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Jemincare’s Avatrombopag Market Filing Accepted for Review by China’s CDE
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China-based Jiangxi Jemincare Group has announced that its market filing for avatrombopag maleate (20mg) has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for the Category 4 chemical drug to treat chronic liver disease-associated thrombocytopenia (CLDT) in patients undergoing elective diagnostic procedures…
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Ascletis Receives FDA Approval for Phase IIa Trial of ASC10 in RSV Infection
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to conduct a Phase IIa clinical study for its investigational drug ASC10 in patients with respiratory syncytial virus (RSV) infection. ASC10 is an oral double prodrug designed to be rapidly and completely converted in vivo into…
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Daewoong Pharmaceutical Licenses Bersiporocin to CSP for Greater China Development
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South Korea-based Daewoong Pharmaceutical has entered into an exclusive licensing agreement with UK-based CS Pharmaceuticals (CSP) for its first-in-class PRS inhibitor, bersiporocin. Under the agreement, CSP will hold exclusive development and commercial rights to the drug in Greater China, including mainland China, Hong Kong, Taiwan, and Macau. The deal covers…
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Sirnaomics Accelerates STP705 Development After Positive Skin Cancer Trial Results
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Sirnaomics Ltd (HKG: 2257) is advancing the clinical development of STP705 following positive results from a Phase IIb study in cutaneous squamous cell carcinoma in situ (isSCC) and a Phase II study in basal cell carcinoma (BCC). The company is actively engaging with the US FDA to finalize the protocol,…
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Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
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China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline. BPI-460372: Targeting the Hippo Signaling…
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Novartis Q4 Results Show Growth in Innovative Medicines Amid Sandoz Spin-Off Plans
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has released its financial results for Q4 and the full-year 2022. Global net sales declined 2% year-on-year (YOY) in US dollar terms but increased 4% in constant currency terms to USD 50.545 billion. In Q4, sales expanded by 3% YOY to USD 12.69 billion.…
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Zhifei Renews Vaccine Supply Agreement with Merck Sharp & Dohme
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China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the renewal of a supply, distribution, and co-promotion agreement with Merck Sharp & Dohme (MSD, NYSE: MRK) for the US firm’s vaccine products. Under the renewed agreement, Zhifei aims to secure the supply of MSD’s human papillomavirus (HPV) and pentavalent…
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Abbott’s Q4 Sales Dip Amid COVID-19 Testing Decline, China Market Updates
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US-based Abbott (NYSE: ABT) released its Q4 2022 financial results last week, showing a 6.1% year-on-year (YOY) decline in global sales to USD 10.091 billion, excluding foreign exchange impacts. Over the full year, sales increased 6.4% YOY to USD 43.65 billion. Abbott Chairman and CEO Robert B. Ford highlighted the…
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Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
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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 breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung…
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Hengrui’s Camrelizumab-Apatinib Combo Approved for Liver Cancer in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). This marks the…
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Yiling Pharmaceutical’s G201-Na Accepted for Review by China’s NMPA for Prostate Cancer
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for G201-Na, a Category 1 chemical being developed to treat prostate cancer requiring androgen castration, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
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Zhaoke Ophthalmology’s Cyclosporine A Eye Gel Nears Market Approval in China
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Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced that its cyclosporine A eye gel for dry eye treatment has passed the market filing review and clinical trial on-site inspection by the National Medical Products Administration (NMPA). This milestone brings the firm’s…
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Sciwind Biosciences Initiates Phase III Trial for Ecnoglutide in Type 2 Diabetes
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Hangzhou-based Sciwind Biosciences Co., Ltd has announced the first subject dosing in a Phase III clinical study for its ecnoglutide (XW003), a novel, long-acting glucagon-like peptide-1 (GLP-1) analog, in adult patients with type 2 diabetes in China. The trial marks a significant milestone in the development of this innovative therapy,…
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Beijing HSA Sets Price for Hainan Simcere’s COVID-19 Therapy SIM0417
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Beijing’s municipal Healthcare Security Administration (HSA) bureau has released details of the initial quote and Chinese market price for Hainan Simcere Pharmaceutical Co., Ltd’s recently approved small-molecule COVID-19 therapy, SIM0417. The drug will be launched at RMB 750 (USD 111) per box, with an ex-factory price including tax (or CIF…
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Qilu Pharmaceutical’s Biosimilar Lucentis Accepted for Review by China’s CDE
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China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of Novartis’ (NYSE: NVS) Lucentis (ranibizumab) has been accepted for review by the Center for Drug Evaluation (CDE) in China. Qilu’s biosimilar is the most advanced version of Lucentis currently under development, positioning the company to…
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RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of…
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Luye Pharma Gains CDE Approval for Goserelin Acetate Microspheres Clinical Study
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China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its goserelin acetate sustained-release microspheres for injection (LY01022, three-month long-acting dosage form). The drug will be evaluated for treating prostate and breast cancers that are suitable for…
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Enkang Pharma Secures Series B Funding for DRIPs-Targeted Cancer Therapy
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Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd, a developer of DNA replication-initiation proteins (DRIPs)-targeted drugs, has reportedly raised “tens of millions” of renminbi in a Series B financing round. The round was solely led by CHER AMI Investment, with proceeds earmarked for new drug research and development. EN002 Gel: First-in-Class Cancer…
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CARsgen and Roche Partner on Clinical Study for Gastric Cancer Treatment
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation agreement with Swiss pharmaceutical giant Roche. The partnership will focus on a clinical study assessing the combination of CARsgen’s Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 with Roche’s PD-L1 therapy Tecentriq (atezolizumab) alongside standard chemotherapy for…
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Zennova Pharmaceuticals Completes Phase 1 of Chengdu Manufacturing and R&D Center
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Zennova Pharmaceuticals Group, a contract manufacturing organization (CMO) with operations in New Jersey, US, and Chengdu, China, has completed Phase 1 construction on a manufacturing site and R&D center in Chengdu, Sichuan province. The 300,000 square foot facility includes a multi-dosage formulation center, warehousing, and administrative buildings, marking a significant…
