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US-based pharmaceutical company AbbVie (NYSE: ABBV) has revealed positive top-line results from the pivotal Phase III TEMPO-2 study for its tavapadon, the world’s first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson’s disease (PD). TEMPO-2 Trial Design and OutcomesThe TEMPO-2 trial assessed the efficacy, safety,…
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) unveiled the latest data from the Phase III BRUIN CLL-321 study for its Jaypirca (pirtobrutinib), an oral, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. BRUIN CLL-321 Study Design and Primary…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has confirmed reports regarding its intention to make a secondary listing on the Hong Kong Stock Exchange. According to a statement released on the Shanghai Stock Exchange, the Chinese pharmaceutical company is poised to engage Ernst & Young as its auditor, following approval…
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced the presentation of the latest data from the Phase I/II study for its bispecific antibody (BsAb) CM336, used for treating relapsed or refractory multiple myeloma (R/R M/M), at the 66th American Society of Hematology (ASH) Annual Meeting. Phase I/II Study Design and…
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China-based Antengene Corporation Limited (Antengene, HKG: 6996) announced the presentation of the latest results from two clinical studies for its Xpovio (selinexor) at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Phase III BENCH Study ResultsThe Phase III BENCH study evaluated the efficacy and safety of the selinexor,…
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic versions of Pfizer’s Xalatan (latanoprost), Novartis/ Alcon’s Travatan (travoprost), and Novartis/ Alcon’s Duotrav (travoprost, timolol). All three generic drugs…
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products Administration (NMPA) of China has accepted a marketing filing for its Category 2.2 chemical drug, SYHX2011. The drug is indicated for the treatment of metastatic breast cancer that has failed combined chemotherapy or has relapsed…
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. The study seeks an indication approval for GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who exhibit…
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China-based Hantech Medical Device Co., Ltd, a Contract Development Manufacturing Organization (CDMO) specializing in medical consumables, has announced the buyout of Becton, Dickinson and Company’s (BD) factory located in Villamarzana, Italy. This acquisition includes all assets such as land, factory buildings, and equipment. Concurrently, the US major has reached an…
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China-based Precision Biotech has announced a strategic partnership with compatriot firm T&L Biotechnology Co., Ltd. to collaborate on the development and supply of cell sorting magnetic bead reagents. This alliance aims to enhance the research and development (R&D) and commercialization efforts in the field of cell and gene therapies (CGT),…
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Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FireFalcon coronary spinous process balloon, a novel device designed to enhance vascular dilation in coronary intervention therapy. Challenges of Traditional Balloon Dilation TechniquesBalloon dilation…
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Shanghai-based HuidaGene Therapeutics has announced the first subject dosing of the HERO clinical trial, which is evaluating HG204, an RNA-editing therapy, for the treatment of MECP2 duplication syndrome (MDS). CRISPR RNA-Editing Therapy and Its MechanismThe CRISPR RNA-editing therapy utilizes a single adeno-associated virus vector to deliver HuidaGene’s proprietary high-fidelity RNA…
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the first patient dosing in a global clinical study for its Pol θ inhibitor, SIM0508, which targets advanced solid tumors. Global Phase I Study Design and ApprovalThe global multi-center, open-label Phase I study is designed to assess the…
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has entered into a significant patent and technology transfer agreement with South China Vaccine Corporation Limited (SCVC) for the development of influenza recombinant protein vaccines. Terms of the AgreementUnder the terms of the agreement, SCVC will grant Livzon Pharma the rights to its…
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China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec Co., Ltd (SHA: 603259) has announced that its wholly owned subsidiary, WuXi PharmaTech Healthcare Fund I L.P., is set to invest EUR 20 million (USD 21.12 million) by subscribing to A shares of Jeito II S.L.P. Jeito II S.L.P. Fund Managed…
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Chinese partners TJ Biopharma and Jumpcan Pharmaceutical (SHA: 600566) have jointly announced that the National Medical Products Administration (NMPA) of China has accepted a Biologic License Application (BLA) for eftansomatropin alfa (TJ101) for review. This product, the first and currently only fusion protein long-acting growth hormone, is anticipated to offer…
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug Administration (FDA) has accepted for review an additional indication filing for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The filing, which seeks approval for the treatment of muscle-invasive bladder cancer (MIBC), has also been…
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US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in…
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Swiss pharmaceutical major Novartis (NYSE: NVS) has released positive topline results from the APPULSE-PNH Phase IIIb study for its complement inhibitor Fabhalta (iptacopan). This study marks a significant milestone in the evaluation of Fabhalta’s efficacy and safety in treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH). APPULSE-PNH Study Design and…
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China-based Jiaxing Pharbers Genesis has reportedly raised RMB 100 million (USD 13.74 million) in a Series A2 financing round. The round was led by the Beijing Isotope and Radiation Innovative Industry Investment Fund, which was initiated by China National Nuclear Corporation (CNNC) and China Isotope and Radiation Corporation, with participation…