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Jiangsu Hengrui Receives NMPA Approval for SHR-2173 Clinical Trial in ITP
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational biologic product, SHR-2173, in patients with primary immune thrombocytopenia (ITP). This development marks a significant step forward in expanding treatment options…
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Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for a suite of drugs including HRS-2189, HRS-5041, HRS-1358, HRS-8080, SHR-8068, adebrelimab, and HRS-6209. The company is set to initiate an open, multi-center Phase…
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Jiangsu Hengrui Medicine Advances Clinical Trials for Cancer Therapies with NMPA Clearance
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability,…
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Hengrui Medicine Considers HKEX Secondary Listing Amid Financing Challenges in Mainland China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, is reportedly planning a secondary listing on the Hong Kong Stock Exchange, according to multiple media sources. The move is anticipated to raise approximately USD 2 billion (RMB 14 billion) and comes amidst concerns regarding “difficulty in financing…
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Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Jiangsu Hengrui’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its drug candidate, hetrombopag olamine. This new indication is for the use of hetrombopag olamine in combination with…
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Jiangsu Hengrui’s HR19042 Earns Breakthrough Designation for Autoimmune Hepatitis Treatment in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its modified drug HR19042, which targets active autoimmune hepatitis (AIH). AIH is a rare liver disease that, if untreated,…
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Jiangsu Hengrui’s RGL-193 Receives NMPA Greenlight for Parkinson’s Disease Clinical Study
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Jiangsu Hengrui Medicine Co., Ltd, a leading pharmaceutical company based in China and listed as (SHA: 600276), has received approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RGL-193. This marks a significant step forward as the drug advances into clinical studies focused on Parkinson’s disease…
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Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Kailera Therapeutics Emerges with USD 400 Million in Series A Funding for Anti-Obesity Pipeline
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Kailera Therapeutics, a newly launched US-based biotechnology company, secured USD 400 million in Series A financing last week. Previously operating as Hercules CM Newco Inc., the company was established by a consortium of investors including Bain Capital Life Sciences, RTW Investments, Atlas Venture, and Lyra Capital. The pipeline of Kailera…
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Hengrui Medicine’s HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Medicine (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Medicine, HR19042 is…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Clinical Trial of TSLP-Targeted Asthma Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 product SHR1905, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb). The product is…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Generic Vizamyl Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of GE Healthcare’s Vizamyl (flutemetamol F-18). This trial aims to evaluate the positron emission tomography (PET)…
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Jiangsu Hengrui Medicine’s SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
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Jiangsu Hengrui’s ANGPTL3 Inhibitor SHR-1918 Earns Breakthrough Designation for HoFH Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s Center for Drug Evaluation (CDE) for its drug candidate SHR-1918. This in-house developed monoclonal antibody (mAb) targeting angiopoietin-like protein 3 (ANGPTL3) is intended for the…
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Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) has given the green light for the review of a new indication submission for Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) ivarmacitinib, as per the latest update on the CDE’s website. The potential new indication is speculated to be adult alopecia areata, aligning with…
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Jiangsu Hengrui and Chongqing Genrix Launch Anti-IL-17 Therapies for Psoriasis in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) and Chongqing Genrix Bio Pharmaceutical Co., Ltd, two leading Chinese pharmaceutical companies, have embarked on the commercialization journey of their innovative anti-IL-17 antibodies, vunakizumab and xeligekimab, respectively. These domestically developed treatments received marketing approval late last month, marking a significant milestone in addressing…
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Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
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Jiangsu Hengrui Medicine Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
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Jiangsu Hengrui Medicine Co., Ltd Announces Resignations of Two Deputy General Managers
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Jiangsu Hengrui Medicine Co., Ltd, a leading pharmaceutical company based in China and listed on the Shanghai Stock Exchange (SHA: 600276), has announced the resignation of two of its key executives, Ms. Jiang Sumei and Mr. Wang Hongsen, both of whom held the position of Deputy General Manager. Both executives…
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Jiangsu Hengrui Medicine Reports 21.78% YOY Revenue Growth and 48.67% Increase in Net Profit for H1 2024
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Jiangsu Hengrui Medicine Co., Ltd, a leading pharmaceutical company based in China with shares traded on the Shanghai Stock Exchange (SHA: 600276), has announced its financial results for the first half of 2024. The company reported a robust revenue of RMB 13.601 billion, reflecting a 21.78% year-on-year (YOY) increase. The…
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Jiangsu Hengrui Medicine Expands R&D Footprint with Jinan Innovation Zone Partnership
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JINAN—The management committee of the Jinan Innovation Zone has entered into a strategic partnership with Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, to collaboratively advance research and development in the fields of novel drugs and devices, as well as high-quality biomedicine industry development. The…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its investigational drug SHR-2106, targeting active primary Sjögren’s syndrome (pSS). Primary Sjögren’s syndrome is a chronic autoimmune disorder predominantly affecting middle-aged and elderly women, characterized by…
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CStone to Manufacture Gavreto Locally Following NMPA Approval, Expanding Market Presence
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg), transitioning from overseas supply. Domestic production is anticipated to begin by late this year or early next year, following the approval of the 300mg…
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Hengrui Medicine Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for its investigational drug SHR7280, aimed at treating heavy menstrual bleeding associated with uterine fibroids. SHR7280 is an oral small molecule…
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Chinese NMPA Approves Hengrui Med’s Generic Abraxane for Metastatic Pancreatic Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
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Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
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Jiangsu Hengrui Medicine Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
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Hengrui Medicine Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Shanghai Medicilon and Jiangsu Hengrui Join Forces to Advance Pre-Clinical Drug Evaluation
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Shanghai Medicilon Biomedical Co., Ltd, a leading biopharmaceutical company based in China, has entered into a strategic partnership with Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent player in the global pharmaceutical industry. This collaboration aims to leverage Medicilon’s pre-clinical research and development expertise with Hengrui’s innovative drive and…
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Jiangsu Hengrui Receives NMPA Approval to Study CDK 4/6 Inhibitor Dalpiciclib in Combination with HRS-1358 for Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
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Jiangsu Hengrui Medicine Faces FDA Setback with Warning Letter for Quality Control Issues
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Jiangsu Hengrui Medicine (SHA: 600276), a prominent player in China’s pharmaceutical industry, has received a warning letter from the US Food and Drug Administration (FDA), following a Form 483 issued earlier this year in June. The FDA’s notice highlights two principal deficiencies at Hengrui’s facility: the company’s quality control unit…
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Jiangsu Hengrui’s Subsidiary Conducts First Surgical Dosing in Parkinson’s Gene Therapy Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shanghai Regenelead Therapies Co., Ltd., has conducted the first surgical dosing in a clinical study for its dual adeno-associated virus (AAV) gene therapy, RGL-193, aimed at treating Parkinson’s disease (PD). The procedure…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for HRS-9813 IPF Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HRS-9813, which is intended for the treatment of idiopathic pulmonary fibrosis (IPF). Preclinical efficacy data from…
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China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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Jiangsu Hengrui’s Henagliflozin Gains Expanded Indication for Type 2 Diabetes Treatment in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Jiangsu Hengrui Medicine Receives FDA Form 483 Following Inspection Discrepancies
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The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui Medicine (SHA: 600276), a leading drug manufacturer in China. The document, which spans eight pages, details several compliance issues observed during an inspection. Notably, it mentions an incident where an employee attempted to divert inspectors…
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Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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Hengrui Medicine Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
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Hengrui Medicine’s Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531. SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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Jiangsu Hengrui’s Camrelizumab/Apatinib Combo Denied FDA Approval Over Manufacturing Issues
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The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
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Hengrui Medicine Strikes Deal with Hercules CM Newco to Supply GLP-1 Products for Global Markets
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has entered into a significant agreement to supply a range of glucagon-like peptide-1 (GLP-1) products to Hercules CM Newco Inc., a newly established US firm backed by a consortium of investors including Bain Capital Life Sciences, RTW Investments,…
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Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SHR-2173, an investigational biologic, in patients with IgA nephropathy. Developed in-house, SHR-2173 is designed to target abnormally…
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Jiangsu Hengrui Medicine Advances HRS-5965 with NMPA Clinical Trial Approval for Glomerular Diseases
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has been granted approval by the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-5965, a novel therapeutic targeting primary or secondary glomerular diseases. The conditions include IgA nephropathy, idiopathic membranous nephropathy, C3…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Medicine Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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Jiangsu Hengrui Medicine Reports 7.26% Revenue Growth in 2023, Driven by Innovative Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has released its financial report for 2023, recording RMB 22.82 billion (USD 3.15 billion) in revenues for the year, marking a 7.26% increase year-on-year (YOY). The net profit attributable to shareholders, after adjustments for non-recurring gains and…
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Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Jiangsu Hengrui Medicine Advances Pipeline with NMPA Approvals for Three Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
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Hengrui Medicine Advances Clinical Trial for PD-L1 Inhibitor Combo in CLDN18.2 Positive Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company, has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ib/III clinical study. The study will evaluate the combination of Hengrui’s PD-L1 monoclonal antibody, adebrelimab (SHR-1316), with the antibody-drug conjugate (ADC) SHR-A1904 in patients with…
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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
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Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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Hengrui Medicine Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-7058, an innovative and selective drug candidate, in patients with advanced solid tumors harboring the KRAS G12C mutation. This development marks a significant step for Hengrui Medicine…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
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Jiangsu Hengrui Receives NMPA Approval for Phase II Study of GLP-1 Agonist for Weight Loss
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its small molecule GLP-1 receptor agonist, HRS-7535, for weight loss treatment. This development marks…
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Jiangsu Hengrui Receives Chinese Approval for First Domestic Category 1 Opioid Analgesic for Postoperative Pain
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has proclaimed the receipt of marketing approval in China for its proprietary drug, tegileridine, indicated for the management of moderate to severe pain following abdominal surgery. This milestone marks the drug as the nation’s inaugural Category 1 opioid analgesic developed indigenously, highlighting a…
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Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
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The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
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Hengrui Medicine Receives NMPA Approval for Phase II Cervical Cancer Study
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will investigate the combination of its PD-L1 monoclonal antibody adebrelimab (SHR-1316) with concurrent chemotherapy for the treatment of locally…
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Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
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Jiangsu Hengrui Medicine Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its fixed dose combination (FDC) drug, henagliflozin, metformin sustained-release tablets. This new formulation is designed to enhance blood glucose control in…
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Jiangsu Hengrui Medicine Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study. The study will assess the efficacy of three of the company’s novel pipeline candidates in combination regimens against general solid tumors. The drugs in…
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Jiangsu Hengrui Medicine Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
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Jiangsu Hengrui’s SHR-A2009 Earns Fast-Track Status for Metastatic NSCLC Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its in-house developed antibody-drug conjugate (ADC), SHR-A2009, has received fast-track status. This designation underscores the drug candidate’s potential as a treatment for metastatic non-small cell lung cancer (NSCLC) patients with EGFR mutations who have progressed after treatment with third-generation EGFR…
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Hengrui Medicine-Backed Nanjing Tianyinshan Hospital Opens as Class 3A Oncology Specialist Center
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Nanjing Tianyinshan Hospital, a private Class 3A oncology specialist hospital invested in by Hengrui Medicine (SHA: 600276), commenced operations on December 22. The hospital is headed by Professor Qin Shukui, a prominent figure in the field of oncology. Situated in the Nanjing Jiangning High Tech Zone, the hospital spans a…
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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
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Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This…
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Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
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Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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China-based Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
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Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
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Jiangsu Hengrui Medicine (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for the drug candidate HR20031 for review. The drug is intended for type 2 diabetes patients with poorly controlled blood glucose who have previously…
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Jiangsu Hengrui Medicine’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
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Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shengdi Pharmaceuticals, has received clinical trial approval from the National Medical Product Administration (NMPA) for HRS-9057 tablets. This Class 1 innovative drug will be assessed in clinical trials as a potential treatment for autosomal…
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Merck KGaA and Jiangsu Hengrui Ink Strategic Collaboration Deal for Next-Gen PARP1 Inhibitor
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Germany-based Merck KGaA (NYSE: MRK) has announced the signing of a strategic collaboration deal with China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276). This agreement grants Merck development, manufacturing, and commercial rights to the next-generation PARP1 inhibitor HRS-1167 for all global territories outside of China. Additionally, Merck has an option…
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Aiolos Bio Inc. Raises USD 245 Million in Series A Funding Led by Top Investors
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Aiolos Bio Inc., a US-based biotech company, has officially launched with the successful completion of a Series A financing round, raising USD 245 million. The round was co-led by Atlas Venture, Bain Capital Life Sciences, Forbion, and Sofinnova Investments, with additional participation from RA Capital Management. Lead Candidate AIO-001Aiolos Bio…
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Jiangsu Hengrui Licenses Camrelizumab-Apatinib Combo to Elevar Therapeutics
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China-based pharmaceutical giant Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has signed a significant licensing agreement with US-headquartered Elevar Therapeutics. The deal grants Elevar global exclusive development and commercialization rights to Hengrui’s programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab in combination with apatinib for the treatment of hepatocellular carcinoma (HCC),…
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Jiangsu Hengrui Medicine Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
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Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
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Jiangsu Hengrui Medicine Secures NMPA Approvals for Two Cancer Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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Jiangsu Hengrui Medicine Wins NMPA Approval for Two Novel Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
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Jiangsu Hengrui Medicine Entangled in Legal Disputes with BeyondSpring and Reistone
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is currently entangled in legal challenges involving two partner companies. The firm has initiated a lawsuit against US-based biotech BeyondSpring Inc. (NASDAQ: BYSI) over a failed partnership deal, while also facing potential disbandment of its subsidiary, Reistone Biopharma (Hong Kong) Ltd, amid…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-7450 Acute Ischemic Stroke Study
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-7450 in patients with acute ischemic stroke. HRS-7450: A Next-Generation Thrombolytic DrugHRS-7450 is…
