UMnyango Wezizwe Zonke

Ngomhlaka-22 Januwari 2025, "i-Nature Medicine" yashicilela imiphumela ye-Akeso ngokuzimela yakha i-PD-1/CTLA-4 bispecific antibody cadonilimab ngokuhlanganiswa ne-oxaliplatin kanye ne-capecitabine yokwelapha kokuqala kwe-infectious in ...Funda kabanzi»

Ngomhlaka-8 Januwari 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-PADCEVTM (enfortumab vedotin) ngokuhlanganiswa ne-KEYTRUDA (pembrolizumab) yeziguli ezindala ezinomdlavuza we-urothelial othuthukisiwe endaweni noma osakazeke kakhulu (la/mUC). Ukuvunyelwa kwe-NMPA kwe-enfortumab vedotin ekamu...Funda kabanzi»

NgoFebhuwari 17, 2025, i-Innovent Biologics yamemezela ukuthi iphrotheni yayo yokuqala ye-PD-1/IL-2α-bias bispecific antibody fusion protein, i-IBI363, ithole i-Fast Track Designation yayo yesibili (FTD) evela ku-US Food and Drug Administration (FDA). Lesi sikhundla sisebenza ekwelapheni i-nonreacuted, ...Funda kabanzi»

Ngomhlaka-16 Januwari 2025, i-IMPACT yamemezela ukuthi ama-Senaparib Capsules (派舒宁®）athole imvume yokumaketha eShayina evela ku-National Medical Products Administration (NMPA) njengokwelashwa okukodwa kokunakekelwa kweziguli ezindala ezine-epithelial ethuthukisiwe (FIGO Stages III and IV) yezinga eliphezulu...Funda kabanzi»

Ngomhlaka-7 kuNhlolanja 2025, iSichuan Kelun-Biotech Biopharmaceutical yamemezela ukuvunyelwa kwe-Cetuximab N01 Injection yayo yi-National Medical Products Administration yokwelapha umdlavuza we-colorectal osakazeke kabanzi (mCRC) eShayina. Ukuvunyelwa kusekelwe ocwaningweni olukhulu lwezokwelapha lwesigaba III...Funda kabanzi»

Ngomhlaka-10 kuNhlolanja 2025, i-CARsgen Therapeutics imemezela ukuthi umuntu wokuqala ophathwe ngokwelashwa kwe-BCMA CAR-T okune-allogeneic okwakhiwe epulatifomu ye-THANK-u Plus™, uthole impendulo ephelele eqinile (sCR) kanye nokungalungi okuncane kwesifo esisele (MRD) ekuhlolweni kosuku lwama-28. Kwakhiwe ngaphakathi endlini...Funda kabanzi»

Ngomhlaka-29 Januwari 2025, ithimba locwaningo laseShayina lashicilela isihloko esithi “I-Neoadjuvant pyrotinib kanye ne-trastuzumab kumdlavuza webele one-HER2 positive ngaphandle kwempendulo yokuqala (NeoPaTHer): ukusebenza kahle, ukuphepha, kanye nokuhlaziywa kwe-biomarker kocwaningo oluhleliwe, olunezikhungo eziningi, oluhambisana nempendulo” ku...Funda kabanzi»

Ngomhlaka-26 Januwari 2025, i-Center for Drug Evaluation (CDE) ye-China National Medical Products Administration yamemezela ukuthi umjovo we-LM-108 uhloselwe ukufakwa ekwelashweni okuphumelelayo kwama-tumors aqinile athuthukile ane-microsatellite instability (MSI-H) noma amaphutha okulungisa okungafani (dMMR) th...Funda kabanzi»

Ngomhlaka-20 Januwari, i-National Medical Products Administration (NMPA) ivuma ukwelashwa okuhlanganisiwe kwe-cisplatin ne-gemcitabine okune-humanized monoclonal antibody tagitanlimab (eyayikade i-KL-A167) kwe-cisplatin kanye ne-gemcitabine ekwelapheni kokuqala kweziguli eziphindaphindayo noma ezisabalele i-nasopharyngeal carcinoma (NPC). ...Funda kabanzi»

Ngomhlaka-16 Januwari 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) ye-limertinib yokwelapha iziguli ezindala ezine-EGFR T790M-mutated non-small cell lung cancer (NSCLC) ethuthukisiwe noma esakazeke endaweni. Mayelana ne-Limertinib Limertinib ...Funda kabanzi»

Ngomhlaka-8 Januwari, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina inikeze i-Breakthrough Therapy Designation (BTD) ye-IBI343, i-TOPO1i anti-CLDN18.2 ADC engcono kakhulu, njengokwelashwa okukodwa kokwelashwa kwe-CLDN18.2-positive advanced pancr...Funda kabanzi»

Ngomhlaka-8 Januwari 2025, i-9MW2821 yanikezwa i-Breakthrough Therapy Designation (BTD) yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) eShayina. I-9MW2821 inikezwa kanye ne-toripalimab, i-antibody ye-anti-PD-1 monoclonal, yokwelashwa okungavamile, okungadingi ukwelashwa...Funda kabanzi»