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New lupus drug shows promise in Long-Term safety trial

NCT ID NCT05352919

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 13 times

Summary

This study looks at the long-term safety of a drug called litifilimab for people with active lupus. About 864 adults who finished earlier studies will continue taking the drug for up to 3 years, along with their usual treatments. The goal is to see how safe it is and how well it controls lupus symptoms. This is not a cure, but it may help manage the disease better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 864 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52. Key Exclusion Criteria: * Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52) * Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period) * Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose) * Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies. NOTE: Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

connective tissue disorder immune system disorder systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus (SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    211 sites in 28 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A2Z Clinical Centro Avancado de Pesquisa Clinica

    Valinhos, São Paulo, 13271-130, Brazil

  • AA MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan, 48504, United States

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires, 1406, Argentina

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000, Mexico

  • Accurate Clinical Research

    Baytown, Texas, 77521, United States

  • Accurate Clinical Research, Inc.

    Humble, Texas, 77338, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • AdventHealth Medical Group

    Tampa, Florida, 33613, United States

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85037, United States

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Arthritis & Rheumatology Research Institute

    Allen, Texas, 75013, United States

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501, United States

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 152, Italy

  • Bekes Varmegyei Kozponti Korhaz

    Gyula, 5700, Hungary

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603, China

  • BioMedica Research Group

    Santiago, 7500710, Chile

  • CE M.V. Sklifosovskyi Poltava Regional Clinical Hospital of PRC

    Poltava, 36011, Ukraine

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450, Brazil

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 01228-200, Brazil

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan, 5400, Argentina

  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.

    Curitiba, Paraná, 80030-110, Brazil

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, Drôme, 63003, France

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • CNE Kyiv City Clinical Hospital #3

    Kyiv, 02125, Ukraine

  • CNE Regional Clinical Hospital of IFRC, Center of Cardiology, Rheumatology & Interventional Med.;

    Ivano-Frankivsk, 76018, Ukraine

  • CPCLIN - Centro de Pesquisas Clinicas

    São Paulo, 01228-200, Brazil

  • CTR Estudios

    Santiago, 7500571, Chile

  • Cannock Chase Hospital

    Cannock, Staffordshire, WS11 5XY, United Kingdom

  • Care Access Research - Huntington Beach

    Huntington Beach, California, 92648, United States

  • Cenemar SRL

    Buenos Aires, 7600, Argentina

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo-To, 162-8655, Japan

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000, Belgium

  • Centro Dermatologico Schejtman

    San Miguel, Buenos Aires, B1663, Argentina

  • Centro Medico Barrio Parque

    Buenos Aires, Ciudad Autonoma Buenos Aires, 1425, Argentina

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, 1425, Argentina

  • Centro Medico Prosalud

    Santiago, 7500000, Chile

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • Centro Peninsular de Investigacion Clinica, SCP

    Mérida, Yucatán, 97000, Mexico

  • Centro Reumatologico

    Caguas, 00725, Puerto Rico

  • Centro de Investigacion Clinica CIC

    Medellín, 050021, Colombia

  • Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic

    Lima, LIMA 11, Peru

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 03720, Mexico

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 080020, Colombia

  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.

    Bogotá, 110221, Colombia

  • Centro de Investigacion y Atencion Integral Durango CIAID

    Durango, 34080, Mexico

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centro de investigacion medica y reumatologia

    Guadalajara, Jalisco, 44950, Mexico

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

    Malbork, 82-200, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Chung Shan Medical University Hospital

    Taichung, 40201, Taiwan

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco, 44650, Mexico

  • Clinical Center "Bezanijska Kosa "

    Belgrade, 11080, Serbia

  • Clinical Research Chile SpA.

    Valdivia, 5090000, Chile

  • Clinical Research of West Florida - Corporate

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606, United States

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700, Mexico

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Clínica de la Costa S.A.S

    Barranquilla, 080020, Colombia

  • Consultorio Alto Dorrego

    Villa Nueva, Mendoza Province, CP 5519, Argentina

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Morelos, 62448, Mexico

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431, Bulgaria

  • DCC 1 - Ruse, EOOD

    Rousse, 7002, Bulgaria

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463, Bulgaria

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210, United States

  • Davao Doctors Hospital

    Davao City, Davao Region, 8000, Philippines

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire, DN2 5LT, United Kingdom

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059, China

  • Eiraku Clinic

    Kagoshima, Kagoshima-ken, 890-0063, Japan

  • Enroll Spa

    Santiago, 7500587, Chile

  • Fakultni nemocnice Olomouc

    Olomouc, 77520, Czechia

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, National Capital Region, 1118, Philippines

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192, Japan

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • Fundacion Cardiomet CEQUIN S.A.S

    Armenia, 630004, Colombia

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004, Colombia

  • GNP Research at Mark Jaffe, MD

    Cooper City, Florida, 33024, United States

  • Gabinety Lekarskie Rivermed

    Poznan, 61-441, Poland

  • Georgetown University Hospital-Medstar

    Washington D.C., District of Columbia, 20007-2113, United States

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317, China

  • Guy's Hospital

    London, Greater London, SE1 9RT, United Kingdom

  • HIPERDIA SA- Centrul de Diagnostic si Tratament Hiperdia Oltenitei

    Bucharest, 041303, Romania

  • HMA - Hospital Maria Auxiliadora

    Lima, LIMA 29, Peru

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-372, Brazil

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Hanyang University Seoul Hospital

    Seoul, 4763, South Korea

  • Healthy Medical Center

    Zipaquirá, 250252, Colombia

  • Highlands Research Institute

    Avon Park, Florida, 33825, United States

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hospital General de Castellon

    Castellon, Castellón, 12004, Spain

  • Hospital Italiano de La Plata

    Buenos Aires, 17251900, Argentina

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560032, Brazil

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Castellón, 39008, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41009, Spain

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Santo Ângelo, Mato Grosso, 78020-500, Brazil

  • IPS Centro Medico Julian Coronel S.A.

    Cali, Valle del Cauca Department, 760001, Colombia

  • IPS Medicos Internistas de Caldas S.A.S.

    Manizales, 170004, Colombia

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786, United States

  • Institute of Rheumatology

    Belgrade, 11000, Serbia

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran

    Mexico City, Mexico City, 14080, Mexico

  • Instituto de Investigaciones Clinicas Quilmes

    Buenos Aires, 3151878, Argentina

  • Instituto de Reumatologia

    Mendoza, 5500, Argentina

  • Invest Clinicas Sac Inst de Ginecologia y Reproduccion

    Lima, LIMA 33, Peru

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000, Mexico

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510, Japan

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyōgo, 670-8540, Japan

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021, China

  • Jiujiang No.1 People's Hospital

    Jiujiang, Jiangxi, 332000, China

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012, Philippines

  • KKR Hamanomachi Hospital

    Fukuoka, Fukuoka, 810-8539, Japan

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401, Taiwan

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730, Brazil

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • Life Clinical Trials

    Margate, Florida, 33063, United States

  • Lorma Medical Center

    San Fernando City, La Union, 2500, Philippines

  • MC Artmed OOD

    Plovdiv, 4002, Bulgaria

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874, Poland

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217, Philippines

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070, Mexico

  • Medical Center Manila

    Manila, 1000, Philippines

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606, Bulgaria

  • NHO Chibahigashi National Hospital

    Chiba, Chiba, 260-8712, Japan

  • NHO Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563, Japan

  • NHO Osaka Minami Medical Center

    Kawachinagano-shi, Osaka, 586-8521, Japan

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575, Japan

  • NNA Hospital

    Athens, Attica, 11521, Greece

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220, United States

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo-To, 173-8610, Japan

  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, 15-707, Poland

  • Nzoz Bif-Med

    Bytom, 41-902, Poland

  • Omega Research Consultants

    DeBary, Florida, 32713, United States

  • Onyx Clinical Research, LLC

    Salisbury, North Carolina, 28144, United States

  • Organizacion Medica de Investigacion (OMI)

    CABA, Buenos Aires, C1015ABO, Argentina

  • Ospital Ng Makati

    City of Taguig, 1642, Philippines

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130, United States

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055, China

  • Policlìnica Red Omip S.A - Ensayos Clinicos GC

    Mar del Plata, Buenos Aires, B7600GNY, Argentina

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Precision Comprehensive Clinical Research Solution

    Colleyville, Texas, 76034-5913, United States

  • Precision Comprehensive Clinical Research Solutions

    Rochester Hills, Michigan, 48307, United States

  • Preventive Care Ltda

    Chía, 250001, Colombia

  • Private Small Enterprise, Medical Centre 'Pulse'

    Vinnytsia, 21001, Ukraine

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Providence Facey Medical Foundation

    Mission Hills, California, 91345, United States

  • Prywatna Praktyka Lekarska prof Pawel Hrycaj

    Poznan, 61-397, Poland

  • Przychodnia Care Access Warszawa

    Warsaw, 00-719, Poland

  • R and H Clinical Research

    Katy, Texas, 77450, United States

  • RDSS Ricardo Diaz Scientific Solution

    São Paulo, 04037-030, Brazil

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Ramesh C Gupta, MD

    Memphis, Tennessee, 38119, United States

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, Shanghai Municipality, 200001, China

  • Revmatologie s.r.o.

    Brno, 63800, Czechia

  • S C Delta Health Care SRL

    Bucharest, 14142, Romania

  • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

    Brasov, 500283, Romania

  • S.C.Centrul Medical Unirea SRL

    Iași, 700023, Romania

  • STAT Research S.A.

    Ciudad Autonoma Buenos Aires, C1013AAB, Argentina

  • Saint Louis Rheumatology

    St Louis, Missouri, 63119, United States

  • Sanatorio Allende

    Córdoba, 5000, Argentina

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Servimed S.A.S.

    Bucaramanga, 680003, Colombia

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006, Romania

  • St. Luke's Medical Center

    Quezon City, National Capital Region, 1102, Philippines

  • Sun Research Institute, LLC

    San Antonio, Texas, 78215, United States

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 87-100, Poland

  • Tekton Research - PARENT

    Austin, Texas, 78745, United States

  • Tel Aviv Sourasky Medical Center Pt

    Tel Aviv, 6423906, Israel

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Medical City Clark

    Mabalacat, Pampanga, 2023, Philippines

  • The Medical City Iloilo

    Iloilo City, 5000, Philippines

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsushe, 215004, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000, China

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo-To, 153-8515, Japan

  • Tonan Hospital

    Sapporo, Hokkaido, 060-0004, Japan

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • UMHAT "Pulmed" OOD

    Plovdiv, 4002, Bulgaria

  • UMHAT 'Sv. Ivan Rilski', EAD

    Sofia, 1612, Bulgaria

  • UMHAT-Plovdiv AD

    Plovdiv, 4003, Bulgaria

  • University Clinic of NPMMU, Vinnytsya (TESC). Dep of Rheumatology with therapeutic beds,

    Vinnytsia, 21018, Ukraine

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655, United States

  • University of the Philippines Manila - Philippine General Hospital

    Manila, National Capital Region, 1000, Philippines

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

    Székesfehérvár, Fejér, 8000, Hungary

  • Vital Medical Center

    Veszprém, 8200, Hungary

  • Wallace Rheumatic Study Center

    Beverly Hills, California, 90211, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008, China

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

  • Zhongshan TCM Hospital

    Zhongshan, Guangdong, 528400, China

  • ZhuZhou Central Hospital

    Zhuzhou, Hu'nan, 412000, China

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