Category Approved News

At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Dizal Pharmaceutical presented three latest research advances in non-small cell lung cancer (NSCLC), covering three products: Sunvozertinib (Sunvozertinib®), DZD6008, and Golidocitinib (Gaoreize®). Among these, the international multicenter Phase III…

At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the landmark positive overall survival (OS) results from the Phase III HARMONi-6/AK112-306 study of Akeso’s global first-in-class PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as a…

On June 1, local time, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for Camzyos (mavacamten) for the treatment of adolescent patients (aged 12 to under…

On June 1, local time, Amgen announced that the European Commission (EC) has approved its DLL3/CD3 bispecific antibody IMDYLLTRA® (tarlatamab) as a monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease…

Ciprofol Injection is a Category 1 intravenous anesthetic drug developed by Haisco with full independent intellectual property rights. In China, the drug was first approved for marketing in December 2020 and has since been approved for multiple indications, including sedation…

On June 2, 2026, Legend Biotech announced today that it will present, for the first time, preliminary clinical data for its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy LB2501 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) at…

Legend Biotech’s legendary status was first written by Carvykti (ciltacabtagene autoleucel). This BCMA CAR-T, licensed to Johnson & Johnson, has become the best-selling cell therapy product in the world.  In 2025, Carvykti’s sales surged 95.05% to reach $1.887 billion, and…

The Parkinson’s disease candidate drug from Biogen and Denali Therapeutics failed to significantly slow disease progression in a Phase IIb study, leading the partners to discontinue the drug. BIIB122, also known as DNL151, is an oral small-molecule LRRK2 inhibitor. LRRK2…

Following the failure of a Category 2.2 improved drug application for the same product, Zhejiang Baidai’s improved new drug, Amlodipine Besylate Granules, has once again received a rejection notice, shattering the industry’s wishful thinking. Amlodipine Besylate was originally developed by…

SHR4640, a Category 1 new drug independently developed, is the first domestically approved URAT1 selective inhibitor in China. It is indicated for the treatment of gout with hyperuricemia. URAT1 is a urate transporter specifically expressed in renal tubular epithelial cells,…