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Ascletis Files IND Application for COVID-19 Oral Inhibitor ASC11 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been filed with the US FDA following a pre-IND consultation. This marks a significant step forward in the development of…
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RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles. Study Design and ResultsThe multicenter,…
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Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
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Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its ATG-017, an extracellular regulated protein kinase 1/2 (ERK1/2) inhibitor. The Shanghai-based biotech company will commence the joint part of the Phase I ETASER study, assessing the safety,…
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China Grand’s STC3141 Reaches Primary Endpoint in ARDS Phase Ib Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study (NCT05000671) for its drug candidate STC3141 in acute respiratory distress syndrome (ARDS) has reached its primary endpoint. This marks a significant step forward in the development of the drug for this critical condition. Phase Ib…
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Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
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Simcere’s SIM0235 Begins US Phase I Trial for Anti-Tumor Therapy
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in a Phase I clinical study for its novel anti-tumor drug candidate SIM0235 (formerly SIM1811-03) in the United States. This marks a significant milestone in the global development of the drug. SIM0235: Mechanism and PotentialSIM0235 is…
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Novartis’ Cosentyx Gains Approval for New Doses in China
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications of Cosentyx (secukinumab) in China. The new 300mg and 75mg prefilled syringe forms are approved for pediatric psoriasis in patients aged six years and above with moderate to severe plaque psoriasis eligible for systemic treatment…
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NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
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Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF) who have previously…
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NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
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The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC). Previous Approvals and Clinical ProgressSerplulimab was initially…
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Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
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Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials. Phase I Clinical Study DesignThe open-label, multi-center Phase…
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Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
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Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of a New Drug Application (NDA) for vamorolone in Duchenne Muscular Dystrophy (DMD) with the US FDA. The drug, with China rights owned by China-based Sperogenix Therapeutics, is expected to enter the US market during the…
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Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
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China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic…
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Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Biogen’s Tecfidera (dimethyl fumarate). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Tecfidera: Drug Profile and Market ContextTecfidera is…
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Innovent’s Parsaclisib Filed for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics Inc’s (HKG: 1801) PI3Kδ inhibitor parsaclisib. The product candidate has been granted priority review status. The targeted indication is relapsed or refractory follicular lymphoma (r/r FL) in patients who have previously received at least two…
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Proheal Pharmaceuticals Initiates Clinical Study for PHP1003 in Thyroid-Associated Ophthalmopathy
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Proheal Pharmaceuticals, a Suzhou-based developer of drugs for ophthalmology and autoimmune diseases, announced the first subject dosing in a clinical study for its in-house developed anti-IGF1R antibody PHP1003 in thyroid-associated ophthalmopathy (TAO). This marks a significant milestone in the development of novel treatments for this condition. Study Design and Drug…
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HutchMed Initiates Phase II/III Study for Elunate and Tyvyt in Renal Cell Carcinoma
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase II/III clinical study for Elunate (fruquintinib) combined with Tyvyt (sintilimab) as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China. The first patient was dosed this week. Study Design and…
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Recbio’s Neoadjuvant HPV Vaccine Accepted for Review by NMPA
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced that a clinical trial filing for its in-house developed neoadjuvant recombinant tetravalent human papillomavirus (HPV) vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of Recbio’s vaccine…
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Kintor Completes Enrollment for GT20029 Phase I Study in US
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced the completion of enrollment for a Phase I clinical study of its GT20029, targeting androgenetic alopecia and acne. The study, which enrolled 120 subjects in the US, is a randomized, double-blind, placebo-controlled, parallel, dosage escalation trial designed to assess the safety, tolerability, and…
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Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial
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Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia/Ib clinical study for its JSKN003. The study will assess the safety and tolerability of JSKN003 in patients with advanced malignant solid tumors and determine the maximum tolerable dose…
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WinHealth’s Ravicti Receives Orphan Drug Designation in Taiwan
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China-based Hong Kong WinHealth Pharma Group Ltd announced that its Swiss partner Immedica Pharma AB’s Ravicti (glycerol phenylbutyrate) has received orphan drug designation (ODD) status in Taiwan. This rare disease drug, which is awaiting regulatory decisions in China with priority review status, can now be used as a long-term adjuvant…
