Postmenopausal Osteoporosis - Pipeline Insight, 2024

This “Postmenopausal osteoporosis- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Postmenopausal osteoporosis 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

Postmenopausal osteoporosis: Understanding

Postmenopausal osteoporosis: Overview

Postmenopausal osteoporosis is a condition that predominantly affects women after menopause, characterized by a significant reduction in bone density and an increased risk of fractures. This condition arises due to the dramatic decrease in estrogen levels following menopause, which is crucial for maintaining bone strength. Estrogen helps balance the activity of osteoblasts (cells that build bone) and osteoclasts (cells that break down bone). Without sufficient estrogen, bone resorption outpaces bone formation, leading to weakened bones and heightened fracture risk.

Several factors elevate the risk of developing postmenopausal osteoporosis. Age is a primary factor, as the risk increases significantly with advancing years. A family history of osteoporosis can also predispose women to the condition. Additionally, lifestyle factors such as smoking, excessive alcohol consumption, and physical inactivity contribute to bone density loss. Nutritional deficiencies, particularly low intake of calcium and vitamin D, exacerbate the risk. Long-term use of certain medications, such as corticosteroids, can further weaken bone integrity.

Symptoms of postmenopausal osteoporosis often remain undetected until a fracture occurs, earning it the moniker "silent disease." Fractures commonly occur in the hip, spine, and wrist, leading to severe pain, loss of height, and a stooped posture. Vertebral fractures, in particular, can cause significant discomfort and deformity. Due to the subtle progression of the disease, many women may not realize they have osteoporosis until they experience a fracture from minimal trauma.

Diagnosis of postmenopausal osteoporosis typically involves a bone mineral density (BMD) test, such as a dual-energy X-ray absorptiometry (DEXA) scan, which measures bone density. Additionally, fracture risk assessments, like the FRAX score, help evaluate the probability of fractures based on various factors, including age, weight, and previous fracture history. Early diagnosis is crucial for managing the disease and preventing fractures.

Treatment aims to prevent fractures, alleviate pain, and maintain functionality. Medications, including bisphosphonates, selective estrogen receptor modulators (SERMs), hormone replacement therapy (HRT), parathyroid hormone analogs, and monoclonal antibodies, are commonly prescribed to enhance bone density and reduce fracture risk. Lifestyle and dietary changes, such as increased calcium and vitamin D intake, regular weight-bearing exercises, and fall prevention strategies, are also vital components of managing postmenopausal osteoporosis. Preventive measures, including a healthy diet, regular exercise, and avoiding smoking and excessive alcohol, are essential to maintaining bone health and mitigating the impact of this disease.

"Postmenopausal osteoporosis- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Postmenopausal osteoporosis pipeline landscape is provided which includes the disease overview and Postmenopausal osteoporosis treatment guidelines. The assessment part of the report embraces, in depth Postmenopausal osteoporosis 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, Postmenopausal osteoporosis 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 Postmenopausal osteoporosis R&D. The therapies under development are focused on novel approaches to treat/improve Postmenopausal osteoporosis.

Postmenopausal osteoporosis Emerging Drugs Chapters

This segment of the Postmenopausal osteoporosis 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.

Postmenopausal osteoporosis Emerging Drugs

HLX14: Shanghai Henlius Biotech, Inc.

HLX14 is a recombinant anti-RANKL human monoclonal antibody injection. It is denosumab biosimilar potentially indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The drug prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Currently, it is in Phase III stage of clinical trial evaluation to treat Postmenopausal osteoporosis.

CMAB807: Mabpharm Limited

CMAB807 is a Denosumab, a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand), which is a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells. CMAB807 is currently undergoing Phase III clinical trial.

SHR-1222: Jiangsu Hengrui Pharmaceuticals

SHR-1222 is a novel humanized monoclonal antibody targeting sclerostin that was developed for the treatment of osteoporosis. Preclinical studies have demonstrated that SHR-1222 exhibits high affinity for human sclerostin. Moreover, the first-in-human clinical trial (NCT03870100) indicated that single doses of SHR-1222 ranging 50-400 mg were generally well tolerated and promoted bone formation, inhibited bone resorption, and increased BMD in healthy men and postmenopausal women with low bone mass. Currently the drug is being evaluated in Phase II for the treatment of postmenopausal women with osteoporosis.

SHR-2017: Suzhou Suncadia Biopharmaceuticals

SHR-2017 is a drug candidate being developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd. for the treatment of osteoporosis in postmenopausal women. The company is being conducting a Phase I, randomized, double-blind, placebo-controlled, single-dose, dose-escalation study to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous injection in postmenopausal women (NCT05930704).

Postmenopausal osteoporosis: Therapeutic Assessment

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

Major Players in Postmenopausal osteoporosis

• There are approx. 20+ key companies which are developing the therapies for Postmenopausal osteoporosis. The companies which have their Postmenopausal osteoporosis drug candidates in the most advanced stage, i.e. Phase III include, Shanghai Henlius Biotech and others.

Phases

This report covers around 20+ 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

Postmenopausal osteoporosis 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.

Postmenopausal osteoporosis: Pipeline Development Activities

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

Postmenopausal osteoporosis Report Insights

• Postmenopausal osteoporosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Suzhou Suncadia Biopharmaceuticals
• Shanghai Henlius Biotech, Inc.
• Mabpharm Limited
• Alvotech
• Samsung Bioepis Co., Ltd.
• Biocon Biologics
• Entera Bio Ltd.
• Genor Biopharma Co. Ltd
• Addpharma

Key Products

• SHR-2017
• HLX14
• CMAB807
• AVT03
• SB16
• Bmab 1000
• EBP05
• GB223
• AD-102

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