Company-reported prevalence

Imlifidase

Overview

Field	Value
Drug	Imlifidase
Indication	Kidney transplantation in highly sensitized patients
Disease	Highly sensitized candidates for kidney transplantation (patients on kidney transplant waiting lists with broad HLA sensitization, defined by the company by calculated panel reactive antibody, cPRA)
Company	Hansa Biopharma AB (worldwide rights outside the territories below); SERB Pharmaceuticals (exclusive license for Idefirix in solid organ transplantation in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and the Middle East and North Africa, closed July 2026)
Documents searched	Hansa: corporate website imlifidase, pipeline, and transplantation focus area pages (accessed October 2026); press releases naming imlifidase or Idefirix, January 2025 to August 2026; annual report for 2025 (March 2026); year-end, first quarter 2026, and second quarter 2026 report press releases (February, May, and July 2026); capital markets day presentation (June 2026). SERB: press release on the Idefirix acquisition (2026) and website search for Idefirix (accessed October 2026)
Data as of	October 14, 2026
Prepared by	AI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Number affected (cPRA above 80%): Hansa Biopharma capital markets day presentation, June 2026

“Highly sensitized US patients have low rates of transplantation” (opens the source at this quote in a new tab)
“~15,000 with cPRA >80%” (opens the source at this quote in a new tab)

Cited source: 2.6 Scientific Registry of Transplant Recipients, undated

Hansa Biopharma (2026) capital markets day presentation, June 25, 2026, quoted passage highlighted — Captured from page 31 of 64 (opens in a new tab)

Number affected (cPRA above 98%): Hansa Biopharma capital markets day presentation, June 2026

“Highly sensitized US patients have low rates of transplantation” (opens the source at this quote in a new tab)
“~7,000 with cPRA >98%” (opens the source at this quote in a new tab)

Cited source: 2.6 Scientific Registry of Transplant Recipients, undated

Number affected (cPRA above 99.9%): Hansa Biopharma capital markets day presentation, June 2026

“Highly sensitized US patients have low rates of transplantation” (opens the source at this quote in a new tab)
“~3,500 with cPRA >99.9%” (opens the source at this quote in a new tab)

Cited source: 2.6 Scientific Registry of Transplant Recipients, undated

Incidence (additions to the kidney waiting list, total and by cPRA): Hansa Biopharma capital markets day presentation, June 2026

“US Transplant Waitlist is growing” (opens the source at this quote in a new tab)
“~45,000 added to the waitlist each year” (opens the source at this quote in a new tab)
“(~ 9,000 cPRA> 80%, ~4,000 cPRA >98%, ~2,000 cPRA>99.9%)” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Number affected (kidney transplant waiting list): Hansa Biopharma capital markets day presentation, June 2026

“~100,000 people in the US are waiting for a kidney transplant” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Prevalence (share of the kidney waiting list with cPRA above 80%): Hansa Biopharma annual report for 2025, March 2026

“In the United States, more than 100,000 people are currently on the” (opens the source at this quote in a new tab)
“wait list, and approximately 10–15% are highly sensitized, with a cPRA above 80%.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Hansa Biopharma (2026) annual report for 2025, quoted passage highlighted — Captured from page 26 of 115 (opens in a new tab)

Number affected (cPRA above 99.9%): Hansa Biopharma annual report for 2025, March 2026

“In the United States, more than 100,000 people are currently on the” (opens the source at this quote in a new tab)
“the roughly 3,500 individuals with cPRA levels exceeding 99.9%” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Europe

No evidence found.

Global

Number affected (end-stage renal disease): Hansa Biopharma website, October 2026

“Kidney transplantation is a lifesaving treatment for patients with kidney failure, also known as end-stage renal disease (ESRD), a serious condition affecting almost 2.5 million patients worldwide.” (opens the source at this quote in a new tab)

Cited source: 2.4 Newsletter Transplant 2022

Hansa Biopharma (2026) transplantation focus area page, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Other countries and regions

Prevalence (share of patients on transplant waiting lists in the U.S. and Europe who are highly sensitized): Hansa Biopharma press release, August 2026

“Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.” (opens the source at this quote in a new tab)

Cited source: 2.1 Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients 2024; 2.2 Jordan 2021

Hansa Biopharma (2026) press release, August 18, 2026, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma press release, August 2026

“There are approximately 170,000 kidney patients in the U.S. and Europe waiting for a new kidney.” (opens the source at this quote in a new tab)

Cited source: 2.4 Newsletter Transplant 2022

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma website, October 2026

“170,000” (opens the source at this quote in a new tab)
“Approximate number of patients across the U.S. and Europe waiting for a kidney transplant.” (opens the source at this quote in a new tab)

Cited source: 2.4 Newsletter Transplant 2022

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma annual report for 2025, March 2026

“In the U.S. and Europe alone, nearly 170,000” (opens the source at this quote in a new tab)
“people are currently waiting for a kidney transplant” (opens the source at this quote in a new tab)

Cited source: 2.5 Newsletter Transplant 2024

Incidence (additions to kidney waiting lists in the U.S. and Europe): Hansa Biopharma annual report for 2025, March 2026

“In the U.S. and Europe alone, nearly 170,000” (opens the source at this quote in a new tab)
“people are currently waiting for a kidney transplant, and more than 50,000” (opens the source at this quote in a new tab)
“new patients join the waiting lists each year.” (opens the source at this quote in a new tab)

Cited source: 2.5 Newsletter Transplant 2024

Geography not stated

Prevalence (share of patients on waiting lists who are highly sensitized): Hansa Biopharma annual report for 2025, March 2026

“Representing 10–15%” (opens the source at this quote in a new tab)
“of patients on waiting lists” (opens the source at this quote in a new tab)

Cited source: 2.1 Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients 2024; 2.3 Heidt 2021

Prevalence (share of patients on waiting lists who are highly sensitized): Hansa Biopharma website, October 2026

“10-15%” (opens the source at this quote in a new tab)
“Patients on the waiting lists who are classified as highly sensitized.” (opens the source at this quote in a new tab)

Cited source: 2.1 Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients 2024

Incidence (additions to the kidney transplant waiting list): Hansa Biopharma website, October 2026

“50,000+” (opens the source at this quote in a new tab)
“New patients are added to the kidney transplant waiting list each year.” (opens the source at this quote in a new tab)

Cited source: 2.4 Newsletter Transplant 2022

Sources the company cites

Organ procurement and transplantation network and scientific registry of transplant recipients 2024

Reference as the company lists it, press release, August 18, 2026

“Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report.” (opens the source at this quote in a new tab)

Reference as the company lists it, annual report for 2025

“Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report.” (opens the source at this quote in a new tab)

Reference as the company lists it, transplantation focus area page

“Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report.” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The company cites the whole OPTN/SRTR 2022 Annual Data Report and no chapter or table. The kidney chapter (Lentine 2024, American Journal of Transplantation) could not be read: the publisher page returned a human-verification challenge, and the PubMed abstract states no share of waiting-list candidates by cPRA.

Jordan 2021

Reference as the company lists it

“Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes).” (opens the source at this quote in a new tab)

Passage carrying the nearest figure

“Of 92 685 patients on the US kidney transplant waiting list in 2017, approximately 30% were sensitized to HLA; of these patients, nearly half were considered highly sensitized, with calculated panel-reactive antibody (cPRA) of at least 80%.” (opens the source at this quote in a new tab)

Jordan 2021, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Heidt 2021

Reference as the company lists it

“Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a Compatible Organ Offer Based on Acceptable Mismatches.” (opens the source at this quote in a new tab)

Passage carrying the nearest figure

“Within Eurotransplant, the percentage of patients awaiting a kidney transplant with a Panel Reactive Antibody (PRA) level of ≥85% increased from 2.0% to 5.6% from 2011 to 2019” (opens the source at this quote in a new tab)

Heidt 2021, quoted passage highlighted — Captured from the passage on the page (opens in a new tab)

Newsletter transplant 2022

Reference as the company lists it, press release, August 18, 2026

“Newsletter Transplant 2022. International figures on donation and transplantation.” (opens the source at this quote in a new tab)

Reference as the company lists it, transplantation focus area page

“Newsletter Transplant 2022. International figures on donation and transplantation.” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The company gives no address for the edition beyond the publisher's Freepub library. The newsletter (European Directorate for the Quality of Medicines and HealthCare, with the Organización Nacional de Trasplantes) reports donation, transplantation, and waiting-list data country by country in tables; no passage stating a combined figure for the U.S. and Europe, or a worldwide count of end-stage renal disease, was located.

Newsletter transplant 2024

Reference as the company lists it

“Newsletter Transplant 2024.” (opens the source at this quote in a new tab)
“International figures on donation and transplantation 2023” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The company gives no address for the edition beyond the publisher's Freepub library. The 2024 edition reports kidney waiting lists country by country in tables (pages 64 to 70 of a copy hosted by The Transplantation Society); it states no combined figure for the U.S. and Europe.

Scientific registry of transplant recipients, undated

Reference as the company lists it

“Based on SRTR data of Kidney Transplant recipients and candidates” (opens the source at this quote in a new tab)

Passage carrying the figure

Not quoted: The company names registry data and no published document or table; no document stating the counts was located.

Overview

1Company statements of prevalence

Number affected (cPRA above 80%): Hansa Biopharma capital markets day presentation, June 2026

Number affected (cPRA above 98%): Hansa Biopharma capital markets day presentation, June 2026

Number affected (cPRA above 99.9%): Hansa Biopharma capital markets day presentation, June 2026

Incidence (additions to the kidney waiting list, total and by cPRA): Hansa Biopharma capital markets day presentation, June 2026

Number affected (kidney transplant waiting list): Hansa Biopharma capital markets day presentation, June 2026

Prevalence (share of the kidney waiting list with cPRA above 80%): Hansa Biopharma annual report for 2025, March 2026

Number affected (cPRA above 99.9%): Hansa Biopharma annual report for 2025, March 2026

Number affected (end-stage renal disease): Hansa Biopharma website, October 2026

Prevalence (share of patients on transplant waiting lists in the U.S. and Europe who are highly sensitized): Hansa Biopharma press release, August 2026

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma press release, August 2026

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma website, October 2026

Number affected (kidney transplant waiting lists in the U.S. and Europe): Hansa Biopharma annual report for 2025, March 2026

Incidence (additions to kidney waiting lists in the U.S. and Europe): Hansa Biopharma annual report for 2025, March 2026

Prevalence (share of patients on waiting lists who are highly sensitized): Hansa Biopharma annual report for 2025, March 2026

Prevalence (share of patients on waiting lists who are highly sensitized): Hansa Biopharma website, October 2026

Incidence (additions to the kidney transplant waiting list): Hansa Biopharma website, October 2026

2Sources the company cites

Reference as the company lists it, press release, August 18, 2026

Reference as the company lists it, annual report for 2025

Reference as the company lists it, transplantation focus area page

Passage carrying the figure

Reference as the company lists it

Passage carrying the nearest figure

Reference as the company lists it

Passage carrying the nearest figure

Reference as the company lists it, press release, August 18, 2026

Reference as the company lists it, transplantation focus area page

Passage carrying the figure

Reference as the company lists it

Passage carrying the figure

Reference as the company lists it

Passage carrying the figure

3References

Company statements of prevalence

Sources the company cites

References