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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…
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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…
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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…
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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,…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…