2020年10月15日 Imlifidase（Idefirix TM），一种源自化脓性链球菌（S.）化脓菌的免疫球蛋白G（ IgG）降解酶的半胱氨酸蛋白酶由Hansa Biopharma AB开发，用

2-year follow-up data demonstrates graft survival of 90% for 31 patients post imlifidase treatment with a median eGFR of 61.5 ml/min. Despite varying levels of DSA

The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Medical Receives FDA Fast Track Designation for Imlifidase for Transplantation Wed, Oct 17, 2018 08:00 CET. Lund, Sweden, October 17, 2018- Hansa Medical AB (NASDAQ Stockholm: HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that the U.S. Food and Drug Administration (FDA) has granted imlifidase Fast Track Hansa Biopharma (”Hansa”), ledaren inom immunmodulerande enzymteknik för behandling av sällsynta IgG-medierade sjukdomar, meddelar idag positiva resultat från en prövarinitierad fas 2-studie som utvärderar säkerheten, tolerabiliteten och effekten av imlifidase hos 15 patienter med svår anti-GBM. Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute 2021-02-08 2021-04-08 * sarepta therapeutics signs agreement with hansa biopharma for imlifidase * SAREPTA THERAPEUTICS INC - SAREPTA OBTAINS AN EXCLUSIVE, WORLDWIDE LICENSE TO DEVELOP AND PROMOTE IMLIFIDASE Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - June, 2020. Imlifidase is a proteolytic immunoglobulin G-degrading endopeptidase enzyme, developed by Hansa Biopharma AB, for the prevention, treatment of kidney transplant Hansa Biopharma is leveraging its proprietary enzyme technology platform to develop immunomodulatory treatments for enabling transplantations and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy and cancer.

Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of Idefirix TM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant 2020-07-02 · Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase July 02, 2020 07:00 ET | Source: Sarepta Therapeutics, Inc. Sarepta Therapeutics, Inc. Hansa Biopharma advances to commercial stage following conditional EU approval of Idefirix; Positive high-level data from investigator-initiated phase 2 trial with imlifidase in anti-GBM Lund October 22, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January – September, 2020 Översikt Hansa Biopharma i korthet. Hansa Biopharma använder sin patenterade immunmodulerande enzymteknologi för att möjliggöra behandlingar för transplantation, sällsynta immunoglobulin G (IgG)-medierade autoimmuna sjukdomar, genterapi och cancer. During 2020 Hansa Biopharma AB certified as A Great Place to Work company, by the independent institute Great Place to Work ® , a global authority on workplace culture, employee experience and leadership behaviour. We are immensely proud.

Hansa Biopharmas partnerstudie en besvikelse, men imlifidase-koncept fortsatt giltigt - Sarepta och Hansa Biopharma har sedan i somras ett samarbete som

Informationen är sådan information som det åligger Hansa Biopharma AB att offentliggöra i enlighet med EU-förordningen om marknadsmissbruk. Om imlifidase Imlifidase är ett unikt antikroppsklyvande enzym av Streptococcus pyogenes, som specifikt klyver IgG och hämmar en IgG-medierad immunrespons. Hansa Biopharma, ledaren inom immunmodulerande enzymteknik för sällsynta IgG-medierade sjukdomar, meddelade idag att Kommittén för humanläkemedel (CHMP) vid Europeiska läkemedelsmyndigheten (EMA) har lämnat ett positivt utlåtande och rekommenderar ett villkorat godkännande av IdefirixTM (imlifidase) för desensitiserings-behandling av högsensitiserade vuxna patienter som ska genomgå 2021-03-29 · Hansa Biopharma AB ”Hansa” (Nasdaq Stockholm: HNSA), som är ett banbrytande bolag inom enzymteknik för sällsynta immunologiska sjukdomar, tillkännagav i dag att de har ingått ett prekliniskt forskningssamarbete med argenx BV för att utvärdera de behandlingsmässiga möjligheterna med att kombinera de båda bolagens immunglobulin G (IgG)-modulerande tekniker. Hansa Biopharma, ledaren inom immunmodulerande enzymteknik för sällsynta IgG-medierade sjukdomar, meddelade idag att Kommittén för humanläkemedel (CHMP) vid Europeiska läkemedelsmyndigheten (EMA) har lämnat ett positivt utlåtande och rekommenderar ett villkorat godkännande av Idefirix[TM ](imlifidase) för desensitiserings-behandling av högsensitiserade vuxna patienter som ska Hansa Biopharma AB ”Hansa” (Nasdaq Stockholm: HNSA), som är ett banbrytande bolag inom enzymteknik för sällsynta immunologiska sjukdomar, offentliggör idag årsredovisningen för 2020.

2019-12-13

The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute 2021-02-08 2021-04-08 * sarepta therapeutics signs agreement with hansa biopharma for imlifidase * SAREPTA THERAPEUTICS INC - SAREPTA OBTAINS AN EXCLUSIVE, WORLDWIDE LICENSE TO DEVELOP AND PROMOTE IMLIFIDASE Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January - June, 2020. Imlifidase is a proteolytic immunoglobulin G-degrading endopeptidase enzyme, developed by Hansa Biopharma AB, for the prevention, treatment of kidney transplant Hansa Biopharma is leveraging its proprietary enzyme technology platform to develop immunomodulatory treatments for enabling transplantations and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy and cancer. The Company’s lead product candidate, imlifidase, 2021-03-30 Den 25 juni 2020 erhöll Hansa Biopharma ett positivt utlåtande från CHMP vid Europeiska läkemedelsmyndigheten (EMA) som rekommenderade ett villkorat godkännande av Idefirix (imlifidase) för desensitiserings-behandling av högsensitiserade vuxna patienter som ska genomgå en njurtransplantation och som uppvisar ett positivt korstest mot en tillgänglig avliden donator. 2021-04-08 Jag återvände nyligen från 2019 American Transplant Congress (ATC) i Boston där jag upplevde ett mycket stort intresse för Hansa Biopharma, vår teknikplattform och vår projektportfölj. Imlifidase lyftes fram i tre presentationer under konferensen, däribland i en plenumpresentation av dr Edmund Huang från Cedars-Sinai Medical Center i Los Angeles.

Efter en överenskommelse med FDA om ett slutgiltigt protokoll för studien, kommer bolaget att genomföra en randomiserad, kontrollerad studie med en begränsad grupp högsensitiserade njurpatienter med njurfunktion (eGFR) som The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as IdefirixTM (imlifidase) will be the Company’s first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company Lund, Sweden August 26, 2020. Hansa Biopharma: Positiva resultat presenterade på ESOT; imlifidase möjliggjorde transplantation hos 46 sensitiserade patienter ons, sep 18, 2019 08:00 CET Lund, 18 september 2019. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of Idefirix TM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant 2020-07-02 · Sarepta Therapeutics Signs Agreement with Hansa Biopharma for Imlifidase July 02, 2020 07:00 ET | Source: Sarepta Therapeutics, Inc. Sarepta Therapeutics, Inc. Hansa Biopharma advances to commercial stage following conditional EU approval of Idefirix; Positive high-level data from investigator-initiated phase 2 trial with imlifidase in anti-GBM Lund October 22, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January – September, 2020 Översikt Hansa Biopharma i korthet. Hansa Biopharma använder sin patenterade immunmodulerande enzymteknologi för att möjliggöra behandlingar för transplantation, sällsynta immunoglobulin G (IgG)-medierade autoimmuna sjukdomar, genterapi och cancer. During 2020 Hansa Biopharma AB certified as A Great Place to Work company, by the independent institute Great Place to Work ® , a global authority on workplace culture, employee experience and leadership behaviour. We are immensely proud.
Frovik

Hansa Biopharma håller en kapitalmarknadsdag den 29 oktober 2020 i Köpenhamn, där det kommer att lämnas mer information om fas 2-studien av anti-GBM. Hansa Biopharma håller en kapitalmarknadsdag torsdagen den 29 oktober 2020 i Köpenhamn Kapitalmarknadsdagen kommer att fokusera på Hansa Biopharmas omvandling till ett fullt integrerat och kommersiellt biopharmabolag och belysa potentialen hos bolagets unika antikroppsklyvande enzymplattform utanför transplantationsområdet inom områden som autoimmunitet och genterapi. 27 Aug 2020 Conditional approval for Hansa's kidney transplant drug The EU Commission has granted conditional approval for use of Hansa Biopharma's 5 Oct 2020 The ExCEEd Orphan announces its cooperation with Hansa Biopharma in commercialization of IDEFIRIX TM (Imlifidase) in the Czech Republic 7 Jul 2020 Swedish company Hansa Biopharma is developing a pretreatment called imlifidase that works to eliminate these neutralizing antibodies prior Streptococcus (S.) pyogenes is being developed by Hansa Biopharma AB for treatment of transplant rejection and rare IgG-mediated autoimmune conditions.

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utvecklat av Hansa Biopharma [1]. Imlifidase (IdeS) Hansa Medical [cited 2019 July, 10]. https://hansamedical.com/en/pipeline/imlifidase-ides/about-ides. 2.

Hansa Biopharma was granted orphan drug designation for imlifidase as a treatment for anti-GBM antibody disease in both the EU and the US in 2018. Hansa Biopharma is hosting a Capital Markets Day planned for October 29, 2020 in Copenhagen, where more … The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as IdefirixTM (imlifidase) will be the Company’s first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company Lund, Sweden August 26, 2020. Hansa Biopharma (“Hansa”), the leader in immunomodulatory enzyme technology for rare IgG mediated Hansa Biopharma has reached an agreement with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients. Upon an agreement with the FDA, and following submission of a final study protocol, the Company will conduct a randomized, controlled clinical study in a limited group of highly sensitized kidney patients using kidney function (eGFR) as Hansa Biopharma har nått en överenskommelse med FDA om en regulatorisk väg framåt för imlifidase vid njurtrans- plantation hos högsensitiserade patienter.

24 Sep 2020 Hansa Biopharma ("Hansa"), the leader in immunomodulatory enzyme of imlifidase in 15 patients with severe anti-GBM antibody disease.

HANSA BIOPHARMA ANNOUNCES EXCLUSIVE AGREEMENT WITH SAREPTA THERAPEUTICS TO DEVELOP AND PROMOTE IMLIFIDASE AS 2 Jul 2020 Imlifidase is an investigational product initially developed to aid in kidney transplantation of highly sensitized patients (patients whose immune 24 Sep 2020 Hansa Biopharma ("Hansa"), the leader in immunomodulatory enzyme of imlifidase in 15 patients with severe anti-GBM antibody disease. Imlifidase. Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated The company's product candidate, imlifidase, is an antibody-cleaving enzyme being developed to enable kidney transplantation in highly sensitized patients and 2020年10月15日 Imlifidase（Idefirix TM），一种源自化脓性链球菌（S.）化脓菌的免疫球蛋白G（ IgG）降解酶的半胱氨酸蛋白酶由Hansa Biopharma AB开发，用 27 Jun 2020 Imlifidase was granted eligibility to PRIME in May 2017. In the US, following overall agreement with the US FDA, Hansa Biopharma submitted a 2 Jul 2020 On 25 June, the Company announced a positive CHMP opinion for its lead product candidate imlifidase, which recommends conditional approval 10 Jul 2020 Swedish firm Hansa Biopharma is 1.1 billion Swedish krone ($121 launch and commercialization of imlifidase in kidney transplantation.

Hansa Biopharma, ledaren inom immunmodulerande enzymteknik för sällsynta IgG-medierade sjukdomar, meddelade idag att Kommittén för humanläkemedel (CHMP) vid Europeiska läkemedelsmyndigheten (EMA) har lämnat ett positivt utlåtande och rekommenderar ett villkorat godkännande av Idefirix[TM ](imlifidase) för desensitiserings-behandling av högsensitiserade vuxna patienter som ska Hansa Biopharma AB ”Hansa” (Nasdaq Stockholm: HNSA), som är ett banbrytande bolag inom enzymteknik för sällsynta immunologiska sjukdomar, offentliggör idag årsredovisningen för 2020. Søren Tulstrup, vd och koncernchef, Hansa Biopharma kommenterar årsredovisningen: 2020 var ett mycket framgångsrikt och omvälvande år för Hansa Biopharma – ett år då vi upplevde betydande […] Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company’s lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute Hansa Biopharma har snart gjort den resan. I slutet av juni gav den europeiska läkemedelsmyndighetens vetenskapliga kommitté ett positivt utlåtande om Hansas läkemedel för njurtransplantation Idefirix (imlifidase). Ett formellt godkännande väntas komma de närmaste månaderna. Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases.