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1. (WO2019024783) ANTIBODY COMPOSITION FOR TNF-α, AND APPLICATION THEREOF
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Pub. No.: WO/2019/024783 International Application No.: PCT/CN2018/097445
Publication Date: 07.02.2019 International Filing Date: 27.07.2018
IPC:
A61K 39/395 (2006.01) ,A61K 47/02 (2006.01) ,A61K 47/10 (2006.01) ,A61K 47/26 (2006.01) ,A61P 19/02 (2006.01) ,A61P 29/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
395
Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19
Drugs for skeletal disorders
02
for joint disorders, e.g. arthritis, arthrosis
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
29
Non-central analgesic, antipyretic or antiinflammatory agents, e.g antirheumatic agents; Non-steroidal antiinflammatory drugs (NSAIDs)
Applicants:
百奥泰生物科技（广州）有限公司 BIO-THERA SOLUTIONS, LTD. [CN/CN]; 中国广东省广州市 高新技术产业开发区科学城开源大道11号A6栋第五层 Enterprise Accelerator A6-5fl 11 Kaiyuan Rd., Science City Guangzhou, Guangdong 510530, CN
Inventors:
林键 LIN, Jian; CN
王盛武 WANG, Shengwu; CN
岳海涛 YUE, Haitao; CN
裴树军 PEI, Shujun; CN
李胜峰 LI, Shengfeng; CN
Priority Data:
201710641907.X31.07.2017CN
Title (EN) ANTIBODY COMPOSITION FOR TNF-α, AND APPLICATION THEREOF
(FR) COMPOSITION D'ANTICORPS ANTI-TNF-α, ET SON APPLICATION
(ZH) 针对TNF-α的抗体组合物及其应用
Abstract:
(EN) The present invention provides an antibody composition for TNF-α. The solvent of the composition comprises water, and the solute of the composition comprises an anti-TNF-α antibody. The pH value of the composition is 4.0-8.0, and the pH value is adjusted by introducing carbon dioxide to the solvent and solute mixture of the composition. Compared with the prior art, the antibody composition of the present invention contains no common buffer system, and carbon dioxide is introduced to replace a buffer system and keep the pH value of a preparation stable; thus, pains and discomfort of a patient during injection is reduced, and the antibody composition is of great significance to treatment of TNF-α-related diseases.
(FR) La présente invention concerne une composition d'anticorps anti-TNF-α. Le solvant de la composition comprend l'eau, et le soluté de la composition comprend un anticorps anti-TNF-α. La valeur de pH de la composition est de 4,0 à 8,0, et la valeur de pH est ajustée par introduction de dioxyde de carbone dans le solvant et le mélange de soluté de la composition. Comparativement à l'état de la technique, la composition d'anticorps selon la présente invention ne contient pas de système tampon commun, et du dioxyde de carbone est introduit pour remplacer ledit système tampon et maintenir à l'état stable la valeur de pH d'une préparation; ainsi, les douleurs et l'inconfort du patient pendant l'injection sont réduits, et la composition d'anticorps est d'une signification majeure pour le traitement des maladies associées au TNF-α.
(ZH) 本发明提供一种针对TNF-α的抗体组合物，其溶剂包括水，溶质包括抗TNF-α抗体；所述组合物具有4.0-8.0的酸碱度，且所述酸碱度是通过向所述组合物的溶剂溶质混合物中压入二氧化碳调节的。与现有技术相比，本发明抗体组合物不含常见缓冲体系，以充入二氧化碳的方式来替代缓冲体系并维持制剂稳定的pH，降低患者注射时的疼痛不适感，对于治疗TNF-α相关疾病有重要意义。
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Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Chinese (ZH)
Filing Language: Chinese (ZH)