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Phil Rivers Technology Secures IND Approval for PR00012 from NMPA’s CDE
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Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
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Hansoh Pharmaceutical’s Ameile Receives NMPA Review for Fifth Indication in NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic…
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China Medical System Holdings Gets NMPA Approval to Test Obesity Treatment CMS-D005
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study in China. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D005 in healthy and overweight and obese adult subjects. Dual…
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Genesis RMN Robotic Magnetic Navigation System Approved by China’s NMPA
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The Genesis RMN cardiac electrophysiological robot magnetic navigation system, represented in China by Shanghai Microport EP Medtech Co., Ltd, (SHA: 688351) has been granted marketing approval by the National Medical Products Administration (NMPA) in China. Global Recognition and Enhanced FeaturesDeveloped by Stereotaxis, the Genesis RMN system has already received approval…
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GSK plc Receives EC Approval for Single-Vial Menveo Vaccine for Meningococcal Disease
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GSK plc (NYSE: GSK) has announced that it has received marketing approval from the European Commission (EC) for its Menveo vaccine, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine), in a single-vial, fully liquid presentation. This formulation is designed for the prevention of invasive meningococcal disease…
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TenNor Therapeutics Partners with Grand Life Sciences for Rifasutenizol Commercialization in China
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China-based TenNor Therapeutics has entered into an exclusive commercialization cooperation agreement with compatriot firm Grand Life Sciences, appointing the latter as the sole commercial promotion service provider in mainland China, Hong Kong, and Macau for TenNor’s rifasutenizol (TNP-2198), a treatment for Helicobacter pylori (H. pylori) infection. Financial Terms and ResponsibilitiesUnder…
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Immunochina Pharmaceuticals’ IM19 CAR-T Therapy Accepted for Review by NMPA
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Beijing-based biotech company Immunochina Pharmaceuticals has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its chimeric antigen receptor T cell (CAR-T) product, IM19. The therapy is being sought for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r…
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Thederma’s TAP-1503 Cream Approved by China’s NMPA for Atopic Dermatitis Treatment
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China-based Thederma has announced that its TAP-1503 cream has been granted approval by the National Medical Products Administration (NMPA) with priority review status. The drug, containing 1% tapinarof as a small molecule chemical drug, is now approved for the treatment of atopic dermatitis (eczema) in children over two years old…
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Novartis’s Kisqali Approved by EC for Adjuvant Treatment of High-Risk Early Breast Cancer
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from the European Commission (EC) for its CDK4/6 inhibitor Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early…
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Sanofi Launches Modulus, a Pioneering Manufacturing Facility in Singapore
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Global healthcare company Sanofi (NASDAQ: SNY) has inaugurated Modulus, its state-of-the-art manufacturing facility in Singapore. This facility, which employs an ‘industry first’ modular concept, is designed to offer flexible manufacturing capabilities for the production of next-generation vaccines and biological medicines. Investment and Capabilities of ModulusThe SGD 800 million (USD 558…
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Chia Tai Tianqing’s Benmelstobart Combo Approved by NMPA for Endometrial Cancer Treatment
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China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is now approved in combination with the multi-target kinase inhibitor anlotinib to treat patients with non-Microsatellite Instability-High (non MSI-H)…
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Sichuan Kelun-Biotech’s SKB264/MK-2870 Approved by NMPA for Triple Negative Breast Cancer
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously…
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NHC Aims for Nationwide Inspection Result Sharing in Medical Consortia by 2030
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The National Healthcare Commission (NHC) has issued the “Guiding Opinions on Further Promoting Mutual Recognition of Inspection and Testing Results in Medical Institutions,” a document designed to encourage the standardization and sharing of medical inspection results across China. Targets for Medical Consortia by 2025The NHC has set clear targets for…
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CORXEL’s Varenicline Nasal Spray Approved by NMPA for Dry Eye Treatment
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Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval from China’s National Medical Products Administration (NMPA) for its varenicline nasal spray, which is indicated for increasing tear secretion in patients diagnosed with xerophthalmia. Clinical Studies Support NMPA ApprovalThe NMPA’s approval was grounded in data…
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Arrowhead and Sarepta Seal $11.38 Billion Global Licensing Deal for Rare Disease Treatments
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US-based companies Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) and Sarepta Therapeutics (NASDAQ: SRPT) have announced a significant global licensing agreement valued at up to USD 11.38 billion. This expansive deal encompasses multiple clinical and preclinical programs targeting rare, genetic diseases affecting the muscle, central nervous system (CNS), and the lungs. Strategic…
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Pfizer Partners with CR Pharma to Expand Cancer Drug Access in China
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US pharmaceutical giant Pfizer Inc. (NYSE: PFE) has entered into a strategic agreement with China Resources Pharmaceutical Group Co., Ltd (HKG: 3320) to leverage their respective strengths in promoting the commercial operations of Pfizer’s established oncology drugs in China. The focus will be on drugs Aromasin (exemestane), Ibrance (palbociclib), Pharmorubicin…
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Roche’s Evrysdi Receives Patent Term Extension in China, Extending Protection to 2035
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The China National Intellectual Property Administration (CNIPA) has granted Swiss pharmaceutical giant Roche (SWX: ROG) a Patent Term Extension (PTE) for its drug Evrysdi (risdiplam), under patent NO. ZL201580027306.9. This marks the first case of its kind in China, where the SMN2 splicing modifier will now enjoy patent protection until…
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CanSino Biologics’ Menhycia Vaccine Aims to Expand Age Range with NMPA Filing
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CanSino Biologics (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted its supplementary market filing for the ACYW135 Meningococcal Conjugate Vaccine (CRM197), trade named Menhycia. The Chinese biotechnology company is looking to extend the vaccine’s approved age range to include children from 3 months to 6…
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Jiangsu Hengrui Medicine’s SHR-1819 Receives NMPA Approval for Atopic Dermatitis Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17…
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AstraZeneca’s Truqap Meets Primary Endpoint in Phase III Prostate Cancer Study
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UK-based pharmaceutical giant AstraZeneca Inc., (AZ, NASDAQ: AZN) has announced that its Phase III CAPItello-281 study has successfully met its primary endpoint of radiographic progression-free survival (rPFS). The study evaluated the efficacy of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient de novo…
