Cutaneous Squamous cell Carcinoma Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Cutaneous Squamous Cell Carcinoma Pipeline Insight 2025" report provides comprehensive insights about 45+ companies and 45+ pipeline drugs in Cutaneous Squamous Cell Carcinoma pipeline landscape. It covers the Cutaneous Squamous Cell Carcinoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cutaneous Squamous Cell Carcinoma 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 Cutaneous Squamous Cell Carcinoma Pipeline Report

* In April 2025, Merck Sharp & Dohme LLC announced a study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR).
* In April 2025, Replimune Inc . announced a Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, lung, or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.
* DelveInsight's Cutaneous Squamous Cell Carcinoma pipeline report depicts a robust space with 45+ active players working to develop 45+ pipeline therapies for Cutaneous Squamous Cell Carcinoma treatment.
* The leading Cutaneous Squamous Cell Carcinoma Companies such as Incyte Corporation, Shanghai Henlius Biotech, Novartis, Rakuten Medical, Morphogenesis, Genentech, Berg Pharma, I-MAB Biopharma, Roche, Genexine, CureVac, and others.
* Promising Cutaneous Squamous Cell Carcinoma Therapies such as MK-3475A, L19IL2 +L19TNF, Cemiplimab, Everolimus, Sirolimus, and others.

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Cutaneous Squamous Cell Carcinoma Emerging Drugs

* HLX 07: Shanghai Henlius Biotech

HLX07 is a bio-better independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and increase the affinity of the product. Pre-clinical studies have shown that HLX07 binds EGFR with similar affinity and had better bioactivity compared to cetuximab. Henlius holds patents of HLX07 in several jurisdictions including China, the United States, the European Union, Australia, and Japan. Moreover, Henlius has received clinical trial approvals for HLX07 in the treatment of solid tumors in Chinese mainland, the United States, and Taiwan China. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Cutaneous Squamous Cell Carcinoma.

* Opzelura: Incyte Corporation

Opzelura, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Cutaneous Squamous Cell Carcinoma.

* RM 1995: Rakuten Medical

RM-1995, developed by Rakuten Medical using its IlluminoxTM platform, is an antibody-dye conjugate comprised of a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor -chain (CD25) and IRDye Registered 700DX (IR700), a light-activatable dye. RM-1995 photo immunotherapy is designed to specifically kill CD25+ regulatory T cells (Tregs) within solid tumors, once illuminated with 690nm nonthermal red light. Rakuten Medical's preclinical data has suggested that RM-1995 photo immunotherapy treatment can be utilized to specifically deplete intratumoral Tregs, thereby alleviating local Treg-mediated restraint within the tumor microenvironment, rapidly improving the CD8 T cell: Treg ratio, and reinvigorating effector CD8+ T cell responses. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of Cutaneous Squamous Cell Carcinoma.

The Cutaneous Squamous Cell Carcinoma pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Cutaneous Squamous Cell Carcinoma 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 Cutaneous Squamous Cell Carcinoma Treatment.
* Cutaneous Squamous Cell Carcinoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Cutaneous Squamous Cell Carcinoma 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 Cutaneous Squamous Cell Carcinoma market.

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Cutaneous Squamous Cell Carcinoma Companies

Incyte Corporation, Shanghai Henlius Biotech, Novartis, Rakuten Medical, Morphogenesis, Genentech, Berg Pharma, I-MAB Biopharma, Roche, Genexine, CureVac, and others.

Cutaneous Squamous Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

* Intra-articular
* Intraocular
* Intrathecal
* Intravenous
* Ophthalmic
* Oral
* Parenteral
* Subcutaneous
* Topical
* Transdermal

Cutaneous Squamous Cell Carcinoma Products have been categorized under various Molecule types such as

* Oligonucleotide
* Peptide
* Small molecule

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Scope of the Cutaneous Squamous Cell Carcinoma Pipeline Report

* Coverage- Global
* Cutaneous Squamous Cell Carcinoma Companies- Incyte Corporation, Shanghai Henlius Biotech, Novartis, Rakuten Medical, Morphogenesis, Genentech, Berg Pharma, I-MAB Biopharma, Roche, Genexine, CureVac, and others.
* Cutaneous Squamous Cell Carcinoma Therapies - MK-3475A, L19IL2 +L19TNF, Cemiplimab, Everolimus, Sirolimus, and others.
* Cutaneous Squamous Cell Carcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Cutaneous Squamous Cell Carcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Cutaneous Squamous cell Carcinoma Executive Summary
* Cutaneous Squamous Cell Carcinoma: Overview
* Cutaneous Squamous cell Carcinoma Pipeline Therapeutics
* Cutaneous Squamous cell Carcinoma Pipeline Therapeutic Assessment
* Cutaneous Squamous Cell Carcinoma- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Drug Name : Company Name
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* HLX 07: Shanghai Henlius Biotech
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* RM 1995: Rakuten Medical
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* Cutaneous Squamous Cell Carcinoma Key Companies
* Cutaneous Squamous Cell Carcinoma Key Products
* Cutaneous Squamous Cell Carcinoma- Unmet Needs
* Cutaneous Squamous Cell Carcinoma- Market Drivers and Barriers
* Cutaneous Squamous Cell Carcinoma- Future Perspectives and Conclusion
* Cutaneous Squamous Cell Carcinoma Analyst Views
* Cutaneous Squamous Cell Carcinoma Key Companies
* Appendix

About Us

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