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GSK’s Nucala Receives New Indication Approval in China for CRSwNP
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UK-based pharmaceutical company GlaxoSmithKline’s (GSK; NYSE: GSK) has announced that it has received another indication approval in China for its anti-interleukin-15 (IL-15) biologic, Nucala (mepolizumab). The drug is now approved as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)…
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Aosaikang’s Generic Livtencity Accepted for Review by China’s NMPA
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for its generic version of Japan-based Takeda’s (TYO: 4502) Livtencity (maribavir) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the potential introduction of a more accessible…
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MicuRx Pharmaceuticals’ MRX-5 Receives NMPA Approval for NTM Infections Clinical Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug MRX-5. The study will focus on infections caused by non-tuberculous Mycobacteria (NTM) that are sensitive to this product. MRX-5: A Promising…
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Huahai Pharmaceutical’s HB0028 and HB002.1T Cleared for Clinical Study by NMPA
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clearance from the National Medical Products Administration (NMPA) for its investigational drugs HB0028 and HB002.1T. The drugs are set to enter clinical studies, either in combination with or without standard chemotherapy, for the treatment of advanced…
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Hengrui Pharmaceuticals Receives NMPA Approval for HRS-6768 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HRS-6768. This approval allows the company to proceed with testing the drug in patients with advanced solid tumors. Innovative Radiation Therapy for…
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AstraZeneca’s Tagrisso Receives NMPA Approval for EGFR-Mutated NSCLC Treatment
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UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received a new indication approval from China’s National Medical Products Administration (NMPA) for its non-small cell lung cancer (NSCLC) treatment, Tagrisso (osimertinib). This approval is for the use of Tagrisso in treating adult patients with locally advanced, unresectable NSCLC, whose…
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NMPA Approves Lynparza as Adjuvant Treatment for High-Risk Breast Cancer Patients
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The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for their drug Lynparza (olaparib). The approval is for adjuvant treatment in adult patients with early high-risk breast cancer who have undergone neoadjuvant or adjuvant…
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Gilead Sciences’ Sunlenca Receives NMPA Approval for Multidrug-Resistant HIV-1 Infection
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US-based pharmaceutical company Gilead Sciences Inc., (NASDAQ: GILD), has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Sunlenca (lenacapavir). The drug is approved for use in combination with antiretroviral drugs for adult patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1)…
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WinHealth Pharma’s Difelikefalin Receives NMPA Review for Market Approval
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China-based Hong Kong WinHealth Pharma Group has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for review for difelikefalin. WinHealth holds exclusive development and commercialization rights to the Category 5.1 drug in China, following a licensing deal secured with Vifor Fresenius Medical Care Renal…
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Thederma’s TAN-118 Receives Tacit Clinical Approval from China’s CDE for Global Trials
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Shanghai-based Thederma has announced that its drug candidate TAN-118 has obtained tacit clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the clearance received from the US FDA in October of the previous year, indicating that TAN-118, an AhR…
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Innovent Biologics’ Taletrectinib Gains NMPA Approval for ROS1 Positive NSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving an additional marketing approval from the National Medical Products Administration (NMPA) for its drug taletrectinib. This second-generation ROS1 tyrosine kinase inhibitor is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer…
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MabPharm’s CMAB807 Biosimilar Infliximab Approved in Pakistan
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J, NYSE: JNJ)’s Remicade (infliximab), in Pakistan. This follows similar approvals in Peru and Indonesia last year. The approval encompasses all six indications, which…
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Zhaoke Ophthalmology’s NVK002 ANDA Accepted for Review by China’s NMPA
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the National Medical Products Administration (NMPA) has accepted for review the Abbreviated New Drug Application (ANDA) for NVK002, an atropine external use eye solution aimed at pediatric myopia progression. NVK002: A Novel Ophthalmic…
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SCG Cell Therapy’s SCG142 Receives NMPA Approval for HPV-Related Solid Tumor Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SCG142. This human papillomavirus (HPV) specific T cell receptor (TCR) therapy is set to be tested in a range of HPV-related…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for MAFLD/MASH Clinical Trial
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and…
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NMPA Grants Conditional Approval for China’s First MSCs Therapy for aGVHD
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The National Medical Products Administration (NMPA) in China has conditionally approved amimestrocel from Beijing-based Platinum Life with priority review status. This mesenchymal stem cells (MSCs) therapy marks the first of its kind in China, now available for treating patients aged 14 and above with acute graft-versus-host disease (aGVHD) that primarily…
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Eli Lilly & Co. Launches Mounjaro (Tirzepatide) in China for Diabetes and Weight Management
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US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the official market launch of its drug Mounjaro (tirzepatide) in China, expanding access to this treatment for patients in the region. Coverage of Two IndicationsThe launch of Mounjaro in China covers two specific indications. The first is for the…
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Shanghai Pharmaceuticals Halts Development of I001-B, I022, and C012 in the US
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China’s Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607) has declared the termination of clinical trials and subsequent development of I001-B (US), I022 (US), and C012 (US). This decision comes after a comprehensive evaluation of the future market value, business collaboration, and development investment required for these projects. I001-B and I022…
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Astellas Pharma’s Vyloy Approved by NMPA for CLDN18.2 Positive Gastric Cancer
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China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive,…
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Sichuan Kelun-Biotech’s Ketailai Receives NMPA Approval for Nasopharyngeal Carcinoma Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb), Ketailai (KL-A167). This treatment is now approved for use in recurrent or metastatic nasopharyngeal carcinoma (NPC) patients…
