Eli Lilly’s Peresolimab and LOXO-783 Gain Tacit Clinical Trial Approvals in China
The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approvals to...
Drug
Hua Medicine Launches Dorzagliatin, a First-in-Class Diabetes Drug, in China
China-based Hua Medicine has announced the commercial launch of its Category 1 drug, dorzagliatin, with...
Yiming and Vitalgen’s Gene Therapy VGR-R01 Receives CDE Approval for Bietti Crystalline Dystrophy
China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai...
LianBio’s TP-03 Begins Phase III Trial for Demodectic Blepharitis in China
Shanghai-based biopharmaceutical company LianBio (OTCMKTS: LIANY) has announced the first patient dosing in a Phase...
Ascletis Files IND Application for COVID-19 Oral Inhibitor ASC11 with FDA
China-based Ascletis Pharma Inc. (HKG: 1672) has announced that the Investigational New Drug (IND) application...
RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II...
Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to...
China Grand’s STC3141 Reaches Primary Endpoint in ARDS Phase Ib Study
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study...
Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products...
Simcere’s SIM0235 Begins US Phase I Trial for Anti-Tumor Therapy
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in...
Novartis’ Cosentyx Gains Approval for New Doses in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications...
NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4)...
NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab),...
Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I...
Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of...
Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY)...
Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
Innovent’s Parsaclisib Filed for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics...
Proheal Pharmaceuticals Initiates Clinical Study for PHP1003 in Thyroid-Associated Ophthalmopathy
Proheal Pharmaceuticals, a Suzhou-based developer of drugs for ophthalmology and autoimmune diseases, announced the first...
HutchMed Initiates Phase II/III Study for Elunate and Tyvyt in Renal Cell Carcinoma
China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase...