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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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…
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market approval with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The filing seeks approval for the checkpoint inhibitor in combination with chemotherapy as a…
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Immorna (Hangzhou) Biotechnology Co., Ltd has announced that the US FDA has cleared its investigational new drug (IND) application to conduct a Phase I/II multi-center study assessing the safety and immunogenicity of JCXH-221, a lipid nanoparticle (LNP) complex broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases, in healthy adult…
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approval from the US FDA for its Category 1 innovative gene therapy eye injection KH631. The targeted indication is neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss in older adults. KH631 ProfileKH631…
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China-based Frontier Biotechnologies Inc. (SHA: 688221) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase II/III clinical study assessing its FB2001 atomized inhalant bofutrelvir in mild and common COVID-19 patients. This marks a significant step forward in the development of innovative treatments for COVID-19.…
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The…