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Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
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Kelun-Biotech’s Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that another indication approval filing for its anti-HER2 antibody drug conjugate (ADC), trastuzumab botidotin (A166), has been accepted for review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the…
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Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
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China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON: GSK, NYSE: GSK) have announced that they have received another breakthrough therapy designation (BTD) from the US FDA for their B7-H3-targeted antibody drug conjugate (ADC), HS-20093 (GSK5764227). The indication this time is for the drug’s…
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Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
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US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its drug Imdylltra (tarlatamab). The approval is for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior…
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Junshi Biosciences’ Loqtorzi Gains Regular Approval for Melanoma Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its PD-1 inhibitor, Loqtorzi (toripalimab), has received regular approval in China for the treatment of unresectable or metastatic melanoma that has previously failed systemic therapy. This marks a significant milestone in the drug’s regulatory journey. Background and Approval…
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Simcere Zaiming’s SIM0505 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SIM0505, which targets CDH6 in advanced solid tumors. Last month, the drug also received clearance for clinical trials…
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Huahui Health’s HH-003 Gains Priority Review Status for Chronic Hepatitis D Treatment
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated that Huahui Health’s HH-003 is on track to obtain priority review status as a “drug eligible for conditional approval.” This designation is specifically for the treatment of chronic hepatitis D virus (HDV) infection. Drug Mechanism…
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WuXi Biologics and Candid Therapeutics Ink Global Research Agreement for Trispecific T-cell Engager
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China-based Contract Research, Development and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a research service cooperation agreement with US-headquartered Candid Therapeutics, Inc. This strategic partnership aims to accelerate the development of innovative T-cell engagers for autoimmune and inflammatory diseases. Terms of the AgreementUnder the terms of the agreement,…
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Amoytop Biotech’s Pegfilgrastim Gains NMPA Approval for Preeclampsia Clinical Trials
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) to reduce the incidence of preeclampsia. This marks a significant milestone in the development of innovative therapies for pregnancy-related complications. Product Overview…
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Solasia Pharma Licenses Episil to GeneScience for Greater China Region
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Japan-based Solasia Pharma K. K (TYO: 4597) has announced a licensing agreement with Changchun GeneScience Pharmaceutical Co., Ltd, granting the Chinese company exclusive commercialization rights to its oncology product episil oral liquid (sodium valproate) in mainland China, Hong Kong, Macau, and Taiwan. The agreement is effective as of the beginning…
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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…
