A Randomised, Double-blind, Parallel, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) vs. Prolia® (EU-sourced) in Postmenopausal Osteoporosis

This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

开始日期2022-03-16

申办/合作机构

mAbxience Research SL

NCT05299073

/ Completed临床1期

A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

开始日期2022-03-01

申办/合作机构

mAbxience Research SL

100 项与 MB-09 相关的临床结果

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100 项与 MB-09 相关的转化医学

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100 项与 MB-09 相关的专利（医药）

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项与 MB-09 相关的文献（医药）

2024-09-01·Clinical and Translational Science

MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects

Article

作者: Carapuça, Elisabete ; Queiruga‐Parada, Javier ; Florez‐Igual, Amalia ; Tomaszewska‐Kiecana, Monika

AbstractThis was a Phase I, randomized, double‐blinded, three‐arm, single‐dose, parallel study aimed to demonstrate pharmacokinetic (PK) similarity between MB09 (a denosumab biosimilar candidate) and reference denosumab (XGEVA® from European Union [EU‐reference] and United States [US‐reference]) in a healthy male population. The primary PK endpoints included: Area under the serum concentration versus time curve from time 0 to the last quantifiable concentration timepoint (AUC0–last); and maximum observed serum concentration (Cmax). Secondary endpoints included: AUC from time 0 extrapolated to infinity (AUC0–∞), time to reach maximum observed concentration, clearance, terminal phase half‐life, pharmacodynamic, safety, and immunogenicity assessments. A total of 255 subjects were randomized (1:1:1) to receive a subcutaneous 35 mg dose of MB09 or reference denosumab. Cmax was reached after denosumab administration, followed by a decline in the concentration with similar terminal phase half‐live across treatment arms. Systemic exposure of MB09 (AUC0–last and Cmax) was equivalent to the reference denosumab, as the 90% confidence intervals around the geometric least square mean ratios laid within the predefined acceptance limits (80.00%, 125.00%) across all comparisons. Pharmacodynamic parameters, based on the percent of change from baseline in serum C‐terminal telopeptide of Type 1 collagen levels, were similar across the three arms. The treatments were considered safe and generally well tolerated, with 92 treatment‐emergent adverse events reported (most Grade 2 and 3) and similarly distributed. Immunogenicity was low and similarly distributed. These results provide strong evidence that supports the biosimilarity between MB09 and denosumab reference products.

2011-02-01·Applied Microbiology and Biotechnology3区 · 工程技术

Decolourization of synthetic wastewater containing azo dyes by immobilized Phanerochaete chrysosporium in a continuously operated RBC reactor

3区 · 工程技术

Article

作者: Naresh Kumar Sahoo ; Kannan Pakshirajan ; Auta Sivasankar

A laboratory-scale rotating biological contactor (RBC) reactor with immobilized fungal biomass of Phanerochaete chrysosporium was investigated for its performance in decolourizing synthetic wastewater containing single or mixture of azo dyes, Direct Red-80 (DR-80) and Mordant Blue-9 (MB-9). Decolourization efficiency in the continuously operated bioreactor was studied by varying dye inlet concentration and disc rotation speed at two different wastewater hydraulic retention times (HRTs), i.e. 24 and 48 h. Results from the single dye-containing experiments showed that the system could completely decolourize the wastewater for a maximum inlet dye concentration within the range 25-200 mg L(-1) and 48 h HRT in the reactor; for an inlet dye concentration above 200 mg L(-1), the decolourization efficiency slightly reduced up to 85% for the same HRT. However, wastewater containing DR-80 was found to be decolourized more efficiently compared to that containing MB-9. Further, the effect of increase in the disc rotation speed from 2 to 6 rpm in the study revealed no large differences in the decolourization efficiencies of the wastewaters. Similar results were obtained with wastewater containing the dyes together at various concentration combinations as per the two-level factorial design of experiments. Enzyme activities of lignin peroxidase and manganese peroxidase by the fungus were also analysed in the study, and the results indicated that while DR-80 showed a large negative effect on both the enzymes, MB-9 affected mainly the MnP activity by the fungus.

International Journal of Molecular Sciences

The Interaction and Effect of a Small MitoBlock Library as Inhibitor of ALR Protein–Protein Interaction Pathway

Article

作者: Gallo, Angelo ; Muzzioli, Riccardo

MIA40 and ALR of the MIA pathway mediate the import of protein precursors that form disulfides into the mitochondrial intermembrane space. This import pathway is suggested to be a linear pathway in which MIA40 first binds to the precursor via a disulfide linkage and oxidizes it. Subsequently, ALR re-oxidizes MIA40 and then ALR transfers electrons to terminal electron acceptors. However, the precise mechanism by which ALR and MIA40 coordinate translocation is unknown. With a collection of small molecule modulators (MB-5 to MB-9 and MB-13) that inhibit ALR activity, we characterized the import mechanism in mitochondria. NMR studies show that most of the compounds bind to a similar region in ALR. Mechanistic studies with small molecules demonstrate that treatment with compound MB-6 locks the precursor in a state bound to MIA40, blocking re-oxidation of MIA40 by ALR. Thus, small molecules that target a similar region in ALR alter the dynamics of the MIA import pathway differently, resulting in a set of probes that are useful for studying the catalysis of the redox-regulated import pathway in model systems.

项与 MB-09 相关的新闻（医药）

2025-03-27

·PipelineReview

Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement

LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) of its operating company Fresenius Kabi, has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia ® (denosumab) and Xgeva ® (denosumab), respectively. In addition, the Fresenius operating company has reached a global settlement with Amgen concerning its denosumab biosimilars. “We are pleased to have reached a global settlement with Amgen for our denosumab biosimilar candidates and to continue to provide patients around the globe with access to high-quality biological medicines. This marks our sixth FDA biosimilar approval, expanding our portfolio to provide more affordable therapies to patients in the U.S.,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma. The FDA approval is based on comprehensive analytical development and similarity assessment supported by two comparative clinical studies: a pharmacokinetic, pharmacodynamic, and immunogenicity study in healthy volunteers, and an efficacy, pharmacodynamic, safety, and immunogenicity study in women with postmenopausal osteoporosis. About Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) Conexxence ® (denosumab-bnht) is approved for use in various adult patient populations at high risk for fractures, including those with osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. In the US Conexxence ® (denosumab-bnht) is a black box warning product and includes a Risk Evaluation and Mitigation Strategy (REMS) program , which aims to educate prescribers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including those on dialysis. Conexxence ® (denosumab-bnht) is contraindicated during pregnancy and in case of known hypersensitivity to denosumab products. For more information aboutConexxence ® please see theimportant safety information and full prescribing information for the U.S. here . Bomyntra ® (denosumab-bnht) is approved for use to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. It is also used to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy and giant cell tumor of bone in adults and skeletally mature adolescents. Bomyntra ® (denosumab-bnht) is contraindicated in case of hypocalcemia and known hypersensitivity to denosumab products. For more information aboutBomyntra ® please see theimportant safety information and full prescribing information for the U.S. here . About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale. For more information, please visit www.fresenius-kabi.com and www.fresenius-kabi.com/us in the United States. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook . SOURCE: Fresenius Kabi

上市批准

2025-03-26

·Fresenius

Fresenius Receives FDA approval for their Denosumab Biosimilars and Secures Global Settlement

Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence®** (denosumab-bnht) and Bomyntra®** (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA). The denosumab biosimilars are approved for all indications of the reference products Prolia®* (denosumab) and Xgeva®* (denosumab), respectively. Additionally, Fresenius’ operating company has reached a global settlement with Amgen, allowing the launch of these biosimilars in the US from mid-2025 and in Europe later in H2 of 2025 subject to regulatory approval. The FDA approval and the global settlement agreement with Amgen are the latest developments in Fresenius’ continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Growing the company's (Bio)Pharma platform is a substantial cornerstone of #FutureFresenius. *Prolia® and Xgeva®* are registered trademarks of Amgen Inc. **Conexxence® and **Bomyntra® are registered trademarks of Fresenius Kabi Deutschland in selected countries. Read the full press release here. Please click to see full Prescribing Information for Conexxence®. Please click to see full Prescribing Information for Bomyntra®.

上市批准专利侵权生物类似药

2025-03-04

·PipelineReview

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

Denosumab biosimilar candidates reference Prolia ® and XGEVA ® Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027 BRIDGEWATER, NJ, USA I March 03, 2025 I Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia ® and XGEVA ® . mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS ® , a bevacizumab biosimilar, which was launched in 2022. “Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Prolia ® : In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA ® : The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA ® , U.S. annual sales for Prolia ® and XGEVA ® for the 12 months ended December 2024 were approximately $5.0 billion. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn . About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( www.mabxience.com ) or connect with us on LinkedIn . SOURCE: Amneal Pharmaceuticals

引进/卖出并购上市批准

100 项与 MB-09 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
绝经期后骨质疏松	临床3期	保加利亚	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	墨西哥	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	爱沙尼亚	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	拉脱维亚	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	波兰	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	匈牙利	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	格鲁吉亚	mAbxience Research SL	2022-03-16
绝经期后骨质疏松	临床3期	塞尔维亚	mAbxience Research SL	2022-03-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05299073 (CTgov)	临床1期	-	257	MB09 (MB09 (Denosumab Biosimilar))	(齋鬱壓網築製廠醖鏇艱) = 鑰糧遞膚壓構齋憲鹽遞鹽鑰醖艱夢糧願簾遞襯 (鹽積鏇襯壓獵艱鹽簾遞, 範艱蓋範艱構鏇觸膚齋 ~ 選醖網餘蓋繭繭餘顧壓) 更多	-	2025-01-03
				Xgeva (US-sourced Xgeva)	(齋鬱壓網築製廠醖鏇艱) = 鏇範艱蓋襯衊願淵淵鑰鹽鑰醖艱夢糧願簾遞襯 (鹽積鏇襯壓獵艱鹽簾遞, 襯簾襯壓憲獵齋構夢鬱 ~ 鑰鬱衊衊網窪醖糧網襯) 更多