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The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the submission of pre-Investigational New Drug (pre-IND) filings to China’s National Medical Products Administration (NMPA) for two of its mRNA vaccine candidates. These candidates target the respiratory syncytial virus (RSV) and herpes zoster, respectively. RSV infection…
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Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received ethical approval for a Phase I study for its oral recombinant Helicobacter pylori (HP) vaccine (Escherichia coli) in Australia. The company has completed the clinical trial filing for this proprietary product.…
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Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children. RSV is among the most…
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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MicuRx Pharmaceuticals (SHA: 688373), a Shanghai-based developer of antibacterial drugs, has announced the successful completion of a Phase I clinical study in China for its new drug candidate MRX-8, which targets gram-negative drug-resistant bacteria. The randomized, double-blinded, placebo-controlled Phase I study aimed to evaluate the safety, tolerability, and pharmacokinetic characteristics…
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced a supplementary licensing agreement with Summit Therapeutics Inc. (NASDAQ: SMMT) for ivonescimab, Akeso’s bispecific antibody (BsAb) that targets PD-1 and VEGF. The original agreement, valued at a potential USD 5 billion, was signed in December 2022 and granted…
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to manufacture the active pharmaceutical ingredients (APIs) for ainuovirine. The APIs correspond to ainuovirine tablets, which are a Category 1 oral therapy for…
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
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Legend Biotech Corporation (NASDAQ: LEGN) has announced results from the Phase II CARTITUDE-2 Cohort D study of its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in multiple myeloma (MM) patients. The data was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, along…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
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Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…