGRX-326, with the objective response rate (ORR) as end point. Secondary objectives include evaluating efficacy profile of other endpoints and safety profiles of the investigational drug. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326.
• In May 2025, Novartis Pharmaceuticals conducted a study is to learn whether the study treatment (capmatinib), which already shows efficacy and safety in non-Chinese patients, could help Chinese patients with controlling their lung cancer in a safe way. Participants will have a type of lung cancer called non-small cell lung lancer (NSCLC), with a specific alteration in a part of their DNA (called mutation) of the MET gene, within a specific part of this gene called exon 14.
• In May 2025, Hoffmann-La Roche organized a study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
• In May 2025, Merck Sharp & Dohme LLC announced a study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
• In May 2025, Turning Point Therapeutics Inc. conducted a Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
• 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.

Stay ahead with the most recent pipeline outlook for ALK+ NSCLC. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ ALK+ NSCLC Treatment Drugs- https://www.delveinsight.com/sample-request/alk-positive-non-small-cell-lung-cancer-alk-nsclc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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

Explore groundbreaking therapies and clinical trials in the ALK+ NSCLC Marketed and Pipeline Drugs. Access DelveInsight's detailed report now! @ New ALK+ NSCLC Drugs- https://www.delveinsight.com/sample-request/alk-positive-non-small-cell-lung-cancer-alk-nsclc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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- https://www.delveinsight.com/sample-request/alk-positive-non-small-cell-lung-cancer-alk-nsclc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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- https://www.delveinsight.com/sample-request/alk-positive-non-small-cell-lung-cancer-alk-nsclc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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