Development of a new recombinant serum albumin-based radiopharmaceutical 99mTc and 68Ga-labelled radiopharmaceutical for lung SPECT/CT and PET/CT (Q3957989): Difference between revisions
Jump to navigation
Jump to search
(Changed an Item: add summary) |
(Changed an Item: Adding English translations) |
||||||||||||||
| Property / summary | |||||||||||||||
The present project of MEDI-RADIOPHARMA Kft. fits into the objective of the call for proposals in question, as the company develops a new, marketable process with significant intellectual added value through its own R & D & I activities: recombinant serum albumin-based radiopharmaceutical production process — and through this new process, a new set of recombinant serum albumin-based radiopharmaceuticals (99 m-Tc (gamma radiator) and 68-Ga (positronic radiant) radiopharmaceuticals for testing the lungs with SPECT/CT and PET/CT devices. During the project, the Ltd. It creates 5 new R & D & I jobs. MEDI-RADIOPHARMA Ltd. has developed and implemented a unique R & D strategy among small businesses: independently cultivate the entire innovation cycle in relation to research and manufacturing of radiopharmaceuticals, the main steps of which are: — synthesis of the basic material; — production technology development of the diagnostic kit; — compiling a registration dossier containing the production quality assurance tests; — submission of the registration dossier to the pharmaceutical authorities; carrying out the registration process; — preparation of final and commercial documentation; — production, domestic and foreign trade of the product; This activity is carried out independently or with contractual partners, depending on the country, without intervening chain vendors. The company has achieved success in the research, development and sale of generic radiopharmaceuticals during its lifetime, but for example, the Senti-Scint kit was developed independently on new radiopharmacies capable of detecting sentinel lymph nodes, which can be used in oncology. Part of the company’s research strategy is the selection of a generic product based on clinical needs, during which it carries out the production of the raw material, the development of manufacturing technology, the manufacturing task, product quality control and stability tests. Following the previous successful product development, the number of commercialised products is presented in 9_8s (currently 14 products are being produced and marketed in the countries listed in the table). The whole innovation cycle described above has been carried out by the company in relation to the following products and countries: Product 1: Medi-MIBI 500 micrograms; — basic material and synthesis: CU(MIBI)4 TBF4 synthesised on the basis of its own patent — EU registration number and date: DK.R.2236, March 2008 — introduced in the following countries: Denmark, Germany, Austria, Italy, Spain, India, Turkey, Colombia, Belarus, South Africa, Croatia Product 2: Medi-Exametazime; — basic material and synthesis: HM-PAO synthesised on the basis of its own patent — EU registration date and number: DK.R.49482...time: 09 October 2012 — introduced in the following countries: Denmark, Germany, Italy, Spain, Austria, Portugal, United Kingdom Product 3: Medi-RenoScint — basic material and synthesis: MAG3 synthesised on the basis of its own know-how — EU registration date and number: intended date of submission: Q2/2016 — planned EU countries: Denmark, the Netherlands, Belgium, Germany, Croatia, Austria, Czech Republic; — planned non-EU countries: Turkey, South Africa, Brazil Product 4: Medi-Tetrofosmin (development planned in the framework of the GINOP project) — raw material and synthesis: Tetrofosmin based on its own know-how — planned submission: Q3/2017 — planned EU countries: Hungary, Denmark, United Kingdom, Germany, Italy, Spain, Netherlands, Belgium, Hungary — planned non-EU countries: Turkey, South Africa, Brazil The R & D work carried out in all cases involved the synthesis of the raw material, the development of the diagnostic kit, followed by the entire process of registration, production and trade. During the successful developments described above, MEDI-RADIOPHARMA Kft. will follow the proven entire innovation cycle during this project as well. The role of radioactive diagnostics in early diagnostics of fundamental diseases affecting mankind, monitoring the effectiveness of chosen therapy and re-diagnosing possible recurrence is of particular importance. Test procedures/instruments (SPECT/PET/) and combinations of these measuring instruments (SPECT/PET/MR) which are specially localised in the event of “changes” and thus accumulated radioactive compounds in various diseases play an essential role in the start of successful diagnosis and healing. A disease recognised in time and depth can save life. The effectiveness of early diagnostic therapy (medicinal, surgical, irradiation) can be established by a re-examination, and after successful therapy, a possible recurrence of the disease can be detected even after months/years. Such specific and safe (English) | |||||||||||||||
| Property / summary: The present project of MEDI-RADIOPHARMA Kft. fits into the objective of the call for proposals in question, as the company develops a new, marketable process with significant intellectual added value through its own R & D & I activities: recombinant serum albumin-based radiopharmaceutical production process — and through this new process, a new set of recombinant serum albumin-based radiopharmaceuticals (99 m-Tc (gamma radiator) and 68-Ga (positronic radiant) radiopharmaceuticals for testing the lungs with SPECT/CT and PET/CT devices. During the project, the Ltd. It creates 5 new R & D & I jobs. MEDI-RADIOPHARMA Ltd. has developed and implemented a unique R & D strategy among small businesses: independently cultivate the entire innovation cycle in relation to research and manufacturing of radiopharmaceuticals, the main steps of which are: — synthesis of the basic material; — production technology development of the diagnostic kit; — compiling a registration dossier containing the production quality assurance tests; — submission of the registration dossier to the pharmaceutical authorities; carrying out the registration process; — preparation of final and commercial documentation; — production, domestic and foreign trade of the product; This activity is carried out independently or with contractual partners, depending on the country, without intervening chain vendors. The company has achieved success in the research, development and sale of generic radiopharmaceuticals during its lifetime, but for example, the Senti-Scint kit was developed independently on new radiopharmacies capable of detecting sentinel lymph nodes, which can be used in oncology. Part of the company’s research strategy is the selection of a generic product based on clinical needs, during which it carries out the production of the raw material, the development of manufacturing technology, the manufacturing task, product quality control and stability tests. Following the previous successful product development, the number of commercialised products is presented in 9_8s (currently 14 products are being produced and marketed in the countries listed in the table). The whole innovation cycle described above has been carried out by the company in relation to the following products and countries: Product 1: Medi-MIBI 500 micrograms; — basic material and synthesis: CU(MIBI)4 TBF4 synthesised on the basis of its own patent — EU registration number and date: DK.R.2236, March 2008 — introduced in the following countries: Denmark, Germany, Austria, Italy, Spain, India, Turkey, Colombia, Belarus, South Africa, Croatia Product 2: Medi-Exametazime; — basic material and synthesis: HM-PAO synthesised on the basis of its own patent — EU registration date and number: DK.R.49482...time: 09 October 2012 — introduced in the following countries: Denmark, Germany, Italy, Spain, Austria, Portugal, United Kingdom Product 3: Medi-RenoScint — basic material and synthesis: MAG3 synthesised on the basis of its own know-how — EU registration date and number: intended date of submission: Q2/2016 — planned EU countries: Denmark, the Netherlands, Belgium, Germany, Croatia, Austria, Czech Republic; — planned non-EU countries: Turkey, South Africa, Brazil Product 4: Medi-Tetrofosmin (development planned in the framework of the GINOP project) — raw material and synthesis: Tetrofosmin based on its own know-how — planned submission: Q3/2017 — planned EU countries: Hungary, Denmark, United Kingdom, Germany, Italy, Spain, Netherlands, Belgium, Hungary — planned non-EU countries: Turkey, South Africa, Brazil The R & D work carried out in all cases involved the synthesis of the raw material, the development of the diagnostic kit, followed by the entire process of registration, production and trade. During the successful developments described above, MEDI-RADIOPHARMA Kft. will follow the proven entire innovation cycle during this project as well. The role of radioactive diagnostics in early diagnostics of fundamental diseases affecting mankind, monitoring the effectiveness of chosen therapy and re-diagnosing possible recurrence is of particular importance. Test procedures/instruments (SPECT/PET/) and combinations of these measuring instruments (SPECT/PET/MR) which are specially localised in the event of “changes” and thus accumulated radioactive compounds in various diseases play an essential role in the start of successful diagnosis and healing. A disease recognised in time and depth can save life. The effectiveness of early diagnostic therapy (medicinal, surgical, irradiation) can be established by a re-examination, and after successful therapy, a possible recurrence of the disease can be detected even after months/years. Such specific and safe (English) / rank | |||||||||||||||
Normal rank | |||||||||||||||
| Property / summary: The present project of MEDI-RADIOPHARMA Kft. fits into the objective of the call for proposals in question, as the company develops a new, marketable process with significant intellectual added value through its own R & D & I activities: recombinant serum albumin-based radiopharmaceutical production process — and through this new process, a new set of recombinant serum albumin-based radiopharmaceuticals (99 m-Tc (gamma radiator) and 68-Ga (positronic radiant) radiopharmaceuticals for testing the lungs with SPECT/CT and PET/CT devices. During the project, the Ltd. It creates 5 new R & D & I jobs. MEDI-RADIOPHARMA Ltd. has developed and implemented a unique R & D strategy among small businesses: independently cultivate the entire innovation cycle in relation to research and manufacturing of radiopharmaceuticals, the main steps of which are: — synthesis of the basic material; — production technology development of the diagnostic kit; — compiling a registration dossier containing the production quality assurance tests; — submission of the registration dossier to the pharmaceutical authorities; carrying out the registration process; — preparation of final and commercial documentation; — production, domestic and foreign trade of the product; This activity is carried out independently or with contractual partners, depending on the country, without intervening chain vendors. The company has achieved success in the research, development and sale of generic radiopharmaceuticals during its lifetime, but for example, the Senti-Scint kit was developed independently on new radiopharmacies capable of detecting sentinel lymph nodes, which can be used in oncology. Part of the company’s research strategy is the selection of a generic product based on clinical needs, during which it carries out the production of the raw material, the development of manufacturing technology, the manufacturing task, product quality control and stability tests. Following the previous successful product development, the number of commercialised products is presented in 9_8s (currently 14 products are being produced and marketed in the countries listed in the table). The whole innovation cycle described above has been carried out by the company in relation to the following products and countries: Product 1: Medi-MIBI 500 micrograms; — basic material and synthesis: CU(MIBI)4 TBF4 synthesised on the basis of its own patent — EU registration number and date: DK.R.2236, March 2008 — introduced in the following countries: Denmark, Germany, Austria, Italy, Spain, India, Turkey, Colombia, Belarus, South Africa, Croatia Product 2: Medi-Exametazime; — basic material and synthesis: HM-PAO synthesised on the basis of its own patent — EU registration date and number: DK.R.49482...time: 09 October 2012 — introduced in the following countries: Denmark, Germany, Italy, Spain, Austria, Portugal, United Kingdom Product 3: Medi-RenoScint — basic material and synthesis: MAG3 synthesised on the basis of its own know-how — EU registration date and number: intended date of submission: Q2/2016 — planned EU countries: Denmark, the Netherlands, Belgium, Germany, Croatia, Austria, Czech Republic; — planned non-EU countries: Turkey, South Africa, Brazil Product 4: Medi-Tetrofosmin (development planned in the framework of the GINOP project) — raw material and synthesis: Tetrofosmin based on its own know-how — planned submission: Q3/2017 — planned EU countries: Hungary, Denmark, United Kingdom, Germany, Italy, Spain, Netherlands, Belgium, Hungary — planned non-EU countries: Turkey, South Africa, Brazil The R & D work carried out in all cases involved the synthesis of the raw material, the development of the diagnostic kit, followed by the entire process of registration, production and trade. During the successful developments described above, MEDI-RADIOPHARMA Kft. will follow the proven entire innovation cycle during this project as well. The role of radioactive diagnostics in early diagnostics of fundamental diseases affecting mankind, monitoring the effectiveness of chosen therapy and re-diagnosing possible recurrence is of particular importance. Test procedures/instruments (SPECT/PET/) and combinations of these measuring instruments (SPECT/PET/MR) which are specially localised in the event of “changes” and thus accumulated radioactive compounds in various diseases play an essential role in the start of successful diagnosis and healing. A disease recognised in time and depth can save life. The effectiveness of early diagnostic therapy (medicinal, surgical, irradiation) can be established by a re-examination, and after successful therapy, a possible recurrence of the disease can be detected even after months/years. Such specific and safe (English) / qualifier | |||||||||||||||
point in time: 9 February 2022
| |||||||||||||||
Revision as of 18:27, 9 February 2022
Project Q3957989 in Hungary
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Development of a new recombinant serum albumin-based radiopharmaceutical 99mTc and 68Ga-labelled radiopharmaceutical for lung SPECT/CT and PET/CT |
Project Q3957989 in Hungary |
Statements
350,299,146 forint
0 references
2,017,586.097 Euro
0.0027336256 Euro
15 December 2021
0 references
738,062,336.185 forint
0 references
47.462349 percent
0 references
2 January 2018
0 references
31 December 2019
0 references
MEDI-RADIOPHARMA Egésszségügyi Szervező, Tanácsadó, Szolgáltató és Kereskedelmi Korlátolt Felelősségű Társaság
0 references
47°22'38.10"N, 18°55'16.97"E
0 references
A) SZAKMAI TARTALOM A MEDI-RADIOPHARMA Kft. jelen projektje illeszkedik szóban forgó pályázati felhívás céljához, hiszen a vállalkozás önálló K+F+I tevékenysége révén jelentős szellemi hozzáadott értéket tartalmazó, - új, piacképes eljárást fejleszt ki: rekombináns serum albumin alapú radiofarmakon előállítási eljárását - és ezen új eljárás révén a tüdő SPECT/CT illetve PET/CT készülékekkel történő vizsgálatára alkalmas új, rekombináns serum albumin alapú 99m-Tc (gamma sugárzó) és a 68-Ga (pozitron sugárzó) izotópokkal jelzett radiofarmakon készletet hoz létre. A projekt során a kft. 5 új K+F+I munkahelyet teremt. A MEDI-RADIOPHARMA Kft. a kisvállalkozások között egyedülálló kutatás-fejlesztési stratégiát dolgozott ki és valósít meg: önállóan műveli a radioaktív gyógyszerek kutatásával, gyártásával kapcsolatosan a teljes innovációs ciklust, amelynek főbb lépései az alábbiak: - az alapanyag szintézise; - a diagnosztikai készlet gyártástechnológiai kidolgozása; - a gyártási minőségbiztosítási vizsgálatokat tartalmazó regisztrációs dosszié összeállítása; - a regisztrációs dokumentáció gyógyszerhatóságokhoz történő benyújtása; a regisztrációs folyamat végzése; - a végleges és a kereskedelmi dokumentáció elkészítése; - a termék gyártása, hazai és külföldi kereskedelme; Ezen tevékenységet országoktól függően önállóan vagy szerződéses partnerekkel végzik, közbeeső láncértékesítők beiktatása nélkül. A cég élete során elsősorban a generikus radiofarmakonok kutatása, fejlesztése és értékesítése terén ért el sikereket, de például az onkológiában kiválóan alkalmazható sentinel nyirokcsomó kimutatására alkalmas új radiofarmakon, a Senti-Scint készlet kifejlesztését is önállóan végezte. A cég kutatási stratégiájának része a klinikai igényeken alapuló generikus termék kiválasztása, amely során az alapanyag előállítását, a gyártástechnológia kidolgozását, a gyártási feladatot, termék minőségi ellenőrzését és a stabilitás vizsgálatokat is végzi. A korábbi sikeres termékfejlesztés követően a kereskedelmi forgalomba került termékek számát a 9_8sz mell mutatja be (jelenleg 14 db termék előállítása és forgalmazása folyik a táblázatban szereplő országokban). Fentiekben bemutatott teljes innovációs ciklust a vállalkozás az alábbi termékek és országok vonatkozásában vitte végig: 1. termék: Medi-MIBI 500 micrograms; - alapanyag és szintézise: Cu(MIBI)4 TBF4 saját szabadalom alapján szintetizálva - EU regisztrációs száma és ideje: DK.R.2236, 2008.március - az alábbi országokban került bevezetésre: Dánia, Németország, Ausztria, Olaszország, Spanyolország, India, Törökország, Kolumbia, Fehéroroszország, Dél-Afrika, Horvátország 2. termék: Medi-Exametazime; - alapanyag és szintézise: HM-PAO saját szabadalom alapján szintetizálva - EU regisztrációs ideje és száma: DK.R.49482…reg.idő: 2012. október 09. - az alábbi országokban került bevezetésre: Dánia, Németország, Olaszország, Spanyolország, Ausztria, Portugália, Egyesült-Királyság 3. termék: Medi-RenoScint - alapanyag és szintézise: MAG3 saját know-how alapján szintetizálva - EU regisztrációs ideje és száma: benyújtás tervezett ideje: 2016.II.negyedév - tervezett EU országok: Dánia, Hollandia, Belgium, Németország, Horvátország, Ausztria, Csehország; - tervezett EU-n kívüli országok: Törökország, Dél-Afrika, Brazília 4. termék: Medi-Tetrofosmin (GINOP projekt keretében tervezett fejlesztés) - alapanyag és szintézise: Tetrofosmin saját know-how alapján - tervezett benyújtás: 2017.III.negyedév - tervezett EU országok: Magyarország, Dánia, Egyesült-Királyság, Németország, Olaszország, Spanyolország, Hollandia, Belgium, Magyarország - tervezett EU-n kívüli országok: Törökország, Dél-Afrika, Brazília Az elvégzett K+F munka minden esetben magában foglalta az alapanyag szintézisét, a diagnosztikai kit kifejlesztését, ezt követi a regisztráció, a gyártás és kereskedelem teljes folyamata. A MEDI-RADIOPHARMA Kft. fentiekben bemutatott, sikeres fejlesztések során a bevált teljes innovációs ciklust fogja követni jelen pályázati projektje során is. A radioaktív diagnosztikumok szerepe az emberiséget sújtó alapvető betegségek korai diagnosztikájában, a választott terápia eredményességének követésében és az esetleges kiújulás ismételt diagnosztizálásában, kiemelt jelentőséggel bír. A különböző megbetegedések során létrejövő „elváltozásokban” speciálisan lokalizálódó és az így halmozódott radioaktív vegyületeket ezt követően leképező vizsgálóeljárások/műszerek (SPECT/PET/) illetve ezen mérőműszerek kombinációi (SPECT/PET/CT/MR) alapvetően kiemelkedő szerepet játszanak a sikeres diagnosztika, illetve gyógyítás megkezdésében. Az időben, megfelelő mélységében felismert betegség pedig életet menthet. A korai diagnosztikán alapuló terápia (gyógyszeres, sebészeti, besugárzás) eredményessége egy ismételt vizsgálattal megállapítható, illetve a sikeres terápiát követően a betegség esetleges kiújulása, hasonlóan kimutatható hónapok/évek múlva is. Az ilyen specifikus és biztonságosan a (Hungarian)
0 references
The present project of MEDI-RADIOPHARMA Kft. fits into the objective of the call for proposals in question, as the company develops a new, marketable process with significant intellectual added value through its own R & D & I activities: recombinant serum albumin-based radiopharmaceutical production process — and through this new process, a new set of recombinant serum albumin-based radiopharmaceuticals (99 m-Tc (gamma radiator) and 68-Ga (positronic radiant) radiopharmaceuticals for testing the lungs with SPECT/CT and PET/CT devices. During the project, the Ltd. It creates 5 new R & D & I jobs. MEDI-RADIOPHARMA Ltd. has developed and implemented a unique R & D strategy among small businesses: independently cultivate the entire innovation cycle in relation to research and manufacturing of radiopharmaceuticals, the main steps of which are: — synthesis of the basic material; — production technology development of the diagnostic kit; — compiling a registration dossier containing the production quality assurance tests; — submission of the registration dossier to the pharmaceutical authorities; carrying out the registration process; — preparation of final and commercial documentation; — production, domestic and foreign trade of the product; This activity is carried out independently or with contractual partners, depending on the country, without intervening chain vendors. The company has achieved success in the research, development and sale of generic radiopharmaceuticals during its lifetime, but for example, the Senti-Scint kit was developed independently on new radiopharmacies capable of detecting sentinel lymph nodes, which can be used in oncology. Part of the company’s research strategy is the selection of a generic product based on clinical needs, during which it carries out the production of the raw material, the development of manufacturing technology, the manufacturing task, product quality control and stability tests. Following the previous successful product development, the number of commercialised products is presented in 9_8s (currently 14 products are being produced and marketed in the countries listed in the table). The whole innovation cycle described above has been carried out by the company in relation to the following products and countries: Product 1: Medi-MIBI 500 micrograms; — basic material and synthesis: CU(MIBI)4 TBF4 synthesised on the basis of its own patent — EU registration number and date: DK.R.2236, March 2008 — introduced in the following countries: Denmark, Germany, Austria, Italy, Spain, India, Turkey, Colombia, Belarus, South Africa, Croatia Product 2: Medi-Exametazime; — basic material and synthesis: HM-PAO synthesised on the basis of its own patent — EU registration date and number: DK.R.49482...time: 09 October 2012 — introduced in the following countries: Denmark, Germany, Italy, Spain, Austria, Portugal, United Kingdom Product 3: Medi-RenoScint — basic material and synthesis: MAG3 synthesised on the basis of its own know-how — EU registration date and number: intended date of submission: Q2/2016 — planned EU countries: Denmark, the Netherlands, Belgium, Germany, Croatia, Austria, Czech Republic; — planned non-EU countries: Turkey, South Africa, Brazil Product 4: Medi-Tetrofosmin (development planned in the framework of the GINOP project) — raw material and synthesis: Tetrofosmin based on its own know-how — planned submission: Q3/2017 — planned EU countries: Hungary, Denmark, United Kingdom, Germany, Italy, Spain, Netherlands, Belgium, Hungary — planned non-EU countries: Turkey, South Africa, Brazil The R & D work carried out in all cases involved the synthesis of the raw material, the development of the diagnostic kit, followed by the entire process of registration, production and trade. During the successful developments described above, MEDI-RADIOPHARMA Kft. will follow the proven entire innovation cycle during this project as well. The role of radioactive diagnostics in early diagnostics of fundamental diseases affecting mankind, monitoring the effectiveness of chosen therapy and re-diagnosing possible recurrence is of particular importance. Test procedures/instruments (SPECT/PET/) and combinations of these measuring instruments (SPECT/PET/MR) which are specially localised in the event of “changes” and thus accumulated radioactive compounds in various diseases play an essential role in the start of successful diagnosis and healing. A disease recognised in time and depth can save life. The effectiveness of early diagnostic therapy (medicinal, surgical, irradiation) can be established by a re-examination, and after successful therapy, a possible recurrence of the disease can be detected even after months/years. Such specific and safe (English)
9 February 2022
0 references
Érd, Pest
0 references
Identifiers
VEKOP-2.1.1-15-2016-00082
0 references