Priority Review Status Anticipated for HH-003, BI655130, VIS649, and Remternetug by CDE
The Center for Drug Evaluation (CDE) website has indicated that Huahui Health’s HH-003, Boehringer Ingelheim’s...
Drug
Bristol-Myers Squibb Launches Zeposia in China for Multiple Sclerosis Treatment
Global pharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced the market launch in China...
Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from...
JW Therapeutics’ Carteyva Receives NMPA Approval for Moderate-to-Severe SLE Clinical Trial
China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National...
Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig...
FDA Issues Complete Response Letters to Six Novel Drugs in Q1 2023
According to an analysis, the US FDA issued complete response letters (CRLs) to six novel...
Yiling Pharmaceutical’s XY0206 Advances to Phase III Trial for FLT3-ITD AML
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase...
MicuRx Pharmaceuticals Initiates Phase III Study for MRX-4 in Diabetic Foot Infection Treatment
Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study...
TYK Medicines Secures FDA Approval for Next-Generation TKI Clinical Trial
China-based TYK Medicines, Inc. has announced that it has received clinical trial approval from the...
Yifan Pharmaceutical Receives NMPA Approval for Hyruan ONE in Knee Osteoarthritis Treatment
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced receiving market approval from the National...
Yantai Dongcheng Pharmaceutical Gets Singapore Regulatory Approval for 177Lu-LNC1004 Phase I Study
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving the green light...
Vcanbio Receives CDE Approval for VUM02 Clinical Trial in Idiopathic Pulmonary Fibrosis
China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial...
Haisco Pharmaceutical Gets CDE Approval for HSK38008 Prostate Cancer Clinical Study
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for...
Yiling Pharmaceutical’s G201-Na Receives CDE Approval for Phase Ia Study in Prostate Cancer Treatment
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for...
Mabwell’s 9MW2821 ADC Shows Positive Signals in Solid Tumor Clinical Data
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its...
AffaMed Digital Initiates Clinical Study for AMD201 at Beijing Tiantan Hospital
AffaMed Digital, a company wholly owned by AffaMed Technologies—a joint venture between AffaMed Therapeutics and...
Corxel Pharmaceuticals’ OC-01 Nasal Spray Approved as Urgently Needed Drug in Hainan
Shanghai-based Corxel Pharmaceuticals (CORXEL), supported by RTW Investments, has announced that its OC-01 (varenicline) nasal...
Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National...
Everest Medicines’ Nefecon NDA Accepted for Review by Singapore’s HSA
China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore...
Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects...