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Envonalkib, Chia Tai Tianqing’s Next-Gen ALK Inhibitor, Wins NMPA Approval for Untreated ALK+ NSCLC
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Chia Tai Tianqing’s next-generation ALK inhibitor, envonalkib, has received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) and have not been previously treated with ALK inhibitors. A…
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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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MicroPort Endovascular’s Vewatch Filter Gets NMPA Green Light for Pulmonary Embolism Prevention
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical device company, has announced that its Vewatch vena cava filter has received approval from the National Medical Products Administration (NMPA) for the prevention of pulmonary embolism caused by thrombus detachment in the inferior vena cava system. This product marks…
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Kintor Pharmaceutical Initiates Phase II Clinical Trial for Acne Treatment GT20029 in China
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Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its drug candidate GT20029, which is being investigated for the treatment of acne in China. The Phase II study is a multi-center, randomized, double-blinded,…
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RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
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RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
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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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Walvax Biotechnology Halts COVID-19 Vaccine Clinical Trials Citing Low Benefits
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Walvax Biotechnology Co., Ltd (SHE: 300142), a biopharmaceutical company based in China, has announced the termination of clinical studies for its recombinant COVID-19 vaccine (CHO cell) and recombinant COVID-19 variant vaccine (CHO cell), due to the assessment of low economic and social benefits. The vaccines were approved for clinical trials…
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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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Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
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Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced that its drug candidate soticlestat did not meet the primary endpoints in two Phase III trials. The drug is currently under development for the treatment of two rare forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome—and…
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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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Takeda Secures Global Rights to Ascentage Pharma’s Olverembatinib Outside of China and Select Territories
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Takeda Pharmaceuticals, a leading biopharmaceutical company based in Japan (TYO: 4502), has entered into an option agreement with China-based Ascentage Pharma (HKG: 6855), securing exclusive development and commercialization rights for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), in markets outside of China, Hong Kong, Macau, Taiwan, and Russia. The…
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CARsgen Therapeutics’ Saikaize and CT071 Show Strong Results in EHA Clinical Trials
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CARsgen Therapeutics, a biopharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 2171), has announced promising results from two pivotal clinical trials at the 29th European Hematology Association Annual Meeting. The data presented highlights the potential of two CAR-T therapies: Saikaize (zevorcabtagene autoleucel), an autologous BCMA-targeted therapy for multiple…
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RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
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CStone Pharmaceuticals Gets NMPA Green Light for Local Production of Gavreto
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to begin local manufacturing of Gavreto (pralsetinib tablets, 300mg), moving away from overseas supply. The company anticipates that domestic production will start by the end…
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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…
