WO2012134240A3 - 보툴리눔 독소의 동결건조제제 - Google Patents

보툴리눔 독소의 동결건조제제 Download PDF

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Publication number
WO2012134240A3
WO2012134240A3 PCT/KR2012/002418 KR2012002418W WO2012134240A3 WO 2012134240 A3 WO2012134240 A3 WO 2012134240A3 KR 2012002418 W KR2012002418 W KR 2012002418W WO 2012134240 A3 WO2012134240 A3 WO 2012134240A3
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WO
WIPO (PCT)
Prior art keywords
botulinum toxin
lyophilized preparation
present
transportation
animal
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PCT/KR2012/002418
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English (en)
French (fr)
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WO2012134240A2 (ko
Inventor
정현호
양기혁
이창훈
김학우
김성범
백승환
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(주)메디톡스
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47282510&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2012134240(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to EP12765216.2A priority Critical patent/EP2692350B2/en
Priority to DK12765216.2T priority patent/DK2692350T4/da
Priority to ES12765216T priority patent/ES2636680T5/es
Priority to CA2831908A priority patent/CA2831908C/en
Priority to EP17168989.6A priority patent/EP3241547B1/en
Priority to JP2014502485A priority patent/JP5826914B2/ja
Priority to AU2012233845A priority patent/AU2012233845B2/en
Priority to BR112013025256-1A priority patent/BR112013025256B1/pt
Priority to SG2013073622A priority patent/SG194039A1/en
Priority to CN201280016784.6A priority patent/CN103596580A/zh
Priority to RU2013148119/15A priority patent/RU2574011C2/ru
Application filed by (주)메디톡스 filed Critical (주)메디톡스
Priority to MX2013011119A priority patent/MX338436B/es
Priority to PL17168989T priority patent/PL3241547T3/pl
Priority to US14/008,326 priority patent/US8920795B2/en
Priority to MX2016004606A priority patent/MX355771B/es
Priority to PL12765216.2T priority patent/PL2692350T5/pl
Priority to EP20172705.4A priority patent/EP3756656A1/en
Publication of WO2012134240A2 publication Critical patent/WO2012134240A2/ko
Publication of WO2012134240A3 publication Critical patent/WO2012134240A3/ko
Priority to IL228607A priority patent/IL228607B/en
Priority to ZA2013/08115A priority patent/ZA201308115B/en
Priority to US14/533,735 priority patent/US9198958B2/en
Priority to US14/954,261 priority patent/US20160089442A1/en
Priority to AU2016201040A priority patent/AU2016201040B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Toxicology (AREA)
  • Urology & Nephrology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)

Abstract

본 발명은 동물 유래의 단백질 안정화제를 함유하지 않는 보툴리눔 독소의 동결건조제제를 제공한다. 본 발명에 따른 보툴리눔 독소의 동결건조제제는 보툴리눔 독소의 보관, 운반, 조작시 발생할 수 있는 고온 조건에서도 보툴리눔 독소의 활성이 유지될 뿐만 아니라 장기안정성이 매우 우수하다.
PCT/KR2012/002418 2011-03-31 2012-03-30 보툴리눔 독소의 동결건조제제 WO2012134240A2 (ko)

Priority Applications (22)

Application Number Priority Date Filing Date Title
EP20172705.4A EP3756656A1 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
PL17168989T PL3241547T3 (pl) 2011-03-31 2012-03-30 Liofilizowany preparat toksyny botulinowej
MX2013011119A MX338436B (es) 2011-03-31 2012-03-30 Preparacion liofilizada de toxinas de botulismo.
CA2831908A CA2831908C (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
DK12765216.2T DK2692350T4 (da) 2011-03-31 2012-03-30 Lyofiliseret præparat af botulinumtoksin
JP2014502485A JP5826914B2 (ja) 2011-03-31 2012-03-30 ボツリヌム毒素の凍結乾燥製剤
AU2012233845A AU2012233845B2 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
US14/008,326 US8920795B2 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
SG2013073622A SG194039A1 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
CN201280016784.6A CN103596580A (zh) 2011-03-31 2012-03-30 肉毒杆菌毒素冻干制剂
RU2013148119/15A RU2574011C2 (ru) 2011-03-31 2012-03-30 Лиофилизированный препарат ботулотоксина
EP12765216.2A EP2692350B2 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
ES12765216T ES2636680T5 (es) 2011-03-31 2012-03-30 Preparación liofilizada de toxina botulínica
EP17168989.6A EP3241547B1 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
BR112013025256-1A BR112013025256B1 (pt) 2011-03-31 2012-03-30 Preparação liofilizada farmacêutica
MX2016004606A MX355771B (es) 2011-03-31 2012-03-30 Preparacion liofilizada de toxinas de botulismo.
PL12765216.2T PL2692350T5 (pl) 2011-03-31 2012-03-30 Liofilizowany preparat toksyny botulinowej
IL228607A IL228607B (en) 2011-03-31 2013-09-29 A preparation of lyophilized botulinum toxins
ZA2013/08115A ZA201308115B (en) 2011-03-31 2013-10-30 Lyophilized preparation of botulinum toxin
US14/533,735 US9198958B2 (en) 2011-03-31 2014-11-05 Lyophilized preparation of botulinum toxin
US14/954,261 US20160089442A1 (en) 2011-03-31 2015-11-30 Lyophilized Preparation of Botulinum Toxin
AU2016201040A AU2016201040B2 (en) 2011-03-31 2016-02-19 Lyophilized preparation of botulinum toxin

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20110029577 2011-03-31
KR10-2011-0029577 2011-03-31
KR10-2012-0033374 2012-03-30
KR1020120033374A KR101395064B1 (ko) 2011-03-31 2012-03-30 보톨리눔 독소의 동결건조제제

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US14/008,326 A-371-Of-International US8920795B2 (en) 2011-03-31 2012-03-30 Lyophilized preparation of botulinum toxin
US14/533,735 Continuation US9198958B2 (en) 2011-03-31 2014-11-05 Lyophilized preparation of botulinum toxin

Publications (2)

Publication Number Publication Date
WO2012134240A2 WO2012134240A2 (ko) 2012-10-04
WO2012134240A3 true WO2012134240A3 (ko) 2013-01-03

Family

ID=47282510

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2012/002418 WO2012134240A2 (ko) 2011-03-31 2012-03-30 보툴리눔 독소의 동결건조제제

Country Status (22)

Country Link
US (3) US8920795B2 (ko)
EP (3) EP3241547B1 (ko)
JP (3) JP5826914B2 (ko)
KR (1) KR101395064B1 (ko)
CN (2) CN103596580A (ko)
AU (2) AU2012233845B2 (ko)
BR (1) BR112013025256B1 (ko)
CA (1) CA2831908C (ko)
CO (1) CO6821888A2 (ko)
DK (2) DK2692350T4 (ko)
ES (2) ES2810098T3 (ko)
HK (1) HK1246174A1 (ko)
HU (1) HUE050037T2 (ko)
IL (1) IL228607B (ko)
MX (2) MX338436B (ko)
PL (2) PL2692350T5 (ko)
PT (1) PT3241547T (ko)
RU (2) RU2640922C1 (ko)
SG (3) SG194039A1 (ko)
SI (1) SI3241547T1 (ko)
WO (1) WO2012134240A2 (ko)
ZA (1) ZA201308115B (ko)

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KR100852822B1 (ko) * 2004-07-26 2008-08-18 메르츠 파마 게엠베하 운트 코. 카가아 보툴리눔 신경독소를 포함하는 치료 조성물
US8323666B2 (en) * 2005-08-01 2012-12-04 Allergan, Inc. Botulinum toxin compositions
JP5259710B2 (ja) * 2007-07-10 2013-08-07 メディ‐トックス、インク． ボツリヌス毒素の安定性が改善された薬学的液状組成物
DK3332805T3 (da) 2008-12-31 2022-05-16 Revance Therapeutics Inc Injicerbare botulinumtoksinformuleringer
BRPI1015938A2 (pt) * 2009-06-25 2016-09-27 Revance Therapeutics Inc formulações da toxina botulínica livre de albumina
EP3241547B1 (en) * 2011-03-31 2020-05-20 Medy-Tox Inc. Lyophilized preparation of botulinum toxin
US9480731B2 (en) * 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
DK3188706T3 (da) 2014-09-02 2020-01-20 American Silver Llc Botulinumtoksin og kolloide sølvpartikler
EP3207936B1 (en) * 2014-11-18 2021-04-21 Shionogi & Co., Ltd. Stable peptide composition
KR101737387B1 (ko) 2015-06-01 2017-05-18 유용우 2차 발효 홍삼을 이용한 건강기능식품의 제조방법
SG11201805195YA (en) * 2016-03-02 2018-07-30 Merz Pharma Gmbh & Co Kgaa Composition comprising botulinum toxin
KR20240023684A (ko) 2016-09-13 2024-02-22 알레간 인코포레이티드 안정화된 비단백질 클로스트리듐 독소 조성물
KR101744900B1 (ko) 2017-01-20 2017-06-08 주식회사 대웅 보툴리눔 독소를 포함하는 안정한 액상 조성물
CN107540732B (zh) * 2017-08-31 2020-07-14 青海省畜牧兽医科学院 一种d型肉毒毒素的仿生矿化加工方法及应用
KR101968873B1 (ko) * 2018-09-21 2019-04-29 아이큐어 주식회사 세포 침투 효과가 우수한 보툴리늄 유래 펩타이드를 포함하는 화장료 조성물
KR102259423B1 (ko) * 2018-11-30 2021-06-02 주식회사 휴온스바이오파마 보툴리눔 독소의 안정화 액상 조성물
WO2020111852A1 (ko) * 2018-11-30 2020-06-04 주식회사 휴온스글로벌 보툴리눔 독소의 안정화 액상 조성물
EP3927355A1 (en) 2019-02-21 2021-12-29 Merz Pharma GmbH & Co. KGaA Novel uses of botulinum neurotoxin for the treatment of tremor
CN110637814B (zh) * 2019-10-22 2021-11-19 青海省畜牧兽医科学院 一种d型肉毒毒素的微囊化制备方法
WO2021086123A1 (ko) * 2019-10-31 2021-05-06 휴젤㈜ 보툴리눔 독소에 대한 마이크로 구조체 제형화 기술
EP4186520A4 (en) 2020-07-23 2024-05-01 Medytox Inc. THERAPEUTIC AGENT AGAINST CANCER
KR102414997B1 (ko) * 2020-09-29 2022-06-29 주식회사 엘지생활건강 안정성이 개선된 재조합 보툴리눔 독소 경쇄 단백질 조성물
KR20220114183A (ko) * 2021-02-08 2022-08-17 주식회사 대웅 장기 저장이 가능한 보툴리눔 독소 동결건조 제형 조성물
KR20230001260A (ko) 2021-06-28 2023-01-04 (주)메디톡스 재조합 보툴리눔 독소 타입 a 경쇄, 재조합 보툴리눔 독소 및 이의 조성물, 용도 및 방법
KR20230001254A (ko) 2021-06-28 2023-01-04 (주)메디톡스 재조합 보툴리눔 독소 타입 a 경쇄, 재조합 보툴리눔 독소 및 이의 조성물, 용도 및 방법
KR102427362B1 (ko) 2021-11-11 2022-08-01 (주)이니바이오 보툴리눔 독소 제제의 건조 공정
CA3238234A1 (en) * 2021-11-15 2023-05-19 Medytox Inc. Botulinum neurotoxin composition

Citations (4)

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