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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
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Shanghai Pharmaceuticals’ Subsidiary Shaphar Med Collaborates with Magic Med to Enter Oncology
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Shanghai Pharmaceuticals Holding Co., Ltd (SPH, SHA: 601607; HKG: 2607), a leading pharmaceutical company in China, has announced that its subsidiary, Shaphar Medical Instruments (Shanghai) Co., Ltd, has entered into a partnership with Magic Med, a Chinese firm. This strategic collaboration signifies Shaphar Med’s inaugural venture into the oncology sector.…
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Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
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Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
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Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
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Novartis Moves Toward Full Ownership of MorphoSys with Shareholder Squeeze-Out
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Novartis AG (NYSE: NVS), the Swiss pharmaceutical giant, is proceeding to fully acquire MorphoSys AG (OTCMKTS: MPSYF) by initiating a squeeze-out of its minority shareholders. Novartis had made a public takeover offer of EUR 68 per share, valuing the company at an aggregate EUR 2.7 billion (USD 2.9 billion), in…
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Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
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Xencor Reclaims Rights to Plamotamab After Janssen Halts Development
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Xencor Inc. (NASDAQ: XNCR), a U.S.-based biotechnology company, has announced that Johnson & Johnson (J&J, NYSE: JNJ)’s Janssen Biotech Inc. has opted not to proceed with the development of the bispecific T-cell engager plamotamab. As a result, Xencor regains exclusive global rights to the molecule, a CD20 x CD3 bispecific…
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Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
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Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase…
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AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
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AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
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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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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…
