-
CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
-
Shanghai Fosun Pharmaceutical Gains NMPA Approval for XH-S003 in PNH Treatment
•
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for XH-S003. The company will initiate Phase II clinical studies for this Category 1 chemical drug candidate as a treatment for paroxysmal nocturnal hemoglobinuria (PNH). Mechanism and…
-
Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
•
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…
-
Jiangsu Aidea’s AD108 Receives NMPA Approval for Acute Ischemic Stroke
•
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…
-
China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
•
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)…
-
Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
•
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…
-
Jiuzhitang’s Stem Cell Therapy for Autism Receives NMPA Clinical Trial Approval
•
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.…
-
Biogen Initiates TRANSCEND Study for Felzartamab in Late AMR Kidney Transplant Patients
•
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…
-
MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
•
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…
-
Ascletis Pharma’s ASC47 Shows Positive Results in Phase Ib Study for Weight Loss
•
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…
-
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
•
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…
-
LiteDD’s LIT0922 Approved for Phase I Trial in Marker-Expressing Advanced Solid Tumors
•
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…
-
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
•
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…
-
AIM Vaccine Co. Ltd Receives NMPA Approval for Human Diploid Rabies Vaccine Trial
•
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…
-
Everest Medicines Begins Clinical Trial for Personalized mRNA Cancer Vaccine EVM16
•
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…
-
Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
•
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…
-
Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
•
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…
-
Suzhou GenAssist’s GEN6050X Receives FDA Clearance for Duchenne Muscular Dystrophy Treatment
•
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.…
-
BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
•
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…
-
ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
•
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,…
