CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Daiichi Sankyo
USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
In a surprising turn of events in the ongoing intellectual property dispute, the US Patent...
Daiichi Sankyo and Esperion Therapeutics Amend Collaboration on Antilipidemic Drugs
Daiichi Sankyo (TYO: 4568)’s European subsidiary, a Japanese pharmaceutical company, has entered into a collaboration...
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
The US Food and Drug Administration (FDA) has accepted under priority review a filing from...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that...
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted...
Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for...
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...
FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO:...
Alibaba Health and Daiichi Sankyo Partner to Innovate in Digital Healthcare Services
China’s Alibaba Health Information Technology Ltd (HKG: 0241) has entered into a strategic partnership with...
AstraZeneca and Daiichi Sankyo’s Enhertu Gains New Indication Approval in China for HER2-Low Breast Cancer
Partners AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have announced that their co-developed...
Kite Pharma’s Yescarta Marketing Rights Transferred to Gilead Sciences K.K. in Japan
US immunotherapy specialist Kite Pharma, Inc. has announced that the Marketing Authorization for Yescarta (axicabtagene...
Enhertu, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and...
CNIPA Releases Patent Linkage Decisions, Paving Way for Generic Drugs in China
The China National Intellectual Property Administration (CNIPA) has released the latest batch of completed patent...
ImmVira’s MVR-C5252 Receives NMPA Approval for Glioma Treatment Development
China-based biotechnology company ImmVira has received approval from the National Medical Products Administration (NMPA) for...
Enhertu Approved in China for HER2-Positive Breast Cancer
Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and...
Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug...
Daiichi Sankyo’s Mirogabalin Nears China Market Entry with CDE Review
Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE)...