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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that its blockbuster nervous system drug Evrysdi (risdiplam) has received market approval from the National Medical Products Administration (NMPA) to treat spinal muscular atrophy (SMA) in patients aged 16 days and above. This marks an expansion of the drug’s indication in China,…
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced receiving clinical trial approvals for its novel anti-microbial agent MRX-4, combined with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in Israel, Bulgaria, Slovakia, Croatia, Poland, and Brazil. In-House Developed Oxazolidinone AntibioticsBoth MRX-4 and contezolid are in-house developed new-generation…
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has signed a three-year collaboration agreement with China-based Cholesgen (Shanghai) Co., Ltd. The partnership focuses on the research and development of new therapies for hypercholesterolemia and other metabolic diseases. The collaboration aims to validate genetic drug targets and advance therapeutic molecules into clinical…
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China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II clinical study in China for HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, in combination with its programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) for the treatment of metastatic…
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Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the results of the Phase III FRESCO-2 study for Elunate (fruquintinib) in previously treated metastatic colorectal cancer (mCRC) have been published in The Lancet journal. The global Phase III study, conducted across the US, Europe, Japan,…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the prestigious journal Nature Cancer has published the overall survival (OS) interim analysis from the registrational clinical study GEMSTONE-302. The study evaluates the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab as a first-line treatment for stage IV non-small cell lung cancer (NSCLC). GEMSTONE-302…
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The Bill & Melinda Gates Foundation has announced the renewal of its collaboration with the Beijing Municipal Government and Tsinghua University to support the Beijing-based Global Health Drug Discovery Institute (GHDDI) in its quest to develop therapies for infectious diseases. This renewed commitment will see the Gates Foundation contribute USD…
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Spain-based Grifols AS (NASDAQ: GRFS), a leading global player in the blood products industry, has announced its intention to sell a portion of its stake in China-based Shanghai RAAS Blood Products Co., Ltd (SHE: 002252). This strategic move is expected to yield up to USD 1.5 billion for Grifols AS,…
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China-based Jiangxi Jemincare Group has announced that it has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug, JYB1907, a monoclonal antibody (mAb) targeting GARP and TGF-β1, in patients with locally advanced malignant solid tumors. The drug had previously…
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China-based rare disease specialist Sperogenix Therapeutics Limited has entered into a partnership with compatriot firm LUCA Healthcare Limited Co., a company specializing in digital targeting and healthcare solutions, to bolster the application of digital therapy in myasthenia gravis. The collaboration aims to enhance the use of digital therapy in treating…
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The National Medical Products Administration (NMPA) has granted marketing approval to Suzhou MicroPort Joint Medical Technology Co., Ltd for its zirconium niobium alloy femoral head. This development marks a significant advancement in the field of orthopedic implants, offering a new option for patients undergoing total hip joint replacement surgery. Product…
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China-based Cytocraft Biotech Development has announced that its cell therapy, SDT-T002, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of advanced liver cancer that has failed standard treatment. Cascade Primed Immune Cells (CAPRI) Cell Therapy OverviewCytocraft boasts its Cascade Primed Immune Cells (CAPRI)…
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Sino-US Laekna (HKG: 2105) has successfully raised £791 million through an initial public offering (IPO) of 63,728,000 shares on the Hong Kong Stock Exchange, with each share priced at HKD12.41. Company Background and Core ProductsFounded in 2016, Laekna has established itself with two core products, both in-licensed from Swiss pharmaceutical…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib REFINE study for its drug candidate STC3141 in sepsis has successfully reached the clinical endpoint in Australia and Belgium. Design and Results of the Phase Ib REFINE StudyThe open-label, multi-center, dosage escalation Phase Ib clinical study was…
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China-based Everest Medicines (HKG: 1952) has announced the appointment of Dr. Mike Berry as Chief Technology Officer, effective immediately. With over 30 years of industrial experience, Dr. Berry brings a wealth of knowledge and expertise to Everest Medicines, particularly in advancing projects from the pre-clinical development phase to commercialization. Dr.…
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US-based AbbVie Inc., (NYSE: ABBV), the company behind the first-in-class Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), has taken legal action against BeiGene’s (NASDAQ: BGNE) BTK inhibitor Brukinsa (zanubrutinib). The lawsuit was filed by AbbVie subsidiary Pharmacyclics in the Delaware District Court on the day it was awarded a new…
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The Janssen subsidiary of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an additional indication application to the US Food and Drug Administration (FDA) for its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel). The application seeks approval for the treatment of relapsed or refractory multiple myeloma (r/rMM) in adults who have…
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Guangdong-based antibody drug developer Dartsbio Pharmaceuticals has partnered with the Shanghai Institute of Materia Medica (SIMM) to receive tacit clinical trial approval from the National Medical Products Administration (NMPA) for their antibody drug conjugate (ADC), DS001. The molecule is set to be assessed as a potential treatment for various advanced…
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China-based Hubei Guangji Pharmaceutical Co., Ltd. (SHE: 000952) has announced a strategic partnership with Jiangnan University to establish a joint innovation laboratory. The focus of this collaboration will be on advancing the key technologies of green manufacturing and biosynthesis of functional polysaccharides and functional proteins, including human milk oligosaccharides. Leveraging…