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Betta Pharmaceuticals’ BPI-460372 Accepted for Clinical Trial Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that its clinical trial filing for the Category 1 drug candidate BPI-460372 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for the drug is advanced solid tumors, marking a significant step forward in the development of…
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Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s first homegrown innovative HIV therapy, has been approved. The approval allows the drug to be administered via intravenous bolus, significantly reducing the administration time. Alfusid: World’s First Long-Acting HIV DrugAlfusid is described as the world’s…
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Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) new indication filing for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the multi-kinase inhibitor famitinib, is set to receive Breakthrough Therapy Designation (BTD) status. The combination is intended as a…
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China Approves GSK’s Juluca for HIV-1 Infection
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The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE: GSK) Juluca (dolutegravir/rilpivirine), a dual therapy for adult patients infected with human immunodeficiency virus type 1 (HIV-1). This approval marks a significant milestone, as Juluca is the first dual therapy approved by the FDA for…
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Hengrui Medicine Files for Dalpiciclib as Initial Therapy for Breast Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for its CDK 4/6 inhibitor, dalpiciclib (SHR6390), as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention…
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Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for its BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), has been accepted for review by the European Medicine Agency (EMA). This marks a significant step forward in the global development and…
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Brii Biosciences Reports Positive Phase I Results for HIV Treatments BRII-732 and BRII-778
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China-based Brii Biosciences Limited (HKG: 2137) has published the latest results of two Phase I clinical studies assessing its long-acting BRII-732 and BRII-778, both being developed to treat HIV infection, in healthy subjects in the US. The results showed that both BRII-732 and BRII-778 produced good safety and tolerability profiles…
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GenScript’s Legend Biotech Reports USD 55M in Carvykti Sales
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has revealed that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of September 30, 2022. The drug is being commercialized in the…
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YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval
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China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house developed insulin aspart (specification 3ml: 300 units, refill) has been approved for marketing by the National Medical Products Administration (NMPA). This approval marks a significant milestone in the company’s efforts to expand its presence in…
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Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China. Previous Approvals and…
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Mabwell Bioscience’s 9MW3011 Accepted for Review by China’s NMPA
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that its clinical filing for the Category 1 drug candidate 9MW3011 in β-Thalassemia and polycythemia vera has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of innovative treatments…
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Zhiyi Biotechnology Receives FDA Clearance for SK10 in Chemotherapy-Induced Diarrhea
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Guangzhou-based Zhiyi Biotechnology has announced receiving clearance from the US FDA for a clinical study of its SK10 (inactivated Bacteroides fragilis) in chemotherapy-induced diarrhea (CID). This marks a significant milestone in the development of live biotherapeutic products (LBPs) for addressing unmet medical needs. First-in-Class IND ApprovalNotably, this is the world’s…
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Abogen Biosciences Receives UAE Clinical Trial Approval for Omicron BA.4/5 mRNA Vaccine
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China’s Abogen Biosciences Co., Ltd, a developer of messenger ribonucleic acid (mRNA) drugs, has announced receiving clinical trial approval in the United Arab Emirates (UAE) for its mRNA COVID-19 vaccine targeting the Omicron BA.4/5 variants. This approval marks a significant step in the global fight against the evolving COVID-19 pandemic.…
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CSPC’s Generic Xofluza Gains NMPA Approval Amid Roche Patent Dispute
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has obtained market approval from the National Medical Products Administration (NMPA) for its generic version of Roche’s (SWX: ROG) Xofluza (baloxavir marboxil) on October 11, 2022. This approval marks a significant development in the availability of generic influenza treatments in China. However,…
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Gracell Biotechnologies Initiates Phase II Dosing for GC007g in B-ALL Patients
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China-based Gracell Biotechnologies Inc. has announced the first patient dosing in the Phase II portion of its registrational Phase I/II clinical study assessing GC007g for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. This milestone marks a significant step forward in the development of innovative treatments…
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Henlius Biotech Gains NMPA Approval for Phase I Trial of HLX60 in Solid Tumors and Lymphomas
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. This marks a significant step forward in the development of innovative treatments for these challenging…
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Sinocelltech’s COVID-19 Vaccines SCTV01C and SCTV01E Show Promising Phase III Results
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced the preliminary interim analysis results of a Phase III clinical study for its in-house developed recombinant COVID-19 vaccines. The study evaluated the bivalent (Alpha + Beta variants) S trimer protein vaccine SCTV01C and the quadrivalent (Alpha + Beta + Delta + Omicron…
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Jemincare’s Sonidegib Receives First Prescriptions in China for Basal Cell Carcinoma
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China-based Jiangxi Jemincare Group has announced the first prescriptions in China for its sonidegib, a smoothened (Smo) inhibitor used to treat basal cell carcinoma (BCC). The initial batch of prescriptions covers more than 50 special drug pharmacies and online platforms across the country. This marks a significant milestone in the…
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Haisco Pharma’s Ciprofol Injection Gains NMPA Approval for Gynecology Use
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving another marketing approval from the National Medical Products Administration (NMPA) for its Category 1 product, ciprofol injection, for use in gynecology outpatient sedation/anesthesia. This approval expands the indications for ciprofol, further solidifying its position in the anesthetic market. Drug…
