US 11,654,194 B2
PD-L1 antibody pharmaceutical composition and use thereof
Zhen Yan, Shanghai (CN); Jianjian Yang, Shanghai (CN); Xiaodan Yan, Shanghai (CN); Shan Wu, Shanghai (CN); and Xun Liu, Shanghai (CN)
Assigned to Jiangsu Hengrui Medicine Co., Ltd., Jiangsu (CN); and Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai (CN)
Appl. No. 16/614,148
Filed by Jiangsu Hengrui Medicine Co., Ltd., Lianyungang (CN); and Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai (CN)
PCT Filed May 15, 2018, PCT No. PCT/CN2018/086866
§ 371(c)(1), (2) Date Nov. 15, 2019,
PCT Pub. No. WO2018/210230, PCT Pub. Date Nov. 22, 2018.
Claims priority of application No. 201710341680.7 (CN), filed on May 16, 2017.
Prior Publication US 2020/0069800 A1, Mar. 5, 2020
Int. Cl. A61K 39/395 (2006.01); A61K 47/26 (2006.01); C07K 16/28 (2006.01); A61K 47/12 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 47/12 (2013.01); A61K 47/26 (2013.01); C07K 16/2827 (2013.01); C07K 2317/24 (2013.01); C07K 2317/565 (2013.01); C07K 2317/76 (2013.01)] 14 Claims
 
1. A pharmaceutical composition, comprising:
(a) 30 mg/mL-80 mg/mL anti-PD-L1 antibody or antigen-binding fragment thereof;
(b) 5 mM-50 mM succinate buffer at pH 4.5-6.0;
(c) 30 mg/mL-90 mg/mL disaccharide, wherein the disaccharide is sucrose or trehalose; and
(d) 0.1 mg/mL-1.0 mg/mL polysorbate 80; wherein, the anti-PD-L1 antibody or the antigen-binding fragment thereof comprises light chain complementary determining regions LCDR1, LCDR2 and LCDR3, and heavy chain complementary determining regions HCDR1, HCDR2 and HCDR3, wherein:
HCDR1 is SYWMH (SEQ ID NO: 7),
HCDR2 is RIX4PNSG X5TSYNEKFKN (SEQ ID NO: 8),
HCDR3 is GGSSYDYFDY (SEQ ID NO: 9),
LCDR1 is RASESVSIHGTHLMH (SEQ ID NO: 10),
LCDR2 is AASNLES (SEQ ID NO: 11),
LCDR3 is QQSFEDPLT (SEQ ID NO: 12),
wherein X4 is selected from H or G, and X5 is selected from G or F.