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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…
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HutchMed’s Orpathys Receives Priority Review for NSCLC Treatment in China
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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Zhaoke Ophthalmology’s TAB014 Achieves Positive Phase III Results for wAMD
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III study for its core candidate drug TAB014 in the treatment of wet (neovascularization) age-related macular degeneration (wAMD). The study successfully met all primary and key secondary endpoints,…
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Alphamab Oncology’s JSKN033 Advances to Phase III Trial for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
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Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema
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Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II…
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Johnson & Johnson’s Rybrevant Combo Approved by EC for First-Line NSCLC Treatment
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US healthcare giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that the European Commission (EC) has granted label extension approval for its Rybrevant (amivantamab) combined with Lazcluze (lazertinib) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletions…
