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J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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AbelZeta and AstraZeneca’s C-CAR031 Shows Promising Results in HCC Treatment
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AbelZeta, a Sino-US biotech company with operations in Rockville, Maryland, and Shanghai, has presented data for its armored autologous GPC3-targeted chimeric antigen receptor (CAR) T cell therapy candidate, C-CAR031, at the American Society of Clinical Oncology (ASCO) annual meeting. The CAR-T therapy, co-developed with AstraZeneca (NASDAQ: AZN), is currently in…
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InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
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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 Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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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 Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
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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 Bio Receives Ethical Approval for Oral Helicobacter pylori Vaccine Trial in Australia
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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 Receives NMPA Approval for Phase III Clinical Trial of RSV Vaccine SP0125
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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’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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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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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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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’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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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’ MRX-8 Achieves Positive Results in Phase I Clinical Study
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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’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
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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 Expands Licensing Deal with Summit Therapeutics for Ivonescimab Bispecific Antibody
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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 Gets Green Light from NMPA for AINUOVirine APIs
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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’ Botox Secures New Indication for Masseter Muscle Protrusion in China
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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’s Carvykti Shows Durable Responses in Multiple Myeloma Patients Post ASCT
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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 Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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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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Akeso Biopharma’s Ivonescimab Outshines Keytruda in NSCLC Trial, Raises FDA Concerns
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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 and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
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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…
