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Immuno Cure BioTech Launches Phase I HIV/AIDS Vaccine Study
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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 Suspends Generic Nesina Trading Due to IP Disputes
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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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Wuhan Binhui’s Oncolytic Virus Therapy Awarded Breakthrough Designation by CDE
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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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CDE Awards Priority Review to Eisai’s Lecanemab for Early Alzheimer’s Disease
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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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CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors
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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…
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Kelun Pharma’s Generic Jardiance Gains New Indication in China
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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:…
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NMPA Approves Keverprazan for Duodenal Ulcers and Reflux Esophagitis
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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…
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AIM Vaccine Gains Approvals for COVID-19 mRNA Vaccine Trials in Pakistan
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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…
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Innovent Biologics Initiates Phase III CLEAR Study for Picankibart in Psoriasis
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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…
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Frontera Therapeutics Initiates FT-002 Clinical Study for X-Linked Retinitis Pigmentosa
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Sino-US gene therapy specialist Frontera Therapeutics has announced the first patient dosing in a clinical study for its in-house developed gene therapy FT-002. This marks a significant milestone in the development of treatments for X-linked retinitis pigmentosa (XLRP), a genetic disorder affecting vision. FT-002: First-in-Class Gene TherapyFT-002 is a recombinant…
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Kanghong’s KH617 Receives Orphan Drug Designation for Glioblastoma
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving an Orphan Drug Designation (ODD) from the US FDA for its Category 1 drug candidate KH617 in glioblastoma. This designation is a significant milestone in the development of KH617, which is aimed at treating advanced solid tumors and…
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Luye Pharma’s BA2101 Begins Phase I Clinical Trial for Allergic Diseases
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China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its Category 1 product BA2101. This marks it as the first long-acting anti-IL-4Rα monoclonal antibody to enter the clinical trial stage in China. BA2101 is being developed to treat allergic diseases…
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CDE Accepts Clinical Trial Filing for Ranok’s First-in-Class BRD4 Degradation Drug RNK05047
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The Center for Drug Evaluation (CDE) website indicates that a clinical trial filing for RNK05047, a potential first-in-class small-molecule degrader targeting BRD4, by Hangzhou-based Ranok Therapeutics Co., Ltd, has been accepted for review. This marks a significant step forward in the development of innovative cancer treatments. Discovery and Mechanism of…
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Junshi Biosciences and Coherus Report Positive JUPITER-02 Trial Results for NPC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) and its US partner Coherus BioSciences Inc., (NASDAQ: CHRS) have announced positive findings from the final analysis of overall survival (OS) in the pivotal Phase III JUPITER-02 (NCT03581786) clinical study. The study assessed the programmed death-1 inhibitor Tuoyi (toripalimab) as a…
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Hengrui Pharmaceuticals Gains NMPA Approval for SHR-A1921 Clinical Study
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921 combined with adebrelimab (SHR-1316) in advanced solid tumors. This marks a significant step in the development of…
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Zelgen’s ZG2001 and ZG0895 Clinical Trials Approved by NMPA
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that separate clinical trial filings for its Category 1 product candidates ZG2001 and ZG0895 have both been accepted for review by the National Medical Products Administration (NMPA) in China. This marks a significant milestone in the development of these innovative drug…
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Innovent Biologics Initiates Phase II Study for IBI311 in Thyroid-Associated Ophthalmopathy
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China-based Innovent Biologics Inc., (HKG: 1801) has announced the first patient dosing in a Phase II clinical study for its IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in thyroid-associated ophthalmopathy (TAO). IBI311 is an IGF-1R-targeting monoclonal antibody independently developed by Innovent, marking a significant step in the…
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Kangtai Biological Begins Phase I Trial for Tetravalent Influenza Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the first subject enrollment in a Phase I clinical study for its tetravalent influenza virus split vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against influenza, particularly for individuals aged…
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Jiangsu Recbio Completes First Tranche Enrollment for Shingles Vaccine REC610
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China-based Jiangsu Recbio Technology Co., Ltd has announced the completion of the first tranche of subject enrollment in a clinical study for its novel adjuvanted recombinant shingles vaccine, REC610. This milestone marks a significant step in the development of a vaccine designed to provide enhanced protection against shingles, particularly for…
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Beijing Wantai Initiates Phase I Study for 20-Valent Pneumonia Vaccine
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China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation and first subject enrollment in a Phase I clinical study for its 20-valent pneumonia vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against pneumonia. Vaccine Development and…
