Claims for Patent: 10,293,045

Summary for Patent: 10,293,045

Title:	Stable liquid formulations of recombinant fusion proteins
Abstract:	Provided is a liquid formulation that enables the stable storage of recombinant fusion proteins, comprising a recombinant fusion protein, a buffer salt, a stabilizer, and a surfactant.
Inventor(s):	Wang; Yinjue (Jiangsu, CN), Li; Junfeng (Jiangsu, CN), Huang; Xiaole (Jiangsu, CN)
Assignee:	INNOVENT BIOLOGICS, INC. (Jiangsu, CN)
Application Number:	15/513,537
Patent Claims:	1. A liquid formulation of a recombinant fusion protein, which comprises a recombinant fusion protein, a buffer salt, a stabilizer, a surfactant and sterile water for injection, wherein, the recombinant fusion protein has a concentration of 5 to 45 mg/mL; the buffer salt is citrate salt, acetate salt or any combination thereof, and has a concentration of 5 to 25 mmol/L; the stabilizer is an amino acid or a combination of a polyol and an amino acid, wherein the amino acid is arginine, and the polyol is sucrose; the amino acid has a concentration of 50 to 350 mmol/L; and the polyol has a concentration of 1-15 wt %, based on total weight of the liquid formulation; the surfactant is polysorbate 20 and has a concentration of 0.01-0.08 wt %, based on total weight of the liquid formulation; and the pH of the liquid formulation is from 5.5 to 7.5; and the recombinant fusion protein is a recombinant fusion protein of human vascular endothelial growth factor receptor-antibody-human complement receptor 1 which comprises the amino acid sequence as set forth in SEQ ID NO: 1 or SEQ ID NO: 4. 2. The liquid formulation of claim 1, wherein the recombinant fusion protein is a recombinant fusion protein of human vascular endothelial growth factor receptor-antibody-human complement receptor 1 which has an amino acid sequence as set forth in SEQ ID NO: 1. 3. The liquid formulation of claim 1, wherein the stabilizer is a combination of arginine and sucrose. 4. The liquid formulation of claim 1, wherein the amino acid has a concentration of 70 to 260 mmol/L. 5. The liquid formulation of claim 1, wherein the polyol has a concentration of 3-10 wt %. 6. The liquid formulation of claim 1, wherein the pH of the liquid formulation is from 5.5 to 7.2. 7. The liquid formulation of claim 1, wherein the pH of the liquid formulation is from 5.5 to 7, and the liquid formulation comprises: TABLE-US-00013 the recombinant fusion protein 5-45 mg/ml; citrate 5-15 mmol/L; arginine 50-100 mmol/L; sucrose 2-8 wt %; polysorbate 20 0.02-0.06 wt %; and the sterile water for injection. 8. The liquid formulation of claim 1, wherein the buffer salt is citrate. 9. The liquid formulation of claim 1, wherein the pH of the liquid formulation is from 5.5 to 7.0. 10. The liquid formulation of claim 1, wherein the buffer salt is citrate and has a concentration of from 8 to 22 mmol/L. 11. A kit comprising the liquid formulation according to claim 1 and a container containing the liquid formulation. 12. A method or treating age-related macular degeneration comprising administering to a subject in need thereof the liquid formulation according to claim 1 or the kit according to claim 11. 13. The method of claim 12, wherein the age-related macular degeneration is wet age-related macular degeneration.

Details for Patent 10,293,045

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2034-09-25