Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer - Pipeline Insight, 2025

DelveInsight’s, “Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer - Pipeline Insight, 2025,” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Understanding

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer: Overview

Lung cancer still represents the leading cause of cancer-related mortality. However, the recent advent of tyrosine kinase inhibitors (TKI), pioneering drugs against targetable mutations, have dramatically improved prognosis of advanced non-small cell lung cancer (NSCLC) patients. Anaplastic lymphoma kinase (ALK) gene rearrangements, identified in 3–7% of NSCLC cases, reflects in the constitutive activation of downstream signalling pathways, stimulating tumour cell proliferation, differentiation and survival. To accurately detect the wide spectrum of ALK rearrangements, the introduction of innovative techniques, like reverse transcriptase polymerase chain reaction (RT-PCR) or next generation sequencing (NGS) now allows for a more precise detection of variants and a more objective reading assessment, compared to the traditional diagnostic approaches. In some occasions, these new tools may dynamically monitor tumor evolution and even guide the choice of the most appropriate ALK inhibitor. In fact, among ALK TKIs available, crizotinib was the first to receive FDA accelerate approval for ALK rearranged NSCLC patients. Notwithstanding its response rate, ranging from 57% to 74%, the majority of patients progress within the first year of drug administration, due to acquired resistance. Both ALK-dependent and independent mechanisms of acquired resistance to TKIs have been identified. If the activation of multiple bypass signaling pathways constitutes the most common ALK-independent mechanism of resistance and one of the most difficult to overcome, ALK-dependent escape strategy mainly consists of mutations in the kinase domain, where the type of mutation largely depends on the TKI administered. Second and third generation TKIs are now available and are demonstrating high systemic and central nervous system (CNS) efficacy in clinical trials. Even though appropriate timing and sequencing of these compounds are still unclear, the large number of ALK inhibitors is now a precious resource aiming to prolong progression-free survival (PFS) and finally overall survival (OS).

""Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer pipeline landscape is provided which includes the disease overview and Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer treatment guidelines. The assessment part of the report embraces, in depth Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer commercial assessment and clinical assessment of the pipeline products under development. In the 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, Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer.
• In the coming years, the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics that are working to assess challenges and seek opportunities that could influence Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A detailed portfolio of major pharma players who are involved in fueling the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer treatment market. Several potential therapies for Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer market size in the coming years.
• Our in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Emerging Drugs Chapters

This segment of the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer 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 clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Emerging Drugs

• XZP-3621: Xuanzhu Biopharmaceutical

XZP-3621 is an anaplastic lymphoma kinase inhibitor being developed by Xuanzhu Biopharmaceutical. The company is conducting a randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC.

• SAF-189: Reata Pharmaceuticals

SAF-189 is company’s proprietary, oral active, highly potent and selective small molecule inhibitor of anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) for the treatment of ALK-positive or ROS1-positive NSCLC. ALK and ROS1 gene rearrangements are important predictive biomarkers and oncogenic drivers for a subgroup of advanced NSCLC. SAF-189 exhibited greatest in vitro and in vivo potency against activating and resistance mutations of ALK and ROS1 compared to approved inhibitors. It possessed superior anti-tumor efficacy, high targeted-tissue distribution to brain, lung and tumor, as well as good to excellent pharmacokinetic and safety profiles. In the ongoing Phase 1b/2 clinical trials in China, SAF-189 exhibited good brain penetration capability and demonstrated improved efficacy and good safety profile compared to approved ALK inhibitors in crizotinib-resistant patients (including brain metastasis patients). It is believed, based on our preclinical and clinical data, that SAF-189 has the potential to be the best-in-class ALK/ROS1 inhibitor targeting ALK-positive or ROS1-positive metastatic NSCLC.

Further product details are provided in the report……..

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer

There are approx. 3+ key companies which are developing the therapies for Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer. The companies which have their Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer drug candidates in the most advanced stage, i.e. phase III include, Xuanzhu Biopharmaceutical.

• Phases

DelveInsight’s report covers around 3+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous
• Molecule Type

Products have been categorized under various Molecule types such as

• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer drugs.

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Report Insights

• Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer drugs?
• How many Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Anaplastic Lymphoma Kinase (ALK) Positive, Advanced 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 clinical studies going on for Anaplastic Lymphoma Kinase (ALK) Positive, Advanced Non–Small Cell Lung Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Xuanzhu Biopharmaceutical
• Fochon Pharmaceuticals Ltd
• Shenzhen TargetRx, Inc.

Key Products

• XZP-3621
• SAF-189
• TGRX-326