Last update 17 May 2024
Crovalimab
Last update 17 May 2024
Overview
Basic Info
Drug Type Monoclonal antibody |
Synonyms Complement c5 inhibitory humanized recycling monoclonal antibody (rg-6107 ), Crovalimab (genetical recombination) (JAN), Crovalimab (USAN/INN) + [17] |
Target |
Mechanism C5 inhibitors(Complement C5 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (06 Feb 2024), |
RegulationPriority Review (CN), Breakthrough Therapy (CN) |
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Gene Sequence
Sequence Code 26187541H
Source: *****
Sequence Code 229613448L
Source: *****
Related
28
Clinical Trials associated with Crovalimab一项在儿童非典型溶血尿毒综合征（aHUS）患者中评价CROVALIMAB的有效性、安全性、药代动力学和药效学的III期、多中心、单臂研究
[Translation] A phase III, multicenter, single-arm study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of CROVALIMAB in pediatric patients with atypical hemolytic uremic syndrome (aHUS)
本研究将评价 crovalimab 治疗非典型溶血尿毒综合征（aHUS）儿童患者的有 效性、安全性、免疫原性、药代动力学和药效学。
[Translation]
This study will evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of crovalimab in pediatric patients with atypical hemolytic uremic syndrome (aHUS).
Start Date19 Dec 2023 |
Sponsor / Collaborator |
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Patients With Guillain-Barré Syndrome
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin (IVIg) in participants with severe GBS.
Start Date30 Nov 2022 |
Sponsor / Collaborator |
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PATIENTS WITH GUILLAIN-BARRÉ SYNDROME - SAROS
Start Date24 Jun 2022 |
Sponsor / Collaborator- |
100 Clinical Results associated with Crovalimab
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100 Translational Medicine associated with Crovalimab
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100 Patents (Medical) associated with Crovalimab
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18
Literatures (Medical) associated with Crovalimab01 Sep 2023·American journal of hematology
Efficacy and safety of the C5 inhibitor crovalimab in complement inhibitor-naive patients with PNH (COMMODORE 3): A multicenter, Phase 3, single-arm study.
Article
Author: Liu, Hui ; Lundberg, Pontus ; Xia, Linghui ; Weng, Jianyu ; Shi, Jane ; Fu, Rong ; He, Chuan ; Zhang, Fengkui ; Chang, Alice C ; Sima, Camelia S ; Gao, Sujun ; Sreckovic, Sasha ; Zhang, Zilu ; Xiao, Zhenyu ; Jia, Jinsong ; Sostelly, Alexandre
The Phase 3 single-arm COMMODORE 3 study (ClinicalTrials.gov, NCT04654468) evaluated efficacy and safety of crovalimab (novel C5 inhibitor) in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). COMMODORE 3 enrolled patients from five China centers. Eligible complement inhibitor-naive patients with PNH were ≥12 years old, had lactate dehydrogenase (LDH) ≥2 × upper limit of normal (ULN), and had ≥4 transfusions of packed red blood cells within the prior 12 months. Patients received crovalimab loading doses (one intravenous, four subcutaneous) and subsequent every-4-weeks subcutaneous maintenance doses per weight-based tiered-dosing schedule. Co-primary efficacy endpoints were mean proportion of patients with hemolysis control (LDH ≤1.5 × ULN) from Week (W)5 through W25 and difference in proportion of patients with transfusion avoidance from baseline through W25 versus within 24 weeks of prescreening in patients who had ≥1 crovalimab dose and ≥1 central LDH assessment after first dose. Between March 17 and August 24, 2021, 51 patients (15-58 years old) were enrolled; all received treatment. At primary analysis, both co-primary efficacy endpoints were met. Estimated mean proportion of patients with hemolysis control was 78.7% (95% CI: 67.8-86.6). Difference between proportion of patients with transfusion avoidance from baseline through W25 (51.0%; n = 26) versus within 24 weeks of prescreening (0%) was statistically significant (p < .0001). No adverse events led to treatment discontinuation. One treatment-unrelated death (subdural hematoma following a fall) occurred. In conclusion, crovalimab, with every-4-weeks subcutaneous dosing is efficacious and well tolerated in complement inhibitor-naive patients with PNH.
01 Aug 2023·European Journal of Haematology
Crovalimab treatment in patients with paroxysmal nocturnal haemoglobinuria: Long‐term results from the phase I/II COMPOSER trial
Article
Author: Nishimura, Jun-Ichi ; Patel, Himika ; Röth, Alexander ; Schrezenmeier, Hubert ; Soret, Juliette ; Lundberg, Pontus ; Panse, Jens ; Sica, Simona ; Usuki, Kensuke ; Shinomiya, Kenji ; Balachandran, Nadiesh ; Yoon, Sung-Soo ; Nagy, Zsolt ; Obara, Naoshi ; Kim, Jin Seok ; Sostelly, Alexandre ; Ichikawa, Satoshi ; Ito, Yoshikazu ; Buri, Muriel
Abstract:
Objectives:
This study reports long‐term outcomes from the open‐label extension (OLE) period of the Phase I/II COMPOSER trial (NCT03157635) that evaluated crovalimab in patients with paroxysmal nocturnal haemoglobinuria, who were treatment‐naive or switched from eculizumab at enrolment.
Methods:
COMPOSER consists of four sequential parts followed by the OLE. The primary OLE objective was to assess long‐term crovalimab safety, with a secondary objective to assess crovalimab pharmacokinetics and pharmacodynamics. Exploratory efficacy endpoints included change in lactate dehydrogenase (LDH), transfusion avoidance, haemoglobin stabilisation and breakthrough haemolysis (BTH).
Results:
A total 43 of 44 patients entered the OLE after completing the primary treatment period. Overall, 14 of 44 (32%) experienced treatment‐related adverse events. Steady state exposure levels of crovalimab and terminal complement inhibition were maintained over the OLE. During the OLE, mean normalised LDH was generally maintained at ≤1.5× upper limit of normal, transfusion avoidance was achieved in 83%–92% of patients and haemoglobin stabilisation was reached in 79%–88% of patients across each 24‐week interval. Five BTH events occurred with none leading to withdrawal.
Conclusions:
Over a 3‐year median treatment duration, crovalimab was well tolerated and sustained C5 inhibition was achieved. Intravascular haemolysis control, haemoglobin stabilisation and transfusion avoidance were maintained, signifying long‐term crovalimab efficacy.
01 May 2023·American journal of therapeutics
Complement Inhibitors in the Management of Complement-Mediated Hemolytic Uremic Syndrome and Paroxysmal Nocturnal Hemoglobinuria.
Article
Author: Malieckal, Deepa A ; Khan, Nida ; Boisclair, Stephanie ; Begum, Farhana ; Chitty, David
BACKGROUND:
Complement-mediated HUS (CM-HUS) and paroxysmal nocturnal hemoglobinuria (PNH) are rare hematologic disorders that cause dysregulation and hyperactivation of the complement system. Historically, treatment of CM-HUS involved plasma exchange (PLEX), often with limited benefit and variable tolerance. Conversely, PNH was treated with supportive care or hemopoietic stem cell transplant. Within the last decade, monoclonal antibody therapies that block terminal complement pathway activation, have emerged as less invasive and more efficacious options for management of both disorders. This manuscript seeks to discuss a relevant clinical case of CM-HUS and the evolving landscape of complement inhibitor therapies for CM-HUS and PNH.
AREAS OF UNCERTAINTY:
Eculizumab, the first humanized anti-C5 monoclonal antibody, has been the standard of care in treating CM-HUS and PNH for over a decade. Although eculizumab has remained an effective agent, the variability in ease and frequency of administration has remained an obstacle for patients. The development of novel complement inhibitor therapies with longer half-lives, has allowed for changes in frequency and route of administration, thus improving patient QOL. However, there are limited prospective clinical trial data given disease rarity, and limited information on variable infusion frequency and length of treatment.
THERAPEUTIC ADVANCES:
Recently, there has been a push to formulate complement inhibitors that improve QOL while maintaining efficacy. Ravulizumab, a derivative of eculizumab, was developed to allow for less frequent administration, while remaining efficacious. In addition, the novel oral and subcutaneous therapies, danicopan and crovalimab, respectively, along with pegcetacoplan are currently undergoing active clinical trials, and poised to further reduce treatment burden.
CONCLUSION:
Complement inhibitor therapies have changed the treatment landscape for CM-HUS and PNH. With a significant emphasis on patient QOL, novel therapies continue to emerge and require an in-depth review of their appropriate use and efficacy in these rare disorders.
CLINICAL CASE:
A 47-year-old woman with hypertension and hyperlipidemia presented with shortness of breath and was found to have hypertensive emergency in the setting of acute renal failure. Her serum creatinine was 13.9 mg/dL; elevated from 1.43 mg/dL 2 years before. The differential diagnosis for her acute kidney injury (AKI) included infectious, autoimmune, and hematologic processes. Infectious work-up was negative. ADAMTS13 activity level was not low at 72.9%, ruling out thrombotic thrombocytopenic purpura (TTP). Patient underwent a renal biopsy, which revealed acute on chronic thrombotic microangiopathy (TMA). A trial of eculizumab was initiated with concurrent hemodialysis. The diagnosis of CM-HUS was later confirmed by a heterozygous mutation in complement factor I (CFI), resulting in increased membrane attack complex (MAC) cascade activation. The patient was maintained on biweekly eculizumab and was eventually transitioned to ravulizumab infusions as an outpatient. Her renal failure did not recover, and the patient remains on hemodialysis while awaiting kidney transplantation.
52
News (Medical) associated with Crovalimab24 Apr 2024
Group sales grew by 2%1 at constant exchange rates (CER) (-6% in CHF), driven by the strong growth of newer medicines and diagnostics. Excluding COVID-19-related products, sales increased by 7%. Going forward, there will be no further material impact of COVID-19 sales declineDue to the appratioss fn of the Swiranc against most currencies, sales were 6% lower when reported in CHFPharmaceuticals Division base business2 grew by 7%, driven by strong sales of medicines to treat severe diseases, such as Vabysmo (eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A). Divisional sales growth was 2%, reflecting the impact of the expected decline in sales of the COVID-19 medicine Ronapreve Diagnostics Division base business2 grew by 8%, supported by growth across all regions because of demand for immunodiagnostic products, clinical chemistry tests and advanced staining solutions. As this growth was partially offset by the lower demand for COVID-19 tests, divisional sales grew by 2%Highlights in the first quarter: US approvals of Xolair (food allergies) and Alecensa (early-stage lung cancer)Positive phase III data for Xolair (food allergies), Columvi (blood cancer) and Ocrevus subcutaneous injection (multiple sclerosis); positive phase II results for zilebesiran (hypertension in people with high cardiovascular risk)New positive long-term data for Vabysmo (retinal vein occlusion, a severe eye disease) US approval for the first molecular test to screen for malaria in blood donorsUS Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis
Outlook for 2024 confirmed Roche CEO Thomas Schinecker: “We had a strong start into the year, with both our divisions reporting high single digit growth in their base business – excluding COVID-19 sales. After this quarter, the COVID-19-related impact on sales is largely behind us. The appreciation of the Swiss franc versus most currencies impacted sales reported in Swiss francs compared to the same period last year. The uptake of our eye medicine Vabysmo continues its momentum. We are pleased about the US approval of Xolair as the first and only medicine for multiple food allergies. Further, we recently received the US approval for Alecensa in early-stage lung cancer. With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for this specific form of lung cancer. We are confident of growing our Group sales in the mid single digit range this year (at constant exchange rates) and therefore we confirm our outlook for 2024.” Sales CHF millions As % of sales % change
January‒March 2024 2023 2024 2023 At CER In CHF
Group 14,399 15,322 100.0 100.0 2 -6
Pharmaceuticals Division 10,921 11,608 75.8 75.8 2 -6
United States 5,692 5,763 39.5 37.6 5 -1
Europe 2,200 2,071 15.3 13.5 11 6
Japan 649 1,390 4.5 9.1 -45 -53
International* 2,380 2,384 16.5 15.6 12 0
Diagnostics Division 3,478 3,714 24.2 24.2 2 -6
All figures shown in the table were restated to reflect the shift of the Foundation Medicine (FMI) business from the Pharmaceuticals Division to the Diagnostics Division. *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Outlook for 2024 confirmedRoche expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop broadly in line with sales growth (CER), excluding the impact from the resolution of tax disputes in 2023. Roche expects to further increase its dividend in Swiss francs.
Group salesIn the first three months of 2024, Group sales increased by 2% CER (-6% in CHF) to CHF 14.4 billion as strong demand for newer medicines as well as diagnostics products including immunodiagnostics, clinical chemistry tests and advanced staining solutions more than offset the anticipated decline in COVID-19-related sales and the impact of biosimilar/generic erosion.
After this quarter, the impact of the drop in COVID-19-related sales is largely over and there will be no further material impact on Group sales. Excluding COVID-19-related products, sales increased by 7%. The appreciation of the Swiss franc against most currencies had a significant adverse impact on the sales reported in Swiss francs compared to constant exchange rates. Pharmaceuticals Division base business grew by 7%, while divisional sales increased by 2% to CHF 10.9 billion as the strong global demand for newer medicines to treat severe diseases was partially offset by the expected decline in COVID-19 Ronapreve sales. The eye medicine Vabysmo was the biggest growth driver, with Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A) being other significant contributors. Together, these medicines generated sales of CHF 4.2 billion, an increase of CHF 0.9 billion (at CER) from the first quarter of 2023. The negative impact of biosimilar/generic erosion on our medicines Lucentis (eye diseases, US commercialisation rights only), MabThera/Rituxan (blood cancer), Herceptin (breast and stomach cancer), Avastin (various types of cancer), Esbriet (lung disease) and Actemra/RoActemra (arthritis, COVID-19) totalled CHF 0.4 billion (at CER), in line with expectations. In the United States, sales increased by 5%, driven by strong demand for newer medicines such as Vabysmo, Polivy, Ocrevus, Phesgo and Evrysdi (spinal muscular atrophy) as well as for Xolair (allergies). This contrasted with lower sales of Lucentis, MabThera/Rituxan, Tecentriq (cancer immunotherapy), Esbriet, Avastin and Perjeta. In Europe, sales grew by 11%, with Vabysmo, Phesgo, Hemlibra, Evrysdi and Ocrevus being the key drivers. Sales in Japan were down by 45%, reflecting the base effect of the supply of Ronapreve to the government in the first quarter of 2023. Sales in the International region increased by 12%, driven by strong growth in Hemlibra, Perjeta, Phesgo, Ocrevus, Tecentriq and Vabysmo. In China, sales grew by 11% due to high demand for Xofluza (influenza), Perjeta, Avastin, Polivy and Tecentriq. The Diagnostics Division’s base business continued good growth (8%), boosted by demand for immunodiagnostic products, clinical chemistry tests and advanced staining solutions. This was partially offset by the expected sales decline of COVID-19-related products, leading to divisional sales growing at 2% to CHF 3.5 billion. Immunodiagnostic products, which include cardiac, oncology and thyroid tests, were the main growth drivers (10%). Additional growth impetus came from clinical chemistry (8%), advanced staining techniques in oncology (12%) and companion diagnostics (47%). As expected, the sales of COVID-19 tests further declined to CHF 0.1 billion in the first quarter of 2024 from CHF 0.3 billion in the corresponding period last year. Sales growth was reported across regions, with Europe, Middle East and Africa (EMEA) growing by 2%, Asia-Pacific by 1% and Latin America by 14%. North America recorded a decline of 1%, reflecting the drop in demand for COVID-19-related tests. Pharmaceuticals: key milestones in the first quarter of 2024 Compound Milestone Regulatory AlecensaLung cancer FDA approves Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer Approval based on phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapyThe National Comprehensive Cancer Network (NCCN) Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selection More information: Media Release, 19 April 2024 Piasky Rare blood disease Chugai obtains regulatory approval for Piasky 340 mg for paroxysmal nocturnal haemoglobinuria in Japan Providing convenience of once every 4 week subcutaneous administration for treatment-naive patients, or for patients switching to this drug from other C5 inhibitors, with paroxysmal nocturnal haemoglobinuria (PNH), a designated intractable diseaseThis approval for not only treatment-naive PNH but also including patients switching from previously approved C5 inhibitors, is the first in the worldSecond approved drug that applies Chugai’s proprietary recycling antibody technology and also the fifth Chugai-originated global product More information: Investor Relations Update, 26 March 2024 Xolair Food allergy FDA approves Xolair as first and only medicine for children and adults with one or more food allergies Approval is based on data from the NIH-sponsored phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as one year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than 50% of adults with food allergies have experienced a severe reaction at least once in their lifetimeDetailed OUtMATCH results were featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology annual meeting More information: Media Release, 16 February 2024 Phase III, pivotal and other key readouts Ocrevus SCMultiple sclerosis Subcutaneous Ocrevus one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of multiple sclerosis Results from the phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeksThe twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centres without IV infrastructure or with IV capacity limitationsUS FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and US approval anticipated in September 2024 More information: Media Release, 17 April 2024 ColumviBlood cancer Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in phase III STARGLO study Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting More information: Media Release, 15 April 2024 ZilebesiranCardiovascular diseases Roche and Alnylam present positive results from the phase II KARDIA-2 study of zilebesiran added to standard-of-care antihypertensives in patients with inadequately controlled hypertension The KARDIA-2 study met its primary endpoint demonstrating additive, placebo-adjusted systolic blood pressure reductions of up to 12.1 mmHg at month three. These results were statistically significant and clinically meaningfulZilebesiran demonstrated an encouraging safety and tolerability profile when added to standard of care antihypertensives Roche and Alnylam have initiated the phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular risk. More information: Investor Relations Update, 7 March 2024 XolairFood allergies New England Journal of Medicine publishes phase III data showing Xolair significantly reduced allergic reactions across multiple foods in people with food allergies Detailed results from the NIH-sponsored phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as one year consumed without an allergic reactionThe US FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies Allergic reactions can be life-threatening and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the US each year More information: Media Release, 25 February 2024 VabysmoSevere eye diseases New long-term data for Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO) Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry visionUp to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart Detailed results from two global phase III RVO studies were presented at Angiogenesis, Exudation, and Degeneration 2024 More information: Media Release, 1 February 2024 Pharmaceuticals sales Sales CHF millions As % of sales % change
January–March 2024 2023 2024 2023 At CER In CHF
Pharmaceuticals Division 10,921 11,608 100.0 100.0 2 -6
United States 5,692 5,763 52.1 49.4 5 -1
Europe 2,200 2,071 20.1 17.8 11 6
Japan 649 1,390 5.9 12.0 -45 -53
International* 2,380 2,384 21.9 20.8 12 0
All figures shown in the table were restated to reflect the shift of the Foundation Medicine (FMI) business from the Pharmaceuticals Division to the Diagnostics Division. *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 1,658 8 1,180 5 310 8 - - 168 28 HemlibraHaemophilia A 1,040 8 592 -1 231 17 79 2 138 51 Perjeta3Breast cancer 936 -3 343 -7 171 -19 36 -19 386 14 TecentriqCancer immunotherapy 865 1 436 -9 210 12 86 -4 133 34 VabysmoEye diseases (nAMD, DME, RVO) 847 108 650 91 138 224 23 33 36 397 Actemra/RoActemra3RA, COVID-19 618 -2 278 -1 188 1 68 5 84 -15 Xolair3Asthma, allergies 496 10 496 10 - - - - - - Kadcyla3Breast cancer 483 3 186 -1 145 -2 21 -4 131 19 PhesgoBreast cancer 388 70 126 36 169 55 19 - 74 165 Herceptin3Breast and gastric cancer 364 -17 67 -22 77 -17 4 -41 216 -14 EvrysdiSpinal muscular atrophy 356 7 135 16 137 27 20 13 64 -29 AlecensaLung cancer 355 4 104 4 72 3 43 3 136 5 MabThera/Rituxan3Blood cancer, RA 351 -18 204 -21 39 -20 4 -20 104 -11 Avastin 3Various cancer types 324 -15 99 -22 21 -27 51 -33 153 3 Activase/TNKase3Cardiac diseases 296 4 282 4 - - - - 14 7 PolivyBlood cancer 250 81 117 166 54 42 44 2 35 181 Gazyva/Gazyvaro3Blood cancer 213 16 100 7 62 17 6 -19 45 47 Pulmozyme3Cystic fibrosis 112 -6 66 -15 20 0 - 27 26 22 Mircera3Anaemia 96 0 - - 10 -8 9 -25 77 6 CellCept3Immunosuppressant 94 0 5 -34 32 0 9 -10 48 8 ** Over 500% DME: diabetic macular oedema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key milestones in the first quarter of 2024 Product Milestone Regulatory Elecsys pTau217 test Alzheimer’s disease FDA Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and CompanyOnce approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s diseaseRoche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis More information: Media Release, 11 April 2024 cobas Malaria testMalaria FDA approval for the first molecular test to screen for malaria in blood donors The cobas Malaria test is the first FDA-approved molecular test to screen US blood donors for malariaMalaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusionRoche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases More information: Media Release, 26 March 2024 Diagnostics sales Sales CHF millions As % of sales % change January–March 2024 2023 2024 2023 At CER In CHF Diagnostics Division 3,478 3,714 100.0 100.0 2 -6 Customer areas4
Core Lab 1,925 1,928 55.4 51.9 9 0 Molecular Lab5 620 683 17.8 18.4 -3 -9 Near Patient Care6 570 774 16.4 20.8 -20 -26 Pathology Lab 363 329 10.4 8.9 19 10 Regions
Europe, Middle East, Africa 1,188 1,253 34.2 33.8 2 -5 North America5 1,055 1,120 30.3 30.3 -1 -6 Asia-Pacific 992 1,098 28.5 29.4 1 -10 Latin America 243 243 7.0 6.5 14 0 More information on Roche sales in the first quarter of 2024: Q1 2024 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2023) and all total figures quoted are reported in CHF.[2] Pharmaceuticals Division base business: excluding COVID-19 medicine Ronapreve.Diagnostics Division base business: excluding COVID-19-related products.[3] Products launched before 2015.[4] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices or directly with patients and integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.[5] Sales in the Molecular Lab customer area include sales from the Foundation Medicine business which moved under the responsibility of the Diagnostics Division from the Pharmaceuticals Division effective 1 January 2024. The comparative information for 2023 has been restated accordingly.[6] Sales in the new Near Patient Care customer area include sales from Diabetes Care and the Point of Care business, both previously shown as separate customer areas. The comparative information for 2023 has been restated accordingly.
Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Nathalie AltermattPhone: +41 79 771 05 25 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Sileia UrechPhone: +41 79 935 81 48
Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com
Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com
Attachments
Communications appendix tables_Q1 2024_Sales
24042024_MR_Roche_Q1results_EN
Clinical ResultPhase 3Drug ApprovalBreakthrough TherapyPhase 2
24 Apr 2024
Pictured: Roche's building in Shanghai, China/iStock, Robert Way
Roche released its first-quarter 2024 earnings results on Wednesday posting a 6% decline in sales compared to the same prior year period, as the company continued to be weighed down by weak demand for COVID-19 products and currency headwinds while narrowly beating analysts’ expectations.
In the first quarter of 2024, the pharma group’s sales brought in around $15.79 billion, down from its Q1 2023 earnings of approximately $16.78 billion. The performance of Roche’s pharmaceuticals division likewise slowed by 6% in the quarter, with its sales falling to $11.96 billion from $12.71 billion in the same period last year.
CEO Thomas Schinecker in a statement attributed the decline to the ongoing contraction of the COVID-19 market and to the “appreciation of the Swiss franc versus most currencies,” which in turn had a significant adverse impact on the group’s sales reported in Swiss francs. At constant exchange rates, Roche’s earnings grew by 2%. Excluding pandemic-related products, sales increased by 7%.
“After this quarter, the COVID-19-related impact on sales is largely behind us,” Schinecker added.
The eye treatment Vabysmo (faricimab-svoa) emerged as Roche’s strongest growth driver, bringing in $927.4 million in Q1, a 108% increase compared with the same period in 2023 while beating the analyst consensus. Vabysmo was first approved in February 2022 for wet age-related macular degeneration and diabetic macular edema. The drug picked up another approval in October 2023 for retinal vein occlusion.
The blood cancer therapy Polivy (polatuzumab vedotin-piiq) and breast cancer medicine Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzfx) were also strong growth contributors in Q1. These assets brought in $424 million and $273 million, respectively, representing sales increases of 70% and 81%.
Roche’s top-performing asset was Ocrevus which secured $1.82 billion in Q1, representing 8% growth from the same time period in 2023.
As for its pipeline, the pharma group disclosed in Wednesday’s earnings presentation that it had discontinued the development of four early-stage assets including camonsertinib—which was being trialed in solid tumors—and belvarafenib, which was likewise being assessed for solid tumors in combination with Genentech’s Cotellic (cobimetinib). Roche also terminated two new molecular candidates—one for colorectal cancer and one for psychiatric disorders.
Looking forward to the rest of the year, Roche reaffirmed its 2024 outlook and noted in its statement that the company expects a sales increase in the mid-single digit range at constant exchange rates.
To meet its forecast, Roche has several milestones lined up including a potential U.S. and European Union approval for crovalimab in paroxysmal nocturnal hemoglobinuria and for subcutaneous Ocrevus in relapsing or primary progressive multiple sclerosis.
The pharma group is also preparing for key readouts for the Phase III VERONA study of Venclexta plus azacitidine in first-line myelodysplastic syndrome, as well as the Phase IIb PADOVA trial of prasinezumab in Parkinson’s disease.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
Drug ApprovalPhase 2Financial StatementPhase 3Phase 1
15 Apr 2024
BUENOS AIRES, Argentina, April 15, 2024 /PRNewswire/ -- LongBio Pharma (Suzhou) Co., Ltd. (referred to as "LongBio"), a leading biotech company dedicated to developing innovative protein treatments for nephrology, allergy, respiratory, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of pre-clinical data of LP-005, a novel bi-functional complement antibody-fusion protein, at the 2024 World Congress of Nephrology (WCN24) held by International Society of Nephrology (ISN).
The poster titled "Bi-functional C5 antibody-fusion protein (LP-005) with potential best-in-class bioactivity for complement inhibition" was presented by LongBio during the conference.
Date and Time: April 15, 2024, at 17:45 pm (UTC -3)
Location
: Exhibition Hall and Main Foyer
Poster Number: MON-100
Methods: Eculizumab, POT-4 (also known as APL-1) was purchased from vendors. The sequences of Ravulizumab, Crovalimab, Pozelimab, Narsoplimab and Ab-fH were obtained from INN and made in-house with LP-005, LP-005C. CP, AP, LP and C3b deposition assays with head-to-head comparison were conducted. Monkey PK/PD assay of LP-005C and Ab-fH was also conducted.
Results: LP-005 shows the most potent inhibition in CP, AP and LP compared to Eculizumab, Ravulizumab, Crovalimab, Pozelimab and Narsoplimab.
In addition, it also has the most efficient inhibition in C3b assay compared to Antibody-fH fusion and POT-4 (APL-1).
The monkey PK/PD study indicates that when fusing to the same C5 antibody, LongBio's unique inhibitor (inCibitorTM) shows a better PK/PD profile compared to the natural fH 1-5 fragment.
LP-005 is a novel bifunctional complement antibody fusion protein targeting both C3 and C5, with better bioactivity in CP, AP, LP and C3b deposition assays. Meanwhile, LP-005 is engineered to optimize surface charge (PI) and FcRn binding, making it first Q4W bi-functional complement inhibitor all over the world. With all these advantages above, LP-005 has the potential to be a best-in-class drug candidate with excellent and full complement inhibitory activity and will be explored in complement mediated disorders.
LP-005's phase I study in healthy volunteers will be completed in 2024Q2 in China. At present, LP-005 showed expected PK/PD profile and well tolerated safety profile. More clinical data will be unveiled at 2024 European Meeting on Complement in Human Diseases in September. The phase II studies with indication of IgAN (IgA Nephropathy) and PNH (Paroxysmal nocturnal hemoglobinuria, rare disease) will initial in 2024Q2. Other indications in neurology and ophthalmology are also scheduled to develop.
About InCibitor™
InCibitorTM is a new generation of complement inhibitor platform developed by LongBio. The bi-functional complement inhibitor LP-005 developed based on this platform is going to start Phase II study of IgAN and PNH. LongBio is also exploring the development of new drugs related to hematology, nephrology, neurology, ophthalmology, oncology, and gene therapy based on this platform.
About LongBio
LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society.
LongBio Pharma aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is about to start Phase III study in 2024Q2, and prepare for BLA in 2025H1. The second leading pipeline is a bi-functional complement antibody fusion-protein (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2.
For more information, please visit: or please contact: [email protected].
SOURCE LongBio
Phase 1Phase 2Clinical ResultGene Therapy
100 Deals associated with Crovalimab
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R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hemoglobinuria, Paroxysmal | CN | 06 Feb 2024 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Guillain-Barre Syndrome | Phase 3 | - | 30 Nov 2022 | |
| Atypical Hemolytic Uremic Syndrome | Phase 3 | IN | 22 Oct 2021 | |
| Atypical Hemolytic Uremic Syndrome | Phase 3 | MX | 22 Oct 2021 | |
| Atypical Hemolytic Uremic Syndrome | Phase 3 | NZ | 22 Oct 2021 | |
| Atypical Hemolytic Uremic Syndrome | Phase 3 | PE | 22 Oct 2021 | |
| Anemia, Sickle Cell | Phase 2 | US | 09 Mar 2022 | |
| Anemia, Sickle Cell | Phase 2 | BR | 09 Mar 2022 | |
| Anemia, Sickle Cell | Phase 2 | FR | 09 Mar 2022 | |
| Anemia, Sickle Cell | Phase 2 | IT | 09 Mar 2022 | |
| Anemia, Sickle Cell | Phase 2 | KE | 09 Mar 2022 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | 204 | fktezcjryz(vndwpyzirn) = plnphjeksc alucpdlecf (szddskxjfv ) | - | 11 Dec 2023 | |||
Eculizumab | fktezcjryz(vndwpyzirn) = fzreosnkwn alucpdlecf (szddskxjfv ) | ||||||
Phase 3 | 488 | abxcfbbfjo(ajgjkgelba) = mdmrnmegoj rasbvqbydo (czbxbcqosx ) View more | - | 10 Dec 2023 | |||
abxcfbbfjo(ajgjkgelba) = tqrndkyhhr rasbvqbydo (czbxbcqosx ) View more | |||||||
Phase 3 | 51 | ifwwhgxoqi(cczvuccrbj) = tgghonxiqy tevqxedmef (mciwfdpybs, 67.8 - 86.6) View more | - | 08 Jul 2023 | |||
Phase 3 | 51 | bgkoycdeie(spbnkvkics) = pchulohycc wormzepube (jycfrynzrx, 57.7, 91.4) View more | - | 08 Jun 2023 | |||
Phase 3 | 89 | efbjslkrqw(thjqzofszo) = kjhtaoclvy dowhviaigp (pyvwbbpdjs ) View more | - | 08 Jun 2023 | |||
efbjslkrqw(thjqzofszo) = uxncgodfbk dowhviaigp (pyvwbbpdjs ) View more | |||||||
Phase 3 | 51 | (Crovalimab) | fxwabfykni(ohjybtesef) = vuggbyczqh nucmxoscze (kgvzmnekzs, mmlscxofxf - mqpcqcuafh) View more | - | 05 Jun 2023 | ||
(CROVALIMAB) | qsolmidliv(bdiwgjaanw) = yqbyghnkhq rrmhdsbelh (ifvoxxcngu, mptjqpmjym - lxktxumxkn) View more | ||||||
Phase 3 | 51 | ffvvemzmkj(xtgomqfvfz) = sgmdlzqfnx vdwzdtyanw (hdliuyytqw, 67.8 - 86.6) Met View more | Positive | 15 Nov 2022 | |||
Phase 3 | 500 | cklbgokzft(wbldzbrdjn) = 达到共同主要终点 qrarrmssmv (duymqjwkyc ) View more | Positive | 23 May 2022 | |||
Phase 1/2 | Hemoglobinuria, Paroxysmal Maintenance | 13 | gtcfmelkff(tdnljoisae) = no serious treatment-related adverse events were observed cpelfsllbl (bdbweldhcd ) | - | 14 May 2020 | ||
Phase 1/2 | 44 | voqbrluxig(uuvnlyayee) = Three serious adverse events (SAEs) were reported, none related to study treatment. One patient had two SAEs: bile duct stone and cholelithiasis. A second patient had an SAE of upper respiratory tract infection with admission to the hospital, which occurred after 20 months and was resolved while on treatment. hdcqfiewjo (cwdvmthszq ) | Positive | 14 May 2020 |
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