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Yiming and WZ Biosciences Collaborate on mRNA Process Platform
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd, also known as Ubrigene, and compatriot firm WZ Biosciences Inc., announced the establishment of a refined mRNA process platform. The collaboration offers comprehensive services ranging from gene synthesis, efficient in vitro transcription template preparation, plasmid linearization, IVT mRNA synthesis, purification, and quality inspection,…
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BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals in Latin America for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for various indications across several Latin American countries. Approvals and IndicationsBrukinsa has received approval to treat…
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Zhaoke Ophthalmology Completes Enrollment for Intrarosa Phase III Trial
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed patient enrollment in a Phase III clinical study for Intrarosa (prasterone). The drug is a vaginal non-estrogen treatment for moderate to severe painful sex due to menopause. Phase III Trial DesignThe multi-center, randomized Phase III…
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JW Therapeutics Partners with 2seventy bio to Develop Cell Therapy Platform
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China-based JW Therapeutics (HKG: 2126) has entered into a partnership with US firm 2seventy bio Inc. (NASDAQ: TSVT) to establish a cell therapy translational and clinical development platform. The collaboration aims to enhance the development of T-cell therapies in mainland China, Hong Kong, and Macau. Initial Focus on MAGE-A4 T-Cell…
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Ascletis Pharma Files IND for Monkeypox Antiviral ASC10 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the submission of an Investigational New Drug (IND) filing with the US FDA for its ASC10, an oral antiviral drug candidate targeting the viral polymerase of the monkeypox virus. This marks a significant step in the development of new treatments for monkeypox, a…
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Simcere Receives FDA Clearance for Clinical Study of SIM0237
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China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US FDA to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is intended for the treatment of locally advanced, unresectable metastatic…
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Ping An Life Insurance Reports Q3 Results, Advances Healthcare Strategy
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Ping An Life Insurance Company of China Ltd released its 2022 Q3 financial report, showing a 6.3% year-on-year (YOY) decrease in net profits to RMB 76.46 billion (USD 10.59 billion). The decline was attributed to the short-term impact of pandemic disruptions and a volatile capital market. However, the company’s operational…
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United Labs Gains NMPA Approval for Ozempic Biosimilar IND
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide). Ozempic is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a seven-day half-life, used to treat…
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China’s NMPA Issues New Drug Recall Management Measures
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The National Medical Products Administration (NMPA) has released the “Drug Recall Management Measures,” which took effect on November 1, 2022. These measures outline the procedures for drug recalls, which refer to the withdrawal of marketed drugs by Marketing Authorization Holders (MAHs) due to quality issues or other potential safety hazards.…
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AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
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AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its blood flow-guided dense mesh stent, marking it as the 181st novel medical device approved in the country. The stent is indicated for the treatment of unruptured saccular or spindle wide-necked aneurysms in the internal carotid…
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InxMed and Huaota Bio Partner to Develop Novel Solid Tumor Combination Therapy
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China-based InxMed (Nanjing) Co., Ltd has entered into a strategic partnership with Shanghai Huaota Biopharmaceutical Co., Ltd to collaborate on pre-clinical and clinical studies for a combination therapy targeting various solid tumors. The partnership will focus on combining InxMed’s IN10018, a selective oral inhibitor of focal adhesion kinase (FAK), with…
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LEPU ScienTech Medical Technology Sets IPO Price Range Ahead of Hong Kong Listing
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China-based LEPU ScienTech Medical Technology (Shanghai) Co., Ltd is gearing up for an initial public offering (IPO) on the Hong Kong Stock Exchange. The company plans to issue 22.46 million shares at a price range of HKD 29.15 (USD 3.71) to HKD 31.45 (USD 4.01) per share, potentially raising up…
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WuXi AppTec Posts Stellar Q3 2022 Results with 209% Profit Surge
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China-based WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359) has released its Q3 2022 financial report, showcasing remarkable growth across key metrics. For the first nine months of 2022, the Contract Research Organization (CRO) reported revenues of RMB 28.395 billion (USD 3.9 billion), a 71.9% year-on-year (YOY) increase, and net…
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OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
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Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). The therapy targets GPRC5D, a receptor highly expressed in multiple myeloma (MM) cells, and is being developed…
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Novartis Q3 Revenues Rise 4% YOY; China Sales Expand Despite COVID Lockdowns
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has reported a 4% year-on-year (YOY) increase in global revenues for the third quarter of 2022, reaching USD 12.54 billion in constant currency terms. However, in dollar terms, sales were down 4% YOY. The growth was driven by both the Innovative Medicines (IM) and…
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ImmVira Secures Series C+ Financing to Advance Oncolytic Virus and Exosome Programs
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China-based biotech ImmVira has successfully secured its Series C+ financing, entering into agreements with a first batch of investors, including China Merchants China Direct Investments Ltd, Wuzhong Biomedical Industry Development Fund, and Qiandao Fund. The proceeds will be used to advance clinical studies of three product pipelines in the US…
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Ascentage Pharma Files for Phase Ib/II Study of Bcl-2 Inhibitor in Systemic Lupus Erythematosus
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the submission of a clinical filing with the Center for Drug Evaluation (CDE) to initiate a randomized, double-blind, placebo-controlled Phase Ib/II clinical study. The study will assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of its Bcl-2 inhibitor, lisaftoclax (APG-2575), in patients…
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Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to conduct a Phase III clinical study evaluating the efficacy and safety of its programmed death-1 (PD-1) inhibitor, Serplulimab (HaiSiZhuang). The study will assess the drug in combination with chemotherapy (carboplatin/cisplatin-etoposide) in patients with limited stage…
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ArieMedi Secures Series A+ Financing to Expand Precision Navigation Solutions
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ArieMedi Medical Science, a leading precision navigation solutions provider based in Beijing, has announced the completion of its Series A+ financing round, raising “hundreds of millions” of renminbi. The funding was backed by Hairui Investment and Haier Capital. The proceeds will be allocated toward scientific research collaboration, clinical studies, technology…
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ClinBrain Raises RMB 200 Million in Series C Financing to Boost Medical Big Data
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Shanghai-based ClinBrain, a leading clinical data repository (CDR) and medical big data services provider, has reportedly secured RMB 200 million (USD 27.5 million) in a Series C financing round. The round was led by Legend Capital, with participation from the Shanghai Prosperity Fund. The company plans to use the funds…
