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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, ZG006, which is under development for the treatment of small-cell lung cancer (SCLC). ZG006 is…
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Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, and SEED Therapeutics Inc., a U.S. biotech firm, have announced their intention to enter into a research collaboration aimed at developing novel molecular glue degraders for neurodegenerative diseases and oncology. Eisai will leverage SEED’s expertise in targeted protein degradation (TPD) to…
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The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade…
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
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China-based Genor Biopharma Co., Ltd (HKG: 6998) has entered into a significant licensing and equity agreement with US-based TRC 2004, Inc., bestowing upon TRC 2004 the exclusive rights to develop, manufacture, and commercialize Genor’s innovative drug candidate, GB261, in all global territories excluding Greater China. This strategic partnership is set…
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Suzhou Degen Biopharmaceutical Co., Ltd, a leading specialist in PROteolysis TArgeting Chimeras (PROTAC) technology in China, has announced that its oral dual-targeted PROTAC drug, DG01, has been granted approval by the National Medical Products Administration (NMPA) to proceed with clinical studies for advanced or metastatic castration-resistant prostate cancer and liver…
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has entered into a licensing agreement with Beijing-based gene therapy specialist Immunochina Pharmaceuticals. The agreement grants Huadong exclusive commercialization rights to Immunochina’s IM19, a promising CD19-targeted autologous chimeric antigen receptor (CAR) T cell therapy, within mainland China. Huadong will make an…
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its decision to end its collaboration with Agenus Inc. (NASDAQ: AGEN) regarding the development of the TIGIT/CD96-targeted bispecific antibody BMS-986442 (AGEN1777). This move follows an initial decision to advance the antibody to Phase II trials earlier this year, which resulted…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has entered into a definitive licensing agreement with US-based Instil Bio Inc. (Nasdaq: TIL), granting InstilBio development and commercial rights outside China for ImmuneOnco’s proprietary PD-L1- and VEGF-targeted bispecific antibody, IMM2510, and its next-generation anti-CTLA-4 antibody, IMM27M. As per the agreement, a subsidiary…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…