# US 11,027,016 B2 · Pharmaceutical preparation stably comprising CD147 monoclonal antibody

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- Number: US 11,027,016 B2
- Document ID: US11027016B2
- Status: Granted
- Kind: B2
- Application number: 16/461,799
- Filed: 2017-12-27
- Published: 2019-11-28
- Granted: 2021-06-08
- Earliest claimed: 2016-12-30
- Assignees: Xiaochun Chen
- Applicants: Xiaochun Chen
- Inventors: Hao Tang; Qiang Feng; Tianyi Yang; Mingxi Chen
- Web page: https://patentgrep.com/patent/US11027016B2

## CPC

- A61K 39/39591: {Stabilisation, fragmentation}
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 35/00: Antineoplastic agents
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

Disclosed is a pharmaceutical preparation comprising a CD147 monoclonal antibody, a buffer, a protein protectant and a surfactant. The pharmaceutical preparation can maintain the stability of the CD147 monoclonal antibody over a long period of time. Also disclosed are the use of the pharmaceutical preparation in the preparation of a drug for treating CD147-related diseases, in particular non-small cell lung cancer, and a method for preparing the pharmaceutical preparation.

## Claims

### Claim 1

A pharmaceutical formulation, comprising a CD147 monoclonal antibody, a buffer, a protein protective agent and a surfactant, wherein the buffer is histidine buffer, the protein protective agent is sucrose, and the surfactant is polysorbate 80, wherein the concentration of the histidine buffer is 9-11 mmol/L, the concentration of the sucrose in the pharmaceutical formulation is 80-110 mg/ml, and the concentration of the polysorbate 80 in the pharmaceutical formulation is 0.35-0.45 mg/ml.

### Claim 2 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the monoclonal anti-CD147 antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17 or SEQ ID NO: 18 and a light chain comprising the amino acid sequence of SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21 or SEQ ID NO: 22, wherein the concentration of the monoclonal anti-CD147 antibody in the pharmaceutical formulation is 1-40 mg/ml, 1-15 mg/ml, 15-25 mg/ml or 25-40 mg/ml.

### Claim 3 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the pharmaceutical formulation has a pH of 5.0-8.0, 5.0-5.5, 5.5-6.5 or 6.5-8.0.

### Claim 4 (depends on 1)

The pharmaceutical formulation of claim 1, wherein the CD147 monoclonal antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 15 and a light chain comprising the amino acid sequence of SEQ ID NO: 19, the concentration of the CD147 monoclonal antibody in the pharmaceutical formulation is 15-25 mg/ml, and the pharmaceutical formulation has a pH of 5.5-6.5.