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Joint Biosciences’ OVV-01 Receives FDA Fast Track Designation for Soft Tissue Sarcoma Trial
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Shanghai-based Joint Biosciences Ltd., a developer of tumor combined immunotherapies, has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its Phase II study of OVV-01. This recombinant vesicular stomatitis virus (VSV) carrying the NY-ESO-1 tumor-associated antigen is being investigated for the treatment of advanced…
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Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on naïve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast…
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Humanwell Healthcare Receives NMPA Approval for Caplyta Generic in Schizophrenia Trial
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of US-based Intra-Cellular Therapies’ Caplyta (lumateperone). This Category 3 chemical drug, with no similar product approved in China, is set for evaluation in schizophrenia treatment.…
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Clover Biopharmaceuticals Receives Termination Notice from GAVI for COVID-19 Vaccine Agreement
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) announced receiving a one-month prior written notice dated March 21, 2025, from the Global Alliance for Vaccines and Immunisation (GAVI). The notice asserts a unilateral termination of the Advance Purchase Agreement entered into between the two parties in 2021 relating to Clover Bio’s COVID-19…
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Simcere Pharmaceutical Group Reports Steady Revenue Amid R&D Investment Shift
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China-based Simcere Pharmaceutical Group (HKG: 2096) has released its 2024 financial performance report, recording RMB 6.6 billion (USD 914 million) in revenues over the 12 months, marking a 0.4% year-on-year (YOY) increase. The profit attributable to equity shareholders rose by 2.6% YOY to RMB 733 million (USD 101 million). Notably,…
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Henlius Biotech Reports 6.1% Revenue Growth with Strong Oncology Product Sales
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Shanghai Henlius Biotech Inc. (HKG: 2696) has published its 2024 financial results, recording revenues of RMB 5.72 billion (USD 788 million), representing a 6.1% year-on-year (YOY) increase. Net profits reached RMB 820.5 million (USD 114 million), up 50.3% YOY, reflecting strong performance across its product portfolio. Core Product PerformanceHenlius Biotech…
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Sichuan Kelun-Biotech Reports 25.5% Revenue Growth with Key Drug Approvals
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has released its 2024 financial report, recording revenues of RMB 1.933 billion (USD 266 million), representing a 25.5% year-on-year (YOY) increase. This growth includes USD 147.5 million in cooperation payments from US partner Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), UK-based…
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Jenscare Scientific’s Ken Valve Receives NMPA Marketing Approval
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Jenscare Scientific Co., Ltd (HKG: 9877), a Ningbo-based structural heart disease device maker, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its transcatheter artificial aortic valve system Ken Valve. The company is now preparing for the commercialization of the product. Product Design and AdvantagesThe in-house…
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SineuGene Therapeutics’ SNUG01 Receives FDA Clearance for ALS Clinical Study
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Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders, announced last week that it has received clearance from the US Food and Drug Administration (FDA) to conduct a clinical study for its lead candidate SNUG01. This best-in-class (BIC) TRIM72-targeted gene therapy will be evaluated for the treatment of…
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GSK’s Nucala Accepted for EMA Review for COPD Treatment
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UK-based GSK plc’s (LON: GSK, NYSE: GSK) application for expanding the use of its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) has been accepted for review by the European Medicines Agency (EMA). The proposed new use is as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who have…
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Opella and JD Healthcare Collaborate to Enhance Fatty Liver Awareness in China
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Opella, the consumer health business of French giant Sanofi (EPA: SAN, NASDAQ: SNY), held a collaboration press conference with JD Healthcare, a unit of China’s e-commerce giant JD.com (NASDAQ: JD), in Beijing this week. The collaboration aims to jointly enhance public awareness of fatty liver through activities such as doctor-patient…
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Chongqing Zhifei Acquires 51% Stake in Chenan Bio for RMB593 Million
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122), the distribution partner for US giant Merck’s Gardasil in China, has announced the acquisition of a 51% stake in compatriot firm Chongqing Chenan Biopharmaceutical Co., Ltd. for RMB 593 million (USD 82 million). This strategic move aims to expand Zhifei’s presence in the…
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Shanghai Ark Biopharmaceutical’s AK0901 Meets Phase III Endpoints in ADHD Trial
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China’s Shanghai Ark Biopharmaceutical Co., Ltd. has announced the completion of a Phase III study evaluating the efficacy, safety, and tolerability of its AK0901 in Chinese children aged 6-12 with Attention Deficit Hyperactivity Disorder (ADHD). The trial successfully achieved both primary and key secondary endpoints, demonstrating statistical significance at all…
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WuXi XDC Reports 90.8% Revenue Surge, Expanding in ADC Market
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA (a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259)), has released its 2024 financial report. The company achieved RMB 4.52 billion (USD 558 million) in revenue for the full year, marking a 90.8% year-on-year (YOY)…
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Suzhou Xueji Biotech’s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT
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China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd’s (HemaCell) XJ-MK-002, described as the world’s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. The designation is for the treatment of congenital amegakaryocytic thrombocytopenia (CAMT), a rare hereditary bone marrow…
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Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment
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China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co., Ltd (SHA: 688068), has announced receiving Fast Track Designation from the United States Food and Drug Administration (FDA) for its SGC001, which is described as the world’s first acute myocardial infarction (AMI) antibody drug. Drug…
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CanSino Biologics Partners with Grand Life Sciences to Commercialize Tetanus Vaccine in Greater China
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Chinese firms CanSino Biologics Inc. (HKG: 6185) and Grand Life Sciences have entered into an agreement to commercialize CanSino’s adsorbed tetanus vaccine. Under the terms of the deal, Grand Life Sciences will exclusively promote the product in Greater China upon its marketing approval. CanSino Biologics will receive an upfront payment,…
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AllianThera Biopharma Starts Global Phase I Trial for ATB102 in Inflammatory Bowel Diseases
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Suzhou-based startup AllianThera Biopharma has announced the first patient dosing in a global Phase I clinical study for its investigational drug ATB102. The trial, a randomized, double-blinded, placebo-controlled, dose-escalation study, is designed to evaluate the safety, tolerability, and pharmacokinetics of ATB102 in healthy subjects. Drug Mechanism and InnovationATB102 is an…
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Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or…
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Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
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Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of…
