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Visen Pharmaceuticals, a China-based joint venture between Denmark-headquartered Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has published primary data from a pivotal Phase III study for its lonapegsomatropin, also known as TransCon hGH, a once-weekly long-acting growth hormone. The study evaluated the efficacy and safety of lonapegsomatropin in…
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China-based biotech BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving marketing approval from the European Committee (EC) for a new indication of its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved across the region to treat adult patients with treatment-naïve (TN) or relapsed/refractory…
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical trial approvals for three in-house developed drug candidates: HRS-1780, HRS-1358, and SHR-7367. These approvals mark significant milestones in the company’s pipeline development, positioning Hengrui to advance innovative treatments for chronic kidney disease and advanced malignant tumors. HRS-1780 ProfileHRS-1780 is an…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that a supplementary market filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) has been accepted for review by the National Medical Products Administration (NMPA). The new indication filing is for the drug’s use as a thrombolytic therapy…
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its drug candidate HSK31858 obtained ethical approval at the First Affiliated Hospital of Guangzhou Medical University. The in-house developed Category 1 drug will be assessed for its efficacy and safety in a multi-center, randomized, double-blind, placebo-controlled Phase II study…
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China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced receiving Orphan Drug Designation (ODD) status for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system, for use in myasthenia gravis (MG). Myasthenia gravis is a rare and chronic autoimmune disease caused…
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for its in-house developed oral programmed-death ligand 1 (PD-L1) small molecule inhibitor ASC61. This approval will accelerate the global development of the drug, which is currently…
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained approval from the National Medical Products Administration (NMPA) to enter a Phase II clinical study in advanced or metastatic non-small cell lung cancer (NSCLC). The…
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China-based Jiangsu Hengrui Pharmceuticals (SHA: 600276) has announced positive results from the randomized, double-blind, placebo-controlled, multi-center RSJ10333 (QUARTZ3) Phase III study for SHR0302 in atopic dermatitis. The study, conducted by Hengrui’s subsidiary Reistone Biopharma Co., Ltd, has reached the pre-set primary efficacy endpoint. Study DetailsThe RSJ10333 study was designed to…
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its Category 1 innovative eye injection KH631 and a generic version of Acadia Pharmaceuticals Inc’s pimavanserin. The approvals are for the treatment of neovascular (wet) age-related macular…
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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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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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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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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb’s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene’s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info & Tech analysis. The approvals mark significant milestones for both drugs…
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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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China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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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…