Fused Polypeptide AJ007 and Its Applications

Claims

1. The fusion polypeptide AJ007, characterized in that the amino acid sequence of the fusion polypeptide is presented as SEQ ID NO:

2.

2. Use of the fusion polypeptide AJ007 according to claim 1 for the preparation of a medicinal product for the prevention or treatment of neovascular diseases of the posterior segment of the eye.

3. The use according to claim 2, characterized in that the neovascular diseases of the posterior segment of the eye include one or more of the following diseases: wet age-related macular degeneration, retinal vein occlusion, diabetic retinopathy and retinopathy of prematurity.

4. The use according to claim 3, characterized in that the neovascular disease of the posterior segment of the eye includes wet age-related macular degeneration.

5. The use according to any one of paragraphs 2-4, characterized in that the medicinal product for the prevention or treatment of neovascular diseases of the posterior segment of the eye contains at least the fusion polypeptide AJ007 and / or its pharmaceutically acceptable carrier.

6. Polypeptide eye drops for the prevention or treatment of neovascular diseases of the posterior segment of the eye, containing the fusion polypeptide AJ007 according to claim 1 or its pharmaceutically acceptable salt form in combination with an excipient.

7. Polypeptide eye drops for the prevention or treatment of neovascular diseases of the posterior segment of the eye according to paragraph 6, containing the following components per 100 ml: 0-50% w / v of the fusion polypeptide AJ007 or a pharmaceutically acceptable salt form thereof; 5-10% w / v 2-hydroxypropyl-β-cyclodextrin; 0.1-5% w / v polysorbate 80; 0.05-5% w / v. tyloxapol; 0.05-10% w / v. Poloxamer 407; 0-1% w / v sodium dihydrogen phosphate; 0-0.005% w / v preservative; 0-1% w / v osmotic pressure regulator to regulate osmotic pressure to 250-350 mOsm / kg; and 0-1% w / v pH regulator to adjust pH to 6.0-8.

0.

8. Polypeptide eye drops for the prevention or treatment of neovascular diseases of the posterior segment of the eye according to claim 7, characterized in that the pharmaceutically acceptable salt form of the fusion polypeptide AJ007 comprises one or more of an acetate form, a trifluoroacetate form, a hydrochloride form, an ammonium salt form, a sodium salt form, a dihydroxynaphthalate form, a citrate form, and a salicylate form; and / or the preservative contains one or more of benzalkonium chloride, the cationic surfactant benzalkonium bromide, benzyl alcohol, trichlorotert-butanol and sorbic acid; and / or the osmotic pressure regulator contains one or more of sodium chloride, boric acid and glucose; and / or the pH adjuster comprises one or more of a phosphate buffer solution, a boric acid buffer solution, hydrochloric acid, and sodium hydroxide.

9. Polypeptide eye drops for the prevention or treatment of neovascular diseases of the posterior segment of the eye according to claim 8, characterized in that the pharmaceutically acceptable salt form of the fusion polypeptide AJ007 contains the acetate form; the preservative contains benzalkonium chloride; the osmotic pressure regulator contains sodium chloride; and the pH level regulator contains sodium hydroxide.

10. A method for preparing polypeptide eye drops for the prevention or treatment of neovascular diseases of the posterior segment of the eye according to any of paragraphs 6-9, comprising the following steps: (1) preparation of an excipient solution: weighing ultrapure water, sequentially adding the specified amounts of sodium dihydrogen phosphate, benzalkonium chloride, polysorbate 80, poloxamer 407 and tyloxapol, continuously stirring until completely dissolved and filtering through a filter membrane with a pore size of 0.22 μm to obtain a solution serving as solution A for subsequent use; (2) preparation of 2-hydroxypropyl-β-cyclodextrin solution: weighing solution A, placing it in a vessel with a water bath and stirring, heating to 60°C, starting stirring, adding 2-hydroxypropyl-β-cyclodextrin in several portions and after complete dispersion and dissolution, taking out the solution and cooling to use it as solution B for subsequent use; (3) pH and osmotic pressure adjustment: determining the pH and osmotic pressure of solution B, adjusting the pH and osmotic pressure using a pH adjuster and an osmotic pressure adjuster, filtering through a filter membrane with a pore size of 0.22 μm to obtain a solution used as solution C for subsequent use; (4) preparing polypeptide eye drops: weighing and adding the fusion polypeptide AJ007 or its pharmaceutically acceptable salt form to solution C, continuously shaking to completely disperse and dissolve the fusion polypeptide AJ007 or its pharmaceutically acceptable salt form to obtain polypeptide eye drops.