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Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sjögren’s Disease
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year. Mechanism…
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AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Clinical Need and Approval SignificanceSCLC is a highly…
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HutchMed and Innovent Announce Positive Results for Fruquintinib and Sintilimab in Renal Cell Carcinoma Trial
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Chinese companies HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) jointly announced positive results from the Phase II/III FRUSICA-2 study. The trial evaluated the combination of fruquintinib and sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with…
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Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction
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German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for its Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The targeted indication is adult patients with heart failure (HF)…
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Livzon Pharmaceutical Receives Approval for Clinical Trials of Adjuvanted Influenza Vaccine LZSN2401
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) announced receiving clinical trial approval for its investigational adjuvanted quadrivalent influenza vaccine LZSN2401 in China. This marks a significant step forward in the development of more effective influenza prevention solutions. Vaccine InnovationLZSN2401 is positioned as the world’s first adjuvanted quadrivalent influenza vaccine to…
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Rona Therapeutics Initiates Phase II Study for RN0361 in Severe Hypertriglyceridemia
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Shanghai-based Rona Therapeutics Inc. announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its RN0361, an APOC3-targeted siRNA therapeutic. The study will assess the drug’s efficacy and safety in patients with severe hypertriglyceridemia (SHTG), mixed dyslipidemia, and familial chylomicronemia syndrome…
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Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its HRS-6213. This novel agent is designed for PET imaging to diagnose and evaluate solid tumors, marking a significant step forward in oncology diagnostics. Mechanism and ApplicationHRS-6213…
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Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. Drug…
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Merck & Co.’s Winrevair Approved for Pulmonary Arterial Hypertension in Hainan
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US-based giant Merck & Co., Inc. (NYSE: MRK) announced receiving approval from the Hainan Medical Products Administration for its Winrevair (sotatercept-csrk) to be imported by Shanghai Ruijin Hospital’s Hainan subsidiary. This approval is significant as it provides a new treatment option for patients with pulmonary arterial hypertension (PAH) in China.…
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Visirna Therapeutics Announces Positive Phase III Results for Plozasiran in FCS Treatment
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Shanghai-based Visirna Therapeutics announced positive topline results from the Phase III study of plozasiran in Chinese patients with familial chylomicronemia syndrome (FCS). The trial successfully met its primary efficacy endpoint and all key secondary endpoints, marking a significant advancement in the treatment of this rare lipid disorder. Study Details and…
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Basilea Pharmaceutica Marks Milestone as Cresemba Sales Soar in Asia Pacific
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Switzerland-based Basilea Pharmaceutica Ltd (SWX: BSLN) announced that its antifungal Cresemba (isavuconazole), commercialized by Pfizer Inc. (NYSE: PFE), has achieved significant sales milestones in the Asia Pacific region and China. This performance has triggered a milestone payment of USD2.5 million to Basilea. Drug Profile and CommercializationCresemba, co-developed with Japan’s Astellas…
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BMS’s Breyanzi Approved by EC for Relapsed or Refractory Follicular Lymphoma
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US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Clinical…
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Life Molecular Imaging Launches Neuraceq in Hong Kong for Alzheimer’s Detection
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Life Molecular Imaging Ltd., a subsidiary of South Africa’s Life Healthcare Group focused on PET radiopharmaceuticals, and St. Teresa’s Hospital, a private hospital in Hong Kong, announced the launch of Neuraceq (florbetaben (18F)) in Hong Kong this month. This marks a significant advancement in the diagnosis and management of Alzheimer’s…
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Frontera Therapeutics Receives NMPA Approval for FT-003 in Diabetic Retinopathy Study
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Sino-US firm Frontera Therapeutics, Inc. announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its FT-003, a recombinant adeno-associated virus (rAAV) gene therapy for diabetic retinopathy (DR). This follows previous approvals for studies in neovascular age-related macular degeneration (nAMD) and diabetic macular edema…
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Jiangsu Hengrui Pharmaceuticals’ Tegileridine Approved for Postoperative Pain Management
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its tegileridine. The Category 1 drug is now approved to treat postoperative moderate to severe pain. Drug Profile and MechanismTegileridine is a μ opioid receptor (MOR)-biased small-molecule agonist. It…
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Doma Biopharmaceutical’s HER3-MUC1 Targeted ADC DM002 Receives NMPA Clinical Approval
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug DM002. This marks a significant milestone in the development of the company’s innovative bispecific antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3) and mucin…
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Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
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China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
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Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug,…
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Simcere Pharmaceutical’s ADC189 NDA Accepted for Influenza Treatment
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Simcere Pharmaceutical Group Limited (HKG: 2096) and AnDiConBio announced that the New Drug Application (NDA) for ADC189, their co-developed anti-influenza drug, has been accepted for review by China’s National Medical Products Administration (NMPA). The drug is intended for treating uncomplicated influenza A and B in adults and adolescents. Mechanism and…
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Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
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Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
