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Lepu Scientech’s ScienCcrown TAVR System Earns NMPA Medical Device License
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading China-based medical technology company, has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative ScienCcrown transcatheter implantable aortic valve system. This development marks a significant milestone in the advancement…
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Eli Lilly’s Kisunla Receives NMPA Approval for Early Alzheimer’s Disease Treatment
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug donanemab-azbt, marketed under the name Kisunla. The drug is administered as a 350 mg/20 mL injection every four weeks…
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BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed/refractory acute leukemia patients carrying KMT2A rearrangement and/or NPM1 mutation in China.…
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Evopoint Biosciences Submits Pre-NDA for Funobactam, Imipenem, and Cilastatin to NMPA
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Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application) for its Category 1 product, a combination of funobactam, imipenem, and cilastatin, to the National Medical Products Administration (NMPA). This product, once approved, is poised to become the world’s first β-lactam/β-lactamase inhibitor (BL/BLI) with a…
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Xtalpi Inc. Partners with Gnosis Neurodynamics to Develop Neural Drug Screening Platform
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Shenzhen-based QuantumPharm Inc., trading as Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with Gnosis Neurodynamics, a leading brain science artificial intelligence (AI) company in China. This collaboration aims to harness AI algorithms and EEG BioMarker recognition models to develop a state-of-the-art neural drug screening platform. The platform will…
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GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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Sciwind Biosciences’ Ecnoglutide Accepted for Review by NMPA for Weight Management
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Sciwind Biosciences Co., Ltd has received a significant boost as the National Medical Products Administration (NMPA) has accepted its filing for review of another indication for ecnoglutide. The Chinese biopharmaceutical company is now seeking NMPA’s approval for the use of its drug in long-term weight management for adult patients, complementing…
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Blackstone and Bain Capital Submit Final Bids for Mitsubishi Tanabe Pharma
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In a significant development in the alternative asset management sector, companies such as Blackstone and Bain Capital have submitted their final takeover bids for Mitsubishi Tanabe Pharma, a subsidiary of Japan’s Mitsubishi Chemical Group. The final market capitalization is anticipated to be between USD3 billion and USD3.5 billion, as reported…
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Everest Medicines’ Velsipity NDA for Ulcerative Colitis Accepted by China’s NMPA
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China-based Everest Medicines (HKG: 1952) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Velsipity (etrasimod), a treatment for moderate to severe active ulcerative colitis (UC). Velsipity’s Mechanism and Licensing BackgroundVelsipity is a once-daily, oral medication that functions as…
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MSD Halts Development of Vibostolimab and Favezelimab Due to Trial Setbacks
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to terminate the clinical development of vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, following recent disappointing data from Phase III trials. Discontinuation of Vibostolimab TrialsThe Phase III KeyVibe-003 and KeyVibe-007 studies, which were assessing…
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Adcendo ApS Expands Partnership with Biocytogen to Enhance ADC Pipeline
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China’s Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has announced that Denmark-based Adcendo ApS has exercised its options within a research, option, and licensing agreement to utilize Biocytogen’s fully human antibodies. This move is aimed at bolstering Adcendo’s antibody drug conjugate (ADC) pipeline. Adcendo’s Focus on First-In-Class ADCsAdcendo is a…
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MicroPort CardioFlow’s VitaFlow Liberty Receives Marketing Approval in Turkey
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China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced that its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty, has received marketing approval from the Turkish Medicines and Medical Devices Agency (TITCK). This marks another global milestone for the product, following its approval in multiple countries and regions,…
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Vcanbio’s VUM02 Secures NMPA Approval and FDA ODD for Cirrhosis and aGvHD
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for its in-house developed VUM02 for injection, receiving approval from the National Medical Products Administration (NMPA) in China to study the treatment of decompensated cirrhosis and obtaining Orphan Drug Designation (ODD) from the Food and Drug…
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Novo Nordisk Invests DKK 8.5 Billion in New Odense Manufacturing Facility
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Denmark-based pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) is making a significant investment in its homeland by establishing a brand-new manufacturing facility in Odense, marking the first time this century the company has embarked on such a project. The capital infusion of DKK 8.5 billion (USD 1.2 billion) will go…
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Johnson & Johnson Submits sBLA to FDA for Simponi in Pediatric Ulcerative Colitis
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US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for its drug Simponi (golimumab), seeking approval to treat children aged two years and older with moderately to severely active ulcerative colitis…
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J&J’s SC Amivantamab Faces Complete Response Letter from FDA for NSCLC Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed with the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) has received a complete response letter (CRL). The application sought approval for the treatment of patients…
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Grand Pharmaceutical’s GPN01768 Accepted for Review by NMPA for Demodex Blepharitis Treatment
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Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its innovative drug GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%). The Chinese company is seeking approval for the drug to treat Demodex blepharitis, a condition…
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Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
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Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
