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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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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 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 (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 (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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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 & 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 (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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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 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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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, 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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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 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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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 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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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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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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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…