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Leqembi Autoinjector Advances with FDA Review for Alzheimer’s Treatment
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) for review. The application seeks approval for the treatment of Alzheimer’s disease (AD) in patients with…
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Mediar Therapeutics and Eli Lilly Ink Deal for IPF Drug MTX-463
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US-based clinical-stage biotech Mediar Therapeutics, Inc. has announced a global license agreement with Eli Lilly and Company (NYSE: LLY) to advance its investigational drug MTX-463 into a Phase II clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF). This strategic partnership aims to further develop and potentially bring to…
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Cornerstone Robotics Raises $68.2M in Series C to Advance Surgical Robots
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Cornerstone Robotics, an innovative surgical robot developer based in Shenzhen, has reportedly raised over RMB 500 million (USD 68.2 million) in a Series C financing round. This significant funding round was led by EQT Partners and included contributions from a prestigious group of investors, such as Qiming Venture Partners, Alpha…
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MGI Tech’s DNBSEQ-E25 Receives NMPA License as World’s First Self-Luminescent Sequencer
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China-based gene sequencing specialist MGI Tech Co., Ltd has announced that it has received a medical license from the National Medical Products Administration (NMPA) for its DNBSEQ-E25. This achievement marks the DNBSEQ-E25 as the world’s first gene sequencer based on the principle of self-luminescent sequencing biochemistry, setting a new standard…
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Medtronic’s BrainSense Technologies Win EU, UK CE Mark for Parkinson’s Treatment
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US-Irish firm Medtronic (NYSE: MDT) has announced that it has received CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI). This approval marks a significant breakthrough in the treatment of Parkinson’s…
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Sansure Biotech to Acquire Sinobioway Hygene for $110M to Boost Product Pipeline
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) has announced plans to acquire 100% of the stakes in compatriot firm Zhongshan Sinobioway Hygene Biomedicine Co., Ltd., a genetic engineering biopharma. The transaction is valued at RMB 807.5 million (USD 110 million), marking a significant strategic move for Sansure. Acquisition…
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Novo Nordisk Launches Rybelsus in China, World’s First Oral GLP-1RA
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has announced the commercial launch of its innovative diabetes treatment, Rybelsus (semaglutide), in China. This marks a significant milestone for the company as it expands its presence in the Chinese market. Rybelsus: A First-in-Class TherapyRybelsus holds the distinction of being the world’s first…
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Merck’s Keytruda Gains NMPA Approval for HNSCC Indication in China
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) has announced that it has received an indication extension approval from the National Medical Products Administration (NMPA) for its blockbuster drug Keytruda (pembrolizumab). The approval is for the use of Keytruda as a monotherapy for the first-line treatment of metastatic or…
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Huadong Medicine Gets FDA Nod for Phase I Study of HDM2006 in Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in…
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Zhaoke Ophthalmology Partners with AFT for Brimochol PF Distribution in ANZ
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China-based Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a strategic distribution and supply agreement with New Zealand-headquartered AFT Pharmaceuticals Limited, a leading healthcare product manufacturer and distributor. The agreement pertains to Brimochol PF, a fixed dose of carbachol and bromonidine tartrate that is preservative free, co-developed by Tenpoint Therapeutics Ltd.…
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Tonghua Dongbao Begins Phase II Trial for GLP-1/GIP Agonist THDBH120 in Weight Loss
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced a significant milestone in its clinical development program with the first patient dosing in the Phase II clinical study of THDBH120. This study is designed to assess the efficacy and safety of the GLP-1/GIP dual-targeted receptor agonist in weight loss applications. THDBH120…
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Neo Modulus Secures $40.9M Series C Funding for Regenerative Medical Devices
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Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., a prominent developer of regenerative implantable medical devices in China, has announced the successful completion of its Series C financing round, raising RMB 300 million (USD 40.9 million). The round was led by the SCGC Manufacturing Industry Transformation and Upgrading to New Materials…
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MediLink Therapeutics and AstraZeneca Collaborate on YL201 and Imfinzi Combo for Solid Tumors
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced a clinical cooperation agreement with UK pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN). The collaboration aims to explore the potential of combining MediLink’s YL201 with AstraZeneca’s Imfinzi (durvalumab) in the treatment of multiple solid tumors. Upcoming Phase I/Ib StudyA multi-center, open…
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Simcere Zaiming and AbbVie Ink $1.055B License Deal for MM Drug SIM0500
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China-based Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced a significant strategic move through its oncology subsidiary, Simcere Zaiming. The company has entered into a license option agreement with global pharmaceutical giant AbbVie Inc. (NYSE: ABBV) for the development of its promising drug candidate, SIM0500. Deal Structure and FinancialsUnder the…
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CSPC’s Prusogliptin Approved in China for Type 2 Diabetes Treatment
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China’s National Medical Products Administration (NMPA) has granted marketing approval to CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) for its drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The approval is for the drug’s use in improving blood sugar control among adult patients with type 2 diabetes (T2D). Mechanism of ActionPrusogliptin…
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3SBio Acquires Licensing Rights to Duality Biologics’ HER2-Targeting ADC DB-1303
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China-based 3SBio Inc. (HKG: 1530) has entered into a strategic partnership with Duality Biologics, a leading antibody conjugate drug (ADC) developer with operations in the United States and China. The collaboration centers on the licensing rights to Duality Biologics’ promising ADC, DB-1303, which targets the HER2 protein. Agreement DetailsPursuant to…
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CBC Group’s R-Bridge Healthcare Fund Boosts Mirxes with $40M for Cancer Detection Expansion
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CBC Group’s R-Bridge Healthcare Fund has made a significant investment of USD 40 million in Mirxes Pte Ltd., a Singapore-based company at the forefront of miRNA technology. This funding is poised to propel Mirxes’ swift growth and its global outreach in the realm of cancer early detection and precision medicine.…
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JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
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China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation recognizes the potential of Carteyva as a second-line treatment for adults with relapsed or refractory…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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Suzhou Ribo and Boehringer Ingelheim Reach Pre-Clinical Milestone in NASH/MASH Partnership
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China-based Suzhou Ribo Life Science Co., Ltd has announced the achievement of a first pre-clinical milestone by Germany-headquartered Boehringer Ingelheim (BI) as part of their partnership struck back in January of last year. This milestone marks a significant step forward in the joint development of siRNA drugs for the treatment…
