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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…
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CSPC Pharmaceutical Receives FDA Approval for Phase I Study of CPO301 in Lung Cancer
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by…
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Shanghai Fosun Pharmaceutical Gets NMPA Approval for FCN-338 Phase II Study
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the…
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Changzhou Qianhong Bio-pharma Receives NMPA Approval for QHRD107 Phase II AML Study
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and/or azacitidine,…
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Cellular Biomedicine Group Initiates Phase III Study for AlloJoin in Knee Osteoarthritis
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has announced the initiation of a Phase III clinical study for its allogeneic human adipose mesenchymal progenitor cell injection, AlloJoin. This follows a successful randomized, double-blind, controlled multi-center Phase II clinical study, which included a 96-week follow-up and preliminarily demonstrated a…
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Fosun Pharmaceutical Gets NMPA Approval for FCN-159 Phase II Study in LCH
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study of its novel small molecule chemical drug, FCN-159. The study will evaluate the drug’s efficacy as a treatment…
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Shanghai Fosun Pharma Commences Phase III Trial for HER2-Targeted FS-1502
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent Chinese pharmaceutical company, has announced the start of a Phase III clinical study in the Chinese mainland for its HER2-targeted antibody drug conjugate (ADC), FS-1502. The study is focused on the treatment of HER2-positive unresectable, locally advanced, or…
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ImmVira’s MVR-C5252 Receives NMPA Approval for Glioma Treatment Development
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China-based biotechnology company ImmVira has received approval from the National Medical Products Administration (NMPA) for its potentially groundbreaking oncolytic virus product, MVR-C5252, which is under development to treat gliomas. This first-in-class product marks a significant step forward in the treatment of brain tumors. Global Context and PrecedenceIn June 2021, Japanese…
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Shanghai Bio-Heart Begins RADIUS-HTN Study for Iberis RDN System in France
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China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced the first patient enrollment in the RADIUS-HTN study for its Iberis renal radiofrequency denervation (RDN) system, marking a significant milestone in Bordeaux, France. Objectives and Design of the RADIUS-HTN StudyThe RADIUS-HTN study is designed to assess the performance of…
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Kintor Pharmaceutical Realigns Funds from COVID-19 Studies to Other Pipeline Candidates
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced a strategic change in the allocation of proceeds from previous subscriptions. The company has decided to redirect HKD 509 million (USD 64.8 million), initially intended for the clinical development and commercialization of proxalutamide, pyrilutamide, and AR-PROTAC GT20029, away from clinical studies for…
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CANbridge Pharmaceuticals Completes Enrollment in Phase II GBM Trial for CAN008
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Sino-US biopharma CANbridge Pharmaceuticals (HKG: 1228) has announced the completion of patient enrollment in a Phase II trial for its pipeline candidate CAN008 (asunercept) in combination with temozolomide for the treatment of glioblastoma multiforme (GBM). The multi-center, randomized, placebo-controlled study, which is potentially registrational, has recruited a total of 117…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Gain Clinical Trial Approvals
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Secure Clinical Trial Approvals for Solid Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Sihuan Pharmaceutical’s KM501 Receives Clinical Trial Approval for HER2-Positive Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its XZP-KM501 (KM501) in solid tumors with HER2 positive, middle to low-expression. This marks a significant step forward in the development of innovative treatments for…
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4B Technologies’ FB1001 Receives CDE Approval for Clinical Trials
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China-based 4B Technologies Investments Ltd has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its potential first-in-class monoclonal antibody (mAb) FB1001 (ZG103). This marks a significant milestone in the development of the drug candidate, which was developed by the company’s founder, Dr.…
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RemeGen’s RC48 Receives Two Clinical Trial Approvals for Breast Cancer Treatments
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RemeGen Ltd (HKG: 9995) has announced the receipt of two clinical trial approvals for its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin). The Chinese firm is set to assess the drug as a neo-adjuvant therapy for HR-positive, HER2 low-expression breast cancer, either in combination with Junshi Bio’s (HKG: 1877, SHA:…
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Hengrui Pharmaceuticals’ HRS-5965 Receives NMPA Approval for Clinical Study in Hemolytic Anemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-5965. The study will focus on complement-mediated hemolytic anemia, including conditions such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic…
