KR102879391B1 - 스트렙토코쿠스 뉴모니아에의 정제된 협막 다당류 - Google Patents

스트렙토코쿠스 뉴모니아에의 정제된 협막 다당류

Info

Publication number
KR102879391B1
KR102879391B1 KR1020217011738A KR20217011738A KR102879391B1 KR 102879391 B1 KR102879391 B1 KR 102879391B1 KR 1020217011738 A KR1020217011738 A KR 1020217011738A KR 20217011738 A KR20217011738 A KR 20217011738A KR 102879391 B1 KR102879391 B1 KR 102879391B1
Authority
KR
South Korea
Prior art keywords
kda
polysaccharide
protein
serotype
pneumococcal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
KR1020217011738A
Other languages
English (en)
Korean (ko)
Other versions
KR20210062669A (ko
Inventor
라젠다 버키
비벡 바부 칸디말라
라잔 스리라만
라메쉬 벤카트 마투르
나렌더 데브 만테나
마히마 다틀라
비라판두 산가레디
Original Assignee
바이오로지칼 이 리미티드
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=69886702&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR102879391(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 바이오로지칼 이 리미티드 filed Critical 바이오로지칼 이 리미티드
Publication of KR20210062669A publication Critical patent/KR20210062669A/ko
Application granted granted Critical
Publication of KR102879391B1 publication Critical patent/KR102879391B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003General processes for their isolation or fractionation, e.g. purification or extraction from biomass
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08HDERIVATIVES OF NATURAL MACROMOLECULAR COMPOUNDS
    • C08H1/00Macromolecular products derived from proteins
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00Compositions of proteins; Compositions of derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6068Other bacterial proteins, e.g. OMP
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Polymers & Plastics (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Sustainable Development (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Medicinal Preparation (AREA)
KR1020217011738A 2018-09-23 2019-09-23 스트렙토코쿠스 뉴모니아에의 정제된 협막 다당류 Active KR102879391B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
IN201841031654 2018-09-23
IN201841031654 2018-09-23
IN201841031653 2018-09-23
IN201841031653 2018-09-23
PCT/IB2019/058036 WO2020058963A1 (en) 2018-09-23 2019-09-23 Purified capsular polysaccharides of streptococcus pneumoniae

Publications (2)

Publication Number Publication Date
KR20210062669A KR20210062669A (ko) 2021-05-31
KR102879391B1 true KR102879391B1 (ko) 2025-10-30

Family

ID=69886702

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020217011738A Active KR102879391B1 (ko) 2018-09-23 2019-09-23 스트렙토코쿠스 뉴모니아에의 정제된 협막 다당류

Country Status (12)

Country Link
US (2) US12048739B2 (https=)
EP (1) EP3852795A4 (https=)
JP (2) JP2022513562A (https=)
KR (1) KR102879391B1 (https=)
CN (1) CN113164581A (https=)
AU (1) AU2019341723C1 (https=)
BR (1) BR112021005425A2 (https=)
MX (1) MX2021003358A (https=)
MY (1) MY206212A (https=)
PH (1) PH12021550539A1 (https=)
WO (1) WO2020058963A1 (https=)
ZA (1) ZA202101663B (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10729763B2 (en) 2017-06-10 2020-08-04 Inventprise, Llc Mixtures of polysaccharide-protein pegylated compounds
TWI725359B (zh) 2017-12-06 2021-04-21 美商默沙東藥廠 包含肺炎鏈球菌多醣-蛋白結合物之組合物及其使用方法
GEAP202415690A (en) 2018-12-19 2024-01-10 Merck Sharp & Dohme Llc Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
MX2021014710A (es) * 2019-06-05 2022-01-18 Merck Sharp & Dohme Llc Un conjugado inmunogenico de polisacarido de neumococo del serotipo 35b- proteina y proceso de conjugacion para preparar el mismo.
PH12022552827A1 (en) * 2020-05-01 2024-02-12 Sinocelltech Ltd Method for improving immunogenicity of protein/peptide antigen
JP2023546446A (ja) * 2020-10-22 2023-11-02 ファイザー・インク 細菌多糖を精製する方法
KR20230097160A (ko) * 2020-11-04 2023-06-30 화이자 인코포레이티드 폐렴구균 백신에 사용하기 위한 면역원성 조성물
WO2022169787A1 (en) * 2021-02-04 2022-08-11 Merck Sharp & Dohme Llc Lipid nanoparticle adjuvant composition for pneumococcal conjugate vaccines
CN120202227A (zh) * 2022-09-19 2025-06-24 生物学E有限公司 纯化荚膜多糖的方法
CN117512031B (zh) * 2023-10-16 2024-06-25 江苏金迪克生物技术股份有限公司 一种肺炎球菌荚膜多糖的纯化方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017173415A2 (en) * 2016-03-31 2017-10-05 Liffey Biotech Limited Saccharide-polypeptide conjugate compositions and methods of use thereof
WO2018064444A1 (en) * 2016-09-30 2018-04-05 Biological E Limited Multivalent pneumococcal vaccine compositions comprising polysaccharide-protein conjugates

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3071552D1 (en) 1979-09-21 1986-05-22 Hitachi Ltd Semiconductor switch
US4673574A (en) 1981-08-31 1987-06-16 Anderson Porter W Immunogenic conjugates
AU685047B2 (en) 1992-02-11 1998-01-15 Henry M. Jackson Foundation For The Advancement Of Military Medicine Dual carrier immunogenic construct
DK0616034T3 (da) 1993-03-05 2005-02-21 Wyeth Corp Plasmid til fremstilling af CRM-protein og diphtheria toxin
NZ274376A (en) 1993-09-22 1997-11-24 Jackson H M Found Military Med Activating soluble carbohydrate using cyanylating reagents for the production of immunogenic constructs
NZ304715A (en) 1995-03-22 1999-07-29 Jackson H M Found Military Med Production of immunogenic constructs using organic cyanylating reagents to activate carbohydrates and then coupling the carbohydrate to a protein, peptide or hapten
US6299881B1 (en) 1997-03-24 2001-10-09 Henry M. Jackson Foundation For The Advancement Of Military Medicine Uronium salts for activating hydroxyls, carboxyls, and polysaccharides, and conjugate vaccines, immunogens, and other useful immunological reagents produced using uronium salts
EP3363806B1 (en) * 2012-12-20 2022-11-16 Pfizer Inc. Glycoconjugation process
IL312327B2 (en) 2014-01-21 2026-02-01 Pfizer Immunogenic preparations comprising conjugated capsular saccharide antigens and their uses
BR112016016580B1 (pt) * 2014-01-21 2024-01-09 Pfizer Inc Processo para a preparação de um conjugado imunogênico, conjugado imunogênico, composição imunogênica, e vacina
US10280409B2 (en) 2014-11-20 2019-05-07 Biological E Limited Codon optimized polynucleotide for high level expression of CRM197
GB201518684D0 (en) * 2015-10-21 2015-12-02 Glaxosmithkline Biolog Sa Vaccine
KR102775456B1 (ko) 2015-11-09 2025-02-28 바이오로지칼 이 리미티드 생물학적 활성 재조합 캐리어 단백질을 회수하기 위한 산업적 확장성이 있는 방법
ES3024474T3 (en) * 2016-12-30 2025-06-04 Vaxcyte Inc Polypeptide-antigen conjugates with non-natural amino acids
CA3050120A1 (en) * 2017-02-24 2018-08-30 Merck Sharp & Dohme Corp. Enhancing immunogenicity of streptococcus pneumoniae polysaccharide-protein conjugates
WO2018193475A2 (en) 2017-04-22 2018-10-25 Biological E Limited An improved method for high level production of crm
EP3678655A4 (en) 2017-09-07 2021-05-05 Merck Sharp & Dohme Corp. PNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN IMMUNOGENIC POLYSACCHARIDE CARRIER PROTEIN CONJUGATES
CN111065387B (zh) 2017-09-07 2023-08-25 默沙东有限责任公司 肺炎球菌多糖及其在免疫原性多糖-载体蛋白缀合物中的用途
PT3678654T (pt) 2017-09-07 2024-08-05 Merck Sharp & Dohme Llc Polissacáridos pneumocócicos e sua utilização em conjugados imunogénicos de polissacárido-proteína transportadora

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017173415A2 (en) * 2016-03-31 2017-10-05 Liffey Biotech Limited Saccharide-polypeptide conjugate compositions and methods of use thereof
WO2018064444A1 (en) * 2016-09-30 2018-04-05 Biological E Limited Multivalent pneumococcal vaccine compositions comprising polysaccharide-protein conjugates

Also Published As

Publication number Publication date
AU2019341723C1 (en) 2026-01-22
WO2020058963A1 (en) 2020-03-26
PH12021550539A1 (en) 2022-02-21
JP2022513562A (ja) 2022-02-09
US20210346488A1 (en) 2021-11-11
US12048739B2 (en) 2024-07-30
US20240325516A1 (en) 2024-10-03
JP2024160305A (ja) 2024-11-13
US12465632B2 (en) 2025-11-11
MX2021003358A (es) 2021-05-27
CN113164581A (zh) 2021-07-23
AU2019341723A1 (en) 2021-05-20
EP3852795A1 (en) 2021-07-28
AU2019341723B2 (en) 2024-03-21
KR20210062669A (ko) 2021-05-31
ZA202101663B (en) 2024-08-28
BR112021005425A2 (pt) 2021-06-15
MY206212A (en) 2024-12-04
EP3852795A4 (en) 2022-11-23

Similar Documents

Publication Publication Date Title
KR102879391B1 (ko) 스트렙토코쿠스 뉴모니아에의 정제된 협막 다당류
JP7403576B2 (ja) 多糖類-タンパク質コンジュゲートを含む多価肺炎球菌ワクチン組成物
JP7558944B2 (ja) 多価肺炎球菌多糖類-タンパク質コンジュゲートワクチン
WO2020157772A1 (en) Multivalent pneumococcal polysaccharide-protein conjugate vaccine compositions
US20230101892A1 (en) Multivalent pneumococcal vaccine compositions comprising polysaccharide-protein conjugates
WO2020152706A1 (en) Multivalent pneumococcal conjugate vaccine compositions
EA048093B1 (ru) Очищенные капсульные полисахариды streptococcus pneumoniae
OA20178A (en) Purified capsular polysaccharides of streptococcus pneumoniae.
EA047156B1 (ru) Мультивалентная вакцина на основе конъюгата пневмококковый полисахарид-белок
OA20315A (en) Multivalent pneumococcal polysaccharide-protein conjugate vaccine.
HK40050226B (zh) 多价肺炎球菌多糖-蛋白缀合的疫苗
HK40050226A (en) Multivalent pneumococcal polysaccharide-protein conjugate vaccine
EA048146B1 (ru) Композиции поливалентной пневмококковой вакцины, содержащие конъюгаты полисахарид-белок
EA040051B1 (ru) Композиции поливалентной пневмококковой вакцины, содержащие конъюгаты полисахарид-белок
OA19223A (en) Multivalent pneumococcal vaccine compositions comprising polysaccharideprotein conjugates.

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

A201 Request for examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E601 Decision to refuse application
PE0601 Decision on rejection of patent

St.27 status event code: N-2-6-B10-B15-exm-PE0601

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T11-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T13-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T13-X000 Administrative time limit extension granted

St.27 status event code: U-3-3-T10-T13-oth-X000

E13 Pre-grant limitation requested

Free format text: ST27 STATUS EVENT CODE: A-2-3-E10-E13-LIM-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-NAP-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

F13 Ip right granted in full following pre-grant review

Free format text: ST27 STATUS EVENT CODE: A-3-4-F10-F13-REX-PX0701 (AS PROVIDED BY THE NATIONAL OFFICE)

PX0701 Decision of registration after re-examination

St.27 status event code: A-3-4-F10-F13-rex-PX0701

F11 Ip right granted following substantive examination

Free format text: ST27 STATUS EVENT CODE: A-2-4-F10-F11-EXM-PR0701 (AS PROVIDED BY THE NATIONAL OFFICE)

PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

U12 Designation fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U12-OTH-PR1002 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

Q13 Ip right document published

Free format text: ST27 STATUS EVENT CODE: A-4-4-Q10-Q13-NAP-PG1601 (AS PROVIDED BY THE NATIONAL OFFICE)