33 stories mentioning HKG:2696Updated 3d ago
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Shanghai Henlius Biotech's (HKG:2696) new drug application for its denosumab HLX1 biosimilar was accepted by China's National Medical Products Administration.The indications covered in the application are bone metastases from solid tumors and multiple myeloma, as well as giant cell tumor of the bone, according to a Friday bourse filing.
Shanghai Henlius Biotech's (HKG:2696) shares were included in Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect, effective Monday.The stock connect programs are a collaboration between the Hong Kong, Shanghai and Shenzhen stock exchanges, enabling international and mainland Chinese investors to trade securities in each other's markets.The biotech firm said its inclusion in the cross-border trading links would expand its shareholder base and boost the liquidity of its shares, Henlius said in a Monday disclosure.Shares of Henlius fell over 3% in Monday's afternoon trade.
Shanghai Henlius Biotech (HKG:2696) reported 430.4 million yuan in profit attributable to equity holders of the parent for the first half, compared with 390.1 million yuan a year ago, a Friday bourse filing showed.EPS moved to 0.79 yuan from 0.72 yuan year over year.For the six months ended June 30, revenue was 3.59 billion yuan, versus 2.82 billion yuan, the biologics medicine company said.
Shanghai Henlius Biotech (HKG:2696) entered into a collaboration with Sandoz covering up to 10 biosimilar monoclonal antibody and antibody-drug conjugate products, according to a Monday Hong Kong bourse filing.The first batch includes the cetuximab biosimilar HLX05-N, the evolocumab biosimilar HLX16, and a belimumab biosimilar.Sandoz will receive the rights to develop, register, and commercialize the products globally, excluding mainland China, Hong Kong, Macau, and Taiwan, subject to product-specific terms.Sandoz will pay up to $77 million in upfront payments, $160 million in development milestones, and $77 million in commercial milestones for the first batch, plus 40% of net sales or net profits in each country, unless otherwise agreed.
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 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.
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 (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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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