An Amince da Sabon Nazarin Maganin Ciwon Kansa na Huhu

Shanghai Henlius Biotech, Inc. ya sanar da cewa binciken farko na wucin gadi ya hadu da farkon binciken ƙarshen rayuwa (OS) na nazarin asibiti na Phase 3 (NCT04063163) na sabon PD-1 inhibitor serplulimab a hade tare da chemotherapy a baya marasa lafiya marasa lafiya ƙananan ciwon huhu na huhu (ES-SCLC). Babu wani anti-PD-1 mAb da aka amince da shi don kula da ƙananan ciwon huhu na huhu (ES-SCLC) a duk duniya.

Babban manufar binciken shine don gano inganci da amincin serplulimab a hade tare da chemotherapy a baya marasa lafiya tare da ES-SCLC. Dangane da sakamakon binciken da aka riga aka tsara na wucin gadi wanda Kwamitin Kula da Bayanai mai zaman kansa (IDMC) ya gudanar, serplulimab a hade tare da chemotherapy ya nuna babban ci gaba a cikin OS game da ilimin chemotherapy, wanda ya cika ka'idodin ingantaccen inganci, tare da aminci mai kyau kuma babu. gano sabon siginar aminci. IDMC ya ba da shawarar cewa kamfanin na iya don haka sadarwa tare da iko mai lafiya.

SCLC yana da muni sosai, kuma maganin da ake samu yana da iyaka

Dangane da bayanan GLOBOCAN, cutar kansar huhu (LC) ita ce ta biyu da aka fi sani da cutar kansa a duniya kuma tana da kashi 11.4% na kamuwa da cutar kansa a duniya a cikin 2020. An kiyasta cewa akwai sabbin masu kamuwa da LC 810,000 a China a cikin 2020, kuma LC ita ce ta farko. babban sanadin kamuwa da cutar daji da mace-mace. SCLC yana lissafin 15% -20% tsakanin LC, kuma shine mafi girman nau'in LC, wanda aka raba zuwa iyakance matakin ƙananan ciwon huhu (LS-SCLC) da ES-SCLC. Yawancin marasa lafiya sun riga sun kasance cikin babban mataki lokacin da aka gano su. Marasa lafiya tare da ES-SCLC ko da yaushe suna da saurin haɓakar ƙwayar cuta da rashin fahimta. Wasu daga cikinsu suna da ɗan gajeren rayuwa saboda ɗimbin ƙwayar ƙwayar cuta da rashin lafiyar jiki kawai tare da kulawar tallafi.

Fiye da shekaru 20, etoposide da carboplatin / cisplatin har yanzu shine ma'auni na kulawa ga ES-SCLC, amma 80% na marasa lafiya da ke da ƙananan cututtuka da kuma kusan dukkanin marasa lafiya da ke da cututtuka masu yawa sun sake komawa cikin shekara guda, tare da rayuwa ta tsakiya na kawai 4 zuwa Watanni 5 bayan sake dawowa. Bayyanar masu hana shingen rigakafin rigakafi yana ba da sabon zaɓi. A halin yanzu, an ba da shawarar anti-PD-L1 mAb hade da chemotherapy ta sabbin jagororin NCCN da jagororin CSCO azaman jiyya ta farko don ES-SCLC. Koyaya, aikace-aikacen immunotherapy a cikin ES-SCLC har yanzu yana fuskantar ƙalubale. A cikin 'yan shekarun nan, adadin PD-1 mAbs sun gaza a yankin. Sabili da haka, ana buƙatar ƙarin ingantaccen magani na layin farko na masu hana PD-1 cikin gaggawa.

Tsayawa akan buƙatun marasa lafiya waɗanda basu cika ba, wanda ke rufe layin farko na kowane nau'in ciwon huhu na huhu

Henlius ya ɗauki dabarun "Combo+Global" daban-daban akan serplulimab. A halin yanzu, an amince da serplulimab don gwajin asibiti a China, Amurka, Tarayyar Turai da sauran ƙasashe da yankuna. Jimlar 10 immuo-oncology therapies gwajin asibiti na serplulimab suna gudana don kimanta amincinsa da ingancinsa a cikin nau'ikan ciwace-ciwace iri-iri waɗanda ke rufe LC, ciwon hanta, carcinoma na esophageal, ciwon kai da wuyan squamous cell carcinoma  da ciwon daji na ciki da dai sauransu. Har zuwa kwanan wata, kimanin marasa lafiya 2300 ne aka yi rajista a duk duniya, wanda ke tabbatar da cewa ingancin serplulimab ya gina amincewa a kasuwannin waje. A cikin Afrilu, Sabuwar Aikace-aikacen Magunguna (NDA) na serplulimab don kula da ciwace-ciwacen MSI-H ta sami karbuwa daga Hukumar Kula da Kayayyakin Magunguna ta ƙasa (NMPA) kuma ta ba da fifikon bita, wanda ake sa ran za a amince da shi a farkon rabin 2022.

Dangane da halayen masu fama da cutar kansa a duk duniya da kuma a China, kamfanin yana mai da hankali kan kansar huhu da kansar gastrointestinal tare da serplulimab a matsayin kashin baya. Henlius ya sami cikakkiyar tsarin tsarin asibiti na farko na LC, kuma ya gudanar da gwaje-gwaje a kan serplulimab a cikin sqNSCLC, marasa ciwon huhu marasa ƙananan ƙwayoyin cuta da SCLC, wanda ke rufe fiye da 90% na marasa lafiya na huhu. Dangane da bazuwar, makafi biyu, gwaje-gwajen asibiti na ƙasa da yawa na lokaci-lokaci 3 da aka gudanar a cikin marasa lafiya da ba a kula da su a baya ba tare da ci gaba na gida ko metastatic sqNSCLC, NMPA ta karɓi NDA na serplulimab don layin farko na ci gaba na gida ko metastatic sqNSCLC ta NMPA . A nan gaba, tare da cikakkun bayanai na bincike na asibiti na duniya, Henlius zai ci gaba da fadada rarrabawar serplulimab na duniya kuma ya amfana da ƙarin marasa lafiya a duniya.