Abstract ▼

Purpose&Contents
○ Toxicological confirmation of growth hormone deficiency treatment agent (AG-B1512) in rodent and non-rodent under GLP (Good Laboratory Practice)

○ Approval of Clinical trial Phase 1 study in advanced countries after completion of the toxicity study of AG-B1512, a treatme

Purpose&Contents
○ Toxicological confirmation of growth hormone deficiency treatment agent (AG-B1512) in rodent and non-rodent under GLP (Good Laboratory Practice)

○ Approval of Clinical trial Phase 1 study in advanced countries after completion of the toxicity study of AG-B1512, a treatment agent that dramatically improved safety, economic efficiency and patient convenience for the growth hormone deficiency

Results
○ Production Process Development of Long acting human growth hormone (AG-B1512)
① Cell Banking
- MCB 300 vials (BIOMEVA, Germany)
- Characterization (13 kinds-Viability 1 item, Purity 5 items, Identity 4 items, Genetic stability 3 items, BioReliance, UK)
② Fermentation and Purification Process Development
- Fermentation in 350L scale (WV 250L)
- Purification of 3-step columns (Affinity, Cation Exchange, Anion Exchange)
③ Analysis method development (12 kinds-Peptide mapping, Molecular weight, pI, Appearance, ELISA, Purity, HCP, HCD, MASS, Protein content, N-term and C-term sequencing, Bio-assay)

○ Long term stability test of Drug Product
- 3 months, DP stability was satisfactory

○ Non-clinical toxicity studies
① Validation for an ELISA method for the quantification of AG-B1512 in rat and monkey serum

② Method Validation of an Anti-Drug Antibody (anti-AG-B1512) Assay in rat and monkey serum

③ A 4-Week Subcutaneous Injection Toxicity in rat and monkey
- There were no AG-B1512-related effects on mortality, clinical observations, body weights, clinical pathology (hematology, coagulation, clinical chemistry and urinalysis) parameters, ophthalmology, and organ weights.
- The no observed adverse effect level (NOAEL) was determined to be 25 mg/kg/occasion in rats and in monkeys.

④ A Subcutaneous Injection Study of safety pharmacology
- The subcutaneous administration of AG-B1512 at a dose up to 25 mg/kg was well tolerated and did not result in any adverse effects on the cardiovascular system, central nervous system and respiratory system.

○ Approval of Phase 1 clinical trials of AG-B1512
- CTN Acknowledgement from the regulatory bodies such as TGA (Therapeutic Goods Administration, Australia) and Medsafe (New Zealand), and EC (Ethics Committee) Approval for Phase 1 clinical trials of AG-B1512 in Australia and New Zealand respectively in Dec. 2019.

Expected Contribution
○ Based on our experience in global manufacturing, development and commercialization of biopharmaceutics, we are able to enter the global bio pharmaceutical market.
○ The national status of the biotechnology field can be reconsidered through the transferring the globally leading technology through the first phase of advanced countries
○ We can expect to lower drug price by lowering the production cost than existing ones, which can improve the accessibility of patients and improve the health insurance corporation finances.
○ To secure the monopoly status of the global market in the bio sector and to raise the level of national R & D technology.

(출처 : SUMMARY 6p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 6
• 목차 ... 8
• 1. 연구개발과제의 개요 ... 9
• 1-1. 연구개발 목적 ... 9
• 1-2. 연구개발의 필요성 ... 9
• 1-3. 연구개발 범위 ... 10
• 2. 국내외 기술개발 현황 ... 12
• 3. 연구수행 내용 및 결과 ... 14
• 3.1. 연구개발 과제의 추진 전략 ... 14
• 3.2. MCB 및 특성 분석 ... 14
• 3.3 생산 공정 최적화 및 기시법 개발 ... 15
• 3.4. 임상 1상용 원제/완제 ... 22
• 3.5. 비임상 독성시험 ... 29
• 3.4. 임상 1상 시험 계획서 승인 ... 38
• 3.5. 연구성과 ... 39
• 4. 목표달성도 및 관련분야 기여도 ... 40
• 4-1. 목표달성도 ... 40
• 4-2. 관련분야 기여도 ... 41
• 5. 연구결과의 활용계획 ... 42
• 5.1. 연구개발의 활용계획 및 추가 연구의 필요성 ... 42
• 6. 연구과정에서 수집한 해외과학기술정보 ... 44
• 7. 연구개발성과의 보안등급 ... 44
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 44
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 45
• 10. 연구개발과제의 대표적 연구실적 ... 45
• 11. 기타사항 ... 45
• 12. 참고문헌 ... 46
• [별첨2]최종보고서 평가 면제요청서 (매출액 달성) ... 49
• [별첨3]최종보고서 비공개 승인요청서 ... 50
• [별첨4]실적 증빙자료 ... 51
• 끝페이지 ... 55