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Mabwell Receives Approval for Clinical Study of 9MW3011 in Polycythemia Vera
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development. Drug Profile9MW3011…
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Henlius’ Serplulimab Phase III Study Approved in Spain for LS-SCLC
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy…
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Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include the treatment of cytomegalovirus retinitis…
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Kangtai Biological Completes Phase III Clinical Data Analysis for COVID-19 Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the completion of the analysis of key Phase III clinical data for its in-house developed COVID-19 inactivated vaccine (Vero cells). The study assessed the vaccine’s efficacy and safety in a global, multi-center, randomized, double-blind, placebo-controlled trial. Study DetailsThe Phase…
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Visen Pharmaceuticals Publishes Phase III Data for Lonapegsomatropin in Growth Hormone Deficiency
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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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BeiGene’s Brukinsa Receives EC Approval for CLL Treatment
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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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Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Three New Drugs
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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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CSPC Pharma’s rhTNK-tPA Accepted for Review by NMPA for Stroke Indication
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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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Haisco’s HSK31858 Gains Ethical Approval for Phase II Study in NCFBE
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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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CANbridge’s CAN106 Receives Orphan Drug Designation for Myasthenia Gravis
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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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Ascletis Pharma’s PD-L1 Inhibitor ASC61 Gains NMPA IND Approval
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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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Kelun Pharma’s SKB264 Advances to Phase II Study for NSCLC
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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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Hengrui Pharmceuticals’ SHR0302 Achieves Positive Results in Phase III Atopic Dermatitis Study
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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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Kanghong Pharma Gains NMPA Approval for Innovative Eye Injection KH631
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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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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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Kelun-Biotech’s SKB264 Receives FDA Approval for Phase II Study
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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 Approves BMS’s Reblozyl and BeiGene’s Brukinsa
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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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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…
