WO2023025120 - GDF15 FUSION PROTEINS AND USES THEREOF

National phase entry:
Publication Number WO/2023/025120
Publication Date 02.03.2023
International Application No. PCT/CN2022/114096
International Filing Date 23.08.2022
Title **
[English] GDF15 FUSION PROTEINS AND USES THEREOF
[French] PROTÉINES DE FUSION GDF15 ET LEURS UTILISATIONS
Applicants **
SUNSHINE LAKE PHARMA CO., LTD. Northern Industrial Area, Songshan Lake Dongguan, Guangdong 523000, CN
Inventors
YAN, Jiangyu Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
CAO, Rongbo Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
XIAO, Lin Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
ZENG, Junnan Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
HUANG, Limei Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
WEI, Xiling Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
LI, Zhaofeng Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
GONG, Qingwei Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
YAN, Xingguo Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
LI, Jing Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
HUANG, Danxia Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
CHEN, Xiaofeng Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
LI, Wenjia Dongyangguang Hi-Tech Park, Zhen An Road No. 368, Shang Sha, Chang An Town Dongguan, Guangdong 523871, CN
Priority Data
202110977378.7   24.08.2021   CN
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Quotation for National Phase entry

Country StagesTotal
China Filing1481
EPO Filing, Examination9211
Japan Filing592
South Korea Filing574
USA Filing, Examination4310
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Total: 16168

The term for entry into the National Phase has expired. This quotation is for informational purposes only

Abstract[English] Provided are GDF15 fusion proteins and uses thereof. The fusion protein comprises an Fc variant and a GDF15 active domain, wherein the Fc variant has amino acid substitutions at position 356 and/or position 439 of the IgG Fc according to EU numbering and still has the ability to form homodimer. By fusing the Fc variant with the GDF15 active domain, the Fc-GDF15 fusion protein has significantly improved physicochemical properties and recombinant expression levels, has in vitro activity equivalent to or better than natural GDF15 molecules, and has significantly prolonged in vivo circulating half-life, which can support the dosing frequency of once every two weeks or even once a month.[French] L'invention concerne des protéines de fusion GDF15 et leurs utilisations. La protéine de fusion comprend un variant Fc et un domaine actif GDF15, le variant Fc ayant des substitutions d'acides aminés en position 356 et/ou en position 439 de l'IgG Fc selon la numérotation EU et ayant encore la capacité de former un homodimère. Par fusion du variant Fc avec le domaine actif GDF15, la protéine de fusion Fc-GDF15 présente des propriétés physico-chimiques et des niveaux d'expression recombinants significativement améliorés, a une activité in vitro équivalente ou meilleure que les molécules de GDF15 naturelles, et a une demi-vie circulante in vivo significativement prolongée, qui peut supporter la fréquence de dosage d'une fois toutes les deux semaines ou même une fois par mois.
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