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Nuvation Bio’s Taletrectinib NDA for ROS1+ NSCLC Receives FDA Priority Review
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US-based Nuvation Bio Inc. (NYSE: NUVB) has announced that the New Drug Application (NDA) for its investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), taletrectinib, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The filing seeks approval for taletrectinib to treat advanced…
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Shanghai Henlius Biotech Initiates Patient Dosing in Global Phase III ELAINE-3 Study for Lasofoxifene
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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RaysightMed’s AngioQFA 100 Receives NMPA Approval for Coronary Artery Function Measurement
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China-based RaysightMed Co., Ltd has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its next-generation FFR imaging product, AngioQFA 100, a revolutionary coronary artery function measurement system. Advanced Fusion Technology for Comprehensive AssessmentThe AngioQFA 100 system employs a sophisticated fusion of artificial intelligence…
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uBriGene Secures RMB 200 Million in Pre-Series D Financing to Expand ATMPs CDMO Services
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China-based uBriGene, a contract development and manufacturing organization (CDMO) focused on advanced therapy medicinal products (ATMPs), has announced the completion of its Pre-Series D financing round, raising close to RMB 200 million (USD 27.4 million). This funding round comes on the heels of the Series C+ financing round completed in…
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WuXi AppTec to Divest WuXi Advanced Therapies and Oxford Genetics to Altaris LLC
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China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec Co., Ltd (SHA: 603259) has announced that its unit, WuXi ATU, will sell all stakes in WuXi Advanced Therapies Inc. and Oxford Genetics Limited, its US and UK operation entities respectively, to Altaris LLC. Altaris LLC is a US-headquartered equity investment…
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Basecare Medical and SolarCare Form Alliance to Advance AI in IVF Services
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Suzhou Basecare Medical Co., Ltd (HKG: 2170), a leading China-based in vitro fertilization (IVF) specialist, has formed a strategic five-year alliance with SolarCare, a private assisted reproductive medicine group supported by investors including Temasek, Government of Singapore Investment Corp, a Malaysian sovereign fund, and two Chinese investors. Agreement Terms and…
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Alphamab Oncology’s JSKN033 Gets Green Light for Phase I/II Study from China’s CDE
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase I/II study for its investigational drug, JSKN033. Design and Objectives of the Upcoming Phase I/II StudyThe imminent open, multi-center…
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CSPC Pharmaceutical’s SYH2062 Receives NMPA Clearance for Hypertension Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, SYH2062. SYH2062: A Novel siRNA Therapy for HypertensionSYH2062 is an N-acetyl-galactosamine (GalNAc)-conjugated small interfering RNA (siRNA) that targets the inhibition of…
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Keymed Biosciences’ Kangyueda Approved for CRSwNP Treatment in China
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis…
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Sichuan Biokin’s GNC-038 Tetra-Specific Antibody Clears for Clinical Trials in Autoimmune Diseases
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials for its innovative tetra-specific antibody, GNC-038. The trials will focus on the treatment of systemic lupus erythematosus and rheumatoid arthritis.…
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Changchun High & New Technology Industries Receives FDA Approval for Menopausal VMS Drug Trial
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China-based Changchun High & New Technology Industries (Group) Inc., (SHE: 000661) has received the green light from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its Category 1 chemical drug, GS1-144, in treating menopausal vasomotor symptoms (VMS). Understanding Menopausal Vasomotor Symptoms and the…
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AstraZeneca’s Tagrisso Secures EU Approval for EGFR-Mutated Locally Advanced NSCLC
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR)…
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Ikena Oncology and Inmagene Biopharmaceuticals to Merge into ImageneBio, Listed on Nasdaq as ‘IMA’
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US-based Ikena Oncology, Inc. (NASDAQ: IKNA) and Sino-US biotech Inmagene Biopharmaceuticals have announced their merger to form a new entity, ImageneBio, which will be listed on Nasdaq with the ticker symbol “IMA”. Focused Development on IMG-007 Post-MergerThe newly merged company, ImageneBio, will concentrate its efforts on the development of IMG-007,…
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Sanofi and SK bioscience Broaden Partnership to Develop Next-Gen Pneumococcal Vaccines
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French pharmaceutical major Sanofi (NASDAQ: SNY) and South Korea-based SK bioscience (KRX: 302440) have announced an expansion of their partnership to develop, license, and commercialize next-generation pneumococcal conjugate vaccines (PCVs) targeting both pediatric and adult populations. Milestone in Pediatric Vaccine DevelopmentTheir existing agreement, which aimed to develop and commercialize a…
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Corxel Pharmaceuticals Secures Global Rights to CX11, a Novel Oral GLP-1 RA, in Licensing Deal with Vincentage
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China-based Corxel Pharmaceuticals (CORXEL) has announced a significant licensing agreement with domestic firm Vincentage, securing global development and commercialization rights to CX11 (also known as VCT220), an oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA), excluding Greater China. The financial details of the agreement have not been disclosed. CX11:…
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ETERN Therapeutics’ YAP/TEAD Inhibitor ETS-006 Wins FDA Clinical Approval for Advanced Solid Tumors
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China-based biopharmaceutical company ETERN Therapeutics has announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its YAP/TEAD inhibitor, ETS-006, which targets multiple advanced solid tumors. ETS-006: A Promising Oral YAP/TEAD PPI InhibitorETS-006 is an oral YAP/TEAD protein-protein interaction (PPI) inhibitor that has shown…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Approved by EC for MSI-H/mCRC
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient…
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Roche’s Lunsumio Receives NMPA Approval for R/R Follicular Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb), Lunsumio (mosunetuzumab). This therapy targets CD20 and CD3 and is designed to treat adult patients with recurrent or refractory follicular lymphoma (R/R FL) who…
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BeiGene Rebrands to BeOne Medicines Ltd, Ticker Symbol Changes to “ONC”
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China-based BeiGene Ltd, listed on Nasdaq (NASDAQ: BGNE, HKG: 6160, SHA: 688235), has announced a significant brand transformation, changing its Nasdaq ticker symbol to “ONC” effective January 2, 2025. This move is accompanied by a proposed English name change to BeOne Medicines Ltd, highlighting the company’s dedication to delivering innovative…
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RAPT Therapeutics Secures Ex-China Rights to Jemincare Group’s Anti-IgE Antibody JYB1904
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US-based biopharmaceutical company RAPT Therapeutics Inc. (NASDAQ: RAPT) has announced that it has obtained the ex-Greater China rights to Jiangxi Jemincare Group’s long-acting anti-IgE antibody, JYB1904, through a significant licensing agreement. The deal involves an upfront payment of USD 35 million and potential milestone payments of up to USD 672.5…
