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...
Drug
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...
CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has...
Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases,...
OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512),...
Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase...
Nanjing Zenshine Pharmaceuticals’ ZX-7101A Meets Primary Endpoint in Phase II Influenza Study
China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd announced that a Phase II...