Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023...
Drug
Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater...
Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase...
Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from...
Junshi Biosciences’ PCSK9 Inhibitor Ongericimab Meets Phase III Endpoints
China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that two randomized, double-blind, placebo-controlled, multi-center...
CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric Cancer
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has...
Sanofi’s VaxigripTetra Approved for Pediatric Influenza Vaccination in China
French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical...
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...
Novartis’ Revolade Approved for Severe Aplastic Anemia in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving another indication approval from the National...
Accutar Biotech Begins Phase I Trial for AC0176 in China
New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the...
BeiGene’s Tislelizumab Approved for Gastric Tumors in China
BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor...
Grand Pharma’s First-in-Class RDC ITM-11 Accepted for IND Review
China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND)...
Mabwell’s IL-11 Monoclonal Antibody 9MW3811 Approved for Australian Clinical Trial
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from...
AstraZeneca’s Calquence Administered in Hainan Ahead of Official Approval
UK major AstraZeneca’s (AZ, NASDAQ: AZN) blood cancer therapy Calquence (acalabrutinib) was first administered at...
CStone’s Sugemalimab Accepted for EU Marketing Authorization by EMA
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted...
CDE Signals Priority Review for Sanofi’s Dupixent and Other Drugs
The Center for Drug Evaluation (CDE) website indicates that France major Sanofi’s (NASDAQ: SNY) Dupixent...
InnoCare and Keymed Announce First Dosing of ICP-B05 Clinical Study
China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly...
Luye Pharma’s Paliperidone Palmitate Approved for European Clinical Trials
China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for...
Zai Lab to Present Zejula OS Study Results at ESMO Congress
China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) is set to present two oral presentations...
Zai Lab’s SUL-DUR NDA Accepted for Review by NMPA
China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application...