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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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AstraZeneca’s ALXN2350 Selected for CDE’s Rare Disease Drug Development Program
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN2350 in the patient-centered rare disease drug development pilot program, known as the Care Plan. The public has until December 23 to provide feedback on the notice. ALXN2350: A Potential Treatment for…
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NMPA’s CDE Releases Draft Proposal for Benefit-Risk Assessment in Global Drug Development
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has issued the “Guiding Principles for Benefit and Risk Assessment Based on Multi-regional Clinical Trial Data in Global Synchronous Development of New Drugs (draft proposal)” and is soliciting public feedback for a period of two months. Consistency in…
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Perennial Real Estate Holdings’ Tianjin Hospital Earns Medical Practice License
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Singapore-based Perennial Real Estate Holdings Limited has announced that its Perennial General Hospital in Tianjin has received the Practice License of Medical Institution from the city’s health commission bureau. This milestone makes the hospital the first wholly foreign-owned Class III comprehensive hospital in China. Tianjin Perennial Hospital’s Strategic Location and…
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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…
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GSK’s Jemperli Receives Positive CHMP Opinion for Endometrial Cancer Indication Extension
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The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel)…
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GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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CanSino Biologics’ DTcP Vaccine for Infants and Young Children Accepted by NMPA for Review
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its DTcP vaccine, designed for infants and young children under the age of 2. Quality Consistency and Market GapThe DTcP vaccine, a component…
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MicroPort NeuroTech Leads Investment Fund to Advance Brain Science Industry
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China-based MicroPort NeuroTech Limited (HKG: 2172) has announced its commitment to invest RMB 200 million (USD 27.46 million) to jointly establish an investment fund aimed at fostering the development of the brain science and brain-Inspired Intelligence industry, aligning with MicroPort NeuroTech’s strategic future direction. Collaboration with Other InvestorsJoining MicroPort NeuroTech…
