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Luye Pharma’s Rykindo Receives FDA Approval for Schizophrenia and Bipolar I Disorder
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China-based Luye Pharma Group (HKG: 2186) has announced receiving market approval from the US Food and Drug Administration (FDA) for its extended-release injectable suspension Rykindo (risperidone). The drug is approved for the treatment of schizophrenia in adults and as a monotherapy or adjunctive therapy to lithium or valproate for the…
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Hengrui’s Generic Cyclophosphamide Capsules Approved by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of cyclophosphamide, marketed as Endoxan by UK firm Hikma Pharmaceuticals USA Inc. The approval allows Hengrui to market its capsules for the treatment of a wide range of…
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Akeso’s Penpulimab Secures New Approval for Lung Cancer Indication
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China-based Akeso Biopharma (HKG: 9926) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for the treatment of first-line or locally advanced/metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. This marks a…
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Clover Biopharmaceuticals Plans COVID-19 Vaccine SCB-2019 Launch in China for 2023
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has provided updates on its plans for the commercialization of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in China, with a strategic focus on 2023. The company expects to begin the commercial launch of SCB-2019 in multiple provinces and municipalities in China during the first…
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Sino Biopharma’s PD-L1 Combo with Anlotinib Accepted for Review by China’s CDE
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its New Drug Application (NDA) filing for the combination of its anti-PD-L1 monoclonal antibody (mAb) TQB2450 and anlotinib has been accepted for review by the Center for Drug Evaluation (CDE). The Phase III study for this combination in first-line small cell…
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Guangzhou’s Overseas Pharma Wins China Clinical Trial Approval for OPL-038
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Guangzhou-based Overseas Pharmaceuticals, Ltd has secured clinical trial approval in China for its sustained and controlled release drug OPL-038. The drug, filed as an Investigational New Drug (IND) under Category 2 (modified drug), aims to address the needs of adult patients with type 2 diabetes through a novel combination therapy.…
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Xinhua Pharma’s OAB-14 Receives NMPA Approval for Phase I Alzheimer’s Study
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China-based Shandong Xinhua Pharmaceutical Co., Ltd (SHE: 000756) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study of its innovative Alzheimer’s disease (AD) drug, OAB-14. The study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and food effects of OAB-14 in…
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Konruns’ KC1036 Advances to Phase II Study for Lung Adenocarcinoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its Category 1 chemical drug KC1036. The study will assess the efficacy and safety of KC1036 in combination with docetaxel for the treatment of…
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Harbour BioMed’s HBM1020 Receives FDA Approval for US Phase I Study
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Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. The study will assess the safety, tolerability,…
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Sanofi’s iGlarLixi Approved in China for Type 2 Diabetes Management
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that the National Medical Products Administration (NMPA) has approved its iGlarLixi (insulin glargine, lixisenatide) for use in adult patients with type 2 diabetes who have poor blood glucose control. This approval marks a significant step in expanding treatment options for patients struggling…
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Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
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MSD China to Take Legal Action Against Market Infringement of Molnupiravir
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Merck Sharp & Dohme (MSD, NYSE: MRK)’s China unit has issued a WeChat notification vowing to take necessary legal actions against certain unnamed drug companies accused of market infringement related to molnupiravir, the oral COVID-19 therapy. The notice states that some manufacturers are falsely claiming authorization from MSD to distribute…
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Kexing Pharmaceutical Initiates Phase I Trial for IFN-Alpha-1b Inhalation Solution
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China-based Kexing Pharmaceutical (SHA: 688136) has announced the enrollment of the first subject and dosing in a Phase I clinical study for its interferon-alfa-1b (IFN-alpha-1b) solution for inhalation. The drug will be assessed for treating lower respiratory tract infections caused by respiratory syncytial virus (RSV) in children, including conditions such…
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CSPC’s Cleviprex Approved for Clinical Study by China’s NMPA
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate cleviprex. The company’s first nanoemulsion, cleviprex, is a dihydropyridine calcium channel blocker being developed to treat hypertension when oral antihypertensive drugs are…
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Takeda’s Mobocertinib Approved in China for EGFR Exon20ins NSCLC
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Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) China unit has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its lung cancer therapy mobocertinib. The drug is indicated for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during…
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Kelun-Biotech’s SKB264 Approved for Phase II Study in EGFR-Mutant NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN)…
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Pfizer’s Nurtec ODT Launches in China via Hainan’s Bo’Ao Lecheng Zone
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US-based Pfizer’s (NYSE: PFE) Nurtec ODT (rimegepant), the world’s first calcitonin gene-related peptide (CGRP) receptor antagonist in rapidly dissolving oral disintegrating tablet form, has become available to patients in China via the Bo’Ao Lecheng Medical Tourism Pilot Zone in Hainan from January 1. The drug is being launched in Hainan…
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Konruns Initiates Phase II Study for KC1036 in Advanced Thymic Tumors
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the initiation of a single-arm, open, multi-center Phase II clinical study to assess the efficacy and safety of its Category 1 chemical drug KC1036 in patients with advanced thymoma and thymic carcinoma. The study focuses on patients whose disease has progressed…
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Dizal’s Sunvozertinib NDA Accepted for Review by China’s NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) filing for sunvozertinib (DZD9008), a next-generation epidermal growth factor receptor (EGFR) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). The drug is indicated for use in locally advanced or metastatic…
