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[국문] 301호 (2017.11.21)
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식품의약품안전처 소식

보도
자료

류영진 식약처장, 치매치료제 개발업체 메디포스트 현장방문

- 첨단바이오의약품 발전방안 모색을 위한 현장간담회 개최 -

식품의약품안전처(처장 류영진)는 류영진 식약처장이 ’치매국가책임제 실현‘과 관련하여 치매치료제 개발업체인 메디포스트㈜(경기도 성남시 소재)를 현장방문한 자리에서 안전하고 효과적인 치매치료제·진단기기 개발을 통해 환자 치료기회를 확대할 수 있도록 ’치매치료제·진단기기 개발 지원방안‘을 마련 중에 있다고 밝혔다.


이날 현장방문에서는 세포치료제, 유전자치료제, 조직공학제제 등 8개 첨단바이오의약품 제조업체 대표들과 간담회도 개최하여 제품 개발 시 애로사항을 청취하는 한편 개발 지원 방안 등을 논의한다.
※ 8개 업체 : CJ헬스케어, 셀트리온, 글락소스미스클라인, 메디포스트, SK케미칼, 코오롱생명과학, 코아스템, 드림CIS

▶ 전문 확인

공무원
지침서
국가출하승인 의약품 제조 및 품질관리 요약서 양식의 사전검토 접수 및 처리 절차

국가출하승인 의약품 제조 및 품질관리 요약서 양식의 사전검토 접수 및 처리 절차의 세부 지침을 정한것으로 식약처 관련 부서 담당 직원의 업무처리를 위한 것임


▶ 원문 확인

교육
알림
'17년 "첨단바이오의약품 비임상 동물실험 전문교육"

목적 : 세포치료제, 유전자치료제 등 첨단바이오의약품 제품화 지원
대상 : 첨단바이오의약품 연구자, 개발자 등 일자별 10명 이내
기간 : 2017년 12월 7~8일 (목~금) 
장소 : 서울대학교 의과대학 종합실습실(서울시 종로구)
주최/주관: 식품의약품안전평가원 세포유전자치료제과/프라임빌 컨설팅
참가비: 무료
참가신청 : 김주아 실장 (ja@primebill.co.kr), 12월 01일 (금)까지

※ 참고사항  
- 교육의 이해도를 높이기 위해 1년 이상 동물실험 수행경험이 있는 연구자 중 기관/업체별로 고루 배정될 수 있도록 교육대상자를 최종 선정하여 별도 안내 예정임. 
- 교육대상자 최종선정 안내 예정일: 2017년 12월 4일 (월) 
- 개인별 실습이 가능토록 하여 인원을 일자별 10명이내로 제한함. 
- 교육 참가 등록비 없음
- 중식 및 주차권 제공
- 수료증 발급


▶ 원문 확인

바이오
의약품
정 보

'치매치료제·진단기기 제품화 기술지원단' 페이지 신설

식품의약품안전처는 국내에서 개발 중인 치매치료제 및 체외진단용 의료기기의 제품화 성공률을 높이기 위해 내외부 전문가로 구성된 ‘치매치료제·진단기기 제품화 기술지원단’을 운영하여 연구개발 초기부터 허가까지 단계별로 맞춤형 기술지원을 하고자합니다.

그 세부사항을 홈페이지를 통해 안내해 드리니 치매치료제 및 체외진단용 의료기기를 연구개발하고 있는 연구자 및 기업에서 이용해 주시기 바랍니다.
(추진체계, 지원대상, 지원내용, 운영절차, 기술지원 신청하기)


▶ 원문 확인

 
 
국내 임상 현황
신청 승인일 제품명 시험
제목
단계
한국
로슈
20171117 조기에 재발하는 재발성 (수술불가능한 국소 진행성 또는 전이성) 삼중-음성 유방암 환자에서 아테졸리주맙 + 화학요법의 유효성 및 안전성에 대한 제 3상, 무작위배정, 이중-눈가림, 위약-대조, 다기관 임상시험 3상 티쎈트릭
(RO554-1267)
해외의약품 허가현황
미국
Drug name Active Ingredients Submission Classification Company Approval date
ABILIFY MYCITE
NDA #207202
ARIPIPRAZOLE 신복합 OTSUKA PHARM CO LTD 11/13/2017
TEKTURNA
NDA #210709
ALISKIREN 신용량 NODEN PHARMA 11/14/2017
FASENRA
BLA #761070
BENRALIZUMAB - ASTRAZENECA AB 11/14/2017
MEPSEVII
BLA #761047
VESTRONIDASE ALFA-VJBK - ULTRAGENYX PHARM INC 11/15/2017
HEMLIBRA
BLA #761083
EMICIZUMAB - GENENTECH INC 11/16/2017
유럽
Name Active Substance Therapeutic Area Date of Authorisation / Refusal
Ritonavir Mylan ritonavir HIV Infections 10/11/2017
Cyltezo adalimumab Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid
Colitis, Ulcerative Crohn Disease
Hidradenitis Suppurativa Psoriasis
Spondylitis, Ankylosing Uveitis
10/11/2017
일본
판매명 업체명 일반명/성분명 승인연월
Cedarcure Japanese Cedar Pollen SublingualTablets 2,000 Tablets 5,000 JAU Torii Pharmaceutical Co., Ltd. N/A 2017.09.27
Vizamyl Intravenous Injectable Nihon Medi-Physics Co., Ltd. Flutemetamol (18F) 2017.09.27
Kevzara 150(200) mg Syringe for SC Injection
Kevzara 150(200) mg Auto-injector for SC Injection
Sanofi K.K. Sarilumab
(genetical recombination)
2017.09.27
Rupafin Tablets 10 mg Teikoku Seiyaku Co., Ltd. Rupatadine fumarate 2017.09.27
Afstyla I.V. Injection 250
(500/1000/1500/2000/2500/3000)
CSL Behring K.K. Lonoctocog alfa
(genetical recombination)
2017.09.27
Rectabul 2 mg Rectal Foam 14 Doses EA Pharma Co., Ltd. Budesonide 2017.09.27
Ibrance Capsules 25(125) mg Pfizer Japan Inc. Palbociclib 2017.09.27
Zinplava for Intravenous Infusion 625 mg MSD K.K. Bezlotoxumab
(genetical recombination)
2017.09.27
Atozet Combination Tablets LD (HD) MSD K.K. Ezetimibe/Atorvastatin calciumhydrate 2017.09.27
Benlysta for I.V. Infusion 120(400) mg
Benlysta for S.C. Injection 200 mg Autoinjector
Benlysta for S.C. Injection 200 mg Syringe
GlaxoSmithKline K.K. Belimumab
(genetical recombination)
2017.09.27
Darzalex Intravenous Infusion 100(400) mg
Janssen Pharmaceutical K.K. Daratumumab
(genetical recombination)
2017.09.27
Alaglio Granules sachets 1.5 g SBI Pharmaceuticals Co., Ltd. Aminolevulinic acidhydrochloride 2017.09.27
Revatio Dry Syrup for Suspension 900 mg
Revatio OD Film 20 mg
Pfizer Japan Inc. Sildenafil citrate 2017.09.27
Maviret Combination Tablets AbbVie GK Glecaprevir hydrate/Pibrentasvir 2017.09.27
Bavencio Injection 200 mg Merck Serono Co., Ltd. Avelumab
(genetical recombination)
2017.09.27
Infliximab BS for I.V. Infusion 100 mg “Nichiiko”

Infliximab BS for I.V. Infusion 100 mg “AYUMI”
Nichi-Iko Pharmaceutical Co., Ltd.

Yakuhan Pharmaceutical Co., Ltd.
Infliximab
(genetical recombination)
[Infliximab biosimilar 2]
2017.09.27
Rituximab BS Intravenous Infusion 100(500)mg [KHK] Sandoz K.K. Rituximab
(genetical recombination)
[Rituximab biosimilar 1]
2017.09.27
 
해외바이오의약품 임상현황
미국
NCT Number Title Conditions Interventions Sponsor/
Collaborators
Phases
NCT03346434 Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Severe Atopic Dermatitis (Liberty AD PRESCHOOL) Dermatitis, Atopic Drug: Dupilumab
Drug: Matching placebo
Regeneron Pharmaceuticals
Sanofi
Phase 2
Phase 3
NCT03346499 Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2 HIV Biological: NK cells and IL-2 University of Minnesota - Clinical and Translational Science Institute Phase 2
NCT03345914 Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD) Dermatitis, Atopic Drug: Dupilumab
Drug: Matching Placebo
Other: Background Treatment:
Topical Corticosteroids
Other: Background Treatment: Moisturizers
Regeneron Pharmaceuticals
Sanofi
Phase 3
NCT03345043 Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects Influenza Biological: VAL-339851
Other: Placebo
Moderna Therapeutics Phase 1
NCT03342937 KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer Gastric Cancer|Esophagus Cancer Drug: Oxaliplatin
+Capecitabine
+Pembrolizumab
Duke University|Merck Sharp & Dohme Corp. Phase 2
NCT03342911 Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery Name Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma|Stage II Oropharyngeal Squamous Cell Carcinoma... Drug: Paclitaxel
Drug: Carboplatin
Biological: Nivolumab
Sidney Kimmel Cancer Center at Thomas Jefferson University|Bristol-Myers Squibb|Thomas Jefferson University Phase 2
NCT03342638 Maximizing Outcome of Multiple Sclerosis Transplantation Multiple Sclerosis, Relapsing-Remitting Drug: Cyclophosphamide
Drug: Mesna
Drug: rATG
Drug: Methylprednisolone
Drug: G-CSF
Biological: IVIg
Biological: Autologous Stem Cells
Northwestern University Phase 3
NCT03342352 Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310) Squamous Cell Carcinoma of the Head and Neck Drug: Nivolumab
Drug: Epacadostat
Drug: Placebo
Drug: Carboplatin
Drug: Cisplatin
Drug: Cetuximab
Drug: 5-Fluorouracil
Incyte Corporation|Bristol-Myers Squibb Phase 3
NCT03341936 Adjuvant Nivolumab and Lirilumab in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Head and Neck Drug: Nivolumab
Drug: Lirilumab
Dana-Farber Cancer Institute|Bristol-Myers Squibb Phase 2
NCT03341806 Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma Glioblastoma|GBM Drug: Avelumab
Combination Product:
MRI-guided LITT therapy
Icahn School of Medicine at Mount Sinai Phase 1
NCT03340883 Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) Multiple Myeloma Biological: BION-1301 Aduro Biotech, Inc. Phase 1
Phase 2
NCT03347838 Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers Bronchial Dysplasia|Tobacco Smoking|History of Non-Small Cell Lung Cancer|History of Head and Neck Cancer Drug: Nivolumab University of Colorado, Denver|Bristol-Myers Squibb Phase 2
NCT03341754 Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Malaria Infection in Malaria Na챦ve Adults Malaria Biological: D/ChAd63-CA
Biological: D/ChAd63-CAT
Other: Infectivity Control (IC) Group
U.S. Army Medical Research and Materiel Command|University of Oxford|Walter Reed Army Institute of Research (WRAIR)|United States Agency for International Development (USAID) Phase 1
NCT03347708 Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration Degenerative Disc Disease Biological: IDCT
Drug: Saline Solution
Drug: Sodium Hyaluronate
DiscGenics, Inc. Phase 1
Phase 2
NCT03346135 Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma Plasma Cell Myeloma|Secondary Amyloidosis Procedure: Autologous
Hematopoietic Stem
Cell Transplantation
Drug: Melphalan
Biological: Daratumumab
Other: Laboratory
Biomarker Analysis
City of Hope Medical Center Phase 2
NCT03345082 A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD Neovascular Age-related Macular Degeneration Biological: OPT-302|Biological: ranibizumab|Other: sham intravitreal injection Opthea Limited Phase 2
NCT03343626 Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants Virus, Zika|Zika Virus Disease|Flavivirus Infections|Healthy Participants Drug: Placebo|Biological: PIZV Takeda Phase 1
NCT03347279 Phase 3 Study to Evaluate the Efficacy & Safety of Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma. Asthma Biological: Experimental: Tezepelumab|Other: Placebo AstraZeneca|Amgen Phase 3
NCT03347188 A Study Comparing 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of PPTH Post-Traumatic Headache Drug: Fremanezumab|Drug: Placebo Teva Branded Pharmaceutical Products, R&D Inc.|Teva Pharmaceutical Industries Phase 2
유럽
NCT Number Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03347292 Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC Carcinoma, Hepatocellular Drug: Regorafenib(Stivarga, BAY73-4506)|Drug: Pembrolizumab Bayer
Merck Sharp
& Dohme Corp.
Phase 1
NCT03345810 Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION) Carcinoma, Non-Small-Cell Lung|Metastatic Lung Cancer|Non Small Cell Lung Cancer|Lung Adenocarcinoma Metastatic|Large Cell Lung Carcinoma Metastatic Drug: Durvalumab|Drug: Vinorelbine|Drug: Gemcitabine|Drug: nab-Paclitaxel|Drug: Carboplatin AIO-Studien
-gGmbH
AstraZeneca
Celgene
Phase 2
NCT03341312 A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus, Type 2 Biological: LY900014|Biological: Insulin Lispro Eli Lilly
and Company
Phase 1
NCT03341299 A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus Diabetes Mellitus, Type 1 Biological: LY900014|Biological: Insulin Lispro Eli Lilly
and Company
Phase 1
NCT03341520 Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma Stage II Grade 1 Follicular Lymphoma|Stage II Grade 2 Follicular Lymphoma|Stage I Follicular Lymphoma Grade 1|Stage II Follicular Lymphoma Grade 2 Drug: Obinutuzumab Injection [Gazyva]|Radiation: Low dose radiation Therapy (LDRT) Heidelberg University
Roche Pharma AG
Phase 2
NCT03347279 Phase 3 Study to Evaluate the Efficacy & Safety of Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma. Asthma Biological: Experimental: Tezepelumab|Other: Placebo AstraZeneca
Amgen
Phase 3
 
중국
NCT Number Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03344705 Safety and Efficacy Evaluation of IM19 Cells Hematological Malignancies Biological: IM19 CAR-T
Drug: Fludarabine
Drug: Cyclophosphamide
Beijing Immunochina Medical Science & Technology Co., Ltd. Phase 1
NCT03344367 Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma Non Hodgkin Lymphoma Biological: JWCAR029 Peking University|MingJu Therapeutics (Shanghai) Co., Ltd Phase 1
 
일본
NCT Number Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03347279 Phase 3 Study to Evaluate the Efficacy & Safety of Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma. Asthma Biological: Experimental: Tezepelumab
Other: Placebo
AstraZeneca
Amgen
Phase 3
 
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