•
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)…
•
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…
•
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…
•
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…
•
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…
•
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.…
•
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…
•
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…
•
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…
•
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…
•
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…
•
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…
•
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…
•
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,…
•
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,…
•
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…
•
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,…
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
•
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
•
Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU). Background…