Kopo ea sethethefatsi se secha sa lipatlisiso (IND) e amohetsoe ke US FDA ka Phuptjane le Setsi sa Tlhahlobo ea Lithethefatsi (CDE) sa Tsamaiso ea Naha ea Lihlahisoa tsa Bongaka ea Chaena ka Mphalane selemong se fetileng ka ho latellana.

Ena ke thuto ea bongaka e bulehileng, e nang le litsi tse ngata tsa Phase I / II tse nang le merero e latelang: ho hlahloba polokeho ea bakuli ba MIBC; ho fumana tekanyo e khothaletsoang ea Mokhahlelo oa 2 (RP2D), le ho lekola ho sebetsa joalo ka kalafo ea neoadjuvant bakeng sa MIBC.

"APL-1202 hammoho le tislelizumab kaha phekolo ea neoadjuvant e na le monyetla oa ho ba khetho e ntle ka ho fetisisa ea phekolo bakeng sa bakuli ba MIBC, re thabile haholo hore ebe mokuli oa pele o tsamaisitse US," ho boletse Dr. Xue Yong, MD, PhD, Chief Medical. Ofisiri ea Asieris. "Re khonne ho ntšetsa pele nyeoe nakong ea seoa sa COVID-19 se sa bontsheng feela ts'ebetso e ntle ea sehlopha sa rona, empa hape le boitlamo ba rona ba ho ntlafatsa bophelo bo botle ba batho."

APL-1202 ke MetAP2 Inhibitor e ka fetolehang ka molomo e nang le anti-angiogenic, anti-tumor, hape e ka khona ho fetola tikoloho ea 'mele ea ho itšireletsa mafung. Hajoale e ntse e le litekong tsa bongaka tsa Mokhahlelo oa III / tsa bohlokoahali naheng ea China, ekaba e le moemeli a le mong joalo ka kalafo ea pele bakeng sa bakuli ba nang le mofetše oa senya oa senya o se nang mesifa (NMIBC), kapa hammoho le chemotherapy joalo ka kalafo ea bobeli bakuli ba nang le NMIBC ea mahareng le e kotsing e kholo ea chemo-refractory. Tislelizumab ke anti-PD-4 anti-PD-1 antibody e entsoeng ke motho ka ho khetheha e etselitsoeng ho fokotsa ho tlama FcγR ho macrophages. China National Medical Products Administration (NMPA) e amohetse tislelizumab ka matšoao a mahlano, ho kenyeletsoa tumello e felletseng ea kalafo ea pele ea bakuli ba nang le mofetše o tsoetseng pele oa squamous non-small cell lung cancer (NSCLC) hammoho le chemotherapy le kalafo ea pele ea bakuli. ka NSCLC e tsoetseng pele e se nang squamous hammoho le chemotherapy. NMPA e boetse e fane ka tumello ea maemo bakeng sa phekolo ea bakuli ba nang le classical Hodgkin's lymphoma (cHL) ba fumaneng bonyane liphekolo tse peli pele ho moo, bakeng sa phekolo ea bakuli ba nang le kankere ea matsoele e tsoetseng pele kapa ea metastatic urothelial carcinoma (UC) e nang le PD-L1 e phahameng eo lefu la bona le ileng la tsoela pele nakong ea bokhachane. kapa ho latela chemotherapy e nang le platinum kapa nakong ea likhoeli tsa 12 tsa phekolo ea neoadjuvant kapa ea adjuvant ka chemotherapy e nang le platinum, le bakeng sa phekolo ea bakuli ba nang le lefu la sebete la sebete (HCC) ba fumaneng bonyane phekolo e le 'ngoe ea tsamaiso. Tumello e felletseng ea matšoao ana e its'etleha holim'a liphetho tsa liteko tse sa fetoheng, tse laoloang tsa netefatso ea tleliniki.

SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:

NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy.
It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC.
The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy.