•
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted a marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab, a programmed death-1 (PD-1) inhibitor. The application is for the use of sugemalimab in combination with chemotherapy as a first-line treatment for…
•
The Center for Drug Evaluation (CDE) website indicates that France major Sanofi’s (NASDAQ: SNY) Dupixent (dupilumab), Sino-US biotech LianBio’s mavacamten, and Anhui Wotai Bio-pharmaceutical Co., Ltd’s sodium benzoate and sodium phenylacetate are on course to obtain priority review statuses. This development highlights the potential of these drugs to address significant…
•
China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly announced the first subject dosing of a clinical study for ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody (mAb) developed by their joint venture, Tiannuojiancheng Pharma. This marks a significant milestone in the…
•
China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for its paliperidone palmitate extended-release injectable suspension (LY03010). This approval marks a significant step forward in the development of this second-generation antipsychotic drug, which is designed for the treatment of schizophrenia and schizoaffective disorders. Paliperidone Palmitate:…
•
China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) is set to present two oral presentations highlighting the ad hoc interim overall survival (OS) study results for the poly (ADP-ribose) polymerase inhibitor (PARPi) Zejula (niraparib). The presentations will focus on the NORA Phase III study and a post hoc analysis from…
•
China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application (NDA) for its sulbactam-durlobactam (SUL-DUR), a novel intravenous combination antibiotic used to treat patients with Acinetobacter infection (including multidrug-resistant and carbapenem-resistant strains), has been accepted for review by the National Medical Products Administration (NMPA). This…
•
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out a Phase I clinical study for its ABSK121, a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor, in advanced solid tumors. This marks a significant…
•
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced receiving clinical clearance from the US FDA for its WST01, an oral micro-ecological live bacterial preparation for weight management. This marks a significant milestone in the development of innovative treatments for obesity. WST01: Product Profile and DevelopmentWST01, co-developed by the…
•
February 23 will mark the oral hearing phase for the patent challenge case brought by Huadong Medicine Co., Ltd (SHE: 000963) against Novo Nordisk (NYSE: NVO) in relation to Ozempic (semaglutide), according to the China National Intellectual Property Administration (CNIPA). This legal proceeding is a significant development in the ongoing…
•
China-based gene therapy specialist Neurophth Biotechnology Ltd has announced the completion of all-patient enrollment and dosing in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01), a recombinant adeno-associated virus serotype 2 (rAAV2) therapy for ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). This marks a significant milestone in the development…
•
China-based AI-powered drug discovery firm Insilico Medicine has announced that its ISM3312, an oral COVID-19 drug designed with the support of the firm’s Chemistry42 platform, has entered clinical trials after receiving approval from the National Medical Products Administration (NMPA). This marks a significant milestone in the development of innovative treatments…
•
The Center for Drug Evaluation (CDE) has released the 67th batch of chemical generic reference preparations, marking a significant update to the existing list. This batch includes 18 new specifications and updates to 50 previously published specifications. The document is open for public feedback until March 6, 2023, ensuring transparency…
•
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Pharmaceutical Research of Chemically Synthesized Peptides (Trial),” effective immediately. These guidelines aim to provide a comprehensive framework for the research and development of chemically synthesized peptide drugs, addressing their unique characteristics and requirements. Peptide Drugs: Background and CharacteristicsPolypeptides,…
•
Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced significant progress in the Phase III TORCHLIGHT study for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The study, which combines Tuoyi with paclitaxel and albumin, has completed its pre-set interim analysis for initially-diagnosed stage IV or recurrent metastatic triple-negative breast…
•
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a leading China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a filing for another indication approval for its potassium-competitive acid blocker (P-CAB), tegoprazan. The drug is being reviewed for the treatment of duodenal ulcers, expanding…
•
China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for its Category 1 gastric acid blocker, X842. The targeted indication for this innovative drug is reflux esophagitis (RE), a condition affecting a significant number of patients…
•
Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biotech firm, has announced the submission of a market approval filing for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), to the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK. The company is seeking approval for the checkpoint inhibitor in…
•
Beijing-based Chinagene Tech, a specialist in hereditary ophthalmopathy diagnosis and gene therapy, has announced the enrollment and dosing of the first subject in a Phase I/II clinical study for its ophthalmology gene therapy ZVS101e in Tianjin. This study marks the first potentially regulatory clinical trial for a gene therapy targeting…
•
China-based Ascletis Pharma Inc. (HKG: 1672) has announced positive results from a Phase I clinical study for its oral double prodrug ASC10. The findings were presented at the CROI 2023 annual meeting, marking a significant step forward in the development of this promising therapeutic candidate. Phase I Clinical Data HighlightsThe…