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Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
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Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus…
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Xeltis AG Enrolls First Patient in US Pivotal Trial for aXess with FDA BTD Status
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Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical…
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Shanghai Leadingtac Pharmaceutical Secures $13.81 Million in Series A Financing
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Shanghai Leadingtac Pharmaceutical Co., Ltd., a China-based small molecule drug developer, has announced the successful completion of its Series A financing round, raising RMB100 million (USD 13.81 million). The round was led by Beijing Longpan Venture Capital Centre, with additional support from Tian Rui Feng Nian Investment and Shanghai Zhangke…
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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
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Biosion Secures Licensing Deal with Aclaris Therapeutics for Global Rights to BSI-045B and BSI-502
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Biosion, a clinical stage biotech company with operations in Delaware, US, and China, has entered into a licensing agreement with US based Acraris Therapeutics, Inc. (NASDAQ: ACRS). The deal grants Acraris exclusive global rights, excluding Greater China, to Biosion’s BSI-045B and BSI-502, further strengthening the two companies’ layout in the…
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Ratio Therapeutics Partners with Novartis on SSTR2 Radiotherapeutic for Cancer
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US-based Ratio Therapeutics Inc. has entered into a global exclusive licensing and cooperation agreement with Swiss pharmaceutical giant Novartis AG (NYSE: NVS) to develop a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer treatment. Details of the AgreementRatio will apply its radioligand therapy discovery and development expertise, along with its…
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Huadong Medicine’s HDM1005 Receives FDA Approval for MASH Clinical Study
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
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TenNor Therapeutics’ Rifasutenizol Shows High Eradication Rate in H. pylori Phase III Study
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China-based TenNor Therapeutics has announced positive results from its Phase III clinical study for rifasutenizol (TNP-2198) in treating Helicobacter pylori (H. pylori) infection. The study successfully met its primary endpoints, showing significant advantages of the rifasutenizol regimen over the bismuth-containing quadruple therapy (BQT), which is the current standard of care.…
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Beijing Wantai Receives NMPA Clearance for Nine-Valent HPV Vaccine Targeting Male Population
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a leading Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its nine-valent human papillomavirus (HPV) vaccine (Escherichia coli), specifically designed for the male population. Global Impact and Vaccine RelevanceGlobally, approximately…
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Hasten Biopharmaceutical Initiates Phase III Clinical Trial for Lerodalcibep in China
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China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year. Study Design and…
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VelaVigo and Avenzo Therapeutics Ink Global Partnership for Nectin4/TROP2 Bispecific ADC
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Shanghai-based biotech company VelaVigo, specializing in bispecific/multi-specific antibodies and antibody drug conjugates (ADCs), has announced a global strategic partnership with US oncology firm Avenzo Therapeutics, Inc. This collaboration will facilitate the global development, manufacturing, and commercialization of VelaVigo’s Nectin4/TROP2 bispecific ADC, excluding Greater China, where VelaVigo retains the rights. Details…
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Youjia Biomedical and Yiling Pharmaceutical Collaborate on RNAi Metabolic Disease Treatments
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China-based Youjia (Hangzhou) Biomedical Technology Co., Ltd, a leading nucleic acid technology developer, has entered into a strategic cooperation agreement with Yiling Pharmaceutical Co., Ltd (SHE: 002603), marking a significant step into the metabolic diseases field utilizing RNAi technologies. This partnership aims to leverage Youjia’s expertise in nucleic acid drug…
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Grand Pharmaceutical Group Expands Distribution Partnership with Sirtex Medical in China
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced an additional distribution agreement with Australian firm Sirtex Medical Ltd. The agreement involves Grand Pharmaceutical’s subsidiaries, Beijing Purevalley Biotechnology Co., Ltd, and Chengdu Purevalley Biotechnology Co., Ltd, which will exclusively distribute Sirtex’s SIR-Spheres (Y-90 microsphere)…
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Keymed Biosciences Enters Global Licensing Agreement with Platina Medicines for CM336
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Keymed Biosciences Inc., a China-based biopharmaceutical company (HKG: 2162), has announced a significant licensing agreement with UK-based Platina Medicines Ltd (PML). The agreement grants Platina Medicines exclusive global development, manufacturing, and commercialization rights to Keymed’s CM336, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial Terms and ConsiderationsUnder the terms…
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CanSino Biologics Initiates Phase I Clinical Trial for Freeze-Dried Hib Conjugate Vaccine
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China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced the commencement of a Phase I clinical study for its freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine, marking a significant step in the development of this important pediatric vaccine. The study has begun with the enrollment of the first subject,…
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Hangzhou Jiuyuan Gene Engineering Passes HKEX IPO Hearing for Orthopedic Treatments
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Hangzhou Jiuyuan Gene Engineering Co., Ltd. has announced that it has successfully passed the listing hearing by The Stock Exchange of Hong Kong Limited for its initial public offering (IPO). While the price and other key details have not been disclosed at this stage, the company’s listing marks a significant…
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NK CellTech Partners with 3SBio to Advance NK Cell Therapy Technology
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China-based natural killer (NK) cell therapy developer NK CellTech has entered into a strategic partnership with 3SBio Inc. (HKG: 1530), a compatriot firm, to focus on advancing NK cell therapy technology. This collaboration aims to leverage the complementary technologies and resources of both companies, accelerating the research, development, and commercialization…
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Shanghai’s Matwings Secures Over $13.8 Million in Series A Financing for AI Protein Design
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Matwings, an AI-based protein design service provider headquartered in Shanghai, has announced the successful completion of its Series A financing round, raising over RMB100 million (USD 13.82 million). The round was led by Qiming Venture Partners, with additional investments from Yonghua Capital, Jingtao Private Equity Fund, and 3E Bioventures, among…
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EMA’s CHMP Recommends Approval for MSD’s Keytruda Combo in Mesothelioma Treatment
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Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its PD-1 inhibitor, Keytruda (pembrolizumab), in combination with pemetrexed plus…
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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
