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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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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…
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Gaush Meditech’s ANTERION Ophthalmic Detector Receives NMPA Market Approval
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for the ANTERION ophthalmic detector. This multimodal imaging diagnostic platform, developed by its German partner Heidelberg Instruments, integrates three functions into one device, enhancing precision and efficiency in ophthalmic diagnostics. Technical Specifications and…
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Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
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Otsuka and Lundbeck Win EU Approval for Rxulti in Adolescent Schizophrenia
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Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU). Background…
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Shanghai Fosun Pharmaceutical Gains NMPA Approval for XH-S003 in PNH Treatment
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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…
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Trinomab Biotech Launches Xintituo for Tetanus Treatment in Zhuhai
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China-based Trinomab Biotech Co., Ltd announced the first delivery of its antitetanus toxin monoclonal antibody (mAb) injection Xintituo (siltartoxatug) in Zhuhai, Guangdong province. This marks a significant advancement in the treatment and prevention of tetanus, offering a more efficient and safer alternative to traditional methods. Advantages Over Traditional ProductsTraditional horse…
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Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
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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…
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Jiangsu Aidea’s AD108 Receives NMPA Approval for Acute Ischemic Stroke
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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…
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Insilico Medicine Closes USD110 Million Series E Round to Advance AI-Driven Drug Pipeline
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine announced the completion of a USD110 million Series E financing round. The round was led by a private equity fund of Value Partners Group (HKG: 0806), with participation from Shanghai Pudong Venture Investment, Shanghai Pudong Development (Group), Wuxi Innovation Investment, and Yixing…
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Sanyou Medical Raises RMB214 Million for Stake in SMTP Technology
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China-based Shanghai Sanyou Medical Co., Ltd (SHA: 688085) announced the completion of a private placement of 13,032,886 shares at RMB16.42 (USD2.27) per share, raising a total of RMB214 million (USD29.5 million). The funds will be used to facilitate Sanyou’s acquisition of a 48.2% stake in compatriot firm SMTP Technology Co.,…
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Gaush Meditech Receives NMPA Approval for Femtosecond Laser Corneal Refractive Surgery System
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for its femtosecond laser corneal refractive surgery system and accompanying disposable eye fixation patient interface. Developed in collaboration with German partner SCHWIND eye-tech-solutions GmbH, the system is designed for producing corneal flaps in…
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Ipsen Appoints Olivia Brown as Global Head of Neurotoxins, Effective April 1st
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France-based pharmaceutical company Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced the appointment of Olivia Brown as Executive Vice-President (EVP), Global Head of Neurotoxins, effective April 1st, 2025. In her new role, Olivia will lead Ipsen’s global neurotoxins franchise, overseeing strategy and execution across both therapeutic and aesthetic indications. Olivia Brown’s…
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China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
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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)…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
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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…
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Johnson & Johnson MedTech Gains FDA Clearance for MONARCH QUEST with AI Algorithms
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US major Johnson & Johnson MedTech announced receiving U.S. 510(k) regulatory clearance for its MONARCH QUEST. This latest advancement in MONARCH navigation technology features AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System. MONARCH QUEST TechnologyThe MONARCH QUEST platform represents a…
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Arvinas and Pfizer Announce Positive Phase III Results for Vepdegestrant in ER+/HER2- Breast Cancer
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase III VERITAC-2 study. The trial assessed vepdegestrant alone versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer who experienced disease progression following prior…
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Harbour BioMed Launches Élancé Therapeutics to Tackle Obesity Treatment Challenges
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China-based Harbour BioMed (HKG: 2142) announced the establishment of Élancé Therapeutics, a new subsidiary focused on developing innovative therapies to address key challenges in current obesity treatment, including muscle preservation and long-term efficacy. This move underscores Harbour BioMed’s commitment to expanding its presence in the global obesity treatment market. Technological…
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Pierre Fabre Partners with RedRidge Bio on BPA Drug Development for Oncology and Dermatology
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France-based Pierre Fabre Laboratories announced an exclusive R&D collaboration and license agreement with Switzerland-headquartered RedRidge Bio AG. The partnership focuses on discovering and developing biparatopic antibody (BPA) drug candidates against multiple targets, with therapeutic applications in precision oncology, dermatology, and rare diseases. Collaboration DetailsUnder the agreement, RedRidge Bio will be…
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Visen Pharmaceuticals IPO Launches on Hong Kong Stock Exchange Amid Growth in Endocrine Therapies
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China-based Visen Pharmaceuticals, a joint venture between Denmark-headquartered Ascendis Pharma and Vivo Capital, has successfully launched its initial public offering (IPO) on the Hong Kong Stock Exchange. The offering price ranges from HKD68.44 to HKD75.28 per share, with net proceeds potentially reaching HKD603.3 million (USD77.6 million) if calculated at the…
