IP Library › Granted Patent US 12,258,394
Granted Patent B2
US 12,258,394 · App. 17/747,627 · Granted Mar 25, 2025

IL-5 antibody, antigen binding fragment thereof, and medical application therefor

Inventors: Hua Ying (Shanghai, CN); Jinping Shi (Shanghai, CN); Yifang Wang (Shanghai, CN); Qiyue Hu (Shanghai, CN); Hu Ge (Shanghai, CN); Weikang Tao (Shanghai, CN)
Assignees: Jiangsu Hengrui Medicine Co., Ltd.; Shanghai Hengrui Pharmaceutical Co., Ltd.
C07K16/244A61P11/06A61K2039/505C07K2317/24C07K2317/54C07K2317/55C07K2317/565C07K2317/569C07K2317/92
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,258,394
App. No.
17/747,627
Granted
Mar 25, 2025
Kind
B2
Abstract

Provided are an IL-5 antibody, an antigen binding fragment thereof, and a medical application therefor. The present invention comprises a mouse-derived antibody containing an IL-5 antibody CDR region, a chimeric antibody, a humanized antibody, and a pharmaceutical composition comprising said IL-5 antibody and said antigen binding fragment thereof, as well as the use of the pharmaceutical composition as a drug.

Claims (16)

1. A method for inhibiting human IL-5 in a human subject in need thereof, wherein the human IL-5 is associated with a disease selected from the group consisting of asthma, malignant attack of asthma, eosinophilia, Churg-Strauss syndrome, atopic dermatitis, nasal polyps and eosinophilic esophagitis, the method comprising administering to the subject a therapeutically effective amount of an anti-IL-5 antibody or antigen-binding fragment thereof, wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region and a light chain variable region, wherein:

the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 region as set forth in amino acid sequences of SEQ ID NO: 16, 17 and 18, respectively; and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 region as set forth in amino acid sequences of SEQ ID NO: 19, 20 and 21, respectively.

2. The method according to claim 1 , wherein the monoclonal antibody is selected from the group consisting of murine antibody, chimeric antibody, and humanized antibody.

3. The method according to claim 2 , wherein the humanized antibody comprises a heavy chain variable region of SEQ ID NO: 49.

4. The method according to claim 3 , wherein the humanized antibody comprises a heavy chain variable region of SEQ ID NO:50 or 51.

5. The method according to claim 2 , wherein the humanized antibody comprises a light chain variable region of SEQ ID NO: 46.

6. The method according to claim 4 , wherein the humanized antibody comprises a light chain variable region of SEQ ID NO: 47 or 48.

7. The method according to claim 1 , wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises:

a heavy chain variable region selected from any one of SEQ ID NO: 49, 50 and 51 and a light chain variable region selected from any one of SEQ ID NO: 46, 47 and 48.

8. The method according to claim 1 , wherein the anti-IL-5 antibody is a full-length antibody, and further comprises a human antibody constant region.

9. The method according to claim 8 , wherein the full-length antibody comprises a human antibody heavy chain constant region as set forth in SEQ ID NO: 52 and a human light chain constant region as set forth in SEQ ID NO:53.

10. The method according to claim 1 , wherein the antigen-binding fragment is selected from the group consisting of Fab, Fab′, F (ab′) 2, single-chain antibody (scFv), dimerized V region (diabody), and disulfide-stabilized V region (dsFv).

11. A method for inhibiting human IL-5 in a human subject in need thereof, wherein the human IL-5 is associated with a disease selected from the group consisting of asthma, malignant attack of asthma, eosinophilia, Churg-Strauss syndrome, atopic dermatitis, nasal polyps and eosinophilic esophagitis, the method comprising administering to the subject a therapeutically effective amount of an anti-IL-5 antibody or antigen-binding fragment thereof, wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region and a light chain variable region, wherein,

the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 region as set forth in amino acid sequences of SEQ ID NO: 16, 17 and 18, respectively; and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 region as set forth in amino acid sequences of SEQ ID NO: 19, 20 and 21, respectively.

12. The method according to claim 11 , wherein the disease is asthma.

13. The method according to claim 11 , wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region of SEQ ID NO: 51 and a light chain variable region of SEQ ID NO: 47.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2022
From: YING, HUA; SHI, JINPING; WANG, YIFANG; HU, QIYUE; GE, HU; TAO, WEIKANG
To: JIANGSU HENGRUI MEDICINE CO., LTD.; SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD.
Reel/Frame 060433/0514 →
Priority Claims (1)
CN 201710906068.X · Sep 29, 2017 · national
Continuity (2)
Division 16651639
Related Publication 20220356239A1 · Nov 10, 2022
References Cited (20)
US 5683892A · Ames, Jr. et al. · 1997 [cited by applicant]
US 7982005B2 · Ames et al. · 2011 [cited by applicant]
US 20100248971A1 · Inagaki et al. · 2010 [cited by applicant]
CN 1175263A · 1998 [cited by applicant]
CN 100391977C · 2008 [cited by applicant]
CN 101883862A · 2010 [cited by applicant]
WO 2009068649A2 · 2009 [cited by applicant]
WO 2017033121A1 · 2017 [cited by applicant]
Ghodsi et al. Int J Reprod BioMed (2022); 20: 213-220. https://doi.org/10.18502/ijrm.v20i3.10713. [cited by examiner]
Jorgensen et al. Peritoneal fluid cytokines related to endometriosis in patients evaluated for infertility. Fertil Steril (2017); 107: 1191-1199. [cited by examiner]
International Search Report; State Intellectual Property Office of the P.R. China (ISA/CN); International Application No. PCT/CN2018/108240; Jan. 4, 2019; 8 pages. [cited by applicant]
Written Opinion of the International Searching Authority; State Intellectual Property Office of the P.R. China (ISA/CN); International Application No. PCT/CN2018/108240; Jan. 4, 2019; 4 pages. [cited by applicant]
Li-Chao Mao et al.; Research Progress of a New Agent—Mepolizumab; Wanfang Data; Practical Pharmacy and Clinical Remedies; 2016 2 pages. [cited by applicant]
Charles G. Garlisi et al.; Effects of Chronic Anti-Interleukin-5 Monoclonal Antibody Treatment in a Murine Model of Pulmonary Inflammation; American Journal of Respiratory Cell and Molecular Biology: 1999; 8 pages; vol.… [cited by applicant]
International Preliminary Report on Patentablity; The International Bureau of WIPO; International Application No. PCT/CN2018/108240; Apr. 9, 2020; 11 pages. [cited by applicant]
Safdari, Yaghoub et al.; Antibody humanization methods—a review and update; Biotechnology and Genetic Engineering Reviews; 2013; pp. 175-186; vol. 29; No. 2; Taylor & Francis. [cited by applicant]
Scwartz et al., “Current strategies in the management of hypereosinophilic syndrome, including mepolizumab”, Current Medical Research and Opinion, Nov. 8, 2010, pp. 1932-1946, vol. 26. [cited by applicant]
Vaglio et al., “Churg-Strauss syndrome: update on pathophysiology and treatment”, Current Opinion, Jan. 20212, pp. 24-30, vol. 24, No. 1. [cited by applicant]
Basu et al., “Economic analysis of the phase III MENSA study evaluating mepolizumab for severe asthma with eosinophilic phenotype”, Expert Review of Pharmacoeconomics & Outcomes Research, Mar. 20, 2017, pp. 1-12. [cited by applicant]
Farne et al., “Anti-IL5 therapies for asthma”, Cochrane Database of Systematic Reviews, 2017, pp. 1-91. [cited by applicant]
Cited By (1)
US 12,742,004