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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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AccurEdit Therapeutics’ ART001 Shows Over 90% TTR Reduction in ATTR Amyloidosis Trial
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Suzhou-based gene editing specialist AccurEdit Therapeutics has announced positive results from an ongoing investigator-initiated trial (ITT) for its in vivo gene editing product, ART001. This lipid nanoparticle (LNP) delivered treatment is designed for transthyretin amyloidosis (ATTR), a rare, progressive, and fatal disease. In subjects who completed at least 48 weeks…
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Huadong Medicine’s SaiYueXin Biosimilar Accepted for Review by NMPA for Pediatric Psoriasis
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication for SaiYueXin, a biosimilar to Johnson & Johnson (J&J, NYSE: JNJ)’s Stelara (ustekinumab). The Chinese pharmaceutical company is now seeking approval for the use of SaiYueXin in…
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Uni-Bio Science Group Achieves Milestones in Medical Aesthetics with New Product Approvals
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China-based Uni-Bio Science Group Limited (HKG: 0690) has announced two significant achievements in the medical aesthetics and skincare fields. The company’s recombinant collagen dressing, co-developed with Chongqing Minji Medical Device Co., Ltd., has been granted a Category II device approval by the National Medical Products Administration (NMPA). Concurrently, its in-house…
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Ocumen Therapeutics’ OT-301 Phase III Denali Study Surpasses 140 Patient Enrollment in China
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Chinese ophthalmology specialist Ocumen Therapeutics (HKG: 1477) has announced the enrollment of more than 140 patients in the second Phase III Denali study for its OT-301 (NCX470) in China. This follows the commencement of the first Phase III MontBlanc study for the drug in the United States in June 2020,…
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Novartis Secures Global Rights to PTC Therapeutics’ Huntington’s Disease Treatment PTC518
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has entered into a global license and collaboration agreement with US firm PTC Therapeutics (NASDAQ: PTCT), obtaining development, manufacturing, and commercialization rights to PTC518, an HTT mRNA splice modulator targeting Huntington’s disease. Financial Terms and Milestones of the AgreementUnder the terms of the agreement,…
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Minghui Pharmaceutical’s MH004 Ointment Meets Primary Endpoints in Atopic Dermatitis Phase III Study
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Shanghai-based Minghui Pharmaceutical, a late-stage biopharmaceutical company specializing in immunology and oncology, has announced positive topline results from its Phase III study for MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents and adults with mild to moderate atopic dermatitis (AD). Study Design and Participant EnrollmentA total of…
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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.…
