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Haisco Pharmaceutical Gets CDE Approval for HSK38008 Prostate Cancer Clinical Study
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug, HSK38008 oral preparation, in the treatment of prostate cancer. HSK38008: An Androgen Mutant AR-V7 Oral Degradation AgentHSK38008 is an androgen mutant…
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Yiling Pharmaceutical’s G201-Na Receives CDE Approval for Phase Ia Study in Prostate Cancer Treatment
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a single-center, randomized, double-blind, placebo-controlled, dosage escalation Phase Ia study. The study will assess the safety, tolerability, and pharmacokinetics of G201-Na in healthy adult males in China. G201-Na: A Small…
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Mabwell’s 9MW2821 ADC Shows Positive Signals in Solid Tumor Clinical Data
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data demonstrated positive therapeutic signals in multiple solid tumors and exhibited a good safety profile at the recommended Phase II dosage (RP2D). Mechanism of Action and Pharmaceutical…
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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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Evopoint Biosciences Partners with Merck for Phase Ib/II Study Combining XNW5004 and Keytruda
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China-based Evopoint Biosciences has announced a collaboration agreement with US major Merck Sharp & Dohme (MSD, NYSE: MRK). The agreement will permit Evopoint to conduct a Phase Ib/II clinical study assessing the combination of the EZH2 inhibitor XNW5004 with MSD’s anti-PD-1 drug Keytruda (pembrolizumab) in advanced solid tumors. XNW5004: A…
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CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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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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Shenzhen Hepalink’s Subsidiary Techdow USA Secures Distribution Rights for ANDA-Approved Drug
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) has announced that its wholly owned subsidiary, Techdow USA Inc., has entered into a distribution and supply agreement with compatriot firm Chia Tai Tianqing. The agreement centers on Chia Tai Tianqing’s ANDA-approved fosaprepitant dimeglutide in the United States, with Techdow being…
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BioNTech and Duality Biologics Ink Exclusive License Agreement for ADC Assets
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Germany-based BioNTech SE (NASDAQ: BNTX) and China-headquartered Duality Biologics (Suzhou) Co., Ltd have announced that they have entered into exclusive license and collaboration agreements focused on two of Duality’s antibody-drug conjugate (ADC) assets. BioNTech is set to acquire all development, manufacturing, and commercialization rights to these two assets globally, excluding…
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Johnson & Johnson’s Talquetamab on Track for Breakthrough Therapy Designation in Multiple Myeloma
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China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s (J&J, NYSE: JNJ) GPRC5D/CD3 bispecific antibody (BsAb) talquetamab is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory (R/R) multiple myeloma (MM) in patients who have undergone at least…
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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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Konruns Pharmaceutical Reports Positive Efficacy Results for KC1036 in Advanced ESCC
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the publication of efficacy study results for its Category 1 chemical drug, KC1036, in the treatment of advanced esophageal squamous cell carcinoma (ESCC). The drug was evaluated as a second-line therapy for patients who have already failed previous standard treatments. Study…
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Abbisko Therapeutics Secures Orphan Drug Designation for FGFR4 Inhibitor ABSK012
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its next-generation FGFR4 mutant inhibitor, ABSK012, intended for the treatment of soft-tissue sarcoma. Preclinical Efficacy of ABSK012 Against FGFR4 MutantsPreclinical studies have…
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HutchMed Completes NDA Submission to US FDA for Frquintinib in Metastatic CRC
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor of VEGFR-1, -2, and -3, fruquintinib. The drug is proposed for the treatment of refractory metastatic…
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Ablaze Pharma Charts Path for GPC3-Targeted Polypeptide with RayzeBio Partnership
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Ablaze Pharma, a Chinese biopharmaceutical company, has announced its development plan for a GPC3-targeted polypeptide drug candidate, as part of an ongoing licensing deal with US-based RayzeBio. The agreement aims to develop and commercialize the product in Greater China, expanding Ablaze’s portfolio and strengthening its commitment to cancer therapies. Licensing…
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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…
