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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…
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…
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…
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…
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)…
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…
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…
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…
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…
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…
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…
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…
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…
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…
Sichuan Huiyu Pharmaceutical’s HY-2003 Approved for Clinical Trials by China’s NMPA
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 modified drug, HY-2003. This drug is designed to improve moderate to severe contour protrusion caused by subcutaneous fat accumulation…
J&J’s Stelara Faces New Biosimilar Competition in China with CSPC Pharmaceutical’s Entry
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Johnson & Johnson (J&J, NYSE: JNJ)’s auto-immune disease drug Stelara (ustekinumab) is set to encounter another potential competitor in the Chinese market. CSPC Pharmaceutical Group Ltd (HKG: 1093), a local firm, has recently announced that the National Medical Products Administration (NMPA) has accepted its market filing for review, marking a…
AstraZeneca’s ALXN1850 (Efzimfotase Alfa) Selected for China’s Rare Disease Care Plan
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The Center for Drug Evaluation (CDE) in China has announced its intention to include AstraZeneca’s (AZ, NASDAQ: AZN) ALXN1850, known as efzimfotase alfa, in the patient-centered rare disease drug development pilot program, referred to as the Care Plan. This move signifies a significant step forward in the global efforts to…
Amgen’s MariTide Showcases Significant Weight Loss in Phase II Study
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US biotechnology company Amgen (NASDAQ: AMGN) has announced positive outcomes from the double-blind, dose-ranging Phase II study of MariTide (maridebart cafraglutide), formerly known as AMG 133, at 52 weeks. This investigational antibody peptide conjugate, administered subcutaneously on a monthly or less frequent basis, has demonstrated significant potential in obesity treatment.…
VectorBuilder and Zhejiang Dapu Biotechnology Form Partnership to Advance Biotech Innovation
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China-based gene delivery technology developer VectorBuilder has entered into a partnership with Zhejiang Dapu Biotechnology Co., Ltd, a specialist in droplet microfluidics and molecular diagnostics. The collaboration aims to integrate the respective technology advantages and platform resources of both companies to overcome technological bottlenecks in life sciences and innovative biopharmaceutical…
Roche’s SKYSCRAPER-01 Study: Tiragolumab-Tecentriq Combo Misses Primary Endpoint in NSCLC
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Swiss pharmaceutical giant Roche (SWX: ROG) has reported an update on the phase III SKYSCRAPER-01 study, which evaluated the combination of tiragolumab with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 Study Details and ResultsThe global, randomized, double-blind…
