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Kafe 바로가기주관연구기관 | 아주대학교 Ajou University |
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연구책임자 | 이범진 |
참여연구자 | 김명진 , 최연웅 , 김관영 , 조해림 , 손세일 , 최용준 |
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 | 한국어 |
발행년월 | 2020-01 |
과제시작연도 | 2019 |
주관부처 | 보건복지부 [Ministry of Health & Welfare(MW)(MW) |
등록번호 | TRKO202100008773 |
과제고유번호 | 1465029439 |
사업명 | 첨단의료기술개발(R&D) |
DB 구축일자 | 2021-08-28 |
키워드 | 글로벌 제품화.혁신개량신약.롤모델.제품 출시.Global Product Development.Innovative Incrementally Modified Drug.iVIPCO.Role model.Product launch. |
○ 글로벌 진출의 경험을 갖춘 통합 센터 구축 및 성공 사례 (매출 포함) 창출
○ 다수의 글로벌 진출이 가능한 개량신약의 개발
1) 제미글립틴 복합제의 개발 (제품 출시 완료, 1단계 조기 종료)
2) 제어방출 개량신약과 흡입형 복합제 개발 (제품1: 레보드로프로피진 제어방출 제형 출시, 제품2: 흡입제 IND 승인 완료, 국내 최초 흡입형 개량신약 사례)
3) 도네페질 경피투과 7일 제형의 개발 (IND 승인 완료)
4) 아리피프라졸 구강붕해 필름의 개발 (미국 임상 1상 완료 및 US FDA Pre-
○ 글로벌 진출의 경험을 갖춘 통합 센터 구축 및 성공 사례 (매출 포함) 창출
○ 다수의 글로벌 진출이 가능한 개량신약의 개발
1) 제미글립틴 복합제의 개발 (제품 출시 완료, 1단계 조기 종료)
2) 제어방출 개량신약과 흡입형 복합제 개발 (제품1: 레보드로프로피진 제어방출 제형 출시, 제품2: 흡입제 IND 승인 완료, 국내 최초 흡입형 개량신약 사례)
3) 도네페질 경피투과 7일 제형의 개발 (IND 승인 완료)
4) 아리피프라졸 구강붕해 필름의 개발 (미국 임상 1상 완료 및 US FDA Pre-NDA Meeting 완료, 해외 선타겟 개발사례 모델)
5) 펠루비프로펜 서방제제 및 복합제의 개발 (서방제 국내 발매 및 해외 출시 완료)
6) 신규전립성비대증 복합치료제 (임상 1상 완료; 3상 신청, 2단계 참여)
○ 과제 완료 시점에서 1) 제미글립틴 복합제 3종(2세부)국내 발매, 2) 레보드로프로피진 제어방출제제(3세부)국내 발매 및 해외 임상 진행, 3)펠루비프로펜 서방제제(6세부)의 국내발매 및 몽골, 남미 및 조지아 등지로 해외 출시 4) CMG 제약의 미국 임상 완료 및 Pre-NDA Meeting 등은 해외 선타겟 개발 사례 모델로, 새로운 GIC 사업을 통한 개발 시간 단축과 괄목할 만한 성공 사례 도출 및 모델 창출 성과임. 본 과제는 2019년 시점 371억원의 매출액이 창출되었으며 최종평가 면제 대상임. 또한 과제 완료후에도 지속적으로 미래형 개량신약의 제품화가 기대됨.
(출처 : 요약서 3p)
□ Purpose & Contents
< Purpose >
Constructing the new integrative center for research and development of innovative incrementally modified drug(IMD), and creating role model cases with global success story which is related to develop and launch
and commercialize innovative IMD in global mar
□ Purpose & Contents
< Purpose >
Constructing the new integrative center for research and development of innovative incrementally modified drug(IMD), and creating role model cases with global success story which is related to develop and launch
and commercialize innovative IMD in global market, that center and the experiences can lead and contribute to the domestic pharmaceutical industry being globalization. Creating successful role model cases with innovative incrementally modified drug through the new integrative center having a capacity for commercialization of innovative incrementally modified drug’s research and development to accelerate and easily launch to global market. Detailed targets to achieve the main goal are 1) Constructing a new role model to prompt the successful commercialization of innovation IMD into global market, 2) Set up research infra to launch into global market which contains the development of formulation strategy and support ways of evaluation method, 3) manage the milestone and evaluate the detailed assignment and operate a total periodical advisory panel, 4) Create global success story with innovative incrementally modified drug (including sales).
< Contents >
○ Constructing a new role model to prompt the successful commercialization of innovation IMD into global market, and set up research infra which contains the development of formulation strategy and support ways of evaluation method, and operate a total periodical advisory panel. Based on these efforts, role model cases with global success story will be created.
○ Set up the GIC(global incrementally modified drug center) in Ajou University as a controlling tower for this project, 6 domestic pharmaceutical companies are selected which have a quite big potential to be globalization, and constructs iVIPCO(Innovative Virtually Integrated Pharmaceutical Company) model.
○ 5 types of diseases related to metabolic, respiratory, CNS and NSAIDs were selected and develop innovative IMDs with various pharmaceutical strategies such as fixed dose combination(FDC), inhalation (including device), orally disintegrating film, 7 days patch, sustained release(SR) to go and launch to global market.
○ Clinical trials in global for globalization as well as launch in domestic/global market were carried out with developed products through GIC(global incrementally modified drug center).
□ Results
○ Constructing the new integrative center with experience of research and development of innovative IMD for global market and success story
○ Achievements of a number of IMDs R&D that can advance into the global market
1) Launched fixed dose combination with gemigliptin
2) Launched controlled release IMD and FDC for inhalation including dry powder inhaler Due to early achievement of goal, the second phase is abandoned.
3) Development of 7 days transdermal patch with donepezil (Approval IND)
4) Development of fast-disintegrating film with aripiprazole (Bioequivalence of Clinical Trial (Phase I) in US and Pre-NDA Meeing)
5) Launched sustained release felubiprofen IMD
6) Development of treatment of BPH(benign prostatic hyperplasia) (Clinical trial)
○ Ending Phase 1 of this study, 1) clinical trial(phase I) of aripiprazole oral disintegration film (CMG) completed in US; 2) Domestic release of gemigliptin fixed dose combination (LG Chemicals), levodropropizine controlled release tablet(Korea United Pharmaceutics), and felubiprofen extended release tablet(Daewon Pharmaceutics);
3) Overseas registration of felubiprofen extended release tablet (Daewon Pharmaceutics) in Georgia etc.; are remarkable achievements of the Global IMD Center.
□ Expected Contribution
○ IMD supported from GIC on pharmaceutical strategy and evaluation method can be used for new pharmaceutical dosage form for new chemical entity and manufacturing clinical trial batch as well as development of IMD. Furthermore, this can be utilized for setting the price of medicine and formulation strategy for globalization pivotally.
○ An advisory panel group can be widely used to help globalization of IMD. In particular, know-how gained through this project is being planned for practical knowledge dissemination services not only to participating companies but also to all of Korean Pharmaceutical Companies through KPBMA.
○ IMDs developed by GIC such as fixed dose combination, inhalation and sustained release dosage forms can be a higher value product, can reduce medical expenses by changing the usage and dose of medicine and can increase the patient compliance. Finally, contributes improvement of QOL(quality of life).
(출처 : SUMMARY 5p)
과제명(ProjectTitle) : | - |
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연구책임자(Manager) : | - |
과제기간(DetailSeriesProject) : | - |
총연구비 (DetailSeriesProject) : | - |
키워드(keyword) : | - |
과제수행기간(LeadAgency) : | - |
연구목표(Goal) : | - |
연구내용(Abstract) : | - |
기대효과(Effect) : | - |
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