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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of…
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The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for…
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced the discontinuation of clinical studies and further development for its drug candidates B001, B001-A, I022, and I022-K. B001, a monoclonal antibody (mAb) intended for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma (B-NHL), has been suspended following the completion of Phase I,…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an equity investment into DELFI Diagnostics, a U.S.-based developer of blood-based cancer tests, without disclosing the financial terms. The investment will enable DELFI to further develop its fragmentomics and artificial intelligence technologies, enhancing early cancer detection and treatment monitoring. DELFI’s proprietary…
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
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HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is…
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), 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 SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…