Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly...
Market approval filings
RemeGen’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation...
RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation...
LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal...
LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food...
Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it...
Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has...
Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
CORXEL, formerly known as Ji Xing Pharmaceuticals and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved...
Jiangsu Hengrui’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center...
Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical...
Johnson & Johnson’s Darzalex Combo Therapy Gets EMA Nod for Multiple Myeloma, Aims to Set New Standard
Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio...
Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104),...
Shanghai Fosun Pharmaceutical’s SBK010 Stroke Treatment Accepted for NMPA Review
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based...
Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted...
China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura...
Haisco Pharmaceutical’s HSK21542 for Itching in Dialysis Patients Receives NMPA Review
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that...
Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment
Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration...
Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in...
J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA)...