17 ga Yuli, 2025 – Innovent Biologics ta sanar da cewa Nature Medicine ta buga sakamakon binciken asibiti na Mataki na 1 na IBI343, wani sabon maganin hana ciwon daji na CLDN18.2 ADC, don maganin ciwon daji na ciki/na ciki (G/GEJ). Bugawa a cikin wannan mujallar ilimi ta duniya mai ban sha'awa ya nuna ƙarfin fahimtar yuwuwar maganin kuma yana nuna wani muhimmin ci gaba a ci gaban China wajen haɓaka sabbin magungunan hana ciwon daji. Dangane da binciken, an ƙaddamar da wani gwaji na asibiti na Mataki na 3 na yankuna da yawa (G-HOPE-001, NCT06238843) a cikin 2024 don ƙara kimanta IBI343 a matsayin zaɓi mai aminci da inganci ga marasa lafiya da ke da G/GEJ AC mai ci gaba.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Imel:myimmnet@163.com
Ciwon daji na ciki ya kasance ɗaya daga cikin cututtukan da suka fi yaduwa a duniya. A cewar kididdigar GLOBOCAN 2022, yana matsayi na biyar a cikin cututtukan da suka fi yaduwa a duniya kuma shine na biyar a cikin manyan cututtukan da suka fi kamuwa da cutar kansa a duniya, inda aka kiyasta sabbin kamuwa da cutar 970,000 da kuma mace-mace 660,000 a kowace shekara. Kowace shekara, China tana ba da rahoton sabbin kamuwa da cutar 359,000 da kuma mace-mace 260,000 daga cutar kansar ciki, wanda ke wakiltar kashi 37.0% da 39.4% na jimillar cutar a duniya, bi da bi, wanda ke nuna babban buƙatar likita da ba a cika ba.
CLDN 18.2 wani sinadari ne mai matsewa wanda ake samu a cikin ƙwayoyin epithelial daban-daban akan mucosa na ciki a ƙarƙashin yanayin ilimin halittar jiki na yau da kullun. Nazarin da aka yi a baya ya nuna cewa Claudin18.2 yana da matuƙar tasiri a cikin nau'ikan ciwon daji daban-daban, ciki har da ciwon daji na ciki (60-80%), ciwon daji na pancreas (50%), ciwon daji na esophageal (30-50%), da ciwon daji na huhu (40-60%). Yin niyya ga CLDN18.2 tare da monoclonal antibodies (mAbs) da ADCs yana wakiltar sabuwar hanya mai kyau don magance ciwon daji na ciki.
Wannan binciken da aka buga gwaji ne na asibiti na mataki na 1 na duniya baki ɗaya, wanda aka tsara don kimanta aminci, juriya da kuma ingancin farko na IBI343 ga marasa lafiya da ke da ciwon daji mai tsanani. Tsakanin 26 ga Oktoba, 2022, da 30 ga Yuni, 2024, an yi rajistar jimillar mutane 116 da ke da ciwon daji mai tsanani na G/GEJ don samun maganin IBI343 guda ɗaya (8 a cikin ƙaruwa da faɗaɗawa).
Game da IBI343(Anti CLDN18.2 ADC)
IBI343 wani maganin rigakafi ne na ɗan adam mai hana CLDN18.2 monoclonal antibody-drug conjugate (ADC) wanda Innovent Biologics ya haɓaka. Yana ɗaure musamman da ƙwayoyin ciwon da ke bayyana CLDN18.2, wanda ke haifar da shigar CLDN18.2 cikin ADC. Da zarar ya shiga cikin tantanin halitta, ana sakin nauyin cytotoxic, wanda ke haifar da lalacewar DNA da kuma a ƙarshe apoptosis na ƙwayoyin ciwon. Maganin da aka saki kuma yana iya yaɗuwa a cikin membrane na plasma don isa da kashe ƙwayoyin maƙwabta, wanda ke haifar da "tasirin kisa ta hanyar da ba ta dace ba".
A matsayin wani sabon TOPO1i ADC, IBI343 ya nuna aminci mai jurewa da kuma alamun inganta aiki a cikin wannan nazarin asibiti na Mataki na 1. A halin yanzu ana binciken yuwuwar warkewar IBI343 a cikin nau'ikan ciwon daji kamar ciwon ciki da ciwon daji na pancreas.
Gwajin asibiti na mataki na 3 na IBI343 don ciwon daji na ciki / esophagus yanzu yana ɗaukar marasa lafiya (G-HOPE-001, NCT06238843). An ba da izinin NMPA ta China don ba da alamar da ta dace.
Gwajin asibiti na mataki na 1 na IBI343 na yankuna daban-daban don ciwon daji na pancreas mai ci gaba yana kuma ɗaukar marasa lafiya (NCT05458219). Wannan alamar ta sami Naɗin Sauri (FTD) daga Hukumar Kula da Lafiya ta Amurka (FDA) kuma NMPA ta China ta ba ta izinin BTD.
IBI343 ya nuna ƙarfafa martanin ciwon daji da fa'idar rayuwa
Binciken ya yi nazarin bayanai kan ingancin mutanen da za a iya kimantawa tare da yawan CLDN18.2 (≥75% ƙwayoyin ciwon daji tare da ƙarfin tabo na membrane ≥2+ ta IHC), a cikin ƙungiyoyi biyu na allurai na 6 mg/kg da 8 mg/kg.
A 6 mg/kg (N=31), marasa lafiya 15 sun sami martani kaɗan (PR) ciki har da marasa lafiya 9 da aka tabbatar da PR da kuma majiyyaci 1 da ke jiran tabbatarwa. ORR da aka tabbatar shine 29.0% (95% CI: 14.2-48.0) kuma ƙimar kula da cutar (DCR) shine 90.3% (95% CI: 74.2-98.0). A cikin marasa lafiya 9 da aka tabbatar da martani, matsakaicin tsawon lokacin amsawa (DoR) shine watanni 5.6 (95% CI: 2.8-7.0). Matsakaicin bin diddigin shine watanni 10.6 (95% CI: 9.7-11.5) ga PFS da OS. Matsakaicin PFS shine watanni 5.5 (95% CI: 4.1-7.0). Bayanan OS ba su cika ba tare da matsakaicin OS na yanzu na watanni 10.8 (95% CI: 6.8-NC). Bayan yanke bayanai, an tabbatar da martanin sauran majiyyaci 1 a ranar 26 ga Yuli, 2024 kuma an sabunta ORR da aka tabbatar zuwa 32.3% (95% CI: 16.7-51.4).
A 8 mg/kg (N=17), an kimanta marasa lafiya 17 da suka nuna yawan CLDN 18.2. Daga cikinsu, marasa lafiya 9 sun sami PR, ciki har da marasa lafiya 8 da suka tabbatar da PR. An tabbatar da ORR 47.1% (95% CI: 23.0-72.2), kuma DCR shine 88.2% (95% CI: 63.6-98.5). A cikin marasa lafiya takwas da aka tabbatar da amsawa, matsakaicin DoR shine watanni 5.7 (95% CI: 2.7-NC). Daga cikin dukkan marasa lafiya na G/GEJ adenocarcinoma da suka sami yawan CLDN18.2 da aka yi wa magani a 8 mg/kg (N=19, gami da majiyyaci 1 daga ƙaruwar yawan magani da kuma marasa lafiya 18 daga faɗaɗa yawan magani), matsakaicin bin diddigin shine watanni 8.1 (95% CI: 7.6-8.5) ga PFS da OS. Matsakaicin PFS shine watanni 6.8 (95% CI: 2.8-7.5), kuma ba a cimma matsakaicin tsarin aiki ba tare da abubuwan da suka faru sun faru a cikin marasa lafiya 36.8%.
IBI343 kuma ya nuna ingantaccen tsaro
Daga cikin dukkan marasa lafiya da ke fama da cutar G/GEJ adenocarcinoma (n=116, ciki har da marasa lafiya 8 da ke fama da cutar kansar ciki daga matakin ƙaruwar allurar), kashi 66.4% na marasa lafiya (77/116) sun sami TEAEs na mataki ≥3. Mafi yawan TEAEs na mataki ≥3 (≥35%) sun ragu da adadin neutrophils (28.4%), adadin fararen ƙwayoyin jini ya ragu (25.9%), da kuma anemia (16.4%). Akwai ƙarancin abubuwan da suka faru na rashin lafiya a cikin hanji na mataki ≥3, ciki har da 1.7% kawai na tashin zuciya na mataki ≥3. Ba a ba da rahoton wata cuta ta huhu ta tsakiya ba. An rage gubar da ke da alaƙa da magani tare da isasshen magani, kuma an jure wa lafiyar gaba ɗaya.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Imel:myimmnet@163.com
Lokacin Saƙo: Yuli-22-2025