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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Innovent Biologics (Hangzhou) Co., Ltd (HKG: 1801, OTCMKTS: IVBXF), a biopharmaceutical company based in China, has announced the successful initiation of a Phase I clinical trial for its proprietary IBR822 cell injection solution at Zhejiang Cancer Hospital. The trial, led by Professor Song Zhengbo from Zhejiang Cancer Hospital, is conducted…
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has entered into a significant licensing agreement with US biotechnology firm RadioMedix Inc. and French company Orano Med, securing global rights to a radioligand therapy (RLT). The agreement centers on AlphaMexi (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) that utilizes a…
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Signet Therapeutics, a pioneering biopharmaceutical company in China specializing in cancer targeted therapies based on organoid disease models and artificial intelligence (AI), has entered into a strategic partnership with Guangzhou Jennio Biotech Co., Ltd. The collaboration aims to leverage organoid disease models and advance tumor immunotherapy drug development. Financial specifics…
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Carisma Therapeutics Inc. (NASDAQ: CARM), a U.S.-based company specializing in chimeric antigen receptor (CAR) macrophage therapies, has announced an expansion of its collaboration with fellow U.S. firm Moderna Inc. (NASDAQ: MRNA). This strategic partnership extension will focus on the development of in vivo CAR macrophage and monocyte (CAR-M) therapies for…
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs…
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Rigel Pharmaceuticals Inc. (NASDAQ: RIGL), a biopharmaceutical company based in the U.S., has entered into a license and supply agreement with Japan’s Kissei Pharmaceutical Co., Ltd. The agreement grants Kissei the rights to develop and commercialize Rigel’s Rezlidhia (olutasidenib) across Japan, South Korea, and Taiwan. Rezlidhia is an oral isocitrate…
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True Health (Guangdong Hengqin) Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative navigation positioning microwave ablation system. This advanced medical device utilizes CT images to devise a precise needle insertion plan prior to surgery and provides real-time guidance for the…
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On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) for the Phase II clinical trial of its investigational drug HX009 in combination therapy for biliary tract cancer (BTC). The application met the relevant requirements for drug registration,…
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Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received a significant boost with the clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HW071021. This novel drug, designed to combat advanced solid tumors, stands as a unique…
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EpimAb Biotherapeutics, a Shanghai-based biotech firm, has inked a licensing deal with Vignette for the development and commercialization of its T-cell engager (TCE) EMB-06 outside of Greater China. The agreement grants Vignette rights to EMB-06, a BCMA-targeting therapy, in regions excluding mainland China, Hong Kong, Macau, and Taiwan, with EpimAb…
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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SHENZHEN—Shenzhen TargetRx, Inc., a leading developer of small-molecule kinase inhibitors, has entered into a licensing agreement with Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a fellow Chinese pharmaceutical company. The deal concerns TargetRx’s TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor currently at the clinical stage. According to the agreement,…
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Evopoint Biosciences’ XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated…