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Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
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Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
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Changshan Biochemical Gets Marketing Nod for Enoxaparin in Kyrgyzstan for Venous Thromboembolic Diseases
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval in Kyrgyzstan for its enoxaparin products, available in 0.4mL and 0.6mL dosages. Enoxaparin, originally developed by Sanofi, is recognized for its significant efficacy in preventing venous thromboembolic diseases following…
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Haisco Pharmaceutical’s PDE4B Inhibitor HSK44459 Gets NMPA Green Light for Interstitial Lung Disease Clinical Trial
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK44459. This phosphodiesterase 4B (PDE4B) inhibitor is now set to be evaluated for its efficacy in treating…
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Servier’s Voranigo Receives FDA Nod for IDH Inhibitor as Brain Tumor Treatment
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The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade…
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Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
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Walvax Biotechnology’s HPV Vaccine Price Cut Sparks Potential Market Price War in China
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Walvax Biotechnology Co., Ltd (SHE: 300142) has significantly reduced the price of its bivalent human papillomavirus (HPV) vaccine to a record low of RMB 27.5 per dose for domestic products, according to the Shandong Center for Disease Control and Prevention’s disclosure of the 2024 purchase transaction data for the vaccine…
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Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
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Hotgen Biotech’s SGC001 Receives NMPA Approval for Clinical Trials in Myocardial Infarction
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb), SGC001. This emergency use mAb is intended for the treatment of anterior ST segment elevation myocardial infarction…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
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Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical study for its insulin aspart 30 injection, a biosimilar version of Novo Nordisk (NYSE: NVO)’s pre-mixed NovoMix 30 used in…
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Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate LY03020, intended for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). LY03020 is developed using Luye’s innovative New Molecular…
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CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone…
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Takeda’s Vonicog Alfa Receives NMPA Approval for Von Willebrand Disease Treatment in China
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Takeda Pharmaceutical Company Limited (TYO: 4502 / NYSE: TAK), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for vonicog alfa, a recombinant von Willebrand factor (rVWF), for the on-demand treatment and control of bleeding events in adult patients…
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Shionogi Files for Chinese Approval of Cefiderocol to Combat Gram-Negative Bacterial Infections
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Shionogi Co., Ltd, a prominent Japanese pharmaceutical company, has announced the filing of a New Drug Application (NDA) in China for its innovative next-generation siderophore cephalosporin antibiotic, cefiderocol. The drug, marketed as Fetcroja or Fetroja in 10 different markets including Europe, Japan, and the United States, is now under consideration…
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Degen Biopharmaceutical’s DG01 PROTAC Drug Receives NMPA Clearance for Solid Tumor Studies
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Suzhou Degen Biopharmaceutical Co., Ltd, a leading specialist in PROteolysis TArgeting Chimeras (PROTAC) technology in China, has announced that its oral dual-targeted PROTAC drug, DG01, has been granted approval by the National Medical Products Administration (NMPA) to proceed with clinical studies for advanced or metastatic castration-resistant prostate cancer and liver…
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Chongqing Genrix’s GR1803 Earns Breakthrough Therapy Designation in China for RRMM Treatment
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The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously undergone…
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Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Innovent Biologics and Sanegene Bio Commence Phase I Clinical Trial for Hypertension siRNA Drug
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
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Walvax Biotechnology’s Bivalent HPV Vaccine Earns WHO Pre-Qualification Status
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China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has achieved a significant milestone with its bivalent human papillomavirus vaccine, which has received pre-qualification (PQ) status from the World Health Organization (WHO). This vaccine, designed to prevent cervical cancer and other diseases associated with high-risk HPV types 16 and 18, was commercially…
