Vasculitis - Pipeline Insight, 2024

This “Vasculitis - Pipeline Insight, 2024” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in Vasculitis 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

Vasculitis: Understanding

Vasculitis: Overview

Vasculitis is a term for a group of rare diseases that cause inflammation of blood vessels. These vessels include arteries and veins. There are many types of vasculitis, and they may vary greatly in symptoms, severity, and duration. Most types of vasculitis are rare, and the causes are generally not known. Vasculitis affects people of both sexes and all ages. A few forms of vasculitis affect certain groups of people. For instance, Kawasaki disease occurs only in children. IgA Vasculitis is much more common in children than adults. On the other hand, giant cell arteritis occurs only in adults over 50-years-old. Vasculitis can result in poor blood flow to tissues throughout the body, such as the lungs, nerves and skin. The different types of vasculitis are classified according to the size and location of the blood vessels that are affected. When largest arteries, aorta and major branches: Giant cell arteritis, Takayasu’s arteritis, aortitis in Cogan’s syndrome, aortitis in spondylarthropathies, isolated aortitis. When medium size arteries are affected: Kawasaki disease, Polyarteritis nodosa. When Arteries and veins of various sizes: Behçet’s disease and Relapsing polychondritis and many more. A result of vasculitis is that the tissues and organs supplied by affected blood vessels do not get enough blood. This can cause organ and tissue damage that can even lead to death.

Symptoms
Vasculitis has a wide range of signs and symptoms (what you see and feel), such as: shortness of breath and cough, numbness or weakness in a hand or foot, red spots on the skin (“purpura”), lumps (“nodules”), or sores (“ulcers”). On the other hand, vasculitis of the kidneys may produce no symptoms at first but is still a serious problem. Vasculitis can be mild, disabling, or even lead to death. Patients can have one episode of vasculitis or have repeated episodes over several years.

Diagnosis
Physicians suspect vasculitis when a patient has symptoms and abnormal results of the physical exam, lab tests or both, and there is no other clear cause. The most common tests are: Biopsy - surgical removal of a small piece of tissue for inspection under a microscope, angiography - a type of X-ray to look for abnormalities of blood vessels and Blood tests. For most patients, doctors can detect the type of vasculitis based on the size of the affected blood vessels (see Table) and the organs involved. To find small-vessel vasculitis, doctors most often do a biopsy, such as of the skin or a kidney. Detection of medium-vessel vasculitis happens by either biopsy (for instance, of skin, nerve or brain) or angiography. Angiography is also the test that often finds large-vessel vasculitis.

Treatment
Doctors sometimes prescribe immune-suppressing drugs because their long-term side effects may be less serious than those of glucocorticoids. This is called “steroid-sparing” treatment. Cyclophosphamide is one of the strongest of these drugs, and doctors may prescribe it when severe disease endangers vital organs.For less serious vasculitis, patients may receive methotrexate, azathioprine or other immune-suppressing drugs. Doctors often prescribe these drugs to treat other rheumatic diseases, but they are useful for vasculitis, too. Damage from severe vasculitis sometimes requires surgery. This may involve vascular bypass grafting (a surgery to redirect blood flow around a blockage in a blood vessel). Depending on where the damage is, other possible operations are sinus surgery or a kidney transplant.

Vasculitis- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Vasculitis pipeline landscape is provided which includes the disease overview and Vasculitis treatment guidelines. The assessment part of the report embraces, in depth Vasculitis 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, Vasculitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Vasculitis R&D. The therapies under development are focused on novel approaches to treat/improve Vasculitis.

Vasculitis Emerging Drugs Chapters

This segment of the Vasculitis 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.

Vasculitis Emerging Drugs

Hemay005: Ganzhou Hemay Pharmaceutical
Hemay-005 is under development for the treatment of moderate to severe ulcerative colitis, plaque psoriasis, atopic dermatitis, Behçet Disease and ankylosing spondylitis. It is administered through the oral route in the form of tablet and suspension. The therapeutic candidate acts by targeting phosphodiesterase 4 (PDE4). The drug candidate is a new chemical entity small molecule. Currently, the drug is in the Phase III stage of its development for the treatment of Vasculitis.

SHR-1703: Guangdong Hengrui Pharmaceutical
SHR-1703 injection is a humanized anti- IL-5 monoclonal antibody (IgG1 subtype) that can bind to IL-5, inhibit the IL-5/IL-5R signaling pathway, and thereby inhibit the proliferation and activation of eosinophils And migration. Reduce the number of asthma attacks in patients with eosinophilic asthma, improve the lung function of patients, and improve the quality of life of patients. At present, three monoclonal antibodies against IL-5/IL-5R have been approved for marketing in the world, namely, Mepolizumab from GlaxoSmithKline, Reslizumab from Teva, and Benralizumab from AstraZeneca, which have been approved for eosinophilic use. Additional maintenance treatment for granulocytic asthma.). Currently, the drug is in the Phase II/ III stage of its development for the treatment of Vasculitis.

KYV-101: David Porter|Kyverna Therapeutics|University of Pennsylvania
CAR T-cell therapy involves modifying a patient's T cells to recognize and remove B cells in the patient's body. Kyverna's CD19 CAR T-cell therapy, KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases. Kyverna plans to continue to explore additional indications for KYV-101 and develop a robust pipeline of promising product candidate immunotherapies aimed at addressing unmet medical needs in autoimmune diseases. Currently, the drug is in the Phase I stage of its development for the treatment of Vasculitis.

Vasculitis: Therapeutic Assessment

This segment of the report provides insights about the different Vasculitis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Vasculitis

• There are approx. 25+ key companies which are developing the therapies for Vasculitis. The companies which have their Vasculitis drug candidates in the most advanced stage, i.e. Phase III include, Ganzhou Hemay Pharmaceutical.

Phases

This report covers around 30+ 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

Vasculitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Vasculitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Vasculitis 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 Vasculitis drugs.

Vasculitis Report Insights

• Vasculitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Vasculitis 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 Vasculitis drugs?
• How many Vasculitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Vasculitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Vasculitis 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 Vasculitis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Mitsubishi Tanabe Pharma Corporation
• Yake Biotechnology Ltd.
• Kyverna Therapeutics
• Guangdong Hengrui Pharmaceutical Co., Ltd
• InflaRx GmbH
• Ganzhou Hemay Pharmaceutical Co., Ltd

Key Products

• MT-2990
• CD19/BCMA CAR T-cells
• KYV-101
• SHR-1703
• IFX-1
• Hemay005

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