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Simcere’s Edaravone, Borneol Sublingual Tablets Reach Phase III Efficacy Endpoint
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that a Phase III clinical study for its edaravone, borneol sublingual tablets in acute ischemic stroke (AIS) has reached the pre-set efficacy endpoint. Preliminary analysis showed that, compared with a placebo, edaravone, borneol sublingual tablets could significantly improve the neurological recovery and…
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ImmuneOnco Initiates Phase II Clinical Study for CD47 Antibody IMM01
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the initiation of a Phase II clinical study for its investigational drug IMM01, an antibody targeting the cluster of differentiation 47 protein (CD47), in combination with a programmed-death 1 (PD-1) inhibitor for the treatment of solid tumors and lymphomas. This marks a significant…
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Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
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Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
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CSL Vifor and Fresenius Kabi Win China Approval for Ferinject
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Swiss firm CSL Vifor and Germany’s Fresenius Kabi have announced the first regulatory approval in China for Ferinject (ferric carboxymaltose), an iron deficiency treatment used to manage anemia in patients with chronic kidney disease and those undergoing surgery. The drug is indicated for adults with iron deficiency for whom oral…
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Youcare’s YKYYO17 Aerosol Inhalation Agent Approved for COVID-19 Clinical Study
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China-based Youcare Pharmaceutical Group’s YKYYO17 aerosol inhalation agent, a broad-spectrum coronavirus membrane fusion inhibitor polypeptide drug, has been approved in China for a clinical study in COVID-19 infection. Drug Mechanism and DevelopmentThe Category 1 drug candidate, co-developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, can play…
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Clover Biopharmaceuticals’ SCB-2019 Vaccine Reduces Household Transmission of COVID-19
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China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced that Clinical Infectious Diseases has published additional data from SPECTRA, a global Phase II/III clinical trial, that showed vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to household members, compared to placebo participants. Trial Results and ImplicationsThere…
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Ascletis Pharma Completes Enrollment for ASC40 Phase II Acne Study
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the completion of enrollment of 180 patients in a Phase II clinical study for ASC40 (denifanstat). The molecule is set to be assessed in treating moderate to severe acne. The study is currently still blinded. Study Design and ObjectivesThe randomized, double-blind, placebo-controlled, multicenter…
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Ascletis Pharma’s COVID-19 Drug Candidate ASC11 Accepted for Review by NMPA
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its Investigational New Drug (IND) filing for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been accepted for review by the National Medical Products Administration (NMPA). Drug Profile and PotencyIn antiviral cellular assays with infectious…
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Luye Pharma Initiates Phase II Study for LY 03014 in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug candidate, LY 03014. The multi-center, randomized, double-blind, placebo-controlled, and positive drug parallel control study aims to assess the preliminary efficacy and safety of the drug in treating…
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Henlius Completes First Dosing in Head-to-Head Study of PD-1 Inhibitor HanSiZhuang
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a head-to-head bridging study for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The study is evaluating serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) against Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), the…
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FDA Rejects Spectrum’s Poziotinib NDA for NSCLC Treatment
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US-based Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) announced last week that its New Drug Application (NDA) for poziotinib, a treatment for previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations, received a complete response letter (CRL) from the US FDA. The CRL cited…
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Luye Pharma Launches Toludesvenlafaxine in China for Depression Treatment
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China-based Luye Pharma Group (HKG: 2186) has officially launched its Category 1 chemical drug toludesvenlafaxine (LY03005) in China. The extended-release treatment for depression has received its first prescriptions and is being launched through a multi-channel strategy that includes hospitals, pharmacies, and online platforms. Drug Profile and MechanismToludesvenlafaxine is a new…
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Hope Medicine Gains Global Approval for Phase II Trial of HMI-115
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China-based Hope Medicine Inc. has announced receiving approval to conduct a global multi-center Phase II clinical study for its monoclonal antibody (mAb) HMI-115, targeting the prolactin receptor (PRL R). The drug is being evaluated as a treatment for endometriosis, a condition that affects many women worldwide. This potential first-in-class (FIC)…
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Lyvgen Biopharma Initiates Phase II Study for LVGN7409 in Advanced NSCLC
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Shanghai-based immuno-oncology therapeutics specialist Lyvgen Biopharma has announced the initiation of an open-label, multi-center, randomized Phase II clinical study to assess the efficacy and safety of its LVGN7409 in combination with docetaxel or nivolumab for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC). The combination study is set to…
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Everest Medicines’ Nefecon Gains Accelerated Approval in Taiwan and South Korea
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China-based Everest Medicines (HKG: 1952) has announced receiving Accelerated Approval Designation (AAD) from the Taiwan Food and Drug Administration and Orphan Drug Designation (ODD) from the Ministry of Food and Drug Safety in South Korea for its lead product Nefecon (targeted-release budesonide). These designations are for the treatment of primary…
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Jiangsu Hengrui Gets NMPA Approval for HR20031 Clinical Study in Type 2 Diabetes
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HR20031 in patients with type 2 diabetes. This marks a significant step forward in the development of a novel treatment option for patients with poorly controlled…
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Fosun Pharma’s Henlius Completes Clinical Trial Filing for HLX301 in Australia
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its subsidiary, Shanghai Henlius Biotech (HKG: 2696), has completed a clinical trial filing for HLX301 in Australia. Henlius will conduct a Phase I clinical study in the country for the bispecific antibody (BsAb) targeting programmed-death-ligand 1 (PD-L1)…
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China Resources Double-Crane Gains Approval for Definity in China
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving market approval from the National Medical Products Administration (NMPA) to act as the domestic agent for Definity (perflutren lipid microsphere injection). The contrast agent can now be used to enhance the recognition of the left ventricular endocardial boundary when…
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Bliss Bio’s BB-1709 Accepted for Review by China’s CDE
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Hangzhou-based oncology-focused clinical stage biotech Bliss Bio has announced that its clinical filing for the Category 1 therapeutic biologic product injectable BB-1709 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BB-1709, a potential first-in-class antibody drug conjugate…
