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Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
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Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
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Sichuan Huiyu Pharmaceutical’s HYP-6589 Receives NMPA Approval for Solid Tumor Clinical Trial
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HYP-6589, which targets advanced solid tumors. HYP-6589’s Mechanism of ActionHYP-6589 is an in-house developed SOS1 small molecule…
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Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
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The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
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AskBio’s AB-1003 Receives Rare Pediatric Disease and Orphan Drug Designations from FDA
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Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned subsidiary of Bayer AG (ETR: BAYN), has announced that it has received both rare pediatric disease designation (RPDD) and orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational gene therapy, AB-1003 (LION-101). The therapy targets limb-girdle muscular dystrophy…
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Teva Pharmaceutical Expands Partnerships in China’s One Health Sector with New Agreements
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Israel based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced new partnerships with Chinese firms Zhejiang International Group Co., Ltd. and Jianmin International Co., Ltd. These collaborations aim to enhance Teva’s commercial layout in the “One Health” sector, increasing the availability of quality products for Chinese consumers. Strategic Agreements at…
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Bayer’s Leap Forward: Implementing Salesforce on Alibaba Cloud for Customer Engagement
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Bayer (ETR: BAYN) has announced that its China Prescription Medicines business has fully adopted the “Salesforce on Alibaba Cloud” solution, creating an all-new customer interaction platform, OPERA 2.0, for thousands of internal Bayer users. Bayer is one of the first multinational pharmaceutical companies in China to implement a new customer…
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CDE Releases Technical Guidelines for Pilot Registration and Phased Manufacturing of ADCs
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The Center for Drug Evaluation (CDE) has issued the “Technical Requirements for Pilot Registration and Application of Phased Manufacturing of Antibody Drug Conjugates (ADC).” This document complements the “Pilot Work Plan for Phased Manufacturing of Biological Products” released last month and aims to guide the pilot work of phased manufacturing…
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Shanghai Pharmaceuticals’ MediTrust Health Partners with Eisai for Comprehensive Patient Services
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Shanghai Pharmaceuticals Holding Co., Ltd’s (HKG: 2607, SHA: 601607) subsidiary, MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a strategic partnership with Japanese pharmaceutical company Eisai (TYO: 4523). This collaboration grants Eisai access to MediTrust Health’s “One-Code Direct Payment-Diversified Payment Platform,” aiming to establish…
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Boehringer Ingelheim Partners with Wuhan Union Hospital to Enhance Clinical Research and Development
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Boehringer Ingelheim, a leading German pharmaceutical company, has entered into a strategic partnership with Wuhan Union Hospital, marking a significant step in the realm of clinical research. This collaboration will extend beyond clinical studies to include academic exchanges, patient education, and talent development, among other areas, in alignment with Boehringer…
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Hainan Haiyao Enters JV with Haikou and Xenios AG to Advance ECMO Technology
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Hainan Haiyao Co., Ltd (SHE: 000566), a prominent Chinese company, has announced the signing of an initial joint venture (JV) agreement with the Haikou National High-tech Industrial Development Zone Management Committee and Xenios AG, a subsidiary of German healthcare giant Fresenius Medical Care AG. This strategic collaboration is aimed at…
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Belief BioMed’s BBM-D101 Receives FDA Orphan Drug and Pediatric Rare Disease Designations for DMD
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Belief BioMed has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Pediatric Rare Disease Designation (RPDD) for its gene therapy drug, BBM-D101 injection, indicated for the treatment of Duchenne muscular dystrophy (DMD). BBM-D101: A Pioneering rAAV Gene Therapy for Duchenne Muscular DystrophyBBM-D101…
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Nanjing Leads Biolabs and Aditum Bio Launch Oblenio Bio with Focus on CD19 Tri-Specific Antibody
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China-based Nanjing Leads Biolabs Co., Ltd and venture capital firm Aditum Bio have announced the establishment of Oblenio Bio, along with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody targeting autoimmune diseases. Aditum Bio will provide funding for Oblenio Bio, and together…
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Sanofi and Cathay Capital Forge Partnership to Boost Sino-French Pharmaceutical Cooperation
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has signed a partnership deal with Cathay Capital, a global private equity and venture capital investment firm, at the 7th China International Import Expo (CIIE). This collaboration aims to deepen their existing long-term cooperation and serves as a positive step towards promoting Sino-French cooperation…
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Eisai and GE Healthcare Sign MoU at CIIE to Collaborate on Alzheimer’s Disease Solutions
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At the 7th China International Import Expo (CIIE), Japan-based Eisai Co., Ltd (TYO: 4523) entered into a Memorandum of Understanding (MoU) with US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC). The partnership, centered on the early detection, precise diagnosis, and treatment of Alzheimer’s disease (AD),…
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Lohmann & Rauscher Partners with Allmed Medical Products at CIIE for Medical Dressings
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Lohmann & Rauscher, a medical group with headquarters in Germany and Austria, has entered into a partnership with China-based Allmed Medical Products Co., Ltd. (SHE: 002950) at the 7th China International Import Expo (CIIE). The collaboration aims to leverage the complementary strengths of both companies to provide a more diversified…
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I-Mab Appoints Sean (Xi-Yong) Fu as Permanent CEO, Effective November 1, 2024
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US-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced the appointment of Sean (Xi-Yong) Fu, PhD, MBA, as its permanent Chief Executive Officer (CEO), effective November 1, 2024. Dr. Fu, who has been serving as Interim CEO since July 15, 2024, will also continue his role as a member of the…
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Novo Nordisk Reports Q3 2024 Financials with 24% YOY Revenue Growth
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Denmark-based pharmaceutical company Novo Nordisk A/S (NYSE: NVO) has released its financial results for the third quarter of 2024. The company reported revenues of DKK 204.72 billion (USD 29.459 billion) for the first nine months, marking a 24% year-on-year (YOY) growth in constant currency terms. Diabetes and Obesity Care Drive…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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Siemens Healthineers AG Reports Fiscal 2024 Results with Targeted Revenue Growth
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Germany-based medical device giant Siemens Healthineers AG (ETR: SHL) has released its financial results for the fourth quarter of fiscal 2024, ended September 30, 2024, and the full fiscal year 2024. The company achieved its targets for revenue growth and earnings per share for FY2024, demonstrating resilience amidst challenging market…
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HutchMed to Present Updated Data from Solvleplenib ESLIM-01 Phase III Trial at ASH and ESMO Congress 2024
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced plans to present new and updated data from the sovleplenib ESLIM-01 Phase III trial, along with several investigator-initiated studies of compounds discovered by HutchMed, at the American Society of Hematology (ASH) Annual Meeting and the European Society for Medical Oncology…
