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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…
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AstraZeneca’s Calquence Administered in Hainan Ahead of Official Approval
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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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CStone’s Sugemalimab Accepted for EU Marketing Authorization by EMA
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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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CDE Signals Priority Review for Sanofi’s Dupixent and Other Drugs
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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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InnoCare and Keymed Announce First Dosing of ICP-B05 Clinical Study
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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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Luye Pharma’s Paliperidone Palmitate Approved for European Clinical Trials
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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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Zai Lab to Present Zejula OS Study Results at ESMO Congress
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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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Zai Lab’s SUL-DUR NDA Accepted for Review by NMPA
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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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Abbisko’s ABSK121 Greenlit for Phase I Clinical Study by NMPA
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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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Shanghai Pharmaceuticals’ WST01 Receives FDA Clinical Clearance
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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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Huadong Medicine’s Patent Challenge Against Novo Nordisk’s Ozempic Heads to Hearing
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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…
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Neurophth’s NR082 Gene Therapy Completes Phase III Enrollment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced the completion of all-patient enrollment and dosing in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01), a recombinant adeno-associated virus serotype 2 (rAAV2) therapy for ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). This marks a significant milestone in the development…
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Insilico Medicine’s COVID-19 Drug ISM3312 Enters Clinical Trials
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China-based AI-powered drug discovery firm Insilico Medicine has announced that its ISM3312, an oral COVID-19 drug designed with the support of the firm’s Chemistry42 platform, has entered clinical trials after receiving approval from the National Medical Products Administration (NMPA). This marks a significant milestone in the development of innovative treatments…
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CDE Releases 67th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 67th batch of chemical generic reference preparations, marking a significant update to the existing list. This batch includes 18 new specifications and updates to 50 previously published specifications. The document is open for public feedback until March 6, 2023, ensuring transparency…
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CDE Releases Guidelines for Chemically Synthesized Peptide Research
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Pharmaceutical Research of Chemically Synthesized Peptides (Trial),” effective immediately. These guidelines aim to provide a comprehensive framework for the research and development of chemically synthesized peptide drugs, addressing their unique characteristics and requirements. Peptide Drugs: Background and CharacteristicsPolypeptides,…
