-
Chipscreen Biosciences Gains NMPA Approval for Epidaza Phase III Study
•
China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
-
Alphamab and CSPC Gain NMPA Approval for JSKN003 Phase III Trial in HER2-Positive Breast Cancer
•
Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in…
-
Gene Cradle’s GC310 Receives Tacit Approval from NMPA for Wilson’s Disease
•
Beijing-based gene therapy specialist Gene Cradle announced that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its GC310, an adeno-associated virus (AAV) gene therapy for hepatolenticular degeneration, also known as Wilson’s disease. This approval marks a significant step forward in the development of a…
-
Hanx Biopharmaceuticals Gains NMPA Approval for HX044 Clinical Trials
•
China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global…
-
Likang Life Sciences Gains FDA Approval for LK101 Clinical Trials
•
Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical trials for its LK101, an mRNA neoantigen vaccine. This marks a significant milestone in the development of personalized cancer treatments. Innovative Vaccine TechnologyLK101 is an innovative…
-
CR Sanjiu Gains SASAC Approval for Tasly Pharma Acquisition
•
China-based CR Sanjiu (SHE: 000999), a state-owned pharmaceutical company, has received approval from the State-owned Assets Supervision and Administration Commission of the State Council (SASAC) to acquire an aggregate of 418,306,002 shares of compatriot firm Tasly Pharma Co., Ltd (SHA: 600535). According to the deal struck in August of last…
-
EMA Committee Backs Subcutaneous Rybrevant for Lung Cancer Treatment
•
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion this week regarding the approval of a subcutaneous (SC) formulation of Johnson & Johnson’s (J&J, NYSE: JNJ) Rybrevant (amivantamab). The recommendation covers the drug’s use in combination with Lazcluze (lazertinib) for…
-
Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
•
China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
-
Bayer Files for EMA Approval of Kerendia for Heart Failure
•
Bayer AG (FRA: BAYN) announced that it has made another market filing with the European Medicines Agency (EMA) for its drug Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist. The German pharmaceutical giant is seeking approval in the EU for the drug to treat adult patients with heart failure (HF) with…
-
Boston Scientific Posts Strong Q4 and Full-Year 2024 Results
•
Boston Scientific Corporation (NYSE: BSX) released its Q4 and full-year 2024 financial report, showing robust growth across its business segments and geographies. Over the 12 months, the firm’s global net revenues reached USD 16.75 billion, up 17.6% year-on-year (YOY) in constant currency terms. During Q4’24, the US major recorded USD…
-
Vigonvita Life Sciences Files for IPO on Hong Kong Stock Exchange
•
Suzhou-based Vigonvita Life Sciences Co., Ltd. has submitted an initial public offering (IPO) filing to the Hong Kong Stock Exchange, seeking a listing on the bourse. This move marks a significant step for the company as it looks to expand its market presence and raise capital for future growth. Company…
-
Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
•
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd has received marketing approval from the National Medical Products Administration (NMPA) for its tulobuterol patch. This marks the first approval of its kind domestically in China for a transdermal patch designed to relieve respiratory distress…
-
Regeneron’s Q4 Financials Show 10% Revenue Growth, Driven by Eylea and Libtayo
•
US-based biopharmaceutical company Regeneron (NASDAQ: REGN) released its Q4 2024 financial report, showing revenues up 10% year-on-year (YOY) to USD 3.79 billion. For the full year, sales grew by 8% to USD 14.2 billion. The results highlight the continued strength of Regeneron’s portfolio, particularly its top-selling products. Top Performers in…
-
Eli Lilly’s Q4 Sales Soar 45% to $13.53B on Strength of GLP-1 Drugs
•
Eli Lilly & Co. (NYSE: LLY) reported a robust finish to 2024, with Q4 revenues climbing 45% year-on-year (YOY) to reach USD 13.53 billion. The surge was primarily fueled by its GLP-1 drugs Mounjaro and Zepbound (tirzepatide). Excluding these incretin-focused drugs, Lilly’s overall portfolio still expanded by 20% YOY. For…
-
GSK Reports 7% Full-Year Sales Growth in 2024, Driven by Specialty Medicines
•
UK-based pharmaceutical giant GSK plc (NYSE: GSK) released its Q4 and full-year 2024 financial results, reporting a 7% year-on-year (YOY) growth in sales over the 12 months to GBP 31.38 billion (USD 40.1 billion). Excluding the impact of COVID-related products, the firm’s sales increased by 8% to GBP 31.36 billion.…
-
MSD Reports Strong Global Sales Growth in 2024, Despite China Challenges
•
US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) released its Q4 2024 financial report, highlighting strong global revenue growth. Global revenues reached USD 15.6 billion in Q4, up 9% year-on-year (YOY) excluding currency impacts. Over the full year, revenues increased 10% to USD 64.17 billion. The growth was driven…
-
Amgen Reports Strong Q4 and Full-Year 2024 Sales Growth
•
Amgen (NASDAQ: AMGN) released its Q4 2024 financial results this week, reporting USD 33.42 billion in annual sales after a robust 19% year-on-year (YOY) increase. Sales during Q4 reached USD 9.09 billion, up 11% YOY. The strong performance was driven by growth across key product lines and the impact of…
-
Novo Nordisk Reports Soaring Global Sales in 2024, Driven by Diabetes and Obesity Care
•
Denmark’s Novo Nordisk (CPH: NOVO-B) reported this week that its global sales during 2024 reached DKK 290.403 billion (USD 42.1 billion), marking a 26% year-on-year (YOY) increase at constant exchange rates (CER). The strong performance was driven by growth across all business sectors, with notable increases in GLP-1 diabetes, Insulin,…
-
Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
•
Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking conditional approval for its avacincaptad pegol intravitreal solution (ACP). The drug is a synthetic aptamer that inhibits the complement C5 protein and is intended…
-
Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
•
Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
