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Jiangsu Hengrui Pharmaceuticals Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals Advances Clinical Trial for PD-L1 Inhibitor Combo in CLDN18.2 Positive Tumors
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals…
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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 Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Receives NMPA Approval for Phase II Cervical Cancer Study
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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Jiangsu Hengrui Pharmaceuticals 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 Pharmaceuticals Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals 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…
