ALK Positive Non-Small Cell Lung Cancer Pipeline
DelveInsight’s, “ALK-positive Non-Small Cell Lung Cancer (ALK+ NSCLC) Pipeline Insight, 2025,” report provides comprehensive insights about 6+ companies and 7+ pipeline drugs in ALK-positive Non-Small Cell Lung Cancer 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 ALK+ NSCLC pipeline products in this space.
Geography Covered
- Global coverage
ALK+ NSCLC Pipeline: Understanding
Fusions of the echinoderm microtubule-associated protein-like 4 (EML4) gene and the anaplastic lymphoma kinase (ALK) gene were first identified as a likely molecular driver in patients with NSCLC. Anaplastic lymphoma kinase (ALK) gene rearrangements occur in a small portion of patients with non-small cell lung cancer (NSCLC). These gene rearrangements lead to constitutive activation of the ALK kinase and subsequent ALK driven tumor formation. Patients with tumors harboring such rearrangements are highly sensitive to ALK inhibitors such as crizotinib, ceritinib, and alectinib.
About 90% of those diagnosed with ALK-positive cancer are diagnosed when the cancer has already spread to other parts of the body (known as metastatic cancer, or stage 4 cancer). Without any cancer treatment, half of patients with metastatic ALK cancer would die within less than 12 months, but with modern treatments that has that has increased more than six-fold, to over six years, in the last decade, and that median survival is continuing to increase as research discovers improved treatments and better medicines.
Lung cancer may not show symptoms until you’ve had it long enough for it to spread to other parts of the body. The symptoms associated with the lung cancer are coughing, worse chest pain with deep breathing or laughing, hoarseness, coughing up blood, weak or tired feeling, and wheezing. Currently, ALK is diagnosed by genetic testing, known as molecular testing, of a sample. The National Comprehensive Cancer Center Network (NCCN) in the United States recommends that testing be performed via a broad, panel-based approach, typically by NGS. For patients who don’t have identifiable driver oncogenes by DNA NGS, consider RNA-based NGS to maximize detection of fusion events. To obtain a sample, it is necessary to undergo a biopsy, typically through a needle biopsy or a small surgical procedure.
Several organizations worked together to develop guidelines on who should be tested for an ALK mutation. The consensus was that all patients with advanced-stage adenocarcinoma should be tested for both ALK and EGFR mutations, regardless of gender, smoking history, other risk factors, and race. Patients diagnosed with lung cancer have to be proactive in requesting molecular testing for lung cancer mutations.
“ALK Positive Non-Small Cell Lung Cancer Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. A detailed picture of the ALK Positive Non-Small Cell Lung Cancer Pipeline Landscape is provided which includes the disease overview and ALK Positive Non-Small Cell Lung Cancer treatment guidelines. The assessment part of the ALK Positive Non-Small Cell Lung Cancer Pipeline Report embraces, in depth ALK Positive Non-Small Cell Lung Cancer commercial assessment and clinical assessment of the pipeline products under development. In the ALK Positive Non-Small Cell Lung Cancer Pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, ALK Positive Non-Small Cell Lung Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
ALK+ NSCLC Pipeline Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence ALK Positive Non-Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve ALK Positive Non-Small Cell Lung Cancer.
ALK+ NSCLC Emerging Drugs Chapters
This segment of the ALK-positive Non-Small Cell Lung Cancer pipeline report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand ALK+ NSCLC clinical trials details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
ALK+ NSCLC Emerging Drugs
- 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.
Further product details are provided in the report……..
ALK+ NSCLC Pipeline Therapeutics Assessment
This segment of the ALK+ NSCLC Pipeline Report provides insights about the different ALK-positive Non-Small Cell Lung Cancer Drugs segregated based on following parameters that define the scope of the report, such as:
ALK+ NSCLC Companies
There are approx. 6+ key ALK+ NSCLC Companies which are developing the ALK+ NSCLC Therapies. The ALK+ NSCLC Companies which have their ALK-positive Non-Small Cell Lung Cancer drug candidates in the mid to advanced stage, i.e. phase III include, Shouyao Holdings.
Phases
DelveInsight’s ALK+ NSCLC Pipeline Report covers around 7+ products under different phases of clinical development like
- Mid-stage products (Phase II and Phase I/II)
- Early-stage products (Phase I/II and Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
Route of Administration
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
Molecule Type
ALK+ NSCLC Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
Product Type
ALK+ NSCLC Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
ALK+ NSCLC Pipeline Development Activities
The ALK+ NSCLC Pipeline Report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analysesALK+ NSCLC Therapeutic Drugs Companies involved in developing key drugs.
ALK+ NSCLC Pipeline Development Activities
The ALK+ NSCLC Pipeline Report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of ALK+ NSCLC Emerging Drugs.
ALK+ NSCLC Pipeline Report Highlights
- The ALK+ NSCLC Companies and academics are working to assess challenges and seek opportunities that could influence ALK-positive Non-Small Cell Lung Cancer R&D. The ALK+ NSCLC Therapies under development are focused on novel approaches to treat/improve ALK-positive Non-Small Cell Lung Cancer.
- August 2020: Ensartinib Improves Progression-Free Survival in Patients with ALK-Positive NSCLC
- ALK+ NSCLC treatment with ensartinib induced longer progression-free survival, compared with Xalkori (crizotinib) in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), according to new ALK+ NSCLC Clinical Trials data presented at International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer Virtual Presidential Symposium.
ALK+ NSCLC Pipeline Report Insights
- ALK-positive Non-Small Cell Lung Cancer Pipeline Drugs Analysis
- ALK+ NSCLC Therapeutic Assessment
- ALK+ NSCLC Unmet Needs
- Impact of ALK+ NSCLC Drugs
ALK-positive Non-Small Cell Lung Cancer Report Assessment
- ALK+ NSCLC Pipeline Drugs Profiles
- ALK+ NSCLC Therapeutics Assessment
- ALK+ NSCLC Pipeline Assessment
- Inactive ALK+ NSCLC Drugs Assessment
- ALK+ NSCLC Unmet Needs
Key Questions
Current ALK+ NSCLC Treatment Scenario and Emerging Therapies:
- How many companies are developing ALK+ NSCLC Drugs?
- How many ALK+ NSCLC Drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the ALK+ NSCLC Treatment?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the ALK-positive Non-Small Cell Lung Cancer therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the ALK+ NSCLC Clinical Trials going on and their status?
- What are the key designations that have been granted to the ALK+ NSCLC Emerging Drugs?
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