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Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the commencement of a Phase I clinical study for its recombinant Group B meningococcal vaccine (Escherichia coli), marking a significant step in assessing the vaccine’s safety, tolerability, and preliminary immunogenicity. This product is the first of its kind to enter clinical…
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The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s (SHA: 688321) Epidaza (chidamide) has been granted priority status for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin,…
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib) and Tyvyt (sintilimab) has been granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with mismatch repair normal (pMMR) advanced endometrial cancer. These patients have previously failed at least one line of…
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the start of the long-term safety trial for KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). This in-house developed treatment has completed its first patient enrollment in China. Phase III Clinical Trial Design and ObjectivesThe…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication of Tuoyi (toripalimab). The drug is proposed to be used in combination with etoposide and platinum for the treatment of extensive stage small cell…
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Hangzhou Qihan Biotech Co., Ltd., a leading specialist in xenotransplantation based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its product QN-019a. This marks the first Investigational New Drug (IND) approval in China for a gene-edited induced pluripotent stem cell…
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced the first patient dosing in its Phase I ERASER study. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ATG-017 in combination with nivolumab for the treatment of advanced solid tumors. The trial is conducted…
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 investigational drug, HYP-2090PTSA. This small molecule drug candidate targets KRAS G12C and PI3K and is under review for potential use…
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France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has received marketing approval from the US Food and Drug Administration (FDA) for their codeveloped drug, Beyfortus (nirsevimab). The drug is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in…
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The National Medical Products Administration (NMPA) has released the 70th batch of reference drugs for the purpose of generic quality consistency evaluation (GQCE) work. This release is a part of ongoing efforts to ensure the quality and consistency of generic drugs in the market. Changes in the Official Version Compared…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its antibody drug conjugate (ADC), 7MW3711, which targets B7-H3. This ADC is set to be assessed as a potential treatment for advanced solid tumors. B7-H3’s Role in Cancer and 7MW3711’s…
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German pharmaceutical giant Bayer’s (ETR: BAYN) Kerendia (finerenone), the first nonsteroidal, selective mineralocorticoid receptor (MR) antagonist, has been officially launched in China for the treatment of type 2 diabetes-related chronic kidney disease (CKD). The drug received market approval in June 2022 and was included in the National Reimbursement Drug List…
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its small molecule pipeline candidate, SAL0119. The upcoming trial will evaluate SAL0119 as a potential treatment for rheumatoid arthritis, ankylosing spondylitis (AS),…
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its BAT4706, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb), in combination with its programmed death-1 (PD-1) inhibitor BAT1308. The study will focus…
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Shanghai Pharmaceuticals (HKG: 2607; SHA: 601607), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its recombinant human adenovirus type 5 in the treatment of malignant ascites. The filing for this trial was accepted for review…
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Nanjing Immunophage Biotech Co., Ltd, a China-based biotechnology company, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed Category 1 pipeline candidate, IPG11406. This small molecule is intended to be assessed as a treatment for systemic lupus erythematosus (SLE)…
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its Netherlands-based partner argenx SE (NASDAQ: ARGX) have announced preliminary positive results from the ADHERE study. The study assessed the effects of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial is the…
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III confirmatory study for the bispecific antibody Rybrevant (amivantamab). The study focused on patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that harbor epidermal growth factor receptor (EGFR) exon…
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment…