Sabbin Aikace-aikacen Magunguna na Kananan Cutar Cancer na Huhu An Karɓa

Shanghai Henlius Biotech, Inc. ya sanar da cewa New Drug Application (NDA) na HANSIZHUANG (serplulimab), wani labari anti-PD-1 monoclonal antibody (mAb) da kansa ɓullo da kansa da kamfanin, a hade tare da chemotherapy ga farko-line jiyya na Hukumar Kula da Kayayyakin Kiwon Lafiya ta Ƙasa (NMPA) ta karɓi babban mataki kan ƙananan ciwon huhu (ES-SCLC). Henlius kuma yana shirin shigar da MAA a cikin EU a cikin 2022. Babu PD-1 da aka amince da shi a duniya don maganin farko na SCLC har zuwa yau kuma HANSIZHUANG mai yiwuwa mai hana PD-1 na farko na duniya don maganin farko na SCLC.

Farfesa Ying Cheng, babban jami'in binciken binciken, Daraktan Cibiyar Jilin Sashen Likita Oncology Cibiyar Cancer, Jilin Lardin Jilin Cancer Diagnosis and Treatment Center, da Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center, ya ce, "ASTRUM-005 shi ne na farko kuma mafi girma na ES-SCLC na kasa da kasa da yawa bincike na asibiti wanda masu bincike na kasar Sin suka jagoranta don anti-PD-1 mAb. Kyakkyawan sakamako na asibiti ya nuna cewa an kai ga ƙarshen binciken farko da aka ƙayyade, yana ba da shaida na aminci da inganci. Muna fatan cewa amincewar HANSIZHUANG don maganin ES-SCLC ya zo nan da nan don gyara gibin kuma ya kawo sabon zaɓi na magani ga marasa lafiya da ke zaune tare da ES-SCLC. "

Mista Jason Zhu, shugaban Henlius, ya ce, "HANSIZHUANG wani sabon mAb ne mai zaman kansa wanda Henlius ya kirkira, kuma SCLC ita ce alama ta uku da NMPA ta amince da NDA kuma kwanan nan Amurka ta ba da izini ga Marayu da Magunguna. Cibiyar Abinci da Magunguna (FDA). Dangane da ɗimbin buƙatun asibiti da ba a biya su ba da kuma cututtukan da ba za a iya magance su ba a duk duniya da kuma a cikin Sin, kamfanin ya aiwatar da ingantaccen tsarin jiyya na layin farko don cutar kansar huhu tare da gwaje-gwajen asibiti da yawa na mataki na 3. A ci gaba, za mu ci gaba da haɓaka haɗin gwiwar rigakafi na HANSIZHUANG da bincike na asibiti, ta yadda za mu amfana da ƙarin marasa lafiya a China da ma duniya baki ɗaya. "

HANSIZHUANG yana inganta haɓakar rayuwa gabaɗaya kuma yana cike gibin buƙatun marasa lafiya tare da SCLC

Kananan ciwon huhu na huhu (SCLC) yana da kashi 15% -20% na duk lokuta kuma shine mafi girman nau'in ciwon huhu (LC). An rarraba shi zuwa matakai guda biyu: ƙayyadaddun mataki (LS-SCLC) da ES-SCLC, tare da duka suna nuna rashin lafiya mai tsanani, ƙaƙƙarfan ɓarna, farkon metastasis, ci gaba da cututtuka da sauri, da rashin fahimta. A halin yanzu, an ba da shawarar anti-PD-L1 mAb hade da chemotherapy ta sabbin jagororin NCCN da jagororin CSCO azaman jiyya na farko don ES-SCLC. A cikin 'yan shekarun nan, duk da haka, adadin PD-1 mAbs sun gaza a yankin.

NDA ta dogara ne akan sakamakon da bazuwar, makafi biyu, na kasa da kasa, cibiyar da yawa, nazarin asibiti na 3 na lokaci (ASTRUM-005) wanda ke nufin kwatanta inganci da aminci na HANSIZHUANG tare da placebo lokacin da aka hade tare da chemotherapy (carboplatin-etoposide). ) a baya marasa lafiya marasa lafiya tare da ES-SCLC. Wannan binciken ya kafa kusan shafuka 128 a China, Turkiyya, Poland, Jojiya, da dai sauransu kuma an yi rajistar batutuwa 585, daga cikinsu 31.5% na Caucasian. A cikin Disamba 2021, ASTRUM-005 ta haɗu da farkon binciken ƙarshen ƙarshen rayuwa (OS) a cikin sakamakon bincike na wucin gadi. Sakamakon binciken ya nuna cewa HANSIZHUANG na iya ƙaddamar da OS zuwa watanni 15.38 ga ƙungiyar HANSIZHUANG, yana rage haɗarin mutuwa da 38% (41% a cikin ƙungiyar Asiya) bayanin martaba mai kulawa. Bayanai na asibiti na duniya suna kafa tushe mai ƙarfi don aikace-aikacen gaba a duk faɗin duniya.

Kasar Sin tana da mafi girman abin da ya faru na LC, kuma HANSIZHUANG an yi niyya ne a matsayin zaɓin jiyya na farko ga duk nau'ikan LC

A cewar GLOBOCAN 2020, LC ita ce ta biyu mafi yawan cutar kansa a duniya. Akwai sabbin shari'o'in LC miliyan 2.2 a duk duniya, yayin da China ke lissafin sabbin cututtukan LC miliyan 0.8. Haka kuma, tare da sabbin mace-mace miliyan 1.8 a cikin 2020, LC shine babban dalilin mutuwar cutar kansa a duniya. Ciwon daji na huhu mara ƙarami (NSCLC) ya kai kusan kashi 85% a tsakanin LC, tare da squamous non-small cell huhu cancer (sqNSCLC) lissafin kusan 30%. Yawancin masu cutar kansar huhu ana gano su a matakin ci gaba kuma ba su da damar yin aikin tiyata. An tabbatar da zuwan masu hana shinge na rigakafi don kawo bege ga marasa lafiya tare da LC.

Henlius ya aiwatar da ingantaccen tsarin rigakafin rigakafi-oncology na layin farko don LC a cikin sqNSCLC, ciwon huhu mara ƙarancin ƙwayar cuta (nsNSCLC), ES-SCLC, da LS-SCLC. Don NSCLC, kamfanin ya gudanar da bazuwar, makafi biyu, gwajin gwaji na asibiti na duniya da yawa a cikin marasa lafiya tare da marasa lafiya na sqNSCLC na gida ko metastatic don kwatanta HANSIZHUANG a hade tare da chemotherapy da chemotherapy dangane da inganci da aminci. An karɓi NDA a sakamakon taron binciken da aka yi na farko. Hakanan, binciken don bincika haɗin haɗin mAbs biyu na HANSIZHUANG da HANBEITAI (bevacizumab) don maganin layin farko na nsNSCLC ya shiga muhimmin mataki na 3. Don SCLC, a gefe guda, binciken sabon aikace-aikacen miyagun ƙwayoyi (IND) na nazarin 3 multicenter na duniya na HANSIZHUANG a cikin marasa lafiya tare da LS-SCLC an amince da NMPA ban da ASTRUM-3 don maganin ES-SCLC. Musamman ma, FDA ta ba da Tsarin Marayu-Drug don HANSIZHUANG don maganin SCLC, yana cin gajiyar ci gaba da ci gaban HANSIZHUANG da jin daɗin wasu tallafin manufofin dangane da rajista da kasuwanci a Amurka.

A nan gaba, kamfanin zai ci gaba da jaddada abubuwan da ba a cika buƙatun asibiti ba kuma yana haɓaka haɓakar haɗin gwiwar rigakafi na HANSIZHUANG da rajista na ƙa'ida na duniya don amfana da ƙarin marasa lafiya a duniya.