**[미래에셋 제약/바이오 김승민]**
**11/3 Daily**

[https://t.me/bioksm](https://t.me/bioksm)


 **글로벌 바이오/제약**
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 [FDA, UniQure 헌팅톤병 유전자 치료제 심사...2027년 5월 결정 예정](https://news.google.com/rss/articles/CBMiuwFBVV95cUxOX2tEaTBsbVQ5cTRGVDFYTTdHMVlablhjbnA3eVdKX05qVGtXZjNOYTlvajlqb1hDN0NlQVliMTdJZlZCSnFLUXB1SlJIUVpKS1ZpZXI4eExLN1l5LVRKLXp2eVdLSjVhdFRvc1BfRE9mZjdRcUZ2RUF5NzA2Um5YckdxM2RhVEhWdktSRFFjZkx4cGd3MWZUNGF0MGUtUFl0dTEtWl9ReVZTVTZwczI5Y3lyc2JfOHpFOUJr?oc=5)

 [FDA, HIV 예방용 제네릭 주사제 레나카파비르 첫 승인](https://news.google.com/rss/articles/CBMipgFBVV95cUxNM2oxdk9DVmdoLXRaZENJRTdob0Fjam5HekFsYzl6LTRVcTQ4WDlpY3FXaVQzYTdiclhFUVdwMldvSjN0VUhYNDU1bVlVWTE5aWwzeUotQlRNZ0Q2VERWM1dFcG03cTEzRGViY2FHd1ZGQkJrRHhkVjNoOU9BRGV3M2thY2piUGk0NE8zczlqQzJzc0JBNlpHb2NIa3BmOWVkNVFBY3FR?oc=5)

[▶️](https://news.google.com/rss/articles/CBMipgFBVV95cUxNM2oxdk9DVmdoLXRaZENJRTdob0Fjam5HekFsYzl6LTRVcTQ4WDlpY3FXaVQzYTdiclhFUVdwMldvSjN0VUhYNDU1bVlVWTE5aWwzeUotQlRNZ0Q2VERWM1dFcG03cTEzRGViY2FHd1ZGQkJrRHhkVjNoOU9BRGV3M2thY2piUGk0NE8zczlqQzJzc0JBNlpHb2NIa3BmOWVkNVFBY3FR?oc=5)[FDA, Inovio의 DNA 기반 면역 치료제 Voceryq 희귀 HPV 기도 질환 치료제로 승인](https://www.fiercepharma.com/pharma/inovio-dna-based-immunotherapy-voceryq-approved-fda-rare-hpv-airway-disease)

 [FDA, 세포·유전자치료 개발 및 품질 관리 지침 발표](http://www.fda.gov/news-events/press-announcements/fda-provides-clarity-support-cell-and-gene-therapy-development-and-quality)

[▶️](https://news.google.com/rss/articles/CBMipgFBVV95cUxNM2oxdk9DVmdoLXRaZENJRTdob0Fjam5HekFsYzl6LTRVcTQ4WDlpY3FXaVQzYTdiclhFUVdwMldvSjN0VUhYNDU1bVlVWTE5aWwzeUotQlRNZ0Q2VERWM1dFcG03cTEzRGViY2FHd1ZGQkJrRHhkVjNoOU9BRGV3M2thY2piUGk0NE8zczlqQzJzc0JBNlpHb2NIa3BmOWVkNVFBY3FR?oc=5) [AbbVie, 베이징에 본사를 둔 Brise와 $757mn 규모 편두통 치료제 전임상단계 계약 체결](https://endpoints.news/abbvie-brise-disclose-deal-for-two-preclinical-migraine-meds/)

 [Novartis 심장약 실패, 의사들 유전적 콜레스테롤 표적 Lp(a) 근거 모색](https://news.google.com/rss/articles/CBMi5gFBVV95cUxORklJSEw2b2RtMkNSZS1JbWpJNEhiUTIwTzlqbmVzclg2Um5vWkc3MDl0N2hBclhYSWVnTlJmQjZLdGkyaUxMTGVDTkNiR2NqM1pUYndMQ0s0ZVdyYWdsRDBoMU5KczJjQ1oxRnlHb0h0VzF5WGE5QzE2U25TbW92bXI4cmVMMmlGT2NkLURGUEtHZW4yM053VGlZbWJpcTc5MlhtaFdmRGJmNFNJVjh3cTlFYXpLTlFEZEVaOE9la2hWenNnVHp6dWl5ckU5RWY5YkcycGZtc29seTJlVGJzTTJ3bTVNdw?oc=5)

 [Hansoh와 Samsung Biologics가 FDA 실사 후 경고 조치](https://www.fiercepharma.com/pharma/hansoh-and-samsung-face-fda-write-after-inspections)

 [Fresenius, 향후 10년간 최대 37개 바이오시밀러를 WuXi Biologics와 협력해 공급할 예정](https://endpoints.news/wuxi-biologics-fresenius-partner-ahead-of-biosimilar-boom/)


 **한국 바이오/제약**
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 [삼성바이오, 320억대 위탁생산계약 '더블'로 올려](https://www.hitnews.co.kr/news/articleView.html?idxno=80438)

 [셀트리온 '짐펜트라', 류마티스 관절염 유럽 3상 시험계획 승인](https://www.hitnews.co.kr/news/articleView.html?idxno=80415)

 [GC녹십자, 콜롬비아 백스테라와 592억 독감백신 원액 공급계약](https://www.hitnews.co.kr/news/articleView.html?idxno=80414)

 [올릭스 황반변성 치료제 후보물질 ‘OLX301A’, 美 2a상 IND 제출](https://news.google.com/rss/articles/CBMiWkFVX3lxTE40aXdLLWYzMXdHWkl1VjR1WGF5VXdEY3IxOFdtQW5Eei1YUlZYdWp5cUR1cDFZblM3amVhXzVxbnNpNmxhamhibTlzMUlJWnB4SGdJNWhCZmlqQQ?oc=5)

 [리가켐바이오 'IKS014', 유방암 임상 1상서 반응률 50%](https://www.hitnews.co.kr/news/articleView.html?idxno=80431)

 [툴젠, 바이오니아와 CRISPR RNP 라이선스 계약 체결](https://www.hitnews.co.kr/news/articleView.html?idxno=80416)

 [대웅제약, 차세대 약물전달 플랫폼 3종 글로벌 시장에 선보여](https://www.hitnews.co.kr/news/articleView.html?idxno=80411)