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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.…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the European Medicine Agency (EMA) has accepted a marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab, a programmed death-1 (PD-1) inhibitor. The application is for the use of sugemalimab in combination with chemotherapy as a first-line treatment for…
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The Center for Drug Evaluation (CDE) website indicates that France major Sanofi’s (NASDAQ: SNY) Dupixent (dupilumab), Sino-US biotech LianBio’s mavacamten, and Anhui Wotai Bio-pharmaceutical Co., Ltd’s sodium benzoate and sodium phenylacetate are on course to obtain priority review statuses. This development highlights the potential of these drugs to address significant…
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China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly announced the first subject dosing of a clinical study for ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody (mAb) developed by their joint venture, Tiannuojiancheng Pharma. This marks a significant milestone in the…
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for its paliperidone palmitate extended-release injectable suspension (LY03010). This approval marks a significant step forward in the development of this second-generation antipsychotic drug, which is designed for the treatment of schizophrenia and schizoaffective disorders. Paliperidone Palmitate:…
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China-based Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) is set to present two oral presentations highlighting the ad hoc interim overall survival (OS) study results for the poly (ADP-ribose) polymerase inhibitor (PARPi) Zejula (niraparib). The presentations will focus on the NORA Phase III study and a post hoc analysis from…
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China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application (NDA) for its sulbactam-durlobactam (SUL-DUR), a novel intravenous combination antibiotic used to treat patients with Acinetobacter infection (including multidrug-resistant and carbapenem-resistant strains), has been accepted for review by the National Medical Products Administration (NMPA). This…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out a Phase I clinical study for its ABSK121, a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor, in advanced solid tumors. This marks a significant…
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China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced receiving clinical clearance from the US FDA for its WST01, an oral micro-ecological live bacterial preparation for weight management. This marks a significant milestone in the development of innovative treatments for obesity. WST01: Product Profile and DevelopmentWST01, co-developed by the…
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February 23 will mark the oral hearing phase for the patent challenge case brought by Huadong Medicine Co., Ltd (SHE: 000963) against Novo Nordisk (NYSE: NVO) in relation to Ozempic (semaglutide), according to the China National Intellectual Property Administration (CNIPA). This legal proceeding is a significant development in the ongoing…