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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-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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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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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 (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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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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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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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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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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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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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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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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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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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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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…
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Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a Phase IIb clinical study for its pipeline candidate HTD1801 in non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled study is designed to assess the histological improvement of HTD1801 compared with placebo in subjects with NASH and…
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Under new rules specifically for the launch of COVID-19 therapeutics in China, US-based Merck Sharp & Dohme (MSD, NYSE: MRK) has proactively submitted the initial quotation and materials for its molnupiravir, the world’s first oral COVID-19 therapy. The Tianjin Medical Purchasing Center has publicized the quoted price at RMB 1,500…
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China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced…
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…