HRP20210440T1 - Kombinirana terapija za rak - Google Patents

Kombinirana terapija za rak Download PDF

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Publication number
HRP20210440T1
HRP20210440T1 HRP20210440TT HRP20210440T HRP20210440T1 HR P20210440 T1 HRP20210440 T1 HR P20210440T1 HR P20210440T T HRP20210440T T HR P20210440TT HR P20210440 T HRP20210440 T HR P20210440T HR P20210440 T1 HRP20210440 T1 HR P20210440T1
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Croatia
Prior art keywords
inhibitor
csf1r antibody
seq
sequence
heavy chain
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HRP20210440TT
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English (en)
Inventor
Brian Wong
Julie Hambleton
Robert Sikorski
Emma Masteller
Kevin Hestir
David BELLOVIN
Katherine E. Lewis
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Five Prime Therapeutics, Inc.
Bristol-Myers Squibb Company
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Publication of HRP20210440T1 publication Critical patent/HRP20210440T1/hr

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3046—Stomach, Intestines
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Claims (16)

1. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu u postupku liječenja raka kod subjekta; pri čemu navedeni postupak obuhvaća istovremeno ili uzastopno administriranje navedenom subjektu anti-CSF1R antitijela i PD-1/PD-L1 inhibitora; i pri čemu: anti-CSF1R antitijelo je odabrano od: a) antitijela koje sadrži teški lanac koji sadrži sekvencu SEQ ID NO: 39 i laki lanac koji sadrži sekvencu SEQ ID NO: 46; b) antitijela koje sadrži teški lanac koji sadrži CDR1 teškog lanca (HC) koji ima sekvencu SEQ ID NO: 15, CDR2 HC koji ima sekvencu SEQ ID NO: 16, i CDR3 HC koji ima sekvencu SEQ ID NO: 17, i laki lanac koji sadrži CDR1 lakog lanca (LC) koji ima sekvencu SEQ ID NO: 18, CDR2 LC koji ima sekvencu SEQ ID NO: 19, i CDR3 LC koji ima sekvencu SEQ ID NO: 20; i c) antitijela koje sadrži teški lanac koji sadrži sekvencu SEQ ID NO: 53 i laki lanac koji sadrži sekvencu SEQ ID NO: 60, i PD-1/PD-L1 inhibitor je anti-PD-1 antitijelo odabrano od: a) antitijela koje sadrži teški lanac koji sadrži varijabilni region teškog lanca nivolumaba i laki lanac koji sadrži varijabilni region lakog lanca nivolumaba; i b) antitijela koje sadrži teški lanac koji sadrži CDR-e teškog lanca nivolumaba, i laki lanac koji sadrži CDR-e lakog lanca nivolumaba.
2. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentnom zahtjevu 1, pri čemu je PD-1/PD-L1 inhibitor nivolumab.
3. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentnom zahtjevu 1 ili 2, pri čemu anti-CSF1R antitijelo i PD-1/PD-L1 inhibitor se administriraju istovremeno.
4. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentnom zahtjevu 1 ili 2, pri čemu jedna ili više doza PD-1/PD-L1 inhibitora se administrira prije administriranja anti-CSF1R antitijela.
5. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentnom zahtjevu 4, pri čemu je subjekt primio kompletan tok terapije PD-1/PD-L1 inhibitorom prije administriranja anti-CSF1R antitijela a anti-CSF1R antitijelo se po izboru administrira tokom drugog toka terapije PD-1/PD-L1 inhibitorom.
6. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od patentnih zahtjeva 3 do 5, pri čemu najmanje jedna doza PD-1/PD-L1 inhibitora se administrira istovremeno sa anti-CSF1R inhibitorom.
7. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentnom zahtjevu 1 ili 2, pri čemu jedna ili više doza anti-CSF1R antitijela se administrira prije administriranja PD-1/PD-L1inhibitora.
8. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema patentom zahtjevu 7, pri čemu je subjekt primio najmanje dvije, najmanje tri, ili najmanje četiri doze anti-CSF1R antitijela prije administriranja PD-1/PD-L1 inhibitora i po izboru najmanje jedna doza anti-CSF1R antitijela se administrira istovremeno sa PD-1/PD-L1 inhibitorom.
9. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu anti-CSF1R antitijelo se administrira pri dozi od 1, 2, ili 4 mg/kg.
10. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu se PD-1/PD-L1 inhibitor administrira pri dozi od 0.5-10 mg/kg.
11. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu se PD-1/PD-L1 inhibitor administrira pri dozi od 1 do 4 mg/kg, kao što je 1, 2 ili 4 mg/kg, a anti-CSF1R antitijelo se administrira pri dozi od 0.5 do 10 mg/kg.
12. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu anti-CSF1R antitijelo i PD-1/PD-L1 inhibitor se administriraju jednom u 1, 2, 3, 4, ili 5 tjedna, kao što je jednom tjedno, ili kao što je jednom svaka 2 tjedna, ili jednom svaka 3 tjedna.
13. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je rak odabran od nesitnostaničnog raka pluća, melanoma, karcinoma skvamoznih stanica glave i vrata, raka jajnika, raka gušterače, karcinoma bubrežnih stanica, hepatocelularnog karcinoma, raka mjehura, malignog glioma, kolorektalnog raka, i raka endometrijuma.
14. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je rak rekurentan ili progresivan nakon terapije odabrane od kirurgije, kemoterapije, terapije zračenjem, ili njihovih kombinacija.
15. Anti-CSF1R antitijelo i/ili PD-1/PD-L1 inhibitor za primjenu prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je rak odabran od nesitnostaničnog raka pluća, melanoma, karcinoma skvamoznih stanica glave i vrata, raka jajnika, raka gušterače, karcinoma bubrežnih stanica, hepatocelularnog karcinoma, raka mjehura, raka endometrijuma i malignog glioma; i pri čemu se anti-CSF1R antitijelo administrira pri dozi od 1, 2, ili 4 mg/kg jednom u 1, 2, 3, 4, ili 5 tjedana, kao što je jednom tjedno, ili kao što je jednom svaka 2 tjedna, ili jednom svaka 3 tjedna i PD-1/PD-L1 inhibitor se administrira pri dozi od 0.5-10 mg/kg jednom u 1, 2, 3, 4, ili 5 tjedna, kao što je jednom tjedno, ili kao što je jednom svaka 2 tjedna, ili jednom svaka 3 tjedna.
16. Kompozicija koje sadrži anti-CSF1R antitijelo i PD-1/PD-L1 inhibitor pri čemu: anti-CSF1R antitijelo je odabrano od: a) antitijela koje sadrži teški lanac koji sadrži sekvencu SEQ ID NO: 39 i laki lanac koji sadrži sekvencu SEQ ID NO: 46; b) antitijelo koje sadrži teški lanac koji sadrži CDR1 teškog lanca (HC) koji ima sekvencu SEQ ID NO: 15, CDR2 HC koji ima sekvencu SEQ ID NO: 16, i CDR3 HC koji ima sekvencu SEQ ID NO: 17, i laki lanac koji sadrži CDR1 lakog lanca (LC) koji ima sekvencu SEQ ID NO: 18, CDR2 LC koji ima sekvencu SEQ ID NO: 19, i CDR3 LC koji ima sekvencu SEQ ID NO: 20; i c) antitijelo koje sadrži teški lanac koji sadrži sekvencu SEQ ID NO: 53 i laki lanac koji sadrži sekvencu SEQ ID NO: 60, i PD-1/PD-L1 inhibitor je anti-PD-1 antitijelo odabrano od: a) antitijela koje sadrži teški lanac koji sadrži varijabilni region teškog lanca nivolumaba i laki lanac koji sadrži varijabilni region lakog lanca nivolumaba; b) antitijelo koje sadrži teški lanac koji sadrži CDR-e teškog lanca nivolumaba, i laki lanac koji sadrži CDR-e lakog lanca nivolumaba; i c) nivolumaba.
HRP20210440TT 2014-10-29 2021-03-16 Kombinirana terapija za rak HRP20210440T1 (hr)

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US201462072035P 2014-10-29 2014-10-29
US201562157368P 2015-05-05 2015-05-05
US201562192025P 2015-07-13 2015-07-13
PCT/US2015/057781 WO2016069727A1 (en) 2014-10-29 2015-10-28 Combination therapy for cancer
EP15798264.6A EP3212670B1 (en) 2014-10-29 2015-10-28 Combination therapy for cancer

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JP (3) JP6920989B2 (hr)
KR (1) KR102636539B1 (hr)
CN (1) CN107567336B (hr)
AU (1) AU2015339306B2 (hr)
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LT (1) LT3212670T (hr)
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