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Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the initiation of a randomized, double-blind, placebo-controlled Phase II clinical study. The study is designed to assess the safety and efficacy of its Category 1 drug OT-202, a tyrosine kinase inhibitor (TKI) intended for the treatment of dry eyes. This marks…
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German major Merck (NYSE: MRK) released its 2022 annual report this week, showing a robust expansion in global net sales. The company reported a 12.9% year-on-year (YOY) increase to EUR 22.2 billion (USD 23.6 billion), driven by growth across all business sectors. This performance underscores Merck’s continued strength in the…
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has announced positive results from a Phase II/III clinical study for its sARX788, an anti-HER2 monoclonal antibody-AS269 conjugate, in the treatment of breast cancer. The study, which assessed the drug’s efficacy and safety in HER2-positive local advanced or metastatic breast cancer, reached its…
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Indonesia. This marks a significant milestone in the global fight against COVID-19, as the company expands its vaccine’s availability to another…
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China-based 3SBio Inc. (HKG: 1530) has announced that a clinical trial filing for its nalfurafine oral disintegrating tablets (TRK-820) for the improvement of pruritus in patients with chronic liver disease has been accepted for review by the National Medical Products Administration (NMPA). This follows the previous acceptance for review of…
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its pipeline candidate JWATM214 in patients with advanced hepatocellular carcinoma (HCC). This first-in-human study is designed to evaluate the safety and tolerability, determine the recommended Phase II dose (RP2D), and evaluate the pharmacokinetic profile and preliminary…
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The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) have reached their primary endpoints. The studies focused on primary hypercholesterolemia and mixed hyperlipidemia, demonstrating significant lipid-lowering effects and good safety profiles. Clinical…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another market filing for its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab. The filing is for the drug’s use in combination with chemotherapy as a first-line treatment of locally advanced or metastatic gastric/gastroesophageal…
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical Products Administration (NMPA) for its VaxigripTetra, a tetravalent influenza virus split vaccine, for use in children aged 6 to 35 months. This approval is significant as children are a primary susceptible population to influenza, with…
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been approved by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Revolade (eltrombopag olamine tablets). The oral thrombopoietin receptor agonist can now be used to treat severe aplastic anemia (SAA) in patients with inadequate previous remission following immunosuppressive therapy. Revolade:…
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0176, an orally bioavailable chimeric degrader molecule targeting the androgen receptor protein. This marks a significant milestone in the development of innovative treatments for prostate cancer.…
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that its programmed death-1 (PD-1) inhibitor tislelizumab has been approved in China as a first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors where PD-L1 is overexpressed. Specifically, tislelizumab is approved for use in combination with fluorouracil plus…
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China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its first-in-class radionuclide drug conjugate (RDC) ITM-11 has been accepted for review. The intended indication for ITM-11 is gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking a significant step forward in the development of novel treatments…
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from the Therapeutic Goods Administration (TGA) of Australia for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb) for the treatment of various advanced malignant tumors and fibrotic diseases. This approval marks a significant step forward…
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UK major AstraZeneca’s (AZ, NASDAQ: AZN) blood cancer therapy Calquence (acalabrutinib) was first administered at the Hainan branch of Shanghai’s Ruijin Hospital this week. The drug is being made available ahead of official approval via the Hainan Bo’ao Lecheng medical pilot zone, offering patients early access to this innovative treatment.…