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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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CBC Group and Mubadala Acquire UCB’s Neurology and Allergy Business in China for $680 Million
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Singapore-based healthcare private equity firm CBC Group and Mubadala Investment Company, a global investment company based in Abu Dhabi, have jointly announced the strategic acquisition of Belgium-based biopharma UCB’s (FRA: UNC) mature neurology and allergy business in China. The deal is valued at USD 680 million and includes UCB’s well-known…
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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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Sunflower Pharmaceutical Group to Establish Joint Lab with Peking University for Bacterial Enzyme Research
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China-based Sunflower Pharmaceutical Group Co., Ltd. (SHE: 002737) is poised to establish a joint laboratory with the Peking University Health Science Center (PKUHSC), focusing on research and development of bacterial enzymes and innovative drugs. This strategic collaboration aims to advance scientific research and pharmaceutical innovation in the field. Investment in…
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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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Affinity (Shanghai) Secures Over RMB 400 Million in Series B2 Financing to Advance Oncology Drugs
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Affinity (Shanghai), the parent company of Shanghai Affinity Biopharmaceutical Co., Ltd., has reportedly raised upwards of RMB 400 million (USD 55 million) in a Series B2 financing round. The funding was led by CMG-SDIC Fund, with contributions from China Growth Capital, Hong Cheng Investment, and others. The proceeds will be…
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Abogen Biosciences and Ruijin Hospital Launch Ruijin Abogen Nucleic Acid Drug Research Institute
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China-based nucleic acid drug developer Suzhou Abogen Biosciences and Ruijin Hospital, a comprehensive Class 3A hospital in Shanghai, have jointly announced the establishment of the Ruijin Abogen Nucleic Acid Drug Research Institute. The new institute aims to further explore the application of mRNA drugs in tumors and autoimmune diseases, with…
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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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Shanghai Cell Therapy Group’s Second Attempt at HK IPO Receives Green Light from CICC and CCB International
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Shanghai Cell Therapy Group Co., Ltd., a leading player in China’s cellular medical health sector, has announced its second filing for an IPO on the Hong Kong Stock Exchange (HKEX), with joint sponsors being China International Capital Corporation Hong Kong Securities Limited (CICC) and CCB International Financial Limited (CCB International)…
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Nanjing Leads Biolabs Commences IPO Process with Focus on Innovative Therapies
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Nanjing Leads Biolabs Co., Ltd., a clinical-stage biopharmaceutical company focused on developing innovative therapies for oncology and autoimmune diseases, has officially submitted its IPO application to the Hong Kong Stock Exchange on November 29. The company, known for its robust pipeline of 12 innovative candidate drugs, has six of which…
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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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OBiO Technology Partners with Hanxin Biotechnology to Advance LNP Delivery System
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China-based gene therapy Contract Research Organization (CRO) OBiO Technology (Shanghai) Co., Ltd (SHA: 688238) has announced a partnership with compatriot firm Hanxin Biotechnology (Suzhou) Co., Ltd. The collaboration is focused on the lipid nanoparticle (LNP) delivery system field, aiming to enhance the clinical application of mRNA and other nucleic acid…
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NMPA Approves Shenzhen Mindray’s Innovative Dual-Mode Ultrasound Diagnostic System
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The National Medical Products Administration (NMPA) has granted approval to Shenzhen Mindray Bio-Medical Electronics Co., Ltd (SHE: 300760) for its innovative ultrasound diagnostic system, as announced on the bureau’s website. Introducing the First Dual-Mode Imaging Product in ChinaThe approved product is hailed as China’s first dual-mode imaging product, integrating both…
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NMPA Approves Hangzhou Ruidi Biotechnology’s Steep Pulse Therapy Equipment for Tumor Treatment
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China’s National Medical Products Administration (NMPA) has granted approval to Hangzhou Ruidi Biotechnology Co., Ltd for its steep pulse therapy equipment and disposable steep pulse ablation needle, as reported on the bureau’s website. This marks a significant advancement in the field of minimally invasive interventional treatments for tumors in China.…
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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…
