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HKG:2696

29 stories mentioning HKG:2696Updated 12m ago

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Henlius Biotech Gets China Nod for Tumor Drug Trial

Shanghai Henlius Biotech (HKG:2696) obtained approval for its investigational new drug application for a clinical trial of HLX43 for injection from China's National Medical Products Administration.The trial will begin in the Chinese Mainland once conditions are fulfilled, according to a Friday Hong Kong bourse filing.The trial will test the drug in combination with bevacizumab with or without chemotherapy for the treatment of advanced/metastatic solid tumors.

Shanghai Henlius Doses First Patient in Phase 1 Trial of Prostate Cancer Drug

Shanghai Henlius Biotech (HKG:2696) said it has dosed the first patient in a Phase 1 clinical trial of HLX3902, its internally developed trispecific antibody, for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors in mainland China.The company also plans to begin the corresponding Phase 1 study in Australia once the required conditions are met, according to a Hong Kong bourse filing.

Henlius Biotech Doses First Patient in Tumor Drug Trial in China

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 1 clinical study of HLX18, according to a Thursday Hong Kong bourse filing.The drug is being tested in patients with multiple resected solid tumors in Mainland China.

Shanghai Henlius Biotech's Cancer Drug Combination Trial Gets IND Approval

Shanghai Henlius Biotech (HKG:2696) said its investigational new drug application for a Phase I clinical trial of HLX37 in combination with chemotherapy or HLX43 has been approved by China's National Medical Products Administration.HLX37, a bispecific antibody targeting PD-L1 and VEGF, is being evaluated for the treatment of advanced or metastatic solid tumors, according to a Hong Kong bourse filing. The company plans to begin the trial in mainland China once the required conditions are met.

Henlius Biotech Doses First Patient in Colorectal Cancer Study

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 1 clinical trial of cetuximab injection biosimilar HLX05-N.The drug is being tested in patients with metastatic colorectal cancer in Mainland China, according to a Wednesday Hong Kong bourse filing.

Henlius Biotech Doses First Patient in Tumor Drug Study

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 1 clinical study of HLX48 for injection in Mainland China.The drug is being tested for the treatment of advanced/metastatic solid tumors, according to a Tuesday Hong Kong bourse filing.

Henlius Biotech Doses First Patient in US Trial of Tumor Drug

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 1 study of Ipilimumab biosimilar HLX13 in the U.S., according to a Thursday Hong Kong bourse filing.The drug has been developed by the company as first-line treatment for patients with unresectable advanced hepatocellular carcinoma.

Henlius Biotech Gets EU Clearance for New Indication of Serplulimab Combo

Shanghai Henlius Biotech (HKG:2696) obtained approval for a new indication of its serplulimab injection from the European Commission, according to a Thursday Hong Kong bourse filing.The approved indication is for serplulimab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.The new indication has been approved in all EU member states as well as in Iceland, Liechtenstein, and Norway.

Fosun Pharma Unit Passes GMP Inspection

Shanghai Fosun Pharmaceutical's (SHA:600196, HKG:2196) subsidiary, Shanghai Henlius Biotech (HKG:2696), passed a drug GMP or good manufacturing practice inspection, according to a Shanghai bourse filing on Thursday.The Shanghai Municipal Medical Products Administration made the inspection at Henlius' manufacturing facility in Songjiang District, which produces the breast cancer drug Hanbeiyou or pertuzumab injection.The company was found to be compliant with GMP requirements.The pharmaceutical company's Shanghai shares rose 2% during the morning trade.

HKG:2196HKG:2696SHA:600196

Fosun Pharma Gets China Nod to Trial HLX3902 Injection

Shanghai Fosun Pharmaceutical (SHA:600196, HKG:2196), through its subsidiary Shanghai Henlius Biotech (HKG:2696), received approval from China's National Medical Products Administration for the clinical trials of HLX3902 injection, according to a Shanghai bourse filing on Thursday.The drug will be tested as a treatment for metastatic castration-resistant prostate cancer and other advanced solid tumors.The pharmaceutical company's Shanghai shares rose 2% during the morning trade.

HKG:2196HKG:2696SHA:600196

Henlius Biotech Unit's Breast Cancer Drug Production Line Passes Shanghai Regulator's Inspection

Shanghai Henlius Biotech (HKG:2696) unit Shanghai Henlius Biologics' drug substance east line, drug product production line, and packaging line of Hanbeiyou passed a compliance inspection by Shanghai Medical Products Administration.The inspection was conducted at the company's biopharmaceutical production base in Songjiang district, Shanghai, according to a Wednesday Hong Kong bourse filing.Hanbeiyou is mainly used for the neoadjuvant/adjuvant treatment of breast cancer.

Henlius Biotech's Trial of Lung Cancer Drug Secures Approval in Australia

Shanghai Henlius Biotech's (HKG:2696) phase 2 trial of HLX43 for injection in combination with Hansizhuang has been approved by the relevant Human Research Ethics Committee and acknowledged by Australia's Therapeutic Goods Administration.The drug is being tested as neoadjuvant therapy of non-small cell lung cancer, according to a Tuesday Hong Kong bourse filing.The clinical study will begin on fulfillment of the relevant conditions.

Henlius Biotech's Trial of Macular Degeneration Drug Meets Primary Endpoint

Shanghai Henlius Biotech's (HKG:2696) phase 3 study of HLX04-O in patients with wet age-related macular degeneration met its primary study endpoint, according to a Tuesday filing with the Hong Kong bourse.HLX04-O had a good safety profile, with similar overall, ocular and non-ocular safety results compared to ranibizumab.The drug is a new ophthalmic preparation product developed based on Hanbeitai, the exclusive rights of which for ophthalmic treatment and therapy worldwide have been granted by the company to Essex Bio-Technology (HKG:1061) and Zhuhai Essex Bio-Pharmaceutical.The company has an agreement to co-develop the relevant product with Essex Bio-Technology.

HKG:1061HKG:2696

Henlius Biotech's Application for New Indication of Hansizhuang Approved in China

Shanghai Henlius Biotech's (HKG:2696) new drug application for a new indication of Hansizhuang was approved by China's National Medical Products Administration, according to a Tuesday Hong Kong bourse filing.The approval is for use of the drug in combination with Oxaliplatin and S-1 for the neoadjuvanttreatment of resectable gastric cancer.

Henlius Biotech Doses First Patient in US Tumor Drug Study

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in an international multi-center phase 1 study of a HLX17 in the United States, according to a Friday Hong Kong bourse filing.The trial is studying the drug in patients with multiple resected solid tumors.A phase 1 trial of the drug is simultaneously being conducted in Mainland China.

Henlius Biotech Doses First Patient in Lung Cancer Drug Trial

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 2/3 clinical study of HLX43 for injection, according to a Thursday Hong Kong bourse filing.The drug is being tested as monotherapy or in combination with pimurutamab HLX07 versus docetaxel for the treatment of advanced/metastatic squamous non-small cell lung cancer in patients whose prior treatment failed in the Chinese Mainland.

Henlius Biotech Doses First Patient in Lung Cancer Drug Study

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 2/3 trial studying pimurutamab HLX07 in combination with Hansizhuang and chemotherapy in the Chinese Mainland, according to a Tuesday filing with the Hong Kong bourse.The drug in this combination is being compared to placebo in combination with Hansizhuang or pembrolizumab and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer.

Henlius Biotech Doses First Patient in Lung Cancer Drug Study

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 2/3 trial studying pimurutamab HLX07 in combination with Hansizhuang and chemotherapy in the Chinese Mainland, according to a Tuesday filing with the Hong Kong bourse.The drug in this combination is being compared to a placebo in combination with Hansizhuang or pembrolizumab and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer.

Henlius Biotech Doses First Patient in Phase 1 Trial of Multiple Myeloma Drug

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a phase 1 trial of HLX15-SC in the Chinese Mainland, according to a Tuesday Hong Kong bourse filing.The drug is being tested for first-line treatment for newly diagnosed multiple myeloma, the filing said.

Henlius Biotech Doses First Patient in Phase 1 Tumor Trial in China

Shanghai Henlius Biotech (HKG:2696) dosed the first patient in a Phase 1 clinical trial of HLX316 for injection, according to a Friday Hong Kong bourse filing.The trial is studying the effects of the drug in patients with advanced/metastatic solid tumors in Mainland China.

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