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CSPC Pharmaceutical Initiates Phase III Study for Mitoxantrone Liposome in Nasopharyngeal Carcinoma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the first patient dosing in a randomized, open, positive controlled, multi-center Phase III study. The study is designed to assess the efficacy and safety of its mitoxantrone hydrochloride liposome in patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) when combined with…
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OcuMension Therapeutics Initiates Phase II Study for Dry Eye Treatment OT-202
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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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Merck Reports 12.9% Sales Growth in 2022 Annual Report
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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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Zhejiang Medicine’s ARX788 Shows Positive Results in Breast Cancer Study
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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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CanSino Biologics’ Inhalable COVID-19 Vaccine Gets EUA in Indonesia
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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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3SBio’s Nalfurafine Tablets Accepted for Review by NMPA for Chronic Liver Disease
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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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JW Therapeutics Initiates Clinical Study for JWATM214 in Advanced Hepatocellular Carcinoma
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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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Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
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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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Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
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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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Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
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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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Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
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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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Junshi Biosciences’ PCSK9 Inhibitor Ongericimab Meets Phase III Endpoints
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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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CStone’s PD-L1 Inhibitor Sugemalimab Accepted for Review in Gastric 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 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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Sanofi’s VaxigripTetra Approved for Pediatric Influenza Vaccination in China
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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 Approved in China for HER2-Positive Breast Cancer
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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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Novartis’ Revolade Approved for Severe Aplastic Anemia in China
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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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Accutar Biotech Begins Phase I Trial for AC0176 in China
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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’s Tislelizumab Approved for Gastric Tumors in China
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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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Grand Pharma’s First-in-Class RDC ITM-11 Accepted for IND Review
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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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Mabwell’s IL-11 Monoclonal Antibody 9MW3811 Approved for Australian Clinical Trial
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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…
