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Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product, jinnamab. This marks a significant milestone for the…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced that it has received its first market approval from the National Medical Products Administration (NMPA) in China for Mounjaro (tirzepatide). The drug is indicated for the treatment of type 2 diabetes mellitus (T2DM) in patients who have…
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Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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Eli Lilly and Company (NYSE: LLY), a global healthcare company, has announced results from a comparative study on its once-weekly insulin efsitora alfa. The study demonstrated that efsitora alfa is non-inferior in reducing A1C levels compared to daily basal insulins degludec or glargine in adults with type 2 diabetes (T2D).…
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China’s Biotheus Inc. has announced the initiation of a Phase III clinical study for its investigational bispecific antibody, PM8002, which targets both PD-L1 and VEGF. The study will evaluate the safety and efficacy of PM8002 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic…
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The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for timdarpacept (IMM01), the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its βKlotho monoclonal antibody (mAb), JMT202. This molecule is intended to reduce triglyceride (TG) levels in patients…
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Switzerland-based healthcare giant Roche (SWX: ROG) has announced preliminary results from a Phase I study of its investigational dual GLP-1/GIP receptor agonist, CT-388. The study is assessing the drug’s effects in obese adults, both healthy and those with type 2 diabetes (T2D). Initial data from the healthy cohort showed that…
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced its commitment to donate 100,000 boxes of the gastresophageal reflux disease (GERD) medication Pariet (rabeprazole) to the Beijing Health Alliance Charitable Foundation. This initiative is designed to support a new program aimed at enhancing the capabilities of grassroots health care…