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Antengene’s ATG-008 Shows Promising Results in Cervical Cancer and Hepatocellular Carcinoma Studies
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Shanghai-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced positive preliminary results from the TORCH-2 study (NCT04337463) for its mTORC1/2 inhibitor ATG-008 (onatasertib) in combination with the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) for recurrent/metastatic cervical cancer. The company also released data from the TORCH study for ATG-008 monotherapy in…
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CStone Pharmaceuticals Launches AML Public Welfare Project with China Social Welfare Foundation
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The acute myeloid leukemia (AML) public welfare project, initiated by the China Social Welfare Foundation (CSWF) and sponsored by CStone Pharmaceuticals (HKG: 2616), has officially been launched. This initiative aims to raise awareness and support for AML, a disease that disproportionately affects the elderly and progresses rapidly. AML ContextAcute myeloid…
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Betta Pharmaceuticals’ BPI-D0316 Accepted for NMPA Review for NSCLC Adjuvant Therapy
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that its clinical trial filing for BPI-D0316, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been accepted for review by the National Medical Products Administration (NMPA). The filing is for the drug’s use as a postoperative adjuvant therapy for…
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Junovabio Secures Pre-Series A Funding for Tumor Molecular Diagnosis
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Junovabio, a Shanghai-based molecular diagnostics specialist, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The round was led by Shenzhen Jinsheng Equity Investment Management Co., Ltd. The proceeds will be used for the clinical filing of its first tumor molecular diagnosis product, product clinical…
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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Yabao Receives FDA Clearance for Generic Nexavar
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received Abbreviated New Drug Application (ANDA) clearance from the US FDA for its generic version of Nexavar (sorafenib), originally developed by German pharmaceutical giant Bayer. This approval marks a significant milestone for Yabao in expanding its presence…
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Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
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The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor…
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CDE Issues Guidelines for Bispecific Antibody Antitumor Drug Development
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Bispecific Antibody Antitumor Drugs.” These guidelines provide recommendations on critical issues in the clinical research and development (R&D) of bispecific antibodies (BsAbs), focusing on general principles rather than specific types. The guidelines are…
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CStone Launches Patient Assistance Program for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals (HKG: 2616) has announced the launch of a patient assistance scheme to support access to Tibsovo (ivosidenib), the world’s first-in-class IDH1 inhibitor used to treat leukemia. The initiative was launched this month by the Shanghai Life Oasis Public Service Center, with support from the Beijing Health Alliance Charitable…
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HutchMed Announces Initial Results from FRUTIGA Phase III Study
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initial results from the FRUTIGA Phase III study, which evaluated Elunate (fruquintinib) combined with paclitaxel in 703 Chinese patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The study aimed to assess the efficacy and safety of…
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Daxiang Biotech Raises RMB 100M in Pre-Series B Financing for Organoid-on-a-Chip
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Beijing-based Daxiang Biotech Co., Ltd., a leading domestic company in the organoid-on-a-chip field, has reportedly raised close to RMB 100 million (USD 14.18 million) in a Pre-Series B financing round. The round was led by Proxima Venture Capital, with participation from Qiandao Investment Fund, Shaanxi Growth Enterprise Guide Fund, and…
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Henlius Biotech’s BRAF V600E Inhibitor HLX208 Approved for Clinical Study in China
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical study for its BRAF V600E inhibitor HLX208. The study will evaluate the combination of HLX208 with HaiSiZhuang (serplulimab) plus standard therapies (cetuximab or trametinib) for the treatment of advanced…
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Peking University Study Identifies Liver Cancer Immune Microenvironment Subtypes
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Researchers at Peking University have uncovered several subtypes in the tumor immune microenvironment (TIME) relevant to liver cancer, according to a study published in Nature this week (title: Liver tumour immune microenvironment subtypes and neutrophil heterogeneity). The research focused on exploring the heterogeneity of the TIME and its impact on…
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Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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CStone’s PD-L1 Inhibitor Sugemalimab Achieves Primary Endpoint in Gastric Cancer Study
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that its GEMSTONE-303 study for the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab, combined with chemotherapy as a first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with PD-L1 expression ≥ 5%, has reached the primary endpoint of progression-free survival (PFS). This…
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BeiGene’s Brukinsa Receives Marketing Approval in Brazil
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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LianBio Initiates Phase I Study of SHP2 Inhibitor BBP-398 in China
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Sino-US biotech LianBio has announced the first patient dosing in a Phase I clinical study for its SHP2 inhibitor BBP-398 in Chinese patients with advanced solid tumors. This marks a significant step forward in the development of BBP-398, which targets the SHP2 protein-tyrosine phosphatase. SHP2 links growth factor, cytokine, and…
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Ascentage Pharma Gains CDE Approval for Phase I Study of APG-5918
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug…
