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US-20260125454-A1 - ANTI-CGRP ANTIBODY AND USE

US20260125454A1US 20260125454 A1US20260125454 A1US 20260125454A1US-20260125454-A1

Abstract

Provided are an antibody specifically binding to CGRP or an antigen-binding fragment thereof, and a composition comprising same. Also provided are a nucleic acid molecule encoding the antibody or the antigen-binding fragment thereof, a vector and a host cell for expressing the antibody or the antigen-binding fragment thereof, and therapeutic and diagnostic methods and use of the antibody or the antigen-binding fragment thereof.

Inventors

  • Chao Dong
  • Jian Yao
  • Yuehua ZHOU
  • Hui Liu
  • Dandan Liu
  • Jing Zhang
  • Hongchuan LIU
  • Hui Feng
  • Sheng Yao

Assignees

  • SHANGHAI JUNSHI BIOSCIENCES CO., LTD.

Dates

Publication Date
20260507
Application Date
20230811
Priority Date
20220811

Claims (20)

  1. 1 . An anti-CGRP antibody or an antigen-binding fragment thereof, comprising an HCDR1, an HCDR2, an HCDR3, an LCDR1, an LCDR2, and an LCDR3, wherein HCDR1: DX 1 NMH or GYTMN, wherein X 1 is F or Y; HCDR2: X 2 X 3 X 4 PYN X 5 X 6 X 7 X 8 YN X 9 X 10 F X 11 X 12 or LINPYIGNTHYNQKFKD, wherein X 2 is Y or N, X 3 is I or V, X 4 is Y, S, or F, X 5 is G or A, X 6 is D, G, V, or H, X 7 is V, T, S, or A, X 8 is V or A, X 9 is Q or R, X 10 is K, N, or D, X 11 is T, K, N, or R, and X 12 is N, F, or S; HCDR3: EGLGGY or ELDSGFDY; LCDR1: X 13 X 14 SQNI Z Y X 15 X 16 , wherein X 13 is K, Q, or R, X 14 is A or S, Z is DYDGYA, DFDGYA, DGNT, VHSNGDT, VHSNADT, DYDGYT, or DYGGYS, X 15 is L or M, and X 16 is N or E; LCDR2: S X 17 FNLES or KVSNRFS, wherein X 17 is V or I; and LCDR3: X 18 QS X 19 X 20 X 21 PYT or YQGSHVPWT, wherein X 18 is Q, X 19 is N or H, X 20 is E or D, X 21 is F, V, Y, or A.
  2. 2 . The antibody or an antigen-binding fragment thereof according to claim 1 , comprising a heavy chain variable region and/or a light chain variable region, wherein the heavy chain variable region comprises: (I) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively, by 1, 2, or 3 amino acids; or (II) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 110, and SEQ ID NO: 4, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 110, and SEQ ID NO: 4, respectively, by 1, 2, or 3 amino acids; or (III) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13, respectively, by 1, 2, or 3 amino acids; or (IV) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 111, and SEQ ID NO: 13, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 111, and SEQ ID NO: 13, respectively, by 1, 2, or 3 amino acids; or (V) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 20, and SEQ ID NO: 21, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 20, and SEQ ID NO: 21, respectively, by 1, 2, or 3 amino acids; or (VI) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 112, and SEQ ID NO: 21, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 112, and SEQ ID NO: 21, respectively, by 1, 2, or 3 amino acids; or (VII) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 26, SEQ ID NO: 27, and SEQ ID NO: 28, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 26, SEQ ID NO: 27, and SEQ ID NO: 28, respectively, by 1, 2, or 3 amino acids; or (VIII) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 31, SEQ ID NO: 32, and SEQ ID NO: 33, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 31, SEQ ID NO: 32, and SEQ ID NO: 33, respectively, by 1, 2, or 3 amino acids; or (IX) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 37, SEQ ID NO: 38, and SEQ ID NO: 39, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 37, SEQ ID NO: 38, and SEQ ID NO: 39, respectively, by 1, 2, or 3 amino acids; or (X) an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 43, SEQ ID NO: 44, and SEQ ID NO: 45, respectively; or an HCDR1, an HCDR2, and an HCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 43, SEQ ID NO: 44, and SEQ ID NO: 45, respectively, by 1, 2, or 3 amino acids; the light chain variable region comprises: (I) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively, by 1, 2, or 3 amino acids; or (II) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 59, SEQ ID NO: 60, and SEQ ID NO: 61, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 59, SEQ ID NO: 60, and SEQ ID NO: 61, respectively, by 1, 2, or 3 amino acids; or (III) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 67, SEQ ID NO: 68, and SEQ ID NO: 69, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 67, SEQ ID NO: 68, and SEQ ID NO: 69, respectively, by 1, 2, or 3 amino acids; or (IV) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 73, SEQ ID NO: 74, and SEQ ID NO: 75, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 73, SEQ ID NO: 74, and SEQ ID NO: 75, respectively, by 1, 2, or 3 amino acids; or (V) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 113, SEQ ID NO: 74, and SEQ ID NO: 75, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 113, SEQ ID NO: 74, and SEQ ID NO: 75, respectively, by 1, 2, or 3 amino acids; or (VI) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 81, SEQ ID NO: 82, and SEQ ID NO: 83, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 81, SEQ ID NO: 82, and SEQ ID NO: 83, respectively, by 1, 2, or 3 amino acids; or (VII) an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 86, SEQ ID NO: 87, and SEQ ID NO: 88, respectively; or an LCDR1, an LCDR2, and an LCDR3 differing from the amino acid sequences set forth in SEQ ID NO: 86, SEQ ID NO: 87, and SEQ ID NO: 88, respectively, by 1, 2, or 3 amino acids.
  3. 3 . The antibody or the antigen-binding fragment thereof according to claim 1 , comprising: (I) a heavy chain variable region, comprising the amino acid sequence set forth in any one of SEQ ID NOs: 5, 6, 7, 8, 9, 14, 15, 16, 17, 22, 23, 24, 29, 34, 35, 40, 41, 46, 47, 48, or 49; and a light chain variable region, comprising the amino acid sequence set forth in any one of SEQ ID NOs: 54, 55, 56, 57, 62, 63, 64, 65, 70, 71, 76, 77, 78, 79, 84, 89, or 90; or (II) a heavy chain variable region, comprising an amino acid sequence having at least 95%, 96%, 97%, 98%, or 99% sequence identity to the amino acid sequence set forth in any one of SEQ ID NOs: 5, 6, 7, 8, 9, 14, 15, 16, 17, 22, 23, 24, 29, 34, 35, 40, 41, 46, 47, 48, or 49; and a light chain variable region, comprising an amino acid sequence having at least 95%, 96%, 97%, 98%, or 99% sequence identity to the amino acid sequence set forth in any one of SEQ ID NOs: 54, 55, 56, 57, 62, 63, 64, 65, 70, 71, 76, 77, 78, 79, 84, 89, or 90; or (III) a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 46 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 78; or a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 47 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 78; or a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 48 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 77; or a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 8 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 63; or a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 24 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 54; or a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 8 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO: 54; preferably, the antibody comprises: (I) a heavy chain, comprising the amino acid sequence set forth in any one of SEQ ID NOs: 92, 94, or 96, and a light chain, comprising the amino acid sequence set forth in any one of SEQ ID NOs: 91, 93, or 95; or (II) a heavy chain, comprising an amino acid sequence having at least 95%, 96%, 97%, 98%, or 99% sequence identity to the amino acid sequence set forth in any one of SEQ ID NOs: 92, 94, or 96, and a light chain, comprising an amino acid sequence having at least 95%, 96%, 97%, 98%, or 99% sequence identity to the amino acid sequence set forth in any one of SEQ ID NOs: 91, 93, or 95; or (III) a heavy chain having the amino acid sequence set forth in SEQ ID NO: 92 and a light chain having the amino acid sequence set forth in SEQ ID NO: 91, or a heavy chain having the amino acid sequence set forth in SEQ ID NO: 94 and a light chain having the amino acid sequence set forth in SEQ ID NO: 93, or a heavy chain having the amino acid sequence set forth in SEQ ID NO: 96 and a light chain having the amino acid sequence set forth in SEQ ID NO: 95.
  4. 4 . The antibody or the antigen-binding fragment thereof according to claim 1 , which has one or more features selected from the following: (1) the antibody is selected from a murine antibody, a chimeric antibody, a humanized antibody, and a fully human antibody, and/or the antigen-binding fragment is selected from Fab, Fab′, F(ab′) 2 , Fv, scFv, and sdAb; (2) the antibody or the antigen-binding fragment thereof is of any IgG subtype, such as IgG1, IgG2, IgG3, or IgG4, preferably IgG1 subtype or IgG4 subtype.
  5. 5 . (canceled)
  6. 6 . An isolated anti-CGRP antibody or an antigen-binding fragment thereof, binding to an epitope on human CGRP protein that is identical to or completely or partially overlaps with that of the antibody or the antigen-binding fragment thereof according to claim 1 .
  7. 7 . A polynucleotide molecule, encoding the anti-CGRP antibody or the antigen-binding fragment thereof according to claim 1 .
  8. 8 . An expression vector, comprising the polynucleotide molecule according to claim 7 , wherein preferably, the vector is a eukaryotic expression vector.
  9. 9 . A host cell, comprising the polynucleotide molecule according to claim 7 or an expression vector comprising the polynucleotide molecule, wherein preferably, the host cell is a eukaryotic cell, more preferably, a mammalian cell.
  10. 10 . A method for preparing an anti-CGRP antibody or an antigen-binding fragment thereof, comprising expressing the antibody or the antigen-binding fragment thereof in the host cell according to claim 9 in a condition suitable for the expression of the antibody or the antigen-binding fragment thereof, and isolating the expressed antibody or antigen-binding fragment thereof from the host cell.
  11. 11 . A multispecific antibody, comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof according to claim 1 .
  12. 12 . A single-chain antibody, comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof according to claim 1 .
  13. 13 . A pharmaceutical composition, comprising (i) the anti-CGRP antibody or the antigen-binding fragment thereof according to claim 1 , (ii) a polynucleotide molecule or expression vector or host cell comprising a nucleotide sequence encoding the anti-CGRP antibody or the antigen-binding fragment thereof, (iii) a multispecific antibody comprising the light chain variable region and the heavy chain variable region of the anti-CGRP antibody or the antigen-binding fragment thereof, or (iv) a single-chain antibody comprising the light chain variable region and the heavy chain variable region of the anti-CGRP antibody or the antigen-binding fragment thereof, and a pharmaceutically acceptable carrier or excipient.
  14. 14 . A pharmaceutical combination, comprising (i) the anti-CGRP antibody or the antigen-binding fragment thereof according to claim 1 , (ii) a polynucleotide molecule or expression vector or host cell comprising an nucleotide sequence encoding the anti-CGRP antibody or the antigen-binding fragment thereof, (iii) a multispecific antibody comprising the light chain variable region and the heavy chain variable region of the anti-CGRP antibody or the antigen-binding fragment thereof, (iv) a single-chain antibody comprising the light chain variable region and the heavy chain variable region of the anti-CGRP antibody or the antigen-binding fragment thereof, or (v) a pharmaceutical composition comprising any one of the foregoing and a pharmaceutically acceptable carrier or excipient, and one or more additional therapeutic agents.
  15. 15 . (canceled)
  16. 16 . A method for treating and/or preventing a CGRP-mediated disease or disorder, comprising administering to a subject in need an effective amount of (i) the antibody or the antigen-binding fragment thereof according to claim 1 , (ii) a polynucleotide molecule or expression vector or host cell comprising an nucleotide sequence encoding the antibody or the antigen-binding fragment thereof, (iii) a multispecific antibody comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof, (iv) a single-chain antibody comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof, (v) a pharmaceutical composition comprising any one of (i) through (iv) and a pharmaceutically acceptable carrier or excipient, or (vi) a pharmaceutical combination comprising any one of (i) through (v) and one or more additional therapeutic agents, wherein the disease or disorder is a symptom having CGRP-associated pain; more preferably, the pain is selected from migraine with aura, migraine without aura, high-frequency episodic migraine, menstrual migraine, hemiplegic migraine, cluster headache, migrainous neuralgia, chronic headache, tension headache, general headache, hot flashes, chronic paroxysmal hemicrania, secondary headache due to potential structural problems in head, secondary headache due to potential structural problems in neck, cranial neuralgia, sinus headache, allergy-induced headache, trigeminal neuralgia, fibromyalgia, and sciatica; preferably, the subject is a human.
  17. 17 . A kit, comprising (i) the antibody or the antigen-binding fragment thereof according to claim 1 , (ii) a polynucleotide molecule or expression vector or host cell comprising an nucleotide sequence encoding the antibody or the antigen-binding fragment thereof, (iii) a multispecific antibody comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof, (iv) a single-chain antibody comprising the light chain variable region and the heavy chain variable region of the antibody or the antigen-binding fragment thereof, (v) a pharmaceutical composition comprising any one of (i) through (iv) and a pharmaceutically acceptable carrier or excipient, or (vi) a pharmaceutical combination comprising any one of (i) through (v) and one or more additional therapeutic agents.
  18. 18 . A method for detecting the presence of CGRP in a sample, comprising: contacting the antibody or the antigen-binding fragment thereof according to claim 1 , or a detection composition comprising the antibody or the antigen-binding fragment thereof with the sample.
  19. 19 . The antibody or the antigen-binding fragment thereof according to claim 1 , which comprises: an HCDR1 having the amino acid sequence set forth in SEQ ID NOs: 2, 11, 19, 26, 31, 37, or 43; an HCDR2 having the amino acid sequence set forth in SEQ ID NOs: 3, 110, 12, 111, 20, 112, 27, 32, 38, or 44; an HCDR3 having the amino acid sequence set forth in SEQ ID NOs: 4, 13, 21, 28, 33, 39, or 45; an LCDR1 having the amino acid sequence set forth in SEQ ID NOs: 51, 59, 67, 73, 113, 81, or 86; an LCDR2 having the amino acid sequence set forth in SEQ ID NOs: 52, 60, 68, 74, 82, or 87; and an LCDR3 having the amino acid sequence set forth in SEQ ID NOs: 53, 61, 69, 75, 83, or 88.
  20. 20 . The antibody or the antigen-binding fragment thereof according to claim 1 , which comprises: (I) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 31, SEQ ID NO: 32, and SEQ ID NO: 33, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or (II) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or (III) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 59, SEQ ID NO: 60, and SEQ ID NO: 61, respectively; or (IV) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 67, SEQ ID NO: 68, and SEQ ID NO: 69, respectively; or (V) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 81, SEQ ID NO: 82, and SEQ ID NO: 83, respectively; or (VI) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 86, SEQ ID NO: 87, and SEQ ID NO: 88, respectively; or (VII) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 26, SEQ ID NO: 27, and SEQ ID NO: 28, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 59, SEQ ID NO: 60, and SEQ ID NO: 61, respectively; or (VIII) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 20, and SEQ ID NO: 21, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or (IX) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 20, and SEQ ID NO: 21, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 67, SEQ ID NO: 68, and SEQ ID NO: 69, respectively; or (X) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 43, SEQ ID NO: 44, and SEQ ID NO: 45, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 73, SEQ ID NO: 74, and SEQ ID NO: 75, respectively; or (XI) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or (XII) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 59, SEQ ID NO: 60, and SEQ ID NO: 61, respectively; or (XIII) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 37, SEQ ID NO: 38, and SEQ ID NO: 39, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively; or (XIV) a heavy chain variable region, comprising an HCDR1, an HCDR2, and an HCDR3 having the amino acid sequences set forth in SEQ ID NO: 19, SEQ ID NO: 112, and SEQ ID NO: 21, respectively; and a light chain variable region, comprising an LCDR1, an LCDR2, and an LCDR3 having the amino acid sequences set forth in SEQ ID NO: 51, SEQ ID NO: 52, and SEQ ID NO: 53, respectively.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a U.S. National Stage application of International Application No. PCT/CN2023/112454, filed Aug. 11, 2023, which claims the benefit of priority to Chinese Patent Application No. 202210962095.X, filed Aug. 11, 2022, the entireties of which are incorporated herein by reference. SEQUENCE LISTING The instant application contains a Sequence Listing which has been submitted electronically in XML file format and is hereby incorporated by reference in its entirety. Said XML file, created on Jan. 15, 2026, is named IEC220365PCT_ST26_revised.xml and is 142,132 bytes in size. TECHNICAL FIELD The present disclosure provides an antibody specifically binding to human calcitonin gene-related peptide (hereinafter referred to as “CGRP”) or an antigen-binding fragment thereof, and a composition comprising same. Also provided are a nucleic acid molecule encoding the antibody or the antigen-binding fragment thereof disclosed herein, a vector and a host cell used for expressing the antibody or the antigen-binding fragment thereof disclosed herein, and therapeutic and diagnostic methods and use of the antibody or the antigen-binding fragment thereof disclosed herein. BACKGROUND CGRP is a neuropeptide consisting of 37 amino acid residues. It is widely distributed in peripheral and central nervous systems, and plays an important role in functional regulation of cardiovascular system, pain, and nervous system, etc. CGRP is a member of the calcitonin gene-related peptide family, which includes two CGRP forms, adrenomedullin, islet amyloid polypeptide, calcitonin, and calcitonin receptor-stimulating peptide. The two forms of CGRP, i.e., CGRP-α and CGRP-β forms, are present in humans and have similar activities. The two forms of CGRP differ by 3 amino acids and exhibit different distributions. CGRP is involved in the regulation of many physiological functions of the body. CGRP has a powerful vasodilative effect and is one of the most potent known peripheral microvasodilators. CGRP is involved in the regulation of various physiological activities by activating CGRP receptors on the cell membrane, and particularly, plays an important role in vasodilation and migraine. Many studies have shown that CGRP is involved in the central nervous system learning and memory processes. Also, it has been reported that CGRP is involved in the regulation of related metabolism during the development of diabetes mellitus. Recent studies have shown that CGRP has a protective effect against several diseases in the cardiovascular system. Migraine is a common trigeminal vascular headache, which seriously affects the daily life of patients. Triptan is used as a specific analgesic during migraine attack but is limited to use in patients with cardiovascular diseases due to its vasoconstrictive effect. Also, some patients demonstrate resistance to triptan, leading to an urgent need for new effective drugs. Clinical studies have shown that CGRP plays an important role in acute migraine attack, and theoretically, the CGRP activity can be reduced by preventing the synthesis and release of CGRP, reducing the concentration of CGRP after release, and preventing CGRP from activating its receptors. In spite of currently available CGRP antibodies for treating migraine and for treating inflammatory pain, and advantages of monoclonal CGRP antibodies such as large molecular weights, long half-lives, difficulties in passing through the blood-brain barrier, the absence of toxic metabolites, strong selectivity, and good tolerance, there is still a need for more novel anti-CGRP antibodies. SUMMARY The present application is intended to provide an antibody capable of specifically binding to CGRP (i.e., an anti-CGRP antibody) or an antigen-binding fragment thereof, a polynucleotide molecule encoding the antibody or the antigen-binding fragment thereof disclosed herein, an expression vector and a host cell for expressing the antibody or the antigen-binding fragment thereof disclosed herein, and use of the antibody or the antigen-binding fragment thereof disclosed herein. In one aspect, the present disclosure provides an anti-CGRP antibody or an antigen-binding fragment thereof, comprising an HCDR1, an HCDR2, an HCDR3, an LCDR1, an LCDR2, and an LCDR3 defined as follows: HCDR1: DX1NMH (SEQ ID NO: 103) or GYTMN (SEQ ID NO: 43), wherein X1 is F or Y;HCDR2: X2X3X4PYNX5X6X7X8YNX9X10FX1X12 (SEQ ID NO: 104) or LINPYIGNTHYNQKFKD (SEQ ID NO: 44), wherein X2 is Y or N, X3 is I or V, X4 is Y, S, or F, X5 is G or A, X6 is D, G, V, or H, X7 is V, T, S, or A, X8 is V or A, X9 is Q or R, X10 is K or N, X11 is T, K, N, or R, and X12 is N, F, or S;HCDR3: EGLGGY (SEQ ID NO: 39) or ELDSGFDY (SEQ ID NO: 45);LCDR1: X13X14SQNIZYX15X16 (SEQ ID NO: 105), wherein X13 is K, Q, or R, X14 is A or S, Z is DYDGYA (SEQ ID NO: 114), DFDGYA (SEQ ID NO: 115), DGNT (SEQ ID NO: 116), VHSNGDT (SEQ ID NO: 117), VHSNADT (SEQ ID NO: 118), DYDGYT (SEQ ID NO: 119