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Betta Pharmaceuticals’ MCLA-129 Approved for Clinical Trial in Advanced Solid Tumors
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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Hangzhou Jiuyuan Gene Engineering Plans HKEX IPO to Raise Up to USD 73.2 Million
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Hangzhou Jiuyuan Gene Engineering Co., Ltd. is poised to conduct an initial public offering (IPO) of 45,398,800 shares on the Hong Kong Stock Exchange (HKEX) on November 26, following the receipt of approval from the exchange earlier this week. The company has priced each share at 12.56, aiming to raise…
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Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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LaNova Medicines Inks Licensing Deal with Sino Biopharmaceutical for Cancer Therapies in China
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Shanghai-based LaNova Medicines Ltd, a developer of cancer therapies, has announced another licensing deal, signing an agreement with compatriot firm Sino Biopharmaceutical Ltd (HKG: 1177) for the development and commercialization of LM-108 and other potential bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs) in mainland China. The specifics of the…
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Worg Pharmaceuticals Secures Major Financing for Allergy and Autoimmune Disease Therapies
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Worg Pharmaceuticals (Zhejiang) Co., Ltd., a China-based biopharmaceutical company specializing in the development of immunotherapies for allergic and autoimmune diseases, has successfully raised hundreds of millions of renminbi in a new financing round. The round saw participation from notable investors such as PICC Investment, Tsing Song Capital, and an undisclosed…
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Abbott Laboratories Expands Global Diabetes Care with New Kilkenny Facility
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Abbott Laboratories (NYSE: ABT), a leading US healthcare company, has announced the opening of its state-of-the-art manufacturing facility in Kilkenny, Ireland. This new site, which serves as a global manufacturing center of excellence for Abbott’s diabetes care business, is expected to create over 800 new jobs. Details of the Kilkenny…
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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Rona Therapeutics’ RN0191 Showcases Positive Phase I Results at AHA Scientific Sessions
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Shanghai-based nucleic acid drug developer Rona Therapeutics has announced the presentation of positive Phase I results for its investigational drug, RN0191, at the American Heart Association’s (AHA) Annual Scientific Sessions in Chicago, IL. The study’s findings highlight the potential of RN0191 in managing lipid levels and offer promising news for…
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Eli Lilly’s Tirzepatide Meets Primary Endpoints in Phase III SUMMIT Heart Failure Study
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Eli Lilly and Company (NYSE: LLY), a leading US pharmaceutical corporation, has announced positive results from the Phase III SUMMIT study assessing the effects of tirzepatide in heart failure. The study successfully met both primary endpoints, marking a significant advancement in the treatment of heart failure. Study Outcomes and EfficacyTirzepatide,…
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Zai Lab Ltd Announces Secondary Public Offering Worth $230 Million
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Zai Lab Ltd (ZLAB; NASDAQ: ZLAB; HKG: 9688), a leading biopharmaceutical company, is set to raise capital through a secondary public offering of American Depositary Shares (ADSs) valued at USD 230 million. The offering consists of 7,843,137 ADSs, with each ADS representing ten ordinary shares of the company, priced at…
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AstraZeneca’s Tagrisso Receives Positive CHMP Opinion for EGFR-Mutated NSCLC
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients…
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Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
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Eli Lilly’s Muvalaplin Demonstrates Potent Lp(a) Reduction in Phase II Study
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced positive results from a Phase II study for its investigational drug, muvalaplin, a selective lipoprotein(a) [Lp(a)] inhibitor. The study successfully met its primary endpoint, showing a significant reduction in elevated Lp(a) levels in adults, a genetic risk…
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Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate…
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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…
