New York, USA, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Rich Insights Into The Robust Osteoporosis Clinical Trials Pipeline Analysis By DelveInsight
Increasing prevalence and rising geriatric population are the main factors driving the development of novel drugs for the treatment of osteoporosis. Major players involved in developing the potential therapies include Celltrion, Teva Pharmaceuticals, Shanghai Henlius Biotech, MAbxience, Alvotech, and several others.
DelveInsight’s 'Osteoporosis Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline osteoporosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the osteoporosis pipeline domain.
Key Takeaways from the Osteoporosis Pipeline Report
- DelveInsight’s osteoporosis pipeline report depicts a robust space with 40+ active players working to develop 40+ pipeline therapies for osteoporosis treatment.
- Key Osteoporosis companies such as Shanghai JMT-Bio Inc., Transcenta Holding, Celltrion, Teva Pharmaceuticals, Enzene Biosciences , Fresenius Kabi, Gedeon Richter, Samsung Bioepis, Alvotech, MAbxience, Shanghai Henlius Biotech, Rani therapeutics, Entera Bio, Paras Biopharmaceuticals, Shenzhen Salubris Pharmaceutical, Enteris Biopharma, Prestige Biopharma, Shinpoong Ltd., Shanghai Biomabs Pharmaceutical, Jiangsu HengRui Medicine Co., Ltd., Angitia Biopharmaceuticals, Dongkook pharmaceutical, Luye Pharma Group, Biocon Biologics UK Ltd, Bonus BioGroup Ltd., Cellatoz Therapeutics, Inc., Keros Therapeutics, Clayton Biotechnologies, Novadip, Eli Lilly and company, Hexal/Sandoz, Solarea Bio, and others are evaluating new osteoporosis drugs candidate to improve the treatment landscape.
- Promising Osteoporosis pipeline therapies in various stages of development include JMT 103, TST-002, CT-P41, GP-2411, ENZ215, FKS518, RGB-14-P, SB 16, AVT 03, MB-09, AGA2118, HLX14, RT-102, VOLT01, PBP1601, SP-35454, SHR-1222, DKF-335, Oral PTH analogs, Bmab 1000, Embryonic stem cell-derived MusculoSkeletal Stem Cell, KER012, and others.
- In July 2022, Entera Bio announced that the US Food and Drug Administration (FDA) had granted Entera’s request for a Type C Meeting based on the revised Phase III registrational study for the lead clinical asset, EB613 (oral formulation of PTH (1-34, teriparatide), as the first oral anabolic drug to treat post-menopausal women with osteoporosis. The meeting is expected in H2 2022.
- In July 2022, Alvotech announced the initiation of a Phase III pharmacokinetic study for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®. The clinical study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.
- In July 2022, Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Collaboration expands and underscores commitment to biosimilars portfolio and focus on women’s health with biosimilar candidates for osteoporosis and breast cancer. HLX14 (recombinant anti-RANKL human monoclonal antibody injection) is a biosimilar candidate of denosumab and is independently developed by Henlius.
- In March 2022, Rani Therapeutics Holdings, Inc. announced the initiation of a Phase I study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis, delivered via RaniPill™ capsule.
- In April 2022, Transcenta Holding Limited announced the successful dosing of first patient in China Phase I Study of TST002 for the treatment of osteoporosis. This Phase I clinical trial is a randomized and double-blind, placebo-controlled, single-ascending-dose, multi-center study designed to evaluate the safety, tolerability, and pharmacokinetics profile of TST002 as a treatment in patients with osteoporosis. In 2019, the company obtained a license from Eli Lilly and Company for developing and commercializing Blosozumab in Greater China.
- JMT103 is the first self-developed new recombinant fully human anti- RANKL monoclonal antibody with independent intellectual property rights developed by Shanghai Jinmante Biotechnology Co. This product obtained the clinical approval of the CFDA for tumor bone metastasis (zero-issue supplement) in March 2017, and the clinical approval of the CFDA for osteoporosis in June 2017. Shanghai JMT-Bio planned a phase II trial in Osteoporosis in China in June 2022.
Request a sample and discover the recent advances in osteoporosis treatment drugs @ Osteoporosis Pipeline Outlook
The osteoporosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage osteoporosis products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the osteoporosis pipeline landscape.
Osteoporosis Overview
Osteoporosis is a bone disease that occurs when bone mineral density and bone mass decline or when bone quality or structure changes. This can result in a loss in bone strength, increasing the risk of fractures (broken bones). Osteoporosis is a "silent" disease since most people have no symptoms and may not even realise they have it until they break a bone.
As there are usually no osteoporosis symptoms until a bone is shattered or one or more vertebrae collapse, osteoporosis is referred to as a "silent" illness (fracture). Severe back discomfort, loss of height, or spine abnormalities such as a stooped or hunched posture are all symptoms of vertebral fracture.
If the doctor suspects the patient has osteoporosis, they may recommend a DEXA (dual-energy x-ray absorptiometry) scan to determine bone density. This is the most common test for osteoporosis diagnosis. The goals of osteoporosis treatment are to halt or stop bone loss and to avoid fractures. People who acquire osteoporosis due to another condition should work with their doctor to identify and treat the underlying osteoporosis causes.
Find out more about osteoporosis medicines @ Osteoporosis Medications
A snapshot of the Osteoporosis Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| CT-P41 | Celltrion | Phase III | Antibody-dependent cell cytotoxicity; RANK ligand inhibitors | Subcutaneous |
| FKS518 | Fresenius Kabi | Phase III | RANK ligand inhibitors | Subcutaneous |
| MB-09 | MAbxience | Phase III | Antibody-dependent cell cytotoxicity; RANK ligand inhibitors | Subcutaneous |
| AVT 03 | Alvotech | Phase III | Antibody-dependent cell cytotoxicity; RANK ligand inhibitors | Subcutaneous |
| JMT 103 | Shanghai JMT-Bio Inc. | Phase II | RANK ligand inhibitors | Subcutaneous |
| TST-002 | Transcenta Holding | Phase I | SOST protein inhibitors | Intravenous |
| SHR-1222 | Jiangsu HengRui Medicine Co., Ltd. | Phase I | SOST protein inhibitors | Subcutaneous |
| SP-35454 | Shin Poong Pharm. Co. Ltd. | Phase I | NA | NA |
| HS-20090-2 | Shanghai Hansoh Biomedical | Phase I | RANK ligand modulators | Subcutaneous |
| SAL023 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Preclinical | NA | NA |
| KN012 | Jiangsu Alphamab Biopharmaceuticals | Preclinical | RANK ligand inhibitors | Subcutaneous |
| Embryonic stem cell-derived MusculoSkeletal Stem Cell | Cellatoz Therapeutics, Inc. | Discovery | NA | NA |
Learn more about the novel and emerging osteoporosis pipeline therapies @ Osteoporosis Clinical Trials
Osteoporosis Therapeutics Assessment
The osteoporosis pipeline report proffers an integral view of the osteoporosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Osteoporosis Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: RANK ligand inhibitors, SOST protein inhibitors, Antibody-dependent cell cytotoxicity
- Key Osteoporosis Companies: Shanghai JMT-Bio Inc., Transcenta Holding, Celltrion, Sandoz, Enzene Biosciences, Fresenius Kabi, Gedeon Richter, Samsung Bioepis, Alvotech, MAbxience, Shanghai Henlius Biotech, and others
- Key Osteoporosis Pipeline Therapies: JMT 103, TST-002, CT-P41, GP-2411, ENZ215, FKS518, RGB-14-P, SB 16, AVT 03, MB-09, AGA2118, HLX14, and others.
Dive deep into rich insights for drugs for osteoporosis treatment, visit @ Osteoporosis Treatment Drugs
Table of Contents
| 1. | Osteoporosis Pipeline Report Introduction |
| 2. | Osteoporosis Pipeline Report Executive Summary |
| 3. | Osteoporosis Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Osteoporosis Pipeline Therapeutics |
| 6. | Osteoporosis Pipeline: Late Stage Products (Pre-registration) |
| 7. | Osteoporosis Pipeline: Late Stage Products (Phase III) |
| 7.1 | CT-P41: Celltrion |
| 8. | Osteoporosis Pipeline: Mid Stage Products (Phase II) |
| 8.1 | JMT 103: Shanghai JMT-Bio Inc. |
| 9. | Osteoporosis Pipeline: Early Stage Products (Phase I) |
| 9.1 | TST-002: Transcenta Holding |
| 10. | Osteoporosis Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Osteoporosis Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Osteoporosis Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the osteoporosis pipeline therapeutics, reach out @ New Osteoporosis Drugs
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