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Jiangsu QYuns Therapeutics Gets NMPA Green Light for CSU Treatment QX013N
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its monoclonal antibody (mAb), QX013N. The drug is intended to treat chronic spontaneous urticaria (CSU), a common…
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Laekna’s ActRIIA Monoclonal Antibody LAE102 Gets Green Light from China’s CDE for Obesity Treatment
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Sino-US biotech firm Laekna has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its monoclonal antibody drug candidate, LAE102, intended for the treatment of obesity. This development follows the drug’s previous clinical trial approval in the US last month. In-house developed, LAE102…
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Novo Nordisk’s Q1 2024 Global Sales Surge 24% YOY on Strength of GLP-1 Therapies
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Denmark-based pharmaceutical giant Novo Nordisk (CPH: NOVO-B) reported a substantial 24% year-on-year (YOY) increase in global sales for the first quarter of 2024, reaching DKK 65.3 billion (USD 9.4 billion) at constant exchange rates (CER). The growth was primarily attributed to strong performances in glucagon-like peptide-1 (GLP-1)-based drugs and obesity…
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Jiangsu Hengrui Pharmaceuticals Advances HRS-5965 with NMPA Clinical Trial Approval for Glomerular Diseases
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has been granted approval by the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-5965, a novel therapeutic targeting primary or secondary glomerular diseases. The conditions include IgA nephropathy, idiopathic membranous nephropathy, C3…
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Innovent Biologics’ Mazdutide Shows Superiority in Type 2 Diabetes Phase III Trial
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase III DREAMS-2 study for mazdutide (IBI362), a dual agonist targeting both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), has met its primary endpoint in Chinese subjects with type 2 diabetes (T2D). The…
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Abbisko and Allist Pharmaceuticals Initiate Phase II Trial for NSCLC Drug Combination
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Abbisko Therapeutics Co., Ltd (HKG: 2256) and Allist Pharmaceuticals Co., Ltd have announced the upcoming start of a multi-center, open Phase II clinical study to evaluate the combination of Abbisko’s ABSK043 and Allist’s furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). The study aims to establish the optimal…
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Boehringer Ingelheim’s Anti-Sema3A BI 764524 Shows Promise in Diabetic Macular Ischemia Trial
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Boehringer Ingelheim (BI) has announced the publication of results from a Phase I/IIa clinical trial for its anti-Sema3A antibody candidate, BI 764524, used in the treatment of diabetic macular ischemia (DMI), a serious complication of diabetic retinopathy (DR) that can result in blindness. The trial successfully met its primary safety…
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Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
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This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year. In…
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J&J’s Erleada Plus ADT Shows 0% Biochemical Recurrence Rate in High-Risk Prostate Cancer Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The…
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Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in Macau has approved the New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC). This makes Macau the first region in Everest’s licensed territory in Asia to grant approval…
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Wanbangde Pharmaceutical’s Huperzine A Earns FDA Rare Pediatric Disease Designation for HIE Treatment
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China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced that its subsidiary, Wanbangde Pharmaceutical Group, has received a rare pediatric disease (RPD) designation from the US Food and Drug Administration (FDA) for its drug huperzine A. This designation is for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE), a…
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LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
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Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar (LEO 90100) in a Phase III clinical trial conducted in China. The trial focused on evaluating Enstilar as a potential treatment for Chinese patients with stable plaque psoriasis. The primary objective of the study was…
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Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
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Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
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Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
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Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
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Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
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Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
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Tonghua Dongbao Pharmaceuticals Commences Phase IIa Trial for Dual-Targeted Gout Drug Candidate
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a China-based pharmaceutical company, has announced that the first patient has been dosed in a Phase IIa clinical study for its dual-targeted drug candidate, THDBH151, which is being evaluated for the treatment of gout. THDBH151 is designed to target both xanthine oxidase (XO) and the…
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Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
