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Jiangsu Hengrui Pharmaceutials Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, announced that the National Medical Products Administration (NMPA) has accepted its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Global IL-17A Products…
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SynerK, a developer of RNA-targeted therapies with operations in Boston, US, and Beijing and Suzhou, China, has announced the completion of first patient dosing in its Phase I clinical study for an investigational small interfering RNA (siRNA). This marks the first time such a therapy has entered the clinical phase…
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Roche (SWX: ROG), the Swiss pharmaceutical and diagnostics giant, reported a 3% year-on-year (YOY) decrease in turnover at constant exchange rates (CER) to CHF 15.3 billion (USD 17.2 billion) in its Q1 2023 report. The decline was attributed to the appreciation of the Swiss franc and a predicted drop in…
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Hong Kong-based biopharmaceutical company SinoMab BioScience Ltd (HKG: 3681) has announced that its Phase III clinical study for the CD22 monoclonal antibody (mAb) SM03, also known as suciraslimab, has successfully reached the primary endpoint in patients with rheumatoid arthritis (RA). Study Design and Efficacy of SuciraslimabThe randomized, double-blind, multi-center, placebo-controlled…
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Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has announced that its multi-center, randomized, open, positive-controlled Phase III RENOTORCH study has reached pre-set endpoints at the interim analysis stage. The study evaluates the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with axitinib for the treatment of moderate to…
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its Phase III clinical study for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has successfully reached the primary endpoint in patients with HR+/HER2- advanced breast cancer that has progressed after previous endocrine therapy combined with fulvestrant. Positive Mid-Term Analysis…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading China-based pharmaceutical company, announced that its market filing for the Category 1 drug prusogliptin, intended for the treatment of type 2 diabetes, has been accepted for review by the National Medical Products Administration (NMPA). Clinical Study Results and Efficacy of PrusogliptinA clinical…
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Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that its histamine H1 receptor-targeted drug, Zerviate (OT-1001), has been granted priority review status by the National Medical Products Administration (NMPA). Zerviate’s Origins and Market PresenceZerviate, originally developed by France-based pharmaceutical firm Nicox SA, is an innovative formulation of…
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The National Medical Products Administration (NMPA) has released 10 notifications regarding revisions to package inserts for 11 drug varieties, impacting 47 products in total. The updates include changes to sections on adverse reactions, contraindications, and precautions. Marketing Authorization Holders (MAHs) are mandated to update the package inserts and labels within…
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced the submission of two market filings for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) for the treatment of primary hypercholesterolemia and mixed hyperlipidemia to the National Medical Products Administration (NMPA). Phase III and II Clinical Studies Support FilingsOngericimab is currently in…
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Shanghai-based gene therapy specialist Belief BioMed Group (BBM) has announced the completion of patient dosing in its Phase III registrational clinical trial (CTR20212816) for BBM-H901, a gene therapy for hemophilia B. The therapy is developed and manufactured in-house by Shanghai Belief-Delivery Biomed Co., Ltd., a wholly owned subsidiary of BBM.…
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), announced that its US partner Visus Therapeutics Inc., has published positive topline results from the pivotal Phase III BRIO-I trial. BRIO-I Trial Success and Regulatory MilestonesThe BRIO-I trial successfully met the pre-specified primary study endpoints that were agreed…
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced that it has received marketing approval from Bolivia’s State Agency of Drugs and Health Technologies (AGEMED) for its insulin glargine product, which comes in a pre-filled format. Insulin Glargine: A Long-Acting Insulin AnalogueInsulin glargine is a long-acting insulin…
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The UK-based pharmaceutical giant GSK plc (NYSE: GSK) has announced the official market launch of a two-dose schedule for its bivalent recombinant human papillomavirus (HPV) vaccine, Cervarix (types 16 and 18), targeting girls aged 9 to 14 in China. Cervarix’s Approval History and Expansion in ChinaCervarix was first approved in…
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China-based Everest Medicines (HKG: 1952) has announced that Nefecon (delayed-release budesonide), the first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN), has been approved by the Hainan Medical Products Administration for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary. This marks the beginning of a new treatment era for IgA nephropathy…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 product candidate, ZG2001. ZG2001 is an in-house discovered oral pan-KRAS mutation inhibitor under development for the treatment of KRAS mutant tumors. Prevalence…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct two clinical studies. One study will investigate the combination of its drug candidate BL-B01D1 with osimertinib (Tagrisso) for the treatment of locally advanced or metastatic non-small…
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its small-molecule HER2 inhibitor, pyrotinib. The drug is now approved for use in combination with Herceptin (trastuzumab) plus chemotherapy to treat recurrent or metastatic breast cancer…
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Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2).…
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ChengDu ShengNuo Biotech Co., Ltd (SHA: 688117), a China-based polypeptide specialist, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Shire’s Firazyr (icatibant). This marks a significant milestone as the company becomes the first manufacturer to file for Drug…