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MicroPort Endovascular MedTech’s Cratos System Approved for Aortic Dissection Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Cratos branched aortic stent graft system has received marketing approval from China’s National Medical Products Administration (NMPA). The approval is for the minimally invasive interventional treatment of thoracic aortic dissection involving branches of the aortic arch. Product InnovationThe Cratos system represents an…
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Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
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China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
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Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug,…
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Simcere Pharmaceutical’s ADC189 NDA Accepted for Influenza Treatment
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Simcere Pharmaceutical Group Limited (HKG: 2096) and AnDiConBio announced that the New Drug Application (NDA) for ADC189, their co-developed anti-influenza drug, has been accepted for review by China’s National Medical Products Administration (NMPA). The drug is intended for treating uncomplicated influenza A and B in adults and adolescents. Mechanism and…
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Rona Therapeutics Secures $25M Pre-B Round to Advance siRNA Therapies
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Shanghai-based Rona Therapeutics announced the successful completion of a $25 million (RMB 180 million) Pre-B financing round. This funding will accelerate the development of the company’s proprietary delivery and chemical modification platform technologies and expand its siRNA clinical pipeline in cardiovascular metabolic, weight loss, and other therapeutic areas. Investor Support…
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Tonghua Golden-Horse Pharmaceutical Embraces AI with DeepSeek R1 for Drug Innovation
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Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) recently held a special meeting to deploy the implementation of the DeepSeek R1 large model, chaired by Chairman Zhang Yufu. The company aims to accelerate the development and commercialization of the SPT-07A project through AI technology, marking a significant step in its…
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Pharmavan and Kefeng Changjian Sign Pact to Accelerate SPT-07A Development
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Suzhou Pharmavan Co., Ltd. has announced plans to enter into a cooperation agreement with Sichuan Kefeng Changjian Pharmaceutical Technology Co., Ltd. (Kefeng Changjian) to advance the development and commercialization of the SPT-07A project. Collaboration DetailsThe agreement, based on the principle of equality and mutual benefit, aims to accelerate the speed…
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Roche’s Itovebi Approved in China for PIK3CA-Mutated Breast Cancer
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Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Quantum Hi-Tech and ECNU Establish AI-Driven Drug Manufacturing Lab
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CRO+CDMO Quantum Hi-Tech (China) Biotechnology Co., Ltd (ChemPartner, SHE: 300149) announced plans to establish an AI drug intelligent manufacturing joint laboratory with East China Normal University (ECNU), a comprehensive research-oriented university in Shanghai. This collaboration aims to set a new paradigm for school-enterprise cooperation in the field of AI-driven pharmaceutical…
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BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
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China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with…
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Shanghai Fosun Pharmaceutical Transfers Unicorn II Holdings Stake to Warburg Pincus Subsidiary
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced plans to transfer its entire stake of 9.4 million shares in Unicorn II Holdings Limited to Calcite Gem, a subsidiary of Warburg Pincus. The transaction, valued at USD13.2 per share, totals USD124 million. Upon completion, Fosun will no…
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Salipro Biotech and Boehringer Ingelheim Collaborate on Drug Development for Membrane Proteins
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Sweden-based Salipro Biotech AB announced a research and license agreement with German pharmaceutical giant Boehringer Ingelheim. The collaboration aims to advance the development of novel drugs targeting G protein-coupled receptors (GPCRs), ion channels, transporters, and other integral membrane proteins, focusing on treatment areas such as mental health and cardio-renal-metabolic diseases.…
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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…
