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1. 发明授权

US11471513B2 Highly glycosylated human blood-clotting factor VIII fusion protein, and manufacturing method and application of same 有权
公开(公告)号：US11471513B2
公开(公告)日：2022-10-18
申请号：US16479494
申请日：2016-11-16
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC. , FUREN PHARMACEUTICAL GROUP CO., LTD , PHARMAB, INC. , KAIFENG PHARMACEUTICAL (GROUP) CO., LTD.
发明人： Qiang Li , Wenchen Zhu , Yuanli Li , Chenggong Zhu , Yongjuan Gao , Zijia Ren , Luyan Zhu , Naichao Sun , Xiaoshan Wang , Bin Liu , Zhi Li , Wenwen Wang , Ming Jiang , Qilei Wang , Lirui Wang , Shuya Wang , Songlin Zhu , Jie Gao , Hongsheng Su
IPC分类号： A61K38/37 , A61K47/68 , A61K47/65 , A61P7/04 , C07K14/59 , C07K14/755 , C07K19/00 , C12N15/62 , C12N15/85
摘要： A highly glycosylated human blood-clotting factor VIII (FVIII) fusion protein, and a manufacturing method and application of same. The fusion protein comprises, from the N-terminus to the C-terminus, a human (FVIII), a flexible peptide connector, at least one rigid unit of a human chorionic gonadotropin β-subunit carboxyl terminal peptide, and a half-life extending portion (preferentially selected from a human IgG Fc variant). The fusion protein has a similar level of biological activity as a recombinant (FVIII) and an extended in vivo half-life, thereby improving pharmacokinetics and drug efficacy.

2. 发明申请

US20210371526A1 HOMODIMERIC BISPECIFIC ANTIBODY, PREPARATION METHOD THEREFOR AND USE THEREOF 有权
公开(公告)号：US20210371526A1
公开(公告)日：2021-12-02
申请号：US17290651
申请日：2019-10-31
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Xinlu Ma , Shixiang Jia , Yuan Yan , Yuhua Zhang , Li Zhou , Rilong Sun , Xueyuan Cui , Lingju Yu , Yujie Yan , Yingying Jin , Yao Xiong , Yuanli Li , Si Chen , Xuemei Liu , Jiasheng Diao
IPC分类号： C07K16/28 , C07K16/30 , C07K16/32 , A61P35/00
摘要： Provided is a tetravalent homodimeric bispecific antibody molecule simultaneously targeting an immune effector cell antigen CD3 and a tumor-associated antigen, wherein the bispecific antibody molecule contains, in order from N-terminus to C-terminus, a first single chain Fv, a second single chain Fv and a Fc fragment; wherein the first single chain Fv can specifically bind to the tumor-associated antigen, the second single chain Fv can specifically bind to CD3, and the first and the second single chain Fvs are connected by a linker peptide, while the second single chain Fv and the Fc fragment are directly connected or connected by a linker peptide; and the Fc fragment does not have effector functions such as CDC, ADCC and ADCP.

3. 发明授权

US11123438B2 Linker peptide for constructing fusion protein 有权
公开(公告)号：US11123438B2
公开(公告)日：2021-09-21
申请号：US16326412
申请日：2016-11-16
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Yuanli Li , Si Chen , Zhu Wang , Zhao Dong , Zirui Li , Xinlu Ma , Lu Yang , Yongjuan Gao , Yuncheng Zheng , Naichao Sun
IPC分类号： A61K47/65 , C07K14/475 , C12N15/62 , C12N15/63 , C07K19/00 , A61P3/04 , A61P3/10 , C07K14/54 , C07K14/755 , C07K16/06 , C07K16/28 , C07K16/46 , C12N15/85
摘要： A linker peptide for constructing a fusion protein. The linker peptide comprises a flexible peptide and a rigid peptide. The flexible peptide consists of one or more flexible units. The rigid peptide consists of one or more rigid units. The flexible unit comprises two or more amino acid residues selected from Gly, Ser, Ala, and Thr. The rigid unit comprises a human chorionic gonadotropin β-subunit carboxy-terminal peptide (CTP) bearing a plurality of glycosylation sites. The linker peptide can more effectively eliminate mutual steric hindrance of two fusion molecules, decreasing a reduction/loss of polymerization or activity resulting from improper folding of an active protein or a conformational change. On the other hand, the negatively charged, highly sialylated CTP can resist renal clearance, further prolonging a half-life of a fused molecule and enhancing bioavailability of a fused protein. Furthermore, a protective effect of a glycosylated side chain CTP can lower the protease sensitivity of the linker peptide, making a linker region of the fusion protein less degradable.

4. 发明申请

US20230073411A1 HOMODIMER-TYPE BISPECIFIC ANTIBODY AGAINST HER2 AND CD3 AND USE THEREOF 有权
公开(公告)号：US20230073411A1
公开(公告)日：2023-03-09
申请号：US17290728
申请日：2019-10-28
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Shixiang Jia , Xinlu Ma , Yuan Yan , Yuhua Zhang , Yuanli Li
IPC分类号： C07K16/28 , A61P35/00 , C12N15/85 , C12N15/62
摘要： A tetravalent, homodimer-type bispecific antibody molecule that simultaneously targets immune effector cell antigen CD3 and human epidermal growth factor receptor 2 (Her2); the bispecific antibody molecule comprises, from in sequence from N-terminus to C-terminus, a first single-chain Fv capable of specifically binding to Her2, a second single-chain Fv capable of specifically binding to CD3, and an Fc fragment; the first and second single-chain Fv are connected by means of a connection peptide, and the second single-chain Fv is connected to the Fc directly fragment or is connected by means of a connection peptide; the Fc fragment does not have effector functions such as CDC, ADCC and ADCP. The bispecific antibody may significantly inhibit or kill tumor cells, and has controlled toxic side effects that may be caused by excessive activation of effector cells. The maximum safe starting dose in preclinical toxicology evaluation tests is significantly higher than other doses having the same target, and no systemic immunotoxicity occurs, suggesting that the drug administration safety window for the bispecific antibody is wide; in addition, said bispecific antibody is a homodimer that does not experience the problem of heavy chain and light chain mismatching; the steps of purification are simple and efficient, expression is high, and the physicochemical and in vivo stability of the antibody are significantly improved.

5. 发明申请

US20210238282A1 ANTIBODY AGAINST TIM-3 AND APPLICATION THEREOF 有权
公开(公告)号：US20210238282A1
公开(公告)日：2021-08-05
申请号：US17050161
申请日：2019-04-22
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC. , SICHUAN KELUN-BIOTECH BIOPHARMACEUTICAL CO., LTD.
发明人： Qiang Li , Tongtong Xue , Yuncheng Zheng , Liang Xiao , Dengnian Liu , Jianyu Sun , Jiangjiang Hu , Xinlu Ma , Kangyong Zhu , Yuanli Li
IPC分类号： C07K16/28 , A61K45/06 , A61P35/00 , C12N5/12 , A61K39/00
摘要： Provided by the present invention are an antibody against human TIM-3 or an antigen-binding fragment thereof, and further provided are a nucleic acid molecule encoding the antibody, an expression vector for expressing the antibody and a host cell, and a method for producing the antibody. Further provided by the present invention are a pharmaceutical composition comprising the antibody or an antigen-binding fragment of the antibody, and an application of the pharmaceutical composition in the preparation of a medicine, the medicine is used for preventing and/or treating various diseases (including tumors, infectious diseases and autoimmune diseases).

6. 发明授权

US11884725B2 Antibody against TIM-3 and application thereof 有权
公开(公告)号：US11884725B2
公开(公告)日：2024-01-30
申请号：US17050161
申请日：2019-04-22
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Tongtong Xue , Yuncheng Zheng , Liang Xiao , Dengnian Liu , Jianyu Sun , Jiangjiang Hu , Xinlu Ma , Kangyong Zhu , Yuanli Li
IPC分类号： C07K16/28 , A61P35/00 , A61K45/06 , A61K39/00 , C12N5/12
CPC分类号： C07K16/2803 , A61K45/06 , A61P35/00 , C12N5/12 , A61K2039/507
摘要： Provided by the present invention are an antibody against human TIM-3 or an antigen-binding fragment thereof, and further provided are a nucleic acid molecule encoding the antibody, an expression vector for expressing the antibody and a host cell, and a method for producing the antibody. Further provided by the present invention are a pharmaceutical composition comprising the antibody or an antigen-binding fragment of the antibody, and an application of the pharmaceutical composition in the preparation of a medicine, the medicine is used for preventing and/or treating various diseases (including tumors, infectious diseases and autoimmune diseases).

7. 发明授权

US11833212B2 Linker peptide for constructing fusion protein 有权
公开(公告)号：US11833212B2
公开(公告)日：2023-12-05
申请号：US17391535
申请日：2021-08-02
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Yuanli Li , Si Chen , Zhu Wang , Zhao Dong , Zirui Li , Xinlu Ma , Lu Yang , Yongjuan Gao , Yuncheng Zheng , Naichao Sun
IPC分类号： A61K47/65 , A61P3/04 , A61P3/10 , C07K14/475 , C12N15/62 , C12N15/63 , C07K19/00 , C07K14/54 , C07K14/755 , C07K16/06 , C07K16/28 , C07K16/46 , C12N15/85
CPC分类号： A61K47/65 , A61P3/04 , A61P3/10 , C07K14/475 , C07K14/5418 , C07K14/755 , C07K16/065 , C07K16/2809 , C07K16/2887 , C07K16/468 , C07K19/00 , C12N15/62 , C12N15/63 , C12N15/85
摘要： A linker peptide for constructing a fusion protein. The linker peptide comprises a flexible peptide and a rigid peptide. The flexible peptide consists of one or more flexible units. The rigid peptide consists of one or more rigid units. The flexible unit comprises two or more amino acid residues selected from Gly, Ser, Ala, and Thr. The rigid unit comprises a human chorionic gonadotropin β-subunit carboxy-terminal peptide (CTP) bearing a plurality of glycosylation sites. The linker peptide can more effectively eliminate mutual steric hindrance of two fusion molecules, decreasing a reduction/loss of polymerization or activity resulting from improper folding of an active protein or a conformational change. On the other hand, the negatively charged, highly sialylated CTP can resist renal clearance, further prolonging a half-life of a fused molecule and enhancing bioavailability of a fused protein. Furthermore, a protective effect of a glycosylated side chain CTP can lower the protease sensitivity of the linker peptide, making a linker region of the fusion protein less degradable.

8. 发明申请

US20220242926A1 FGF21 FC FUSION PROTEIN, GLP-1 FC FUSION PROTEIN, AND COMBINATION THERAPEUTIC AGENT COMPRISING SAME AND USE THEREOF 有权
公开(公告)号：US20220242926A1
公开(公告)日：2022-08-04
申请号：US17629277
申请日：2020-07-08
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Zhao Dong , Chi Zhou , Jiyu Zhang , Yuanli Li , Qiang Li
IPC分类号： C07K14/50 , C07K14/605 , A61P3/04 , A61P1/16 , A61P3/06 , A61P3/10 , A61P9/00
摘要： An FGF21 Fc fusion protein, a GLP-1 Fc fusion protein, and a combination therapeutic agent. The combination therapeutic agent consists of a first pharmaceutical composition comprising an FGF21 Fc fusion protein and a second pharmaceutical composition comprising a GLP-1 Fc fusion protein. The fusion proteins or a combination thereof is used for preventing or curing cardiovascular diseases and/or metabolic diseases; the diseases comprise obesity, diabetes, hyperlipidemia, nonalcoholic fatty liver disease, atherosclerosis, diabetic cardiomyopathy, coronary atherosclerotic cardiomyopathy, and other diseases related to insulin resistance.

9. 发明授权

US11161904B2 Anti-PD-1 antibody and use thereof 有权
公开(公告)号：US11161904B2
公开(公告)日：2021-11-02
申请号：US16471909
申请日：2017-07-06
申请人： AMPSOURCE BIOPHARMA SHANGHAI INC.
发明人： Qiang Li , Yuncheng Zheng , Lu Yang , Xinlu Ma , Yuanli Li
IPC分类号： C07K16/28 , A61K47/55 , C07K16/22 , C07K16/32 , C07K16/46
摘要： This disclosure provides an antibody specifically binding to PD-1 with high affinity. Also provided are a nucleic acid molecule for coding the antibody, an expression vector and a host cell for expressing the antibody, and a production method for the antibody. In addition, also provided are an immunoconjugate and a pharmaceutical composition comprising the antibody and use of the antibody in preparation of drugs for treating cancers, infectious diseases, and inflammatory diseases.

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