NDA ya kane kuri Kelun-Biotech's TROP2 ADC sacituzumab tirumotecan (sac-TMT) yemejwe n'Ikigo gishinzwe gusuzuma imiti

Ku ya 22 Gicurasi 2025, Kelun Bio yatangaje ko ubusabe bw'ikimenyetso gishya cya trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, izwi kandi nka SKB264/MK - 2870) (®) bwemejwe n'Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) mu Bushinwa. Iki kimenyetso gishya ni icyo kuvura abarwayi bakuru bafite kanseri y'ibere idakira cyangwa idafite imisemburo isanzwe cyangwa idafite imisemburo isanzwe (HR+) hamwe na kanseri y'ibere y'abantu ifite imisemburo 2-negative (HER2-) (BC) bahawe mbere ubuvuzi bw'imisemburo n'ubundi buryo bwo kuvura mu buryo bugezweho cyangwa busanzwe. Uku kwemerwa kwashingiye ku bisubizo byiza by'inyigo y'icyiciro cya 3 OptiTROP - Breast02. Ubu busabe ni ubusabe bwa kane bw'ikimenyetso cya sac - TMT bwemejwe na NMPA.

OptiTROP – Breast02 ni inyigo y’ubuvuzi yakozwe mu cyiciro cya 3, ifunguye, ifite amashami menshi, yasuzumye imikorere n’umutekano wa sacituzumab tirumotecan monotherapy ku gipimo cya 5 mg/kg buri byumweru bibiri (Q2W) ugereranije n’ihitamo rya muganga rya chimiotherapie ku barwayi bafite kanseri y’ibere idakira cyangwa idafite HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, cyangwa IHC 2+/in situ hybridization [ISH]-) idakira. Hashingiwe ku isesengura ry’agateganyo ryavuzwe mbere, iherezo ry’ibanze ry’ubu bushakashatsi bw’ubuvuzi bwa Phase 3 ryagezweho. Ugereranyije n’ihitamo rya muganga rya chimiotherapie, sac-TMT monotherapy yagaragaje iterambere rikomeye kandi rifite akamaro mu mibare mu mpera y’ibanze yo kubaho nta guhindagurika (PFS) nk’uko byagenzuwe na komite yigenga isuzuma (BIRC), hamwe n’ibyago bigabanuka cyane byo kwiyongera kw’indwara cyangwa urupfu. Sac-TMT kandi yagaragaje icyerekezo cyiza mu kubaho muri rusange (OS).

Ku ya 16 Gicurasi 2024, urubuga rwemewe rwa CDE rwatangaje ko Ubusabe buzasuzumwa binyuze mu isuzuma ry’ibanze no kwemeza. Iki ni ikimenyetso cya kane cya sac-TMT cyo kunyura mu isuzuma ry’ibanze no kwemeza rya CDE, aho ibimenyetso bitatu bya sat-TMT byabanje byemejwe nyuma y’isuzuma ry’ibanze.

Ibyerekeye sac-TMT (佳泰莱 ®)

Sac-TMT, igikoresho cy'ingenzi cy'iyi sosiyete, ni TROP2 ADC nshya y'umuntu aho iyi sosiyete ifite uburenganzira ku mutungo bwite mu by'ubwenge, yibanda ku bibyimba bikomeye nka kanseri y'ibihaha itari nto (NSCLC), BC, kanseri y'igifu (GC), ibibyimba by'abagore, n'ibindi. Sac-TMT yakozwe ifite uburyo bushya bwo guhuza umutwaro, inhibitor ya topoisomerase I ikomoka kuri belotecan ifite ikigereranyo cya 7.4 cy'umuti-ku-antibody-ratio (DAR). Sac-TMT imenya by'umwihariko TROP2 ku buso bw'uturemangingo tw'ibibyimba binyuze mu budahangarwa bwa monoclonal buhuza anti-TROP2, hanyuma ikemurwa n'uturemangingo tw'ibibyimba hanyuma ikarekura KL610023 mu ngirabuzima fatizo. KL610023, nk'inzitizi ya topoisomerase I, itera kwangirika kwa ADN ku turemangingo tw'ibibyimba, bigatuma uturemangingo tw'uturemangingo duhagarara no kuzura kw'uturemangingo. Byongeye kandi, inarekura KL610023 mu bidukikije by'ibibyimba. Bitewe nuko KL610023 ishobora kwinjira mu ruhu, ishobora gutuma habaho ingaruka zo kureba inyuma, cyangwa mu yandi magambo kwica uturemangingo twa kanseri twegeranye.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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