考察健康受试者在空腹条件下，单次口服1粒由杭州中美华东制药有限公司提供的伏环孢素软胶囊（受试制剂T，规格：7.9mg）与单次口服1粒由Aurinia Pharmaceuticals, Inc.持证的伏环孢素软胶囊（参比制剂R，商品名：Lupkynis®，规格：7.9mg）的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of cyclosporine soft capsule (test preparation T, specification: 7.9 mg) provided by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. and a single oral dose of cyclosporine soft capsule (reference preparation R, trade name: Lupkynis®, specification: 7.9 mg) certified by Aurinia Pharmaceuticals, Inc. in healthy subjects under fasting conditions, and to evaluate the bioequivalence and safety of the two preparations, so as to provide a basis for the registration application of the test preparation.

Start Date16 Feb 2025

Sponsor / Collaborator

Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.

NCT05962788

/ Enrolling by invitationPhase 3

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent Subjects with Lupus Nephritis

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

Start Date27 Mar 2024

Sponsor / Collaborator

Aurinia Pharmaceuticals, Inc.

[+1]

CTR20234019

/ CompletedNot Applicable

伏环孢素软胶囊的生物等效性研究

[Translation] Study on the bioequivalence of cyclosporine soft capsules

研究空腹状态下单次口服受试制剂伏环孢素软胶囊与参比制剂伏环孢素软胶囊（Lupkynis®）在健康成年受试者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性和安全性。

[Translation]

To study the pharmacokinetics of a single oral dose of the test preparation cyclosporine soft capsule and the reference preparation cyclosporine soft capsule (Lupkynis®) in healthy adult subjects under fasting conditions and to evaluate the bioequivalence and safety of the two preparations under fasting conditions.

Start Date04 Jan 2024

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Voclosporin

100 Translational Medicine associated with Voclosporin

100 Patents (Medical) associated with Voclosporin

156

Literatures (Medical) associated with Voclosporin

02 May 2025·Cureus Journal of Medical Science

Combination Therapy With Voclosporin and Anifrolumab in Two Patients With Lupus Nephritis and Discoid Lupus Erythematosus

Article

Author: Dykema, Arbor G ; Karagenova, Ralina ; Vodusek, Ziga ; Timlin, Homa ; Krieger, Adam

Current therapeutic options in systemic lupus erythematosus (SLE) vary in effectiveness, and remission may not be achievable in many patients. Unfortunately, although many patients achieve an initial response with conventional immunosuppressant regimens, relapse is common, and current therapies are associated with damaging adverse effects and the risk of infection. Therefore, it is critical to identify safe targets for lupus disease activity, minimizing drug toxicity and preventing damage accrual. We present two cases with disease features of discoid lupus erythematosus (DLE) and lupus nephritis (LN), who were treated safely and successfully with Voclosporin and Anifrolumab, resulting in disease remission without the use of oral steroids.

04 Mar 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A focused report on IFN-1 targeted therapies for lupus erythematosus

Review

Author: Furie, Richard ; Vashistha, Himanshu ; Bhatt, Anushka ; Gupta, Pramiti

INTRODUCTION:

Patients with Systemic Lupus Erythematosus (SLE) experience varied manifestations and unpredictable flares, complicating treatment and drug development. Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA. These treatments complement, but don't replace, traditional therapies like NSAIDs, corticosteroids, antimalarials, and immunosuppressives. Therefore, there remains an unmet need for more effective medications targeting excessive proinflammatory cytokines in SLE patients.

AREAS COVERED:

This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial. Anifrolumab reduced SLE activity in both phase II and III trials. Deucravacitinib decreased disease activity by multiple measures in its phase II trial.

EXPERT OPINION:

High levels of IFN-I (type 1 interferon) are present in most SLE patients, making this pathway an attractive target for drug development. Litifilimab downregulates IFN-I by targeting BDCA2, while dexadilimab targets ILT7 to recruit effector cells, reducing IFN-I production by killing PDCs. Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients.

01 Mar 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling

Article

Author: Teng, Y K O ; Metscher, E ; Meziyerh, S ; de Vries, A P J ; Moes, D J A R ; Swen, J J ; Arends, E J

Voclosporin is a potent immunosuppressive agent currently approved for treating active lupus nephritis. Based on its potential antiviral activity, it has also been investigated as immunosuppressive agent in an investigator-initiated study in SARS-CoV2 positive kidney transplant recipients. As with many immunosuppressive agents, optimizing dosing regimens to achieve therapeutic efficacy while minimizing toxicity remains a critical challenge in clinical practice. To prevent organ rejection as well as infections, the prescribed immunosuppression needs to be well balanced. Dried blood spot (DBS) sampling has enabled development of remote voclosporin therapeutic drug monitoring. Here, we report on the development and analytical validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for quantification of voclosporin in dried blood spots. Method development was based on previously developed assays for the quantification of tacrolimus, everolimus, sirolimus, cyclosporin, mycophenolic acid, creatinine and iohexol in DBS and voclosporin in whole blood using LC-MS/MS. HemaXis™ volumetric blood spot devices were used for sample collection. The sample purification was based on the extraction of voclosporin from the DBS samples. Stable isotopically labeled voclosporin-D4 was used as an internal standard prior to sample purification. Bland Altman and Passing bablok analysis were performed for cross validation between whole blood and DBS samples. The method was successfully validated following the current ICH M10 guidelines. The dynamic range for the analyte was 10-600 µg/L with an excellent mean coefficient of correlation of 0.9978. The within run and between run precision and accuracy were both within the acceptance criteria. The cross-validation against the whole blood method shows that the quantified voclosporin results are promising. This developed dried blood spot LC-MS/MS method was successfully validated and provides an easy, efficient workflow for therapeutic drug monitoring in kidney transplant patients or remote pharmacokinetic studies in lupus nephritis patients treated with voclosporin.

160

News (Medical) associated with Voclosporin

08 May 2025

·www.prnewswire.com

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses. Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers. The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids. Learn more about LUPKYNIS projected market size for lupus nephritis @ LUPKYNIS Market Potential Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting 40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately 211K cases, a figure projected to grow by 2034. Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids. Currently, there are only two FDA-approved medications for lupus nephritis: BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor. Leading pharmaceutical companies such as Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting. Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder. Discover more about the lupus nephritis market in detail @ Lupus Nephritis Market Report Emerging Competitors of LUPKYNIS The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including ianalumab (VAY736) (Novartis), GAZYVA (obinutuzumab) (Roche), SAPHNELO (anifrolumab) (AstraZeneca), FABHALTA (iptacopan) (Novartis), ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like CABA-201 (Cabaletta Bio) and YTB323 (Novartis). In March 2025, the FDA accepted a supplemental Biologics License Application based on data from the Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of USD 400 million by 2034. To know more about the number of competing drugs in development, visit @ LUPKYNIS Market Positioning Compared to Other Drugs Key Milestones of LUPKYNIS In September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @ LUPKYNIS Lupus LUPKYNIS Market Dynamics LUPKYNIS, developed by Aurinia Pharmaceuticals, is the first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function. The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a strong unmet medical need, a growing prevalence of lupus nephritis, and increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a dedicated commercial infrastructure and patient support programs to drive uptake and adherence. However, LUPKYNIS faces competitive and reimbursement challenges. One of the main competitors is BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels. Looking ahead, the market potential for LUPKYNIS will depend on its ability to expand its label, demonstrate long-term real-world effectiveness, and potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications. Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies. Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @ LUPKYNIS Market Drug Report Table of Contents Related Reports Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including Hoffmann-La Roche, Chugai Pharmaceutical, Novartis Pharmaceuticals, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Clinical ResultImmunotherapy

30 Apr 2025

·www.businesswire.com

Glass Lewis Recommends That Aurinia Shareholders Vote “FOR” All Proposals at 2025 Annual General Meeting

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (“Aurinia” or the “Company”) (NASDAQ: AUPH) today announced that leading independent proxy advisor Glass, Lewis & Co. LLC (“Glass Lewis”) has recommended that Aurinia shareholders vote FOR all proposals put forth by the Board of Directors (the “Board”) at the Company’s 2025 Annual General Meeting (the “Meeting”) on Thursday, May 15, 2025, at 12:00 p.m., Eastern Time. Glass Lewis supports all of the proposals in the Company’s proxy statement and management information circular (the “Proxy Statement/Circular”), including approving the six director nominees, the proposed auditor, the non-binding advisory vote on the Company’s approach to executive compensation, and an amendment to the Company’s Equity Incentive Plan. Shareholders of record at the close of business on April 12, 2025, are entitled to notice of, and to vote on the proposals described in the Proxy Statement/Circular. All votes must be received no later than 12:00 PM EST on May 13, 2025, to be counted for the Meeting. The proposals and details on how to vote are more fully described in the Proxy Statement/Circular, which can be found on the Company's profiles on EDGAR at www.sec.gov and SEDAR+ at www.sedarplus.ca. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases.

Drug Approval

27 Feb 2025

·www.businesswire.com

Aurinia Pharmaceuticals Reports Financial Results for the Three and Twelve Months Ended December 31, 2024 and Provides Update on Recent Corporate Progress

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three and twelve months ended December 31, 2024 and provided an update on recent corporate progress. Fourth Quarter 2024 Financial Results Total Revenue: For the three months ended December 31, 2024, total revenue was $59.9 million, up 33% from $45.1 million in the same period of 2023. – Net Product Sales: For the three months ended December 31, 2024, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $57.6 million, up 36% from $42.3 million in the same period of 2023. – License, Collaboration and Royalty Revenue: For the three months ended December 31, 2024, license, collaboration and royalty revenue, which includes manufacturing services revenue and royalties from Aurinia’s collaboration partner, Otsuka, was $2.3 million, down 18% from $2.8 million in the same period of 2023. Net Income (Loss): For the three months ended December 31, 2024, net income (loss) was $1.4 million, compared to $(26.9) million in the same period of 2023. Cash Flow Provided by Operating Activities: For the three months ended December 31, 2024, cash flow provided by operating activities was $30.1 million, up 110% from $14.3 million in the same period of 2023. Full Year 2024 Financial Results Total Revenue: For the twelve months ended December 31, 2024, total revenue was $235.1 million, up 34% from $175.5 million in 2023. – Net Product Sales: For the twelve months ended December 31, 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023. – License, Collaboration and Royalty Revenue: For the twelve months ended December 31, 2024, license, collaboration and royalty revenue, which includes a milestone payment, manufacturing services revenue and royalties from Otsuka, was $18.9 million, up 11% from $17.0 million in 2023. Net Income (Loss): For the twelve months ended December 31, 2024, net income (loss) was $5.8 million, compared to $(78.0) million in 2023. Cash Flow Provided by (Used in) Operating Activities: For the twelve months ended December 31, 2024, cash flow provided by (used in) operating activities was $44.4 million, compared to $(33.5) million in 2023. Cash Position As of December 31, 2024, Aurinia had cash, cash equivalents, restricted cash and investments of $358.5 million, compared to $350.7 million at December 31, 2023. For the year ended December 31, 2024, the Company repurchased 6.1 million of its common shares for $41.0 million. Full Year 2025 Total Revenue and Net Product Sales Guidance For 2025, Aurinia expects total revenue in the range of $250 million to $260 million and net product sales in the range of $240 million to $250 million. Research and Development Update In September 2024, Aurinia initiated a Phase 1 study of AUR200, its potentially best-in-class dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL). BAFF and APRIL are cytokines that stimulate B cell proliferation and activity and are upregulated in many autoimmune diseases. In preclinical studies, AUR200 potently inhibited B cell proliferation and production of IgA and IgM antibodies and exhibited pharmacokinetic and pharmacodynamic properties consistent with once-monthly dosing. Aurinia expects to report initial results from its Phase 1 study of AUR200 in the second quarter of 2025. “We are pleased to have delivered strong LUPKYNIS sales growth in 2024,” stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. “We expect 2025 to be an exciting year for Aurinia. We remain focused on increasing LUPKYNIS’s adoption among the many lupus nephritis patients who could benefit from this important treatment, while, at the same time, advancing our important pipeline product, AUR200, which has the potential to treat a wide range of autoimmune diseases.” Webcast & Conference Call Details A webcast and conference call will be hosted today, February 27th, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: LUPKYNIS net product sales, the timing of clinical study results and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com. AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands) December 31, 2024 December 31, 2023 ASSETS Current assets: Cash, cash equivalents and restricted cash $ 83,433 $ 48,875 Short-term investments 275,043 301,614 Accounts receivable, net 36,544 24,089 Inventory, net 39,228 39,705 Prepaid expenses and deposits 11,219 9,486 Other current assets 1,129 1,031 Total current assets 446,596 424,800 Finance right-of-use lease assets 92,072 108,715 Intangible assets, net 4,355 4,977 Operating right-of-use lease assets 4,068 4,498 Property and equipment, net 2,731 3,354 Long-term investments — 201 Other noncurrent assets 823 1,517 Total assets $ 550,645 $ 548,062 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 5,187 $ 4,327 Accrued expenses 64,971 50,062 Finance lease liabilities, current portion 14,046 14,609 Deferred revenue 11,002 4,813 Operating lease liabilities, current portion 1,026 989 Other current liabilities 1,531 2,388 Total current liabilities 97,763 77,188 Finance lease liabilities, less current portion 58,554 75,479 Deferred compensation and other noncurrent liabilities 11,107 10,911 Operating lease liabilities, less current portion 5,743 6,530 Total liabilities 173,167 170,108 Shareholders' equity Common shares - no par value, unlimited shares authorized, 140,883 and 143,833 shares issued and outstanding at December 31, 2024 and 2023, respectively 1,187,696 1,200,218 Additional paid-in capital 126,999 120,788 Accumulated other comprehensive loss (647 ) (730 ) Accumulated deficit (936,570 ) (942,322 ) Total shareholders' equity 377,478 377,954 Total liabilities and shareholders’ equity $ 550,645 $ 548,062 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) Three months ended Years ended December 31, 2024 December 31, 2023 December 31, 2024 December 31, 2023 (unaudited) Revenue Net product sales $ 57,582 $ 42,315 $ 216,186 $ 158,533 License, collaboration and royalty revenue 2,285 2,780 18,947 16,980 Total revenue 59,867 45,095 235,133 175,513 Operating expenses Cost of revenue 5,552 5,395 28,248 14,148 Selling, general and administrative 37,032 50,072 172,028 195,036 Research and development 8,107 10,228 20,785 49,641 Restructuring 15,351 — 23,106 — Other (income) expense, net (4,506 ) 9,074 (4,347 ) 8,379 Total operating expenses 61,536 74,769 239,820 267,204 Loss from operations (1,669 ) (29,674 ) (4,687 ) (91,691 ) Interest income 3,988 4,568 16,970 16,997 Interest expense (1,146 ) (1,310 ) (4,835 ) (2,775 ) Net income (loss) before income taxes 1,173 (26,416 ) 7,448 (77,469 ) Income tax (benefit) expense (256 ) 459 1,696 551 Net income (loss) $ 1,429 $ (26,875 ) $ 5,752 $ (78,020 ) Basic $ 0.01 $ (0.19 ) $ 0.04 $ (0.54 ) Diluted $ 0.01 $ (0.19 ) $ 0.04 $ (0.54 ) Shares used in computing earnings (loss) per share Basic 142,179 142,927 143,057 143,236 Diluted 147,675 142,927 146,194 143,236 AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) Years ended December 31, 2024 2023 2022 Cash flows from operating activities: Net income (loss) $ 5,752 $ (78,020 ) $ (108,180 ) Adjustments to reconcile consolidated net income (loss) to net cash provided by (used in) operating activities: Share-based compensation 31,596 45,311 32,300 Amortization and depreciation 19,445 11,647 2,706 Foreign exchange (gain) loss on revaluation of finance lease liability (Monoplant) (5,910 ) 5,949 — Net amortization of premiums and discounts on investments (12,731 ) (12,141 ) (1,572 ) Non-cash write-down of inventory — 916 3,646 Other, net 788 (1,515 ) (1,612 ) Net changes in operating assets and liabilities: Accounts receivable, net (12,455 ) (10,606 ) 1,927 Inventory, net 477 (15,869 ) (9,072 ) Prepaid expenses and other current assets (1,834 ) 4,399 (2,404 ) Other noncurrent operating assets 31 (16 ) (363 ) Accounts payable 860 1,240 (792 ) Accrued expenses and other liabilities 13,330 12,154 1,491 Deferred revenue 5,789 3,763 3,048 Operating lease liabilities (750 ) (673 ) (652 ) Net cash provided by (used in) operating activities 44,388 (33,461 ) (79,529 ) Cash flows from investing activities: Proceeds from the sale and maturities of investments 585,418 529,376 464,316 Purchases of investments (545,832 ) (523,500 ) (523,993 ) Upfront lease payments (43 ) (11,864 ) (663 ) Purchases of property, equipment and intangible assets (281 ) (718 ) (292 ) Net cash provided by (used in) investing activities 39,262 (6,706 ) (60,632 ) Cash flows from financing activities: Repurchase of common shares (40,239 ) — — Principal portion of finance lease payments (11,989 ) (10,025 ) — Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs 8,186 5,324 1,561 Proceeds from issuance of common shares under ESPP 1,084 1,850 1,912 Taxes paid related to net settlement of exercises of stock options and vesting of RSUs (6,134 ) (2,279 ) (1,040 ) Net cash (used in) provided by financing activities (49,092 ) (5,130 ) 2,433 Net increase (decrease) in cash, cash equivalents and restricted cash 34,558 (45,297 ) (137,728 ) Cash, cash equivalents and restricted cash, beginning of the period 48,875 94,172 231,900 Cash, cash equivalents and restricted cash, end of the period $ 83,433 $ 48,875 $ 94,172

Phase 1Drug ApprovalFinancial Statement

100 Deals associated with Voclosporin

External Link

KEGG	Wiki	ATC	Drug Bank
D09033	Voclosporin	L04AD03	DB11693

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Nephritis	United States	Aurinia Pharmaceuticals, Inc.	22 Jan 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Kerato conjunctivitis sicca	Phase 3	United States	Aurinia Pharmaceuticals, Inc.	14 Oct 2019
Acute rejection of renal transplant	Phase 3	-	Aurinia Pharmaceuticals, Inc.	01 Mar 2013
Uveitis	Phase 3	United States	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Austria	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Brazil	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Canada	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Czechia	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	France	Lux Biosciences, Inc.	01 Feb 2011
Uveitis	Phase 3	Germany	Lux Biosciences, Inc.	01 Feb 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	Lupus Nephritis	179	Voclosporin-based, triple immunosuppressive regimen	valmtkppbn(tgjhepwoxh) = The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants in ALMS over the 6-month period. More participants in AURA-LV and AURORA 1 reported hypertension and anemia. Due to the known hemodynamic effects of calcineurin inhibition, there was a small decrease in mean eGFR in the AURA-LV/AURORA 1 participants in the first few weeks of treatment after which mean eGFR remained stable; a greater number of events of GFR decreased were reported by AURA-LV/AURORA 1 participants. The incidence of serious AEs was similar across groups. sniytddgpw (eigvmpwhjf ) View more	Positive	05 Jun 2024
				High-dose glucocorticoid and mycophenolate mofetil-based therapy
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	25	LUPKYNIS, MMF, and steroids	mwjbeqxfje(zmafgtlnrj) = ctfjakaiaa wtpuiwakjc (qtzwhfjnpc )	Positive	09 May 2024
				MMF and glucocorticoids	mwjbeqxfje(zmafgtlnrj) = bvkuljjkmp wtpuiwakjc (qtzwhfjnpc )
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS	tcplsijawu(jkvqjfwvpg) = jfqrywkbed lydhlcuboy (pjrqwrtmjd )	Positive	09 May 2024
NCT03021499 (phase 3 study, Pubmed)	Phase 3	Lupus Nephritis	148	Voclosporin	fqdcywcext(qqjcfjhedb) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms utueukjzds (nwajokgwdw ) View more	Positive	18 Dec 2023
				Placebo
ACR2023	Not Applicable	Proteinuria	-	Voclosporin	bqcytnigog(wybsjfnnar) = anmqfkbvep gfhsqgdxyk (rptvtwqbhh ) View more	-	14 Nov 2023
				Placebo	bqcytnigog(wybsjfnnar) = asfvhhgayz gfhsqgdxyk (rptvtwqbhh ) View more
NCT03597464 (AURORA 2, Biospace) Manual	Phase 3	Lupus Nephritis	26	LUPKYNIS® in combination + MMF + glucocorticoids	rivnimxemk(hqrgvycvvh) = experienced numerically greater mean reductions jgcqnmxief (iryzylgwmt ) View more	Positive	07 Nov 2023
				MMF + glucocorticoids
NCT03021499 (AURORA, Biospace) Manual	Not Applicable	Lupus Nephritis	-	LUPKYNIS + MMF + glucocorticoids (Black patients)	apfhuzjaol(bmxwgdrmqn) = uvelkmutim yznndcchwg (nuxhbqobkb )	Positive	07 Nov 2023
				MMF + glucocorticoids (Black patients)	apfhuzjaol(bmxwgdrmqn) = kqwjdgtcic yznndcchwg (nuxhbqobkb )
NCT03021499 \| NCT02141672 (AURORA 1, Biospace) Manual	Phase 2/3	Lupus Nephritis	-	LUPKYNIS® + MMF+ glucocorticoids (proteinuria >=2 g/day)	xvfzcybilw(dglbswomnp) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day xfoylbrdtp (vmuvcmajzd ) View more	Positive	07 Nov 2023
				LUPKYNIS® + MMF+ glucocorticoids (UPCR ≥2 g/g at baseline)
AURA-LV and AURORA 1 (EULAR2023)	Phase 2/3	Proteinuria	-	Voclosporin	hjrznvangb(vviuzzofso) = iorlwhmjqt kjnopphavh (pcvjkcleit ) View more	Positive	31 May 2023
				Placebo	hjrznvangb(vviuzzofso) = jktdihjudz kjnopphavh (pcvjkcleit ) View more

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