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The National Medical Products Administration (NMPA) website indicates that China-based Shanghai Henlius Biotech’s (HKG: 2696) HLX04, a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab), has been approved for use in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (CRC). Henlius’s drug becomes the eighth…
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China-based Biosion, Inc’s US partner Pyxis Oncology, Inc. (NASDAQ: PYXS) announced receiving clinical trial approval from the US FDA for its PYX-106 (BSI-060T). The anti-Siglec-15 monoclonal antibody (mAb) can now be assessed in clinics in bladder cancer, bile duct cancer, colorectal cancer, kidney cancer, and more. Preclinical Data and Drug…
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced that the Phase II clinical study for its AR antagonist KX-826 (pyrilutamide) in female patients with androgenetic alopecia (AGA) in China has reached the primary endpoint. Study Design and ResultsThe randomized, double-blind, placebo-controlled, multicenter study, with 160 patients enrolled, is designed to assess…
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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 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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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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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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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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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…