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Daiichi Sankyo Initiates Global Phase II Study of DS7300 for Small-Cell Lung Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced the first patient dosing in a global pivotal Phase II clinical study (S7300-127) assessing the efficacy and safety of its DS7300 (DS7300a), a potential first-in-class antibody drug conjugate (ADC), in patients with extensive small-cell lung cancer (SCLC) in China. DS7300 is an…
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Abbisko’s ABSK021 Gets CDE Approval for Phase III Study in Giant Cell Tumor of Tendon Sheath
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase III clinical study for its Category 1 drug, ABSK021. The randomized, double-blind, placebo-controlled, multi-center Phase III study is designed to assess the efficacy and…
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Livzon Launches National Rollout of COVID-19 Vaccine V-01 in China
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China-based Livzon Pharmaceutical Group (HKG: 1513) has announced the national promotion of its recombinant novel coronavirus fusion protein vaccine, V-01. The vaccine was first administered as a sequential booster shot in Guangdong on September 21. V-01 is being co-developed by Livzon subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co., Ltd and…
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Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of…
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MicuRx Pharmaceuticals Concludes US Phase I Study for MRX-8
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the conclusion of Phase I of its first-in-human study for MRX-8, a new drug targeting gram-negative drug-resistant bacteria, in the United States. The results demonstrated that at the expected clinical dose, MRX-8 exhibited an acceptable safety and pharmacokinetic profile in…
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Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar, Hanbeitai. The drug is now approved for the treatment of hepatocellular carcinoma (HCC), expanding its therapeutic applications in China. Previous Approvals and Therapeutic IndicationsHanbeitai was first…
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Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan Food and Drug Administration (TFDA) for its drug Xpovio (selinexor) in three indications. The approvals cover the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large…
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AIM Vaccine Receives CDE Approval for Serum-Free Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its investigational lyophilized human rabies vaccine (serum-free Vero cells). This approval marks a significant step forward in the company’s efforts to develop and commercialize innovative rabies vaccines. Vero Cells…
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Sinopharm’s Wuhan Institute Isolates Monkeypox Strains, Begins Vaccine Research
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China’s Wuhan Institute of Biological Products, a research affiliate of Sinopharm’s China National Biotech Group (CNBG), has announced that it has successfully isolated monkeypox strains from clinical samples. This development marks a significant step in the global effort to combat the infectious disease. Research has now begun on developing vaccines…
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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…
