Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance

FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort

Kelun-Biotech’s Sac-TMT shows breakthrough results in first-line lung cancer trial

Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors

FDA supports new ANDA prioritization pilot to support US generic drugs

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis