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Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
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China-based Tasly Pharma Co., Ltd (SHA: 600535) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its NR-20201, an in-house developed allogeneic adipose-derived mesenchymal stromal cell-based therapy. This marks a significant step forward in the development of innovative treatments for acute ischemic stroke…
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Jiangsu Aidea’s AD108 Receives NMPA Approval for Acute Ischemic Stroke
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China’s Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug AD108. This modified version of Japan-based Nichi-Iko Pharmaceutical Co., Ltd’s kallidinogenase is designed to improve neurological deficits caused by acute ischemic stroke (AIS). Drug Mechanism and…
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China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
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China Medical System Holdings (CMS; HKG: 0867) announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of its investigational drug CMS-D003. The study will focus on healthy adults and those with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…
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Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its Category 1 chemical drug HSK44459. The drug will be assessed for use in treating psoriasis and atopic dermatitis (AD), chronic, recurrent, and immune-inflammatory skin diseases with…
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Jiuzhitang’s Stem Cell Therapy for Autism Receives NMPA Clinical Trial Approval
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China-based Jiuzhitang Co. Ltd (SHE: 000989) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product, human bone marrow mesenchymal stem cells (hBMSCs), to treat autism spectrum disorder (ASD). This marks a significant step forward in exploring novel therapeutic options for ASD.…
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Biogen Initiates TRANSCEND Study for Felzartamab in Late AMR Kidney Transplant Patients
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US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical…
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MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
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China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food and Drug Administration (FDA) to initiate a clinical study for its MRANK-106, a dual inhibitor of WEE1 and YES1 kinases. This marks a significant milestone for the company as it expands its innovative oncology pipeline…
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Ascletis Pharma’s ASC47 Shows Positive Results in Phase Ib Study for Weight Loss
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China-based Ascletis Pharma Inc. (HKG: 1672) announced positive topline results from a Phase Ib clinical study of its ASC47 in Australia. This adipose-targeted drug candidate, developed in-house, is designed to achieve weight loss without losing muscle mass. Clinical Study ResultsIn the study, ASC47 demonstrated a half-life of up to 26…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for HRS-4029. The novel neuroprotective agent will now be assessed in a clinical study as a treatment for acute ischemic stroke (AIS). Preclinical FindingsPreclinical studies have demonstrated that HRS-4029 can…
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LiteDD’s LIT0922 Approved for Phase I Trial in Marker-Expressing Advanced Solid Tumors
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The Center for Drug Evaluation (CDE) of China has approved LiteDD’s Category 1 product LIT0922 to enter a Phase I clinical study in advanced solid tumors expressing specific markers. This approval marks a significant milestone for LiteDD in developing innovative therapies for oncology patients. Mechanism of ActionLIT0922 is positioned as…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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AIM Vaccine Co. Ltd Receives NMPA Approval for Human Diploid Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its human diploid rabies vaccine. This marks a significant step forward in the development of more effective rabies prevention measures. Vaccine Features and AdvantagesThe updated human…
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Everest Medicines Begins Clinical Trial for Personalized mRNA Cancer Vaccine EVM16
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China-based Everest Medicines (HKG: 1952) has announced the first patient dosing of an investigator-initiated clinical trial (IIT) for its personalized mRNA cancer vaccine, EVM16. The trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 alone or combined with a PD-1 inhibitor in advanced or recurrent…
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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for its small molecule inhibitor ABSK131. This follows a similar approval from US regulators in December of last year. ABSK131: Promising Anti-Tumor ActivityABSK131…
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Suzhou GenAssist’s GEN6050X Receives FDA Clearance for Duchenne Muscular Dystrophy Treatment
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced receiving clearance from the US Food and Drug Administration (FDA) to initiate clinical trials for its base editing drug, GEN6050X, as a treatment for Duchenne muscular dystrophy (DMD). This groundbreaking therapy represents a significant advancement in gene editing technologies for rare diseases.…
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BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
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Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant…
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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical Products Administration (NMPA) for JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. The targeted indication for this novel therapy is advanced malignant tumors, marking a significant step forward in the development of innovative cancer treatments in China.…
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Peijia Medical Completes First Two Implants of Trilogy THV System in Taiwan
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China’s Peijia Medical Ltd (HKG: 9996) announced the completion of the first two implant surgeries using its Trilogy transcatheter heart valve (THV) System for the treatment of severe aortic valve regurgitation in Taiwan. Product DetailsThe Trilogy THV System, a proprietary transcatheter aortic valve replacement product with CE mark, is designed…
