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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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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 Faces Investigation in China Over Data Privacy and Unapproved Drugs
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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 Strikes Deal with Kissei for Development and Commercialization of Rezlidhia in East Asia
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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’s Advanced Microwave Ablation System Gains NMPA Nod for Liver Tumor Treatment
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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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Hanx Biopharmaceuticals Receives NMPA Approval for HX009 Combination Therapy Phase II Trial
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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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European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
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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’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
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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’s EMB-06 Secures $635 Million Licensing Agreement with Vignette for Multiple Myeloma Therapy
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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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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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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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Jiangsu Simcere Acquires Exclusive Rights to TargetRx’s TGRX-326 in Licensing Deal
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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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China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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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…
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Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
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Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US pharmaceutical giant Regeneron Pharmaceuticals Inc. to oversee the market launch and commercialization of Libtayo (cemiplimab), Regeneron’s proprietary programmed death-1 (PD-1) inhibitor, in South Korea and Taiwan. Financial details of the agreement were not disclosed. Libtayo…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
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Allist Pharmaceuticals Acquires Jacobio’s G12C Inhibitor and SHP2 Inhibitor Rights for Greater China Region
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SHANGHAI—Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech company, has entered into a licensing agreement with fellow Chinese firm Jacobio Pharma (HKG: 1167), securing rights to Jacobio’s KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 for research, development, manufacturing, regulatory filings, and commercialization in Greater China. The agreement encompasses mainland China,…
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CNGB Virogin’s VG161 On Track for Breakthrough Designation in China for Advanced Liver Cancer
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BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised to secure a breakthrough therapy designation (BTD) from China’s National Medical Products Administration (NMPA) for its innovative drug VG161. The targeted indication for this recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection is…
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Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
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HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
