A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

Start Date02 Jul 2019

Sponsor / Collaborator

Sandoz AG

[+1]

100 Clinical Results associated with Denosumab-BBDZ

100 Translational Medicine associated with Denosumab-BBDZ

100 Patents (Medical) associated with Denosumab-BBDZ

Literatures (Medical) associated with Denosumab-BBDZ

01 Sep 2024·Clinical Therapeutics

The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab

Review

Author: Kivitz, Alan ; Body, Jean-Jacques ; Schwebig, Arnd ; Eastell, Richard ; Krivtsova, Natalia ; Poetzl, Johann ; Sekhar, Susmit ; Renner, Oliver ; Vogg, Barbara

PURPOSESandoz biosimilar denosumab (GP2411 [SDZ-deno]; Jubbonti/Wyost) is approved by the US FDA, EMA and Health Canada for all indications of reference denosumab (REF-deno; Prolia/Xgeva), a fully human IgG2κ monoclonal antibody that binds with high affinity and specificity to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab blocks RANKL, preventing bone resorption and loss of bone density/architecture in conditions characterized by excessive bone loss such as osteoporosis in postmenopausal women and metastatic bone disease, among others.METHODSThis narrative review summarizes the totality of evidence (ToE) for SDZ-deno that supported its approval as Jubbonti/Wyost in the EU and US.FINDINGSAnalytical evaluation indicated that SDZ-deno has high purity and structural homology with REF-deno. SDZ-deno also demonstrated similar binding affinities, size and charge variants, and disulfide isoforms to REF-deno, and did not trigger clinically meaningful antibody-dependent cellular cytotoxicity. In clinical evaluation, SDZ-deno was similar to REF-deno in pharmacokinetics (PK) and pharmacodynamics (PD) in a 39-week Phase I study in 502 healthy male participants, and to REF-deno in a 72-week Phase III study in 527 postmenopausal women with osteoporosis. In both studies, the 90% and 95% confidence intervals (for PK and PD endpoints, respectively) of the geometric mean ratios for AUC_inf, C_max (and AUC_last in the Phase I study; PK endpoints), and area under the effect versus time curve of percent change from baseline in serum carboxy-terminal crosslinked telopeptide of type I collagen (PD endpoint), were fully contained within the prespecified equivalence margins (0.80, 1.25). The Phase III study also demonstrated SDZ-deno is similar in efficacy to REF-deno in postmenopausal women with osteoporosis, as the difference in percent change from baseline in lumbar spine bone mineral density at week 52 between REF-deno and SDZ-deno was fully contained within the prespecified equivalence margins (-1.45, 1.45). SDZ-deno was well tolerated in both studies. As the ToE has established biosimilarity of SDZ-deno and REF-deno, extrapolation to all indications is justified based on the common mechanism of action and the comparable PK, safety, and immunogenicity across all indications.IMPLICATIONSThe ToE for SDZ-deno suggests it will be an effective biosimilar to REF-deno, and its lower unit price is anticipated to increase the number of appropriate patients who will benefit.

05 Aug 2024·Journal of Bone and Mineral Research

Correction to: Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

19 Apr 2024·Journal of Bone and Mineral Research

Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Article

Author: Body, Jean-Jacques ; Dokoupilová, Eva ; Krivtsova, Natalia ; Vogg, Barbara ; Sekhar, Susmit ; Kivitz, Alan ; Eastell, Richard ; Banerjee, Samik ; Poetzl, Johann ; Schwebig, Arnd ; Jeka, Sławomir ; Żuchowski, Paweł

AbstractDenosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia®; Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to 2 60-mg doses of GP2411 or REF-DMAb, one at study start and one at week 26. At week 52, the REF-DMAb group was re-randomized 1:1 to a third dose of REF-DMAb or switch to GP2411. The primary efficacy endpoint was percentage change from baseline (%CfB) in LS-BMD at week 52. Secondary efficacy endpoints were %CfB in LS-BMD, FN-BMD, and TH-BMD at weeks 26 and 78 (and week 52 for FN-BMD and TH-BMD). Primary PK and PD endpoints were the area under the serum concentration–time curve extrapolated to infinity and maximum drug serum concentration at week 26, and the area under the effect–time curve of the %CfB in serum CTX at week 26. Secondary PK and PD endpoints included drug serum concentrations and %CfB in serum CTX and P1NP during the study period. Similar efficacy was demonstrated at week 52, with 95% CIs of the difference in %CfB in LS-BMD between treatment groups fully contained within prespecified equivalence margins. Similarity in PK and PD was demonstrated at week 26. Immunogenicity was similar between groups and was not impacted by treatment switch. The rate of new vertebral fractures was comparable. Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis.

News (Medical) associated with Denosumab-BBDZ

30 Oct 2024

·www.globenewswire.com

Sandoz reports third-quarter and nine-month 2024 sales

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

Drug ApprovalBiosimilarAcquisition

09 Aug 2024

·www.fiercepharma.com

Sandoz lifts guidance after Humira biosimilar drives another quarter of sales growth

Novartis spinout Sandoz garnered $2.6 billion in second-quarter product sales. After the performance, the company raised its sales guidance for the year. After taking a market share lead in the crowded Humira biosimilar space and with other key launches in the works, Novartis spinout Sandoz is raising its full-year sales guidance.Sandoz previously communicated that it expects 2024 sales growth to reach mid-single-digit percentages. Now, after reporting second-quarter results, the company said it expects mid- to high-single-digit growth for the year.The company collected $2.6 billion in net sales during the second quarter, representing 9% sales growth compared to the same period last year.The boost was driven by the drugmaker’s clutch of biosimilars, which together saw an "exceptional" growth rate of 29%, CEO Richard Saynor said on Sandoz’s recent earnings call. Sandoz does not report individual product sales. Within the drugmaker’s biosimilar franchise, Humira copycat Hyrimoz is the standout. The med holds an 81% market share in the crowded space of biosimilar competitors to AbbVie’s popular immunology drug and has the “broadest payer coverage” of them all, according to a Sandoz investor presentation (PDF).Sandoz took on a unique strategy with its Hyrimoz, launching both a branded and an unbranded version and linking with CVS Health’s biosimilar subsidiary Cordavis on a co-labeled version. Earlier this year, CVS Caremark pulled AbbVie’s branded Humira from its national commercial formularies, in turn sending Hyrimoz prescriptions skyrocketing.Outside of Hyrimoz, the biosimilar maker has a number of potentially big launches in the works. Just recently, Sandoz launched its version of Johnson & Johnson’s Stelara in Europe. That biosim is expected to hit the U.S. in February 2025 in accordance with a J&J settlement. After that, the company looks to launch its copies of Amgen’s bone drugs Xgeva and Prolia, which will be branded as Wyost and Jubbonti, respectively, in the second quarter of next year. Regeneron and Bayer’s ophthalmology powerhouse Eylea is another potential victim of Sandoz's biosimilar ambitions. The companies are engaged in patent litigation right now, but Saynor said the company's Eylea biosimilar should arrive in the coming years.In the meantime, Sandoz can also still rely on its aging Omnitrope to buoy sales alongside Hyrimoz. That drug, a biosimilar to Pfizer’s human growth hormone Genotropin, predates even the FDA’s biosimilar approval pathway with its 2006 nod. Since then, Omnitrope has overtaken Pfizer’s original as the market leader, and its sales were still on the rise in the second quarter of 2024.It hasn’t yet been a year since Sandoz spun out of Novartis, but the company is already hard at work initiating a “multi-year transformation program” to simplify its organizational structure. Under that program, the company expects savings of $50 million in this year's second half. By 2026, Sandoz is targeting annual savings of $200 million.

BiosimilarPatent InfringementPatent Expiration

23 May 2024

·www.pharmaceutical-technology.com

EC approves Sandoz’s biosimilars for bone-related ailments

Sandoz plans to launch the biosimilar products for bone-related ailments from November 2025. Credit: Tong_stocker / Shutterstock.com. The European Commission (EC) has granted marketing authorisation for Sandoz ’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments. Wyost and Jubbonti are the first biosimilars of reference medicines Xgeva and Prolia to receive approval in Europe. Wyost is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. It is also intended for the treatment of adult and skeletally mature adolescent patients with giant cell bone tumours. Sandoz’s Jubbonti can be used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, among other bone loss conditions. The company plans to launch these products from November 2025. See Also: ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success FDA advisory committee reviews Novo Nordisk insulin icodec for T1D Wyost and Jubbonti contain denosumab, a human monoclonal antibody that hinders the RANKL/RANK interaction. This mechanism is crucial as it prevents the formation and activity of osteoclasts, cells responsible for bone resorption, thus aiding in the maintenance of bone integrity. The EC’s authorisation for Wyost and Jubbonti was based on comprehensive development programmes that demonstrated biosimilarity to their reference medicines. The biosimilars have been developed to match the original products in terms of dosage form, route of administration, dosing regimen and presentation. Sandoz chief scientific officer Claire D’Abreu-Hayling stated: “Primary and secondary bone loss, as well as cancer-related bone events, represent an immense disease burden for patients, the economy and society as a whole. “The approval of the first European denosumab biosimilars is a crucial recognition of the need for increased access to these potentially life-changing medicines and demonstrates our continued commitment to delivering more sustainable treatment options for patients, in Europe and beyond.” In March 2024, the US Food and Drug Administration approved Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) as denosumab biosimilars .

Drug Approval

100 Deals associated with Denosumab-BBDZ

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Approved

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Indication	Country/Location	Organization	Date
Humoral Hypercalcemia of Malignancy	AU	Sandoz Pty Ltd.	23 Aug 2024
Multiple Myeloma	AU	Sandoz Pty Ltd.	23 Aug 2024
Bone Cancer	NO	Sandoz GmbH	17 May 2024
Bone Cancer	EU	Sandoz GmbH	17 May 2024
Bone Cancer	IS	Sandoz GmbH	17 May 2024
Bone Cancer	LI	Sandoz GmbH	17 May 2024
Bone Diseases, Metabolic	IS	Sandoz GmbH	16 May 2024
Bone Diseases, Metabolic	LI	Sandoz GmbH	16 May 2024
Bone Diseases, Metabolic	NO	Sandoz GmbH	16 May 2024
Bone Diseases, Metabolic	EU	Sandoz GmbH	16 May 2024
Bone Diseases	US	Sandoz, Inc.	05 Mar 2024
Bone metastases	US	Sandoz, Inc.	05 Mar 2024
Giant Cell Tumor of Bone	US	Sandoz, Inc.	05 Mar 2024
Glucocorticoid-induced osteoporosis	US	Sandoz, Inc.	05 Mar 2024
Hypercalcemia	US	Sandoz, Inc.	05 Mar 2024
Osteoporosis	US	Sandoz, Inc.	05 Mar 2024
Osteoporosis, Postmenopausal	US	Sandoz, Inc.	05 Mar 2024
Osteoporotic Fractures	US	Sandoz, Inc.	05 Mar 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fractures, Bone	NDA/BLA	US	Sandoz International GmbH	06 Feb 2023
Humoral Hypercalcemia of Malignancy	NDA/BLA	US	Sandoz International GmbH	06 Feb 2023
Osteoporosis, Postmenopausal	Discovery	JP	Hexal AG	02 Jul 2019
Osteoporosis, Postmenopausal	Discovery	JP	Sandoz AG	02 Jul 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03974100 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	527	GP2411	bncpklfhkl(nkaclhisjn) = ziyzsbfebw tghkdpybyq (ujdijxncad, mutpylwstx - dttpuvdnvq) View more	-	08 Mar 2023
NCT03974100 (GlobeNewswire) Manual	Phase 3	Osteoporosis	-	Denosumab-GP2411	(gvebsfjxoc) = ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis eqjzoklkbr (wxeeviaqol )	Similar	19 Sep 2022
NCT03974100 (GlobeNewswire) Manual	Phase 3	Osteoporosis	-	Denosumab		Similar	19 Sep 2022

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