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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…
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NMPA Drafts Medical Representative Management Measures, Seeks Public Input
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The National Medical Products Administration (NMPA) has released the “Medical Representative Management Measures (draft proposal)”, which has been developed in consultation with the Ministry of Public Security, National Healthcare Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and National Bureau of Disease…
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Daiichi Sankyo Invests RMB 1.1 Billion in New ADC Manufacturing Plant in Shanghai
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Japanese pharmaceutical company Daiichi Sankyo (TYO: 4568) is significantly increasing its investment in China with a RMB 1.1 billion outlay to establish a new antibody drug conjugate (ADC) manufacturing plant in Zhangjiang, located in Shanghai’s Pudong New Area. This strategic move by the firm is aimed at addressing the escalating…
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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.…
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Lingyi Biotechnology and Jolly Pharmaceutical Ink Comprehensive Collaboration Agreement
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China-based gene therapy specialist Lingyi Biotechnology Co., Ltd has entered into a comprehensive collaboration agreement with Zhejiang Jolly Pharmaceutical Co., Ltd. The partnership aims to leverage the respective strengths of both companies in equity, research and development (R&D), and sales. Enhancing Drug Development and CommercializationUnder the terms of the agreement,…
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Sichuan Biokin Pharmaceutical’s BL-M08D1 ADC Receives NMPA Approval for Clinical Trials
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
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Huadong Medicine Receives FDA Clearance for HDM1005 Clinical Study in Obstructive Sleep Apnea
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a clinical study assessing its HDM1005 in patients with obstructive sleep apnea (OSA) who are overweight or obese. HDM1005: A Dual GLP-1 and GIP Receptor AgonistHDM1005…
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Laekna, Inc. Initiates IND-Enabling Study for Monoclonal Antibody LAE123 in Severe Diseases
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe…
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CORXEL Partners with Apeloa Pharmaceutical for CDMO Services Expansion
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China-based contract development and manufacturing organization (CDMO) Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced a strategic partnership with CORXEL, formerly known as Ji Xing Pharmaceuticals. The financial details of the agreement have not been disclosed, but it is confirmed that Apeloa will provide professional CDMO services to CORXEL on…
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Wuhan Union Hospital to Transfer Hereditary Thrombophilia Detection Patent to Kingmed Diagnostics
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, also recognized as Wuhan Union Hospital of China, has announced plans to transfer its invention patent, titled “A Primer Probe Combination and Kit for Detecting Common Mutation Sites in Hereditary Thrombophilia Based on ARMS-PCR Method,” to Kingmed Diagnostics (SHA:…
