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Mabwell Bioscience’s 9MW3011 Accepted for Review by China’s NMPA
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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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Zhiyi Biotechnology Receives FDA Clearance for SK10 in Chemotherapy-Induced Diarrhea
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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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Abogen Biosciences Receives UAE Clinical Trial Approval for Omicron BA.4/5 mRNA Vaccine
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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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CSPC’s Generic Xofluza Gains NMPA Approval Amid Roche Patent Dispute
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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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Gracell Biotechnologies Initiates Phase II Dosing for GC007g in B-ALL Patients
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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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Henlius Biotech Gains NMPA Approval for Phase I Trial of HLX60 in Solid Tumors and Lymphomas
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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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Sinocelltech’s COVID-19 Vaccines SCTV01C and SCTV01E Show Promising Phase III Results
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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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Jemincare’s Sonidegib Receives First Prescriptions in China for Basal Cell Carcinoma
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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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Haisco Pharma’s Ciprofol Injection Gains NMPA Approval for Gynecology Use
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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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ScienCare Pharma’s Naltrexone Implant Prioritized for Review by CDE
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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…
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Grand Pharma’s TLX591-CDx Approved for Prostate Cancer Diagnosis in China
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Investigational New Drug (IND) filing for TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the National Medical Products Administration (NMPA). This approval marks a significant step forward…
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Akeso Biopharma’s Cadonilimab Recommended as First-Line Treatment for Cervical Cancer
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China-based biotech Akeso Biopharma (HKG: 9926) has revealed that its cadonilimab (AK104) has been included as the first recommended treatment for second-line recurrent or metastatic cervical cancer in the Chinese Society of Clinical Oncology’s (CSCO) cervical cancer diagnosis and treatment guidelines (2022). This marks a significant milestone in the recognition…
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Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
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China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, has revealed that Yescarta (axicabtagene ciloleucel) has obtained priority review status for adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has…
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Genor Biopharma Initiates First Patient Dosing for GB263T in China
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May…
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Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
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China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for…
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Innovent Biologics Publishes Mazdutide Phase Ib Study Results for Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the results of the higher-dose cohorts in a Phase Ib study for mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in overweight or obese Chinese participants have been published online at eClinicalMedicine. Licensing Deal and Drug ProfileInnovent struck…
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BeiGene’s Brukinsa Receives Positive CHMP Opinion for CLL Approval
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). This recommendation is…
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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
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RemeGen’s Telitacicept Gains EU, China Approvals for Global Phase III Study
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China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative…
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Zelgen’s Jacktinib Shows Strong Efficacy in Phase III Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has published major data from a Phase III clinical study for its Janus kinase (JAK) inhibitor, jacktinib, in patients with medium- to high-risk myelofibrosis (MF). The results indicate an excellent efficacy and safety profile for the drug. A New Drug Application (NDA) for…
