The EMA’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending European orphan drug designation for Hemispherian AS’s GLIX-1 for the treatment of glioma.
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
Erasca Inc. has obtained IND clearance by the FDA for ERAS-4001, an oral selective pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors.
Shanghai Circode Biomed Co. Ltd. has obtained IND clearance from the FDA for HM-2002 for ischemic heart disease. It previously received IND clearance in China in January this year.
Kexing Biopharm Co. Ltd. has announced IND clearances this month by China’s National Medical Products Administration (NMPA) and the U.S. FDA for GB-18, a biologic product for the treatment of cancer cachexia.
Avenzo Therapeutics Inc. has announced IND clearance by the FDA for AVZO-1418 (DB-1418), an EGFR/HER3 bispecific antibody-drug conjugate (ADC). A first-in-human phase I/II study will begin later this year and will evaluate AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.
Ascletis Pharma Inc. has announced IND clearance by the FDA for a phase I trial of ASC-50 for the treatment of mild to moderate plaque psoriasis. Dosing is expected to start in the third quarter of this year.
Avenzo Therapeutics Inc. has gained IND clearance from the FDA for AVZO-023 (formerly ARTS-023), a CDK4-selective inhibitor. The company also announced it has exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing and commercialization rights.
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
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