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ProteLight Pharma’s Peceleganan (PL-5) Accepted for Review by China’s CDE
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China’s Center for Drug Evaluation (CDE) website has indicated that a market filing by local firm ProteLight Pharma for its Category 1 product peceleganan (PL-5) has been accepted for review by the bureau. This development follows a licensing deal in January 2023, through which Chia Tai Tianqing obtained the exclusive…
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Innovent Biologics Partners with Suzhou ForLong to Explore Sintilimab and FL115 Combination in Solid Tumors
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a clinical study and supply agreement with Suzhou ForLong Biotechnology Co., Ltd, a collaboration aimed at exploring the potential of Innovent’s sintilimab combined with ForLong’s FL115 in treating advanced solid tumors. Sintilimab and FL115: A Promising Combination for Cancer TreatmentSintilimab, a PD-1…
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Zhejiang Huahai Pharmaceutical’s Subsidiary Huaota Bio Secures $27.4 Million Investment
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that its macromolecular drug-focused subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd., has successfully raised RMB 200 million (USD 27.4 million) through a new issuance of 20 million shares. The shares were exclusively subscribed by Linhai Haijing Venture Capital. This transaction has increased…
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Bristol-Myers Squibb’s Sotyktu Meets Primary Endpoints in POETYK PsA Studies
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from the pivotal Phase III POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) studies for its drug Sotyktu (deucravacitinib). These studies assessed the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA). Achievement of Primary and…
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Bio-Thera Solutions Enters Licensing Agreement with Tabuk Pharmaceutical for BAT2206 in Saudi Arabia
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China-based Bio-Thera Solutions (SHA: 688177) has announced a licensing agreement with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and North Africa (MENA) region. The agreement pertains to BAT2206, Bio-Thera’s biosimilar version of Roche’s (SWX: ROG) Stelara (Ustekinumab).…
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Achilles Therapeutics and AstraZeneca Seal $12 Billion Deal for TRACERx NSCLC Study Data
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UK-based Achilles Therapeutics plc has announced a landmark deal worth USD 12 billion with AstraZeneca (AZ, NASDAQ: AZN), which involves the transfer of the UK company’s commercial license of data and samples from the TRACERx Non-Small Cell Lung Cancer (NSCLC) study. TRACERx Study: A Pioneering Effort in Tumor Evolution ResearchThe…
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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…
