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32 stories mentioning SHA:600276Updated 1d ago

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Hengrui Pharma Wins China Regulator's Nod for Three Drugs

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) has received market approval from China's National Medical Products Administration (NMPA) for its insulin sudelidec injection, according to a Wednesday filing to the Hong Kong stock exchange.The company independently developed the Class 1 therapeutic biological product for treating adults with type 2 diabetes mellitus, with approvals granted for 3ml:300 units in both pre-filled injection pen and cartridge formats.Additionally, the pharmaceutical firm secured regulatory acceptance for its drug marketing authorization application for Ruikang Luzetutamab for Injection (SHR-A2009), intended for adult patients with lung cancer that has progressed after epidermal growth factor receptor tyrosine kinase inhibitor therapy.In a separate filing, Hengrui announced that its subsidiary, Fujian Shengdi Medicine, received NMPA approval to initiate a Phase II clinical trial for HRS5580 for Injection, a selective neurokinin-1 receptor antagonist designed to prevent postoperative nausea and vomiting.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets China Nod for Five Cancer Drug Trials

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) subsidiaries obtained China's regulatory approval to conduct clinical trials for five anticancer drugs.These drugs are SHR-4610, SHR-1826, SHR-A2009, Ruikang Trastuzumab and SHR-8068, according to a Monday filing with the Shanghai bourse.Shares of the company slid 1% on the Shanghai bourse and rose 1% in Hong Kong.

HKG:1276SHA:600276

Jiangsu Hengrui Pharmaceuticals Gets China Nod for Hypertension Drug Trial

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) subsidiary Shandong Shengdi obtained China's regulatory approval to conduct Phase II/III clinical trials for HRS-1780 tablets.The tablets are used for uncontrolled or resistant hypertension, according to a Monday filing with the Shanghai bourse.

HKG:1276SHA:600276

Hengrui Pharmaceuticals' Pancreatic Cancer Drug Gets US FDA Orphan Status

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) said its SHR-4375 Injection has received orphan drug designation from the U.S. Food and Drug Administration for treating pancreatic cancer.The designation will provide the company with opportunities to receive U.S. policy support in the areas of product development, registration and commercialization, according to a Monday filing with the Shanghai bourse.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets Marketing Approval for Cervical Cancer Combo Treatment

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) said China's drug regulator approved the marketing of camrelizumab in combination with famitinib malate for the first-line treatment of patients with recurrent or metastatic cervical cancer.This approval marks the official upgrade of the combination therapy to first-line treatment from second-line for advanced cervical cancer, according to a Thursday filing with the Shanghai bourse.Shares of the pharmaceutical company were down 1% in recent trade.

HKG:1276SHA:600276

Hengrui Pharma Gets China Clinical Trial Nod for Osteoarthritis Injection; Shares Fall 4%

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) received Phase 3 clinical trial approval from China's National Medical Products Administration for its HRS9531 injection, according to a Friday filing with the Shanghai bourse.Hengrui will initiate trials for the drug in obese adult patients with knee osteoarthritis.The HRS9531 injection targets the gastric inhibitory peptide receptor and glucagon-like peptide-1 receptor. It has been previously tested on type 2 diabetes, obesity with heart failure, sleep apnea, and polycystic ovary syndrome.The company's cumulative investment in the drug reached 700.8 million yuan.Shares fell 4% in Hong Kong and Shanghai during morning trading on Friday.

HKG:1276SHA:600276

Hengrui Pharma Wins China Nod for Stroke Drug Clinical Trial

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) unit Beijing Shengdi Pharmaceutical obtained clinical trial approval from China's National Medical Products Administration for its HRS-8829 injection concentrate, according to a Thursday filing on the Shanghai bourse.The clinical trials will evaluate the drug's use for the treatment of acute ischemic stroke.The Hengrui unit has so far invested 16.6 million yuan in the drug's research and development.The pharmaceutical company's shares slipped over 2% in Shanghai trade recently.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets Nod for Atopic Dermatitis Drug Testing

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) received approval from China's National Medical Products Administration for the clinical trial of HRS-8797 tablets, according to a Thursday disclosure on the Shanghai bourse.The drug will be tested as a treatment for atopic dermatitis.The pharmaceutical company's shares slipped 1% during the morning trade.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Gets China Nod For Lupus, Arthritis Drug Trials

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) has secured clearance from China's drug regulator to begin clinical trials for its SHR-3079 injection to treat adult systemic lupus erythematosus and adult rheumatoid arthritis.There are currently no similar drugs approved for marketing globally, the company said in a Shanghai bourse filing on Tuesday.The drug is also already in Phase I trials for B-cell non-Hodgkin's lymphoma.Hengrui has invested about 24.4 million yuan in the project to date.

HKG:1276SHA:600276

Hengrui Pharmaceuticals' Pancreatic Cancer Drug Gains Breakthrough Therapy Status

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) said its HRS-7058 capsules have been granted breakthrough therapy designation by China's drug regulator.The drug is used for treating KRAS G12C-mutant pancreatic cancer after prior systemic therapy failure, according to a Monday filing with the Shanghai bourse.

Jiangsu Hengrui Pharmaceuticals' Contrast Agent Added to China's Essential Medicines List

Jiangsu Hengrui Pharmaceuticals (SHA:600276) said its contrast agent Ioversol injection was included in China's list of national essential medicines, effective Sept. 1.The drug is indicated for cardiovascular angiography, contrast-enhanced computed tomography scans and excretory urography, according to a weekend filing with the Shanghai bourse.Shares of the pharmaceutical company were down 1% in recent trade.

Hengrui Pharma Gets Nod to Trial Drug Combination for Hepatocellular Carcinoma

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276), through its subsidiaries, received approval from China's National Medical Products Administration for the clinical trials of a drug combination for the treatment of hepatocellular carcinoma, according to a Shanghai bourse filing on Friday.The pharmaceutical company was given the green light to trial SHR-8068 injection in combination with adebelimab injection, and apatinib mesylate tablets.Adebelimab injection was already approved as a lung cancer treatment, while apatinib mesylate tablets was approved as a treatment for various cancers, including gastric, hepatocellular and breast cancer.The company's Hong Kong shares rose 2% and Shanghai shares increased 1% during the morning trade.

HKG:1276SHA:600276

Hengrui Pharma Obtains Priority Review for Breast Cancer Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276) subsidiary Suzhou Suncadia received acceptance and priority review designation from China's medical products administrator for Recurcept as a treatment for HER2-low metastatic breast cancer.Recurcept, already approved for HER2-mutant non-small cell lung cancer and HER2-positive breast cancer, has now received 11 breakthrough therapy designations, according to a Thursday filing with the Shanghai bourse.

Hengrui Pharma Gets Nod to Trial HRS-4508 Tablets As Advanced Tumor Treatment; Shares Down 4%

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) received approval from China's National Medical Products Administration to conduct clinical trials on HRS-4508 tablets, according to a Shanghai bourse filing on Friday.The drug will be tested as a treatment for advanced solid tumors.The pharmaceutical company invested 81.8 million yuan into the research and development of the drug.The company's Hong Kong shares dropped 4%, while Shanghai shares slipped 1% during the morning trade.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Unit Wins China Approval to Expand Indication of Cancer Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) said a unit received China's National Medical Products Administration approval to expand the indication of adebrelimab, according to a Thursday Hong Kong bourse filing.The drug can now be used as neoadjuvant therapy in non-small cell lung cancer. It was previously approved as a first-line treatment of extensive-stage small cell lung cancer.

HKG:1276SHA:600276

Hengrui Pharmaceuticals Unit Wins China Marketing Approval for Dry Eye Drug

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) said a unit received marketing approval from China's National Medical Products Administration for Cyclosporine Ophthalmic Solution (IV), marketed as CyclASol, according to a Thursday Hong Kong bourse filing.CyclASol is indicated to promote tear secretion and improve the signs and symptoms of dry eye disease in patients with reduced tear production.

HKG:1276SHA:600276

Jiangsu Hengrui Pharmaceuticals Withdraws Atopic Dermatitis Ointment Application

Jiangsu Hengrui Pharmaceuticals (SHA:600276) withdrew its marketing application for ivarmacitinib ointment, citing the need to refine submission materials.The topical drug is used to treat mild-to-moderate atopic dermatitis, according to a Tuesday filing with the Shanghai bourse.Shares of the pharmaceutical company rose nearly 4% in recent trade.

European Drug Regulator Accepts Hengrui Pharma's Marketing Application for Revulutamide Tablets

The European Medicines Agency accepted Jiangsu Hengrui Pharmaceuticals' (SHA:600276, HKG:1276) marketing application for revulutamide tablets, according to a Shanghai bourse filing on Tuesday.The drug is used in combination with androgen deprivation therapy for the treatment of adult male patients with prostate cancer.The Chinese pharmaceutical company's shares rose 2% during the morning trade.

HKG:1276SHA:600276

China Greenlights Clinical Trials for Two Hengrui Pharma Drugs, Approves Another Indication for Breast Cancer Drug

China's drug regulator approved clinical trials for Jiangsu Hengrui Pharmaceuticals' (SHA:600276, HKG:1276) SHR-6914 injection and HRS-7525 tablets, according to separate filings with the Shanghai bourse on Wednesday.The SHR-6914 injection, produced by subsidiary Suzhou Shengdiya Biopharmaceutical, is indicated for tumors related to prostate cancer.Hengrui's HRS-7525 tablets are indicated for solid tumors.The regulator also approved another indication for its dalpiciclib isethionate tablets for early-stage breast cancer with high risk of recurrence, and are hormone receptor-positive and human epidermal growth factor receptor 2-negative.

HKG:1276SHA:600276

Hengrui Pharma Secures China Registration for Gout Drug; Shares Up 3%

Jiangsu Hengrui Pharmaceuticals (SHA:600276) obtained drug registration from China's medical products regulator for its luzinuole sodium tablets.The drug is used for gout with hyperuricemia, according to a Thursday filing with the Shanghai bourse.Shares of the pharmaceutical company rose 3% in recent trade.

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