-
CDE Releases Guidelines for Chemically Synthesized Peptide Research
•
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’ PD-1 Inhibitor Tuoyi Shows Promise in Phase III TNBC Study
•
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…
-
Luoxin’s Tegoprazan Gains NMPA Review for Duodenal Ulcer Treatment
•
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…
-
Shanghai Pharmaceuticals’ X842 Accepted for NMPA Review for Reflux Esophagitis
•
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 Seeks UK MHRA Approval for PD-1 Inhibitor Tuoyi
•
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…
-
Chinagene Tech Initiates ZVS101e Gene Therapy Trial for Bietti’s Crystalline Dystrophy
•
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…
-
Ascletis Pharma’s ASC10 Shows Promising Phase I Results at CROI 2023
•
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…
-
Zhaoke’s Generic Bimatoprost + Timolol Maleate Eye Drops Approved in China
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) former subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a significant milestone. The company’s generic version of AbbVie’s (NYSE: ABBV) bimatoprost and timolol maleate eye drops has been granted approval in China. This approval is for use in lowering the intraocular pressure of patients…
-
Sino Biopharmaceutical’s Limaprost Approved by NMPA for Lumbar Spinal Stenosis Treatment
•
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug limaprost. This therapeutic drug targets analgesia and microcirculation, addressing a significant health issue among the country’s population. Lumbar Spinal Stenosis: A Prevalent ConditionTubular stenosis, particularly lumbar spinal…
-
Biosyngen’s BRG01 Gets FDA Nod for NPC Clinical Study
•
Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative…
-
BRL Medicine Achieves First Cure of Thalassemia Major with BRL-101
•
Shanghai-based BRL Medicine Inc. has announced a significant breakthrough in the treatment of thalassemia major. The company reported the first cure in a multi-center Phase clinical study assessing the safety and efficacy of its BRL-101, an autologous hematopoietic stem progenitor cell therapy. This marks a major milestone in the development…
-
Immuno Cure BioTech Launches Phase I HIV/AIDS Vaccine Study
•
China-based Immuno Cure BioTech has announced the initiation of a Phase I clinical study for its ICVAX, a therapeutic vaccine against HIV/AIDS, in Shenzhen. This marks a significant step forward in the development of innovative treatments for HIV/AIDS, a condition that affects millions of people globally. Study Design and ObjectivesThe…
-
Zhejiang Suspends Generic Nesina Trading Due to IP Disputes
•
Zhejiang’s Provincial Center for Drug & Medical Device Procurement has issued a notification suspending the online trading qualifications for generic versions of Takeda’s (TYO: 4502) Nesina (alogliptin). The notice specifically targets products manufactured by Jiangsu Zhongtian Pharmaceutical Co., Ltd and Sinopharm Guorui Pharmaceutical Co. Ltd. This suspension is part of…
-
Wuhan Binhui’s Oncolytic Virus Therapy Awarded Breakthrough Designation by CDE
•
The Center for Drug Evaluation (CDE) website indicates that China-based Wuhan Binhui Biotechnology Co., Ltd’s GM-CSF oncolytic herpes simplex virus type II (OH2) for injection (Vero cells) has been awarded breakthrough therapy designation (BTD) status. This designation is for the treatment of patients with unresectable or metastatic melanoma who have…
-
CDE Awards Priority Review to Eisai’s Lecanemab for Early Alzheimer’s Disease
•
The Center for Drug Evaluation (CDE) website indicates that Japan-based Eisai’s (TYO: 4523) lecanemab has been awarded priority review status. The drug falls under the category of “clinically urgent shortage drugs and innovative and modified drugs for the prevention and treatment of major infectious diseases and rare diseases.” This designation…
-
CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors. NBL-020: Anti-Tumor Necrosis Factor Type…
-
Kelun Pharma’s Generic Jardiance Gains New Indication in China
•
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has obtained another indication approval in China for its generic version of BI/Eli Lilly’s Jardiance (empagliflozin). The hypoglycemic agent can now be used to reduce the risk of hospitalization due to heart failure in adult patients with symptomatic chronic heart failure. Jardiance:…
-
NMPA Approves Keverprazan for Duodenal Ulcers and Reflux Esophagitis
•
The National Medical Products Administration (NMPA) has granted approval to Jiangsu Carephar Pharmaceutical Co., Ltd’s Category 1 drug, keverprazan, for the treatment of duodenal ulcers and reflux esophagitis in China. This approval marks a significant advancement in the treatment options available for these gastrointestinal conditions. Keverprazan: A New Potassium Competitive…
-
AIM Vaccine Gains Approvals for COVID-19 mRNA Vaccine Trials in Pakistan
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving separate approvals in Pakistan to initiate a Phase I clinical study for its mRNA vaccine against COVID-19 variants and a Phase III study for its mRNA vaccine against the COVID-19 prototype as a sequential booster. This marks a significant step…
-
Innovent Biologics Initiates Phase III CLEAR Study for Picankibart in Psoriasis
•
China-based Innovent Biologics (HKG: 1801) has announced the first subject dosing in the Phase III CLEAR study for its picankibart (IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection, in moderate-to-severe plaque psoriasis. This marks a significant advancement in the development of innovative treatments for this chronic skin condition. Phase…
