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Sinocare Inc’s TRUE VIE CGMS Advances to 510(k) Substantive Review Stage at FDA
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Sinocare Inc (SHE: 300298), a China-based medical technology company, has announced that its continuous glucose monitoring system (CGMS), TRUE VIE CGMS, has entered the 510(k) substantive review stage at the US Food and Drug Administration (FDA). This milestone follows the successful passage of the initial acceptance review for the FDA…
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Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1501 Combo in Bladder Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for the combination of SHR-1501 with adebrelimab (SHR-1316) for the treatment of non-muscle invasive bladder cancer. Adebrelimab: A PD-L1 Monoclonal Antibody with…
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Sino Biopharmaceutical’s Benmelstobart Meets Primary Endpoint in Phase III NSCLC Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from the Phase III study (TQB2450-Ⅲ-05) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The study evaluated benmelstobart, with or without multi-target kinase inhibitor anlotinib, as a consolidation therapy for locally advanced/unresectable (stage…
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Hansoh Pharmaceutical Secures Global Licensing Deal with Merck for HS-10535
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China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced a significant global license deal with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) concerning its investigational oral molecule, HS-10535, a GLP-1 receptor agonist. Terms of the Agreement and Financial ImplicationsAccording to the agreement, Merck will secure exclusive…
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Ascletis Pharma’s ASC47 Outperforms Semaglutide in Weight Loss Study
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced encouraging results from a study on its in-house developed drug candidate, ASC47, which is designed to achieve weight loss without compromising muscle mass. The study combined ASC47 with semaglutide in a diet-induced obesity (DIO) mouse model, demonstrating superior weight loss effects compared…
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UCB’s Minzasolmin Fails to Meet Endpoints in ORCHESTRA Study for Early Parkinson’s
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Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept (POC) study for minzasolmin, an alpha-synuclein misfolding inhibitor co-developed with Swiss pharmaceutical giant Novartis (NYSE: NVS). The study was designed to assess the efficacy of minzasolmin in treating early Parkinson’s disease, but it failed to…
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HealthyWay Inc. Completes HKD 220 Million IPO on the Hong Kong Stock Exchange
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China-based HealthyWay Inc. (HKG: 2587) has made a significant debut on the Hong Kong Stock Exchange with an initial public offering (IPO) of 25 million shares, priced at HKD 8.8 per share. This translates to a capital raise of HKD 220 million (USD 28.3 million), marking a significant milestone for…
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Sino Biopharmaceutical and Sinopharm Group Collaborate to Expand Retail Pharmacy Network
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In a significant move for China’s pharmaceutical industry, Sino Biopharmaceutical Ltd (HKG: 1177) and Sinopharm Group Co., Ltd (HKG: 1099) have announced a strategic partnership to delve into the ex-hospital market. This collaboration will capitalize on Sino Biopharmaceutical’s extensive product portfolio and Sinopharm Group’s robust retail presence, including GuoDa Drugstore…
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Everest Medicines’ Velsipity (Etrasimod) Receives First Prescription in Foshan under GBA Policy
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced that its Velsipity (etrasimod) has been prescribed for the first time at Foshan Fosun Chancheng Hospital. This prescription was made possible under the “Hong Kong-Macau Drug and Device Access” policy, which is part of the Greater Bay…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of a Phase Ib study for its innovative dual-target macromolecular drug, amulirafusp alfa (IMM0306), in patients with neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step as the first patient has been dosed in the…
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Henlius Biotech Joins Biosimilars Forum to Expand Global Biosimilars Access
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biopharmaceutical company, has announced its membership in the Biosimilars Forum, a nonprofit organization dedicated to advancing the biosimilars industry in the United States. The membership aims to expand access to biological medicines and improve healthcare outcomes. Henlius anticipates that this membership…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty Flex Receives NMPA Approval
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a prominent player in the medical device industry in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its third-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty Flex. This marks a significant advancement in…
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Lepu Scientech’s ScienCcrown TAVR System Earns NMPA Medical Device License
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading China-based medical technology company, has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative ScienCcrown transcatheter implantable aortic valve system. This development marks a significant milestone in the advancement…
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Eli Lilly’s Kisunla Receives NMPA Approval for Early Alzheimer’s Disease Treatment
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug donanemab-azbt, marketed under the name Kisunla. The drug is administered as a 350 mg/20 mL injection every four weeks…
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BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed/refractory acute leukemia patients carrying KMT2A rearrangement and/or NPM1 mutation in China.…
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Evopoint Biosciences Submits Pre-NDA for Funobactam, Imipenem, and Cilastatin to NMPA
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Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application) for its Category 1 product, a combination of funobactam, imipenem, and cilastatin, to the National Medical Products Administration (NMPA). This product, once approved, is poised to become the world’s first β-lactam/β-lactamase inhibitor (BL/BLI) with a…
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Xtalpi Inc. Partners with Gnosis Neurodynamics to Develop Neural Drug Screening Platform
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Shenzhen-based QuantumPharm Inc., trading as Xtalpi Inc. (HKG: 2228), has announced a strategic partnership with Gnosis Neurodynamics, a leading brain science artificial intelligence (AI) company in China. This collaboration aims to harness AI algorithms and EEG BioMarker recognition models to develop a state-of-the-art neural drug screening platform. The platform will…
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GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
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The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK) Blenrep (belantamab mafodotin) and Star Pharmaceutical Ltd.’s topiramate oral solution are on track to receive priority review statuses in China. Blenrep: An Antibody-Drug Conjugate for Multiple MyelomaBlenrep is an innovative antibody drug conjugate (ADC) that…
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Sciwind Biosciences’ Ecnoglutide Accepted for Review by NMPA for Weight Management
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Sciwind Biosciences Co., Ltd has received a significant boost as the National Medical Products Administration (NMPA) has accepted its filing for review of another indication for ecnoglutide. The Chinese biopharmaceutical company is now seeking NMPA’s approval for the use of its drug in long-term weight management for adult patients, complementing…
