Skip to content Skip to footer
Subscribe Now
Remegen
NEWS

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Shots: Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndrome Trial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conference Telitacicept is a…
August 13, 2025

Read more

NEWS

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 UC Toripalimab is an anti-PD-1…
August 12, 2025

Read more

NEWS

Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

Shots: Visirna Therapeutics, a subsidiary of Arrowhead, has granted Sanofi exclusive rights to develop & commercialize plozasiran for treating familial chylomicronemia syndrome (FCS) & severe hypertriglyceridemia (SHTG) in Greater China As per the deal, Visirna will receive $130M upfront & ~$265M in milestone payments across indications, along with net sales-based royalties in Greater China, as…
August 4, 2025

Read more

INSIGHTS+

New Drug Designations: June 2025 

Shots:      PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…
July 29, 2025

Read more

NEWS

Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

Shots: China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…
July 14, 2025

Read more

INSIGHTS+

New Drug Designations – May 2025  

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

Read more

NEWS

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots: China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
June 5, 2025

Read more

Akesobio
NEWS

Akeso’s Cadonilimab Receives the NMPA’s Approval for 1L Treatment of Cervical Cancer

Shots: The NMPA has approved cadonilimab + Pt-based CT ± Avastin as a 1L treatment of persistent, recurrent, or metastatic cervical cancer Approval was based on the P-III (COMPASSION-16) trial assessing cadonilimab vs SoCs, which met its PFS & OS endpoints, showing efficacy in PD-L1-negative tumors (CPS <1; 27.9% vs 24.2%) with subgroup analyses demonstrating benefit…
June 5, 2025

Read more

Load more