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The Phase 3 Clinical Trial of Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS
PR Newswire
May 12, 2025
RemeGen Co., Ltd. announced that its phase 3 clinical trial (Study ID: RC48-C016) has reached its two primary endpoints of progression-free survival (PFS) and overall survival (OS).
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Everest Medicines Announces NMPA Full Approval of NEFECON, Broadening Treatment Access for IgA Nephropathy Patients in China
ACN Newswire
May 07, 2025
Everest Medicines announced that the supplemental New Drug Application (sNDA) for NEFECON has received full approval from the China National Medical Products Administration (NMPA).
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InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA
PharmaSources
May 06, 2025
InnoCare Pharma announced today that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the CDE of China NMPA.
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InnoCare Announces Approval of Orelabrutinib for the First-line Treatment of CLL/SLL in China
PharmaSources
April 27, 2025
InnoCare Pharma announced that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) for the first-line treatment of patients with chronic lymphocytic leukemia / small lymphocytic lymphoma.
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HighTide Therapeutics to Showcase New Analyses of Phase 2 MASH/T2DM Studies of Berberine Ursodeoxycholate (HTD1801) and Pre-Clinical Results of Rimtoregtide (HTD4010) in Presentations at EASL Congress
ACN Newswire
April 25, 2025
HighTide Therapeutics announced that it will present at the EASL Congress 2025. The presentations include New Analyses of Phase 2 MASH/T2DM Studies of Berberine Ursodeoxycholate (HTD1801) and Pre-Clinical Results of Rimtoregtide (HTD4010).
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Berberine Ursodeoxycholate (HTD1801) Consistently Demonstrates Comprehensive Benefits for Patients with Type 2 Diabetes Mellitus, Approaching NDA
ACN Newswire
April 16, 2025
HighTide Therapeutics Announces HTD1801 Meets the Primary Endpoints in Two Phase 3 Clinical Trials in Patients with Type 2 Diabetes Mellitus.
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InnoCare Announces the Acceptance of New Drug Application for pan-TRK Inhibitor Zurletrectinib in China
PharmaSources
April 16, 2025
InnoCare's zurletrectinib NDA for treating NTRK fusion - positive advanced solid tumors in adults and adolescents was accepted. It shows good efficacy and safety.
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InnoCare Announces First Patient Dosed in the Phase III Registrational Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for CLL/SLL Patients in China
PharmaSources
March 28, 2025
InnoCare announced the first patient dosed in the Phase III trial of ICP-248 combined with orelabrutinib for CLL/SLL. It's a potential treatment, with other trials advancing.
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InnoCare Releases 2024 Results and Business Highlights
PharmaSources
March 27, 2025
InnoCare announced 2024 annual results, including financials, R&D progress in oncology and autoimmune diseases, and globalization efforts.
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Kelun-Biotech's Radionuclide-Drug Conjugate (RDC) SKB107 Receives NMPA Approval For The Treatment of Bone Metastases in Solid Tumors
PR Newswire
March 26, 2025
Kelun-Biotech's RDC drug SKB107 got clinical trial approval for bone metastases. It's jointly developed, with expected advantages.