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Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
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Nanjing Sanhome’s Oritinib Wins NMPA Approval for EGFR T790M Positive NSCLC
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Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
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BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
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BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
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Haisco Pharmaceutical’s BRAF Inhibitor HSK42360 Gains NMPA Approval for Clinical Trials
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that it has secured another clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK42360. This BRAF V600 inhibitor is now poised to be evaluated in clinical trials for…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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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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Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
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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’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
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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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Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
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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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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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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 Halts Development of B001 and I022 for Selected Indications
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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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MSD Makes Undisclosed Equity Investment in Cancer Diagnostics Firm DELFI Diagnostics
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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’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
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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…
