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Sirnaomics Initiates Phase I/II Trial for STP705 in Facial Squamous Cell Carcinoma
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the first subject systemic dosing in a Phase I/II clinical study for its therapeutic candidate STP705 in facial squamous cell carcinoma in situ (isSCC). The study is expected to be completed during Q1 2023. Study Design and ObjectivesThe open-label, dosage escalation…
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CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
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BRL Medicine’s BRL-101 Receives Clinical Trial Approval for Beta-Thalassemia
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Shanghai-based BRL Medicine Inc. has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its BRL-101. The therapy is an autologous hematopoietic stem progenitor cell treatment for transfusion-dependent beta-thalassemia. Drug DetailsBRL-101 is a gene therapy developed through BRL’s in-house developed hematopoietic stem cell…
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Innovent Biologics Initiates Phase I Study of IBI311 for Thyroid-Associated Ophthalmopathy
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China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI311, an insulin-like growth factor 1 (IGF-1R) monoclonal antibody (mAb). Study DetailsThe Phase I dosage escalation study (CTR20221581) is designed to assess the safety and tolerability of…
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Zelgen Biopharmaceuticals’ ZGGS18 Receives NMPA Approval for Solid Tumor Treatment
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate ZGGS18. The molecule will be assessed as a treatment for general advanced solid tumors. Drug DetailsZGGS18 is a bispecific antibody (BsAb) targeting vascular…
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Sanjin Pharma’s Subsidiary Gets NMPA Nod for BC007 Cancer Study
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China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Biopharmaceutical (Shanghai) Co., Ltd, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study of BC007. The study will assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy…
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Ascletis Pharma’s Gannex Initiates DDI Study for ASC42 in PBC
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Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has initiated the first subject dosing in a drug – drug interaction (DDI) study for its drug candidate ASC42 in primary biliary cholangitis (PBC) in the United States. The study is designed to provide additional evidence…
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Alphamab Oncology Doses First Patient in KN046-209 Study for NSCLC
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China-based Alphamab Oncology (HKG: 9966) announced the first patient dosing in the multi-center, open-label Phase II KN046-209 study. The trial evaluates the efficacy, safety, and tolerability of KN046 (erfonrilimab) combined with axitinib in first-line locally advanced or metastatic PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) patients who have…
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Zhaoke Ophthalmology Enrolls First Patient in ZKY001 Phase II TPRK Study
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) announced the enrollment of the first patient in a Phase II clinical study for its ZKY001 in transepithelial photorefractive keratectomy (TPRK), a surgical procedure to treat myopia. ZKY001 is based on a peptide composed of seven amino…
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LianBio Completes Enrollment for Mavacamten Phase III Trial in oHCM
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China-based biotech LianBio (OTCMKTS: LIANY) announced that enrollment has been completed in the Phase III EXPLORER-CN clinical trial, assessing mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Drug BackgroundMavacamten, discovered by MyoKardia Inc. (Nasdaq: MYOK), is a first-in-class small-molecule drug that reversibly binds to myosin. It targets the…
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Inmagene and HutchMed Dose First Subject in IMG-004 Phase I Study
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China-based Inmagene Biopharmaceuticals and Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) announced that the first subject has been dosed in the US in a global Phase I clinical study for their drug candidate IMG-004. The double-blind, randomized, placebo-controlled, single and multiple dosage escalation study is designed to assess the…
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Gan & Lee Pharmaceuticals’ GZR4 Wins FDA Approval for Diabetes Treatment
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 therapeutic biologic product GZR4 for the treatment of diabetes. Product DetailsThe half-life of long-acting basal insulin analogs currently on the market ranges from…
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Innovent Biologics Doses First Subject in IBI324 Phase I Study for DME
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China-based biotech Innovent Biologics Inc. (HKG: 1801) announced that the first subject has been dosed in a Phase I clinical study for its IBI324, a bispecific antibody (BsAb) targeting vascular endothelial growth factor A (VEGF-A) and angiopoietin2 (Ang-2) in diabetic macular edema (DME). Study DetailsThe Phase I dosage escalation study…
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CSPC Pharmaceutical’s rhTNK-tPA Meets Primary Endpoint in Stroke Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the Phase III clinical study for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) in acute ischemic stroke has reached the pre-set primary endpoint. Study DetailsThe multi-center, prospective, randomized, open, blinded, non-inferiority Phase III clinical study was designed to…
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Hybio Pharmaceutical’s HY3000 Nasal Spray for COVID-19 Enters NMPA Review
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its clinical trial filing for HY3000 nasal spray, a Category 1 chemical drug targeting COVID-19, has been accepted for review by the National Medical Products Administration (NMPA). Drug DetailsHY3000 is a novel polypeptide membrane fusion inhibitor that binds to the HR1…
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Ascletis Pharma’s ASC10 Receives IND Approval for COVID-19 Treatment in US and China
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China-based Ascletis Pharma Inc. (HKG: 1672) has provided updates on the clinical progress of ASC10, its oral RNA-dependent RNA polymerase (RdRp) drug therapy for COVID-19. The National Medical Products Administration (NMPA) has accepted an Investigational New Drug (IND) filing for review, and the US Food and Drug Administration (FDA) has…
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ProfoundBio Receives FDA Approval for PRO1184, Appoints New CMO
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China-based macromolecular targeted therapy developer ProfoundBio (Suzhou) Co., Ltd announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) PRO1184 in advanced tumors. The announcement was made alongside the appointment of Dr. Naomi Hunder as the company’s chief…
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Lynk Pharma Gets NMPA Green Light for LNK01004 Atopic Dermatitis Study
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Hangzhou-based Lynk Pharmaceuticals Co., Ltd announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its drug LNK01004 for atopic dermatitis (AD). The drug was previously approved for a clinical trial in mild to moderate plaque psoriasis, with the first patient dosed…
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Shouyao Holdings Receives Approval for CT-3505 ALK Inhibitor Study in NSCLC
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) announced it has received ethical approval from the Cancer Institute and Hospital at the Chinese Academy of Military Science to conduct a Phase I/II clinical study (CT-3505-I-01) of its CT-3505 in patients with ALK-positive non-small cell lung cancer (NSCLC). Drug ProfileCT-3505, an…
