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Luye Pharma’s Zepzelca Receives NMPA Approval for Metastatic Small Cell Lung Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
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Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC)…
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Merck’s Recarbrio Approved by NMPA for Hospital-Acquired Infections and Complicated UTIs
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its combination antibacterial drug, Recarbrio (imipenem, cilastatin, and relebactam). This new treatment is indicated for patients aged 18 years and older with hospital-acquired…
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Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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Hefan Medicine’s Piracetam Production and Marketing Suspended Over GMP Violations
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The National Drug Alliance Procurement Office has issued a notification to suspend the manufacturing and marketing of piracetam by Zhuhai Hefan Medicine Co., Ltd. The suspension comes as a result of severe defects found in the company’s manufacturing management process, which are in direct violation of the Good Manufacturing Practice…
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InventisBio’s Oral TYK2 Inhibitor D-2570 Achieves Positive Results in Phase II Psoriasis Study
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China-based InventisBio (Shanghai) Co., Ltd (SHA: 688382) has announced the successful completion of a Phase II study for its oral TYK2 inhibitor, D-2570, in the treatment of psoriasis, with positive outcomes. Understanding Psoriasis and the Role of TYK2 InhibitionPsoriasis is an immune-mediated chronic disease characterized by recurrent, inflammatory, and systemic…
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Shanghai Henlius Biotech’s Serplulimab Approved for First-Line nsNSCLC Treatment in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Zhejiang Huahai Pharmaceutical Initiates Clinical Study for HB0056 in New Zealand
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Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
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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…
