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NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
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Guangdong Zhongsheng Pharmaceutical’s RAY1225 Shows Positive Results in Phase II Study
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line results from Part A of a Phase II clinical study for its Category 1 innovative polypeptide drug candidate, RAY1225. The drug demonstrated significant superiority over placebo in achieving weight loss targets and alleviating multiple cardiovascular…
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US FDA Grants ODD to Ractigen’s siRNA Therapy RAG-21 for ALS Treatment
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China-based small activating RNA (saRNA) drug developer, Ractigen Therapeutics, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate RAG-21. This FUS gene-targeted siRNA therapy is indicated for the treatment of amyotrophic lateral sclerosis (ALS), an incurable and…
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UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
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Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
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GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
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Brii Biosciences’ Elebsiran Shows Promising Results in Phase II ENSURE Study for Chronic HBV
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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218), an investigational small interfering ribonucleic acid (siRNA) therapy for chronic hepatitis B virus (HBV) infection. Phase II ENSURE Study Design and Initial FindingsThe active-controlled and randomized Phase II…
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Epigenic Therapeutics Receives Approval for EPI-003 Clinical Study in New Zealand
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Shanghai-based Epigenic Therapeutics, a biotechnology company specializing in the development of novel gene modulation therapies, has announced that it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and The Health and Disability Ethics Committees (HDEC) to conduct a clinical study for its investigational drug,…
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UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study
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Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a…
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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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Rona Therapeutics’ RN0191 Showcases Positive Phase I Results at AHA Scientific Sessions
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Shanghai-based nucleic acid drug developer Rona Therapeutics has announced the presentation of positive Phase I results for its investigational drug, RN0191, at the American Heart Association’s (AHA) Annual Scientific Sessions in Chicago, IL. The study’s findings highlight the potential of RN0191 in managing lipid levels and offer promising news for…
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Eli Lilly’s Tirzepatide Meets Primary Endpoints in Phase III SUMMIT Heart Failure Study
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Eli Lilly and Company (NYSE: LLY), a leading US pharmaceutical corporation, has announced positive results from the Phase III SUMMIT study assessing the effects of tirzepatide in heart failure. The study successfully met both primary endpoints, marking a significant advancement in the treatment of heart failure. Study Outcomes and EfficacyTirzepatide,…
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AstraZeneca’s Tagrisso Receives Positive CHMP Opinion for EGFR-Mutated NSCLC
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients…
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Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
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Eli Lilly’s Muvalaplin Demonstrates Potent Lp(a) Reduction in Phase II Study
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced positive results from a Phase II study for its investigational drug, muvalaplin, a selective lipoprotein(a) [Lp(a)] inhibitor. The study successfully met its primary endpoint, showing a significant reduction in elevated Lp(a) levels in adults, a genetic risk…
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Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate…
