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NEWS

Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

Shots:Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in ChinaAdditionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
September 12, 2025

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Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots:                                                                                                                                                                 China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC)sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UCToripalimab is an anti-PD-1…
August 12, 2025

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Junshi Biosciences Reports the CHMP’s Positive Opinion of Loqtorzi (Toripalimab) Across Two Indications 

Shots:   The CHMP has granted positive opinion to 1L Loqtorzi with cisplatin & gemcitabine for recurrent, metastatic NPC as well as with cisplatin & paclitaxel for unresectable advanced, recurrent or metastatic ESCC; valid across the EU plus Iceland & Norway The opinions for NPC & ESCC were supported by P-III (JUPITER-02 & JUPITER-06) trials, respectively;…
July 26, 2024

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