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Yantai Dongcheng Pharmaceutical’s 177LuLNC1011 Gets FDA Green Light for Prostate Cancer Clinical Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its prostate specific membrane antigen (PSMA)-targeted radioactive in vivo therapeutic drug, 177LuLNC1011. The molecule is intended for evaluation…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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Boao Lecheng Approves Use of Sanofi’s Tzield as First-Line Therapy for Type 1 Diabetes Delay
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Tzield (teplizumab), recognized as the world’s first and only targeted therapy for delaying the onset of type 1 diabetes, has received approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. Developed by French pharmaceutical giant Sanofi, Tzield is indicated for use…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
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Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
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China’s Sichuan Huiyu Pharmaceutical Halts Generic Cytosar Launch Following Strategy Review
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a pharmaceutical company based in China, has announced the withdrawal of its market filing for a generic version of Cytosar (cytarabine), a drug originally developed by US firm Viatris. The decision to withdraw the filing, which was initially submitted in September 2022, is…
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Eisai and Biogen Launch Alzheimer’s Drug Leqembi in China Following Market Approval
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
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Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
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Jiangsu Hengrui’s Henagliflozin Gains Expanded Indication for Type 2 Diabetes Treatment in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to…
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Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
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Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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Staidson Pharmaceutical’s Bemiltenase Alfa Earns Orphan Drug Designation from US FDA for Hemophilia Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Category 1 biologic bemiltenase alfa (STSP-0601). This designation is for the treatment of hemophilia A or B.…
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Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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Henlius Pharmaceutical’s HLX15 Biosimilar Meets Phase I Clinical Endpoints
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the…
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CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Johnson & Johnson Achieves Positive Phase III Results for Nipocalimab in Generalized Myasthenia Gravis
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results from the Phase III trial for nipocalimab, a potential first-in-class anti-FcRn (neonatal Fc receptor) antibody, for the treatment of generalized myasthenia gravis (gMG). The company has achieved its primary endpoint and is preparing for regulatory…
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Bio-Thera Solutions’ BAT2094 Wins NMPA Nod for Acute Coronary Syndrome Treatment
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Takeda’s CEO Weber Eyes Further Partnerships with Chinese Biotechs Amid Innovation Surge
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Takeda Pharmaceutical Co., (TYO: 4502, NYSE: TAK), a leading Japanese pharmaceutical company, is actively seeking potential partnerships with Chinese biotech firms, according to CEO Christophe Weber in a recent Bloomberg interview. Weber highlighted that despite finalizing two recent agreements with Chinese companies, Takeda is still “very open” to further collaborations,…
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Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating…
