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Chinese Drug Regulator Accepts Hengrui Pharmaceuticals Unit's Marketing Application for SHR-2004 Injection

China's National Medical Products Administration accepted the drug marketing authorization application of Jiangsu Hengrui Pharmaceuticals' (SHA:600276, HKG:1276) unit, Beijing Shengdi Pharmaceutical, for SHR-2004 injection, according to a Tuesday disclosure in a Shanghai bourse filing.The drug is used to prevent venous thromboembolism in adult patients undergoing elective knee replacement surgery.

HKG:1276SHA:600276

Hengrui Pharmaceuticals' Lung Cancer Drug Included in China's Breakthrough Therapy Designation List

China's drug regulator included Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) subsidiary Suzhou Shengdia Biopharmaceutical's ruzaltatug rezetecan drug for non-small cell lung cancer in its breakthrough therapy designation list, according to a Saturday filing with the Shanghai bourse.The drug is indicated for combination with bevacizumab to treat advanced or metastatic non-squamous non-small cell lung cancer with epidermal growth factor receptor tyrosine kinase inhibitors, the filing said.

HKG:1276SHA:600276

Hengrui Pharma Gets China Nod for Two Indications of Hetrombopag Olamine Tablets

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) obtained approval for two new indications of its Hetrombopag Olamine Tablets from China's National Medical Products Administration.The first indication is for the treatment of adult patients with thrombocytopenia caused by chemotherapy-based anti-tumor therapy for solid tumors, according to a Thursday bourse filing.The other indication is for pediatric patients over six years of age with chronic primary immune thrombocytopenia.

HKG:1276SHA:600276

Hengrui Pharma Wins China Clinical Trial Nod For Two Weight Management Products

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) subsidiaries received clinical trial approval from China's National Medical Products Administration for two weight management tablets, HRS-1597 and SHR-1179, according to separate Tuesday filings with the Shanghai bourse.Research and development investment for the HRS-1597 product so far reached 16.9 million yuan, while that for SHR-1179 is at 24.2 million yuanThe drug company's Hong Kong and Shanghai shares slipped 1% during Tuesday's morning session.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets China Nod to Trial Two Tumor Drugs

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) obtained approval from China's National Medical Products Administration for the clinical trials of HRS-6209 capsules and HRS-4508 tablets, according to a Shanghai bourse filing on Tuesday.HRS-6209 is a novel selective CDK4 inhibitor that is clinically intended for the treatment of advanced malignant solid tumors, while HRS-4508 is a tyrosine kinase inhibitor that inhibits the proliferation of tumor cells.The pharmaceutical company has invested 160.9 million yuan into the research and development of HRS-6209 and 96.7 million yuan in HRS-4508's research.Hengrui's Shanghai and Hong Kong shares both slipped 1% during the morning trade.

HKG:1276SHA:600276

Hengrui Pharmaceuticals' Unit Gets Chinese Drug Regulator's Nod to Market Yeast Infection Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Chengdu Shengdi Pharmaceutical received approval from China's National Medical Products Administration to market its Oteseconazole capsules, according to a Shanghai bourse filing on Friday.The drug is indicated for the treatment of severe vulvovaginal candidiasis, or yeast infection.

HKG:1276SHA:600276

Update: Hengrui Pharma Unit Secures China Nod For Diabetes Drug Application

(Updates to add Hong Kong ticker)Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Shandong Shengdi received regulatory acceptance in China for the marketing application of its HRS-7535 tablets.The drug is indicated for blood sugar control in patients with type two diabetes mellitus, according to a Wednesday aftermarket filing with the Shanghai bourse.Shares of the company were up 1% in recent trade.

HKG:1276SHA:600276

Chinese Drug Regulator Accepts Hengrui Pharma's Drug Marketing Application for HRG2010 Capsules

China's National Medical Products Administration accepted Jiangsu Hengrui Pharmaceuticals' (SHA:600276, HKG:1276) drug marketing authorization application for HRG2010 capsules, according to a Shanghai bourse filing on Tuesday.The drug is used for the treatment of Parkinson's disease.

HKG:1276SHA:600276

Nomura Adjusts Jiangsu Hengrui Pharmaceuticals' Price Target to HK$82.18 From HK$87.49, Keeps at Buy

Jiangsu Hengrui Pharmaceuticals (HKG:1276) has an average rating of overweight and mean price target of HK$81.15, according to analysts polled by FactSet.

Jiangsu Hengrui Pharmaceuticals Gets China Marketing Nod for Rare Blood Condition Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) subsidiary Chengdu Shengdi Pharmaceutical received marketing approval from China's National Medical Products Administration for its self-developed HRS-5965 drug, according to a Friday filing with the Shanghai bourse.The drug is indicated for paroxysmal nocturnal hemoglobinuria, a rare blood condition that causes complications mainly through intravascular hemolysis, thrombosis, and bone marrow failure.

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Hengrui Pharma Gets China Nod for Autoimmune Blood Disorder Trials

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Chengdu Shengdi Pharmaceutical obtained the approval of China's drug regulator to begin clinical trials for its HRS-3095 tablets.The drug is being developed to treat primary immune thrombocytopenia and autoimmune hemolytic anemia, according to a Thursday aftermarket filing with the Shanghai Stock Exchange.

HKG:1276SHA:600276

Hengrui Pharma Gets Nod to Trial SHR-8203 Injection

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) received approval from China's National Medical Products Administration for the clinical trial of SHR-8203 injection, according to a Shanghai bourse filing on Friday.The drug will be tested as a monotherapy for advanced solid tumors.The Chinese pharmaceutical company's Shanghai shares dropped 3% during the morning trade.

HKG:1276SHA:600276

Hengrui Pharma Unit Gets China Nod for Lupus Drug Trial

Jiangsu Hengrui Pharmaceuticals (SHA:600276) unit Guangdong Hengrui Medicine obtained approval from China's drug regulator to begin clinical trials for SHR-7012 injection.SHR-7012 targets cutaneous lupus erythematosus, according to a Thursday aftermarket filing.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Unit Gets China Marketing Nod for Paroxysmal Nocturnal Hemoglobinuria Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Chengdu Suncadia Medicine obtained marketing approval for its Licancopan Fumarate Capsules from China's National Medical Products Administration.The approved indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy, according to a Thursday bourse filing.

HKG:1276SHA:600276

Hengrui Pharma's H1 Profit Flat, Revenue Down 2%; Launches Share Buyback

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) posted a profit attributable to owners of the parent of 4.46 billion yuan for the first half, versus 4.45 billion yuan a year earlier.Earnings per share stood at 0.68 yuan, compared with 0.70 yuan in the year-ago period, according to a Wednesday Hong Kong bourse filing.Revenue decreased 1.9% year over year to 15.5 billion yuan from 15.8 billion yuan.The drugmaker said it plans to spend 1 billion yuan to 2 billion yuan to buy back A-shares through centralized price bidding, with the repurchased shares to be used for an employee stock ownership scheme.Hengrui Pharma will pay no more than 81.78 yuan per share, with the repurchase period lasting up to 12 months from the date of board approval.

HKG:1276SHA:600276

Hengrui Pharma Gets China Nod For Inflammatory Bowel Injection Clinical Trial

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) has received approval from China's National Medical Products Administration to carry out clinical trials for its therapeutic biological product, SHR-7590 Injection.The injection is indicated for the treatment of inflammatory bowel diseases, ulcerative colitis and Crohn's disease, according to a Shanghai Stock Exchange filing on Thursday.The company has so far invested 32.5 million yuan in the research and development of the injection.

HKG:1276SHA:600276

Hengrui Pharma Gets China Nod For Phase II Diabetes Drug Trial

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) has received approval from China's National Medical Products Administration to conduct a Phase II clinical trial for its HRS-4729 injection in adult patients with type 2 diabetes.The drug is a triple agonist targeting GLP-1R, GIPR, and GCGR receptors, designed to improve glucose metabolism, aid weight loss, and suppress appetite.The company is already conducting a separate Phase II trial for the drug as a weight-loss treatment, according to a Shanghai Stock Exchange filing on Thursday.The company has invested about 81.6 million yuan in the research and development of the injection to date.

HKG:1276SHA:600276

Hengrui Pharma Gets Nod to Add Fifth Indication for Ivarmacitinib Sulfate Tablets

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) received approval from China's National Medical Products Administration to add a fifth indication for its ivarmacitinib sulfate tablets or SHR0302 tablets, according to a weekend disclosure on the Hong Kong bourse.The pharmaceutical company's shares rose 1% during Monday's morning trade.The regulator approved the drug as a treatment for adult patients with active nonradiographic axial spondyloarthritis, who have had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs and who have objective signs of inflammation.

HKG:1276SHA:600276

Hengrui Pharma Unit Gets Marketing Nod for Colorectal Cancer Drug in China

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Suzhou Suncadia Biopharmaceuticals' third indication for trastuzumab rezetecan for injection was approved for marketing by China's National Medical Products Administration.The drug is now the first anti-HER2 product approved for the treatment of colorectal cancer in China.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets China Nod for Lung Cancer Combo Trials

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) obtained China's regulatory approval for Phase Two clinical trials combining SHR-A2009 with Adebrelimab or third-generation EGFR-TKI in non-small cell lung cancer patients, according to a Tuesday aftermarket filing with the Shanghai bourse.

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