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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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TransThera and Akeso Biopharma Collaborate on HCC Study with Tinengotinib and Bispecific Antibodies
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Chinese companies TransThera Sciences (Nanjing) Inc. and Akeso Biopharma (HKG: 9926) have formed a strategic research collaboration to advance an open, multi-center Phase II study combining TransThera’s tinengotinib (TT-00420) with Akeso’s cadonilimab or ivonescimab for advanced hepatocellular carcinoma (HCC). The National Medical Products Administration (NMPA) has granted clearance for the…
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NMPA Approves Qingfeng’s Suraxavir Marboxil for Influenza A and B Treatment
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China’s National Medical Products Administration (NMPA) has approved suraxavir marboxil, a Category 1 drug developed by Qingfeng Pharmaceutical Group Co. Ltd’s subsidiary Jiangxi Kerui Pharmaceutical Co., Ltd, for the treatment of influenza A and B. The drug is intended for adolescents aged 12 and above as well as adults with…
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Huadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). This marks a significant step forward for the company in expanding its portfolio in autoimmune diseases. Drug Profile and Preclinical ResultsHDM3019…
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YiChang HEC’s Yiqibuvir Approved by NMPA for Chronic HCV Infection
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd. (HKG: 1558) announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug yiqibuvir. The non-structural protein 5B (NS5B) inhibitor is approved for use in combination with netanasvir in adult chronic hepatitis C virus (HCV) infections of genotypes…
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Hengrui Pharmaceuticals Gets NMPA Green Light for HRS-1738 and HRS-5817 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its two Category 1 chemical drugs, HRS-1738 and HRS-5817, targeting prostate cancer and overweight/obesity respectively. HRS-1738: Prostate Cancer Diagnostic InnovationHRS-1738 is an internally developed radiopharmaceutical designed for in…
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Sanofi’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
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French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate targeting the prevention of chlamydia infection. This designation represents a significant step forward in the development of the vaccine, which is designed to…
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Merck, Sharp & Dohme’s Capvaxive Approved by European Commission for Pneumococcal Prevention
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced the European Commission (EC) approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is approved to prevent invasive disease and pneumonia caused by 21 different Streptococcus pneumoniae serotypes in adults: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-9803 and SHR-A2102 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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Bio-Thera Solutions Inks Licensing Deal with Dr. Reddy’s for Biosimilar Commercialization
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories Ltd. (BSE: 500124). The deal centers on Bio-Thera’s BAT2206, a biosimilar version of Stelara (ustekinumab), and BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab). Dr. Reddy’s will gain exclusive rights to commercialize…
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Shanghai Junshi Biosciences’ Loqtorzi Approved in Singapore for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Singapore Health Sciences Authority (HSA) for its Loqtorzi (toripalimab). The anti-PD-1 monoclonal antibody (mAb) is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for recurrent, not amenable to surgery…
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Zhejiang Funow Medicine Launches Triple Cream for Melasma Treatment in China
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China-based Zhejiang Fonow Medicine Co., Ltd. (formerly known as: Zhejiang Rishengchang Pharmaceutical Co., Ltd.) has announced the official market launch of its fluocinolone acetonide, hydroquinone, and tretinoin cream in China for the treatment of melasma. This marks a significant advancement in the treatment landscape for this common pigmentation disorder. Innovative…
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Luye Pharma’s BA1302 Receives FDA Orphan Drug Designation for Lung and Pancreatic Cancer
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) has announced receiving orphan drug designation (ODD) from the US FDA for its novel antibody drug conjugate (ADC) BA1302. The designation covers two indications: squamous non-small cell lung cancer and pancreatic cancer. Innovative ADC DevelopmentBA1302,…
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AstraZeneca’s Calquence Approved by NMPA for CLL/SLL Treatment
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UK pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a monotherapy. This marks the third…
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Sichuan Huiyu Pharmaceutical Wins Marketing Approvals in Italy, Portugal, Saudi Arabia
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China-based Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553) has announced its its subsidiaries Seacross Pharma (Europe) and Seacross Pharmaceuticals Ltd. receiving a series of marketing approvals for its products in Italy, Portugal, and Saudi Arabia. The approved products include valproate concentrated solution, zoledronic acid, teicoplanin, and plerixafor. Valproate Concentrated SolutionValproate,…
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GSK’s Blujepa Approved by FDA for Uncomplicated Urinary Tract Infections
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its drug Blujepa (gepotidacin). The approval allows the use of Blujepa in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract…
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Guangzhou Doublle Bioproduct Receives IND Approval for E101 in Type 2 Diabetes
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Guangzhou Doublle Bioproduct Co., Ltd. has announced receiving Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for its E101, a human umbilical cord mesenchymal stem cells (HUC-MSCs) product. The approval allows the company to initiate clinical trials for the treatment of type 2 diabetes (T2D). Product…
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Sanofi’s Tolebrutinib Accepted for FDA Review in Non-Relapsing Secondary Progressive Multiple Sclerosis
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that a market filing for its tolebrutinib as a treatment for non-relapsing secondary progressive multiple sclerosis (nrSPMS) has been accepted for review by the US FDA. The agency is expected to make its decision by September 28, 2025. A regulatory submission is also under…
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Shanghai Henlius Biotech Receives NMPA Approval for HLX79 in Glomerulonephritis Trial
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China’s Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HLX79 (E-602) in combination with Hanlikang (rituximab biosimilar) for the treatment of active glomerulonephritis. Innovation and MechanismHLX79 is a first-in-class human sialidase fusion…
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Chia Tai Tianqing’s TQB2210 Approved for Advanced Malignant Tumor Study
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Chia Tai Tianqing’s Category 1 drug TQB2210 for clinical study in advanced malignant tumors. This marks a significant step forward for the company in the field of oncology. Drug Profile and InnovationTQB2210 is a human…
