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Hua Medicine’s Second-Generation GKA HM-002-1005 Completes Phase Ia Study in the US
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China-based Hua Medicine (HKG: 2552) has announced the successful completion of a Phase Ia study for its second-generation glucokinase activator (GKA) HM-002-1005 in the United States. The study focused on the safety, tolerability, and pharmacokinetics of HM-002-1005, a prodrug of dorzagliatin (HMS5552), in 40 subjects with type 2 diabetes (T2D).…
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Shanghai MicuRx’s MRX-4/Contezolid Meets Primary Endpoint in Phase III cSSTI Study
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Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373) has announced that its Phase III study for MRX-4, transitioning to oral contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI), has successfully met its primary efficacy endpoint. Phase III Study Design and ResultsThe multi-center, randomized,…
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Simcere Zaiming Launches Phase III Trial for SERD Inhibitor SIM0270 in Breast Cancer
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Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the initiation of a Phase III study for SIM0270 (SCR-6852), an oral brain-penetrating selective estrogen receptor down-regulator (SERD) inhibitor. The study includes the first patient dosing and is designed to assess the anti-tumor effect and safety of SIM0270 in…
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Hua Medicine’s SENSITIZE Study Illuminates Dorzagliatin’s β-Cell Glucose Sensitivity Mechanism
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China-based innovative drug developer Hua Medicine (HKG: 2552), with operations in the US and Hong Kong, China, has announced the successful completion of the SENSITIZE study. The study, led by Professor Juliana Chan, an international endocrinology specialist at the Chinese University of Hong Kong, investigates the mechanism by which HuaTangNing…
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Simcere Pharmaceutical’s Edaravone and Borneol Sublingual Tablets Approved for AIS Treatment in China
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China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its edaravone and borneol sublingual tablets. These tablets are designed to improve neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke (AIS). Rapid Dissolution and Absorption…
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Shanghai Pharmaceuticals Concludes Phase II Study for I037 in Acute Ischemic Stroke
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Shanghai Pharmaceuticals Holding Co., Ltd. (HKG: 2607, SHA: 601607) has announced the completion of data analysis from the Phase II study for its drug candidate I037, used in the treatment of acute ischemic stroke (AIS). LT3001 is recognized as a first-in-class AIS therapy that combines targeted thrombolysis with neuroprotective functions…
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Henlius Biotech Initiates US Commercial Supply of Hanquyou, Biosimilar to Herceptin
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the initiation of commercial supply of its biosimilar product, Hanquyou (trastuzumab; HLX02), in the US market. This move marks the expansion of the company’s commercial supply network to include China, South Asia, North America, Europe, the Middle East, and Latin America. Herceptin…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for Lupus Nephritis Phase II Study
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for its dual-target macromolecular drug, amulirafusp alfa (IMM0306), in lupus nephritis (LN). Dual-Targeting Therapy with IMM0306IMM0306 is a bispecific antibody (BsAb) that targets…
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Healthgen Biotechnology’s Plant-Made Albumin Breakthrough: A Milestone in Serum Therapy
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On November 30th, Healthgen Biotechnology Corp. announced a significant research outcome at the 9th Pharmaceutical Innovation and Investment Conference. The company’s independently developed recombinant human serum albumin injection (Aofumin®) has successfully met its clinical study endpoints, marking a notable advancement in the field of plant-based recombinant protein drugs globally. Clinical…
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XellSmart Bio-Pharmaceutical Achieves Milestone with First Patient Enrollment in Global iPSC Clinical Study for ALS
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XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd., in collaboration with Shanghai East Hospital (Tongji University Affiliated East Hospital) and Liu Zhongmin’s team, has successfully enrolled the first patient in the global clinical study for “Clinical Grade iPSC-Derived Subtype Neural Progenitor Cell Therapy for Amyotrophic Lateral Sclerosis (ALS).” This marks a significant milestone…
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Cutia Therapeutic’s CU-20401 Shows Positive Results in Phase II Subcutaneous Fat Reduction Study
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China-based dermatology specialist Cutia Therapeutic (HKG: 2487) has revealed a positive readout from its Phase II study for the potential Category 1 drug CU-20401, a recombinant mutant collagenase, in the treatment of subcutaneous fat accumulation, meeting its primary endpoint. Efficacy and Safety Profiles of CU-20401The treatment efficacy rates of both…
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CDE Expands Care Plan with Approvals for Ractigen’s RAG-17 and Vitalgen’s VGR-R01
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In a swift succession of actions, China’s Center for Drug Evaluation (CDE) has added two more rare disease drugs to its patient-centered rare disease drug development pilot program, known as the Care Plan. This follows three other approvals within a 10-day period. The latest inclusions are Ractigen Therapeutics’ RAG-17 and…
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Jiangsu Kanion Pharmaceutical Gets NMPA Clearance for Oncolytic Virus Product KYS202003A
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational product, KYS202003A. The Chinese company is set to initiate a clinical study assessing this Category 1 biologic product for the treatment of advanced solid tumors.…
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Sichuan Biokin Pharmaceutical’s BL-M08D1 ADC Receives NMPA Approval for Clinical Trials
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
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Laekna, Inc. Initiates IND-Enabling Study for Monoclonal Antibody LAE123 in Severe Diseases
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe…
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Eisai and Biogen Launch Alzheimer’s Treatment Leqembi in South Korea
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the commercial launch of their co-developed amyloid-beta (Aβ) monoclonal antibody, Leqembi (lecanemab), in South Korea. The Ministry of Food and Drug Safety (MFDS) had previously approved the drug in May 2024 for the treatment of adult…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Cryopyrin-Associated Periodic Syndromes
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
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Huadong Medicine’s Elahere (Mirvetuximab Soravtansine) Approved by NMPA for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have…
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MicuRx Pharmaceuticals’ MRX-4 Combo Shows Positive Results in Phase III Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced positive results from a Phase III study for its drug MRX-4 in combination with contezolid as sequential therapy for complex skin and soft tissue infections. The study successfully met its primary efficacy endpoint, demonstrating good clinical and microbiological efficacy. The regimen’s…
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Jiangsu Kanion Pharmaceutical Secures NMPA Approvals for KYHY2302 and KYHY2303
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
