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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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…
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The Center for Drug Evaluation (CDE) website indicates that the market filing by China-based Shenzhen ScienCare Pharmaceutical Co., Ltd for its naltrexone implant has been prioritized for review. The drug, used to prevent relapse among opioid-dependent patients after detoxification, was awarded priority status as a “breakthrough therapy.” This marks a…