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Oxford BioTherapeutics Partners with Roche on Cancer Therapeutics Discovery
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On March 19, 2025, Oxford BioTherapeutics announced a multiyear collaboration with Roche (SWX: ROG, OTCMKTS: RHHBY) to discover novel potentially first-in-class antibody-based therapeutics for the treatment of cancer. This partnership leverages Oxford BioTherapeutics’ innovative discovery platform to identify and validate new targets for cancer therapies. OGAP-Verify Discovery PlatformOxford BioTherapeutics’ recently…
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MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
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China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food and Drug Administration (FDA) to initiate a clinical study for its MRANK-106, a dual inhibitor of WEE1 and YES1 kinases. This marks a significant milestone for the company as it expands its innovative oncology pipeline…
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Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
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China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy. Drug ProfileFP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA).…
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Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study
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Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC)…
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Chipscreen Biosciences Gains NMPA Approval for Epidaza Phase III Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
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Light Horse Therapeutics Partners with Novartis in First-in-Class Drug Development
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US-based Light Horse Therapeutics Inc., a small molecule drug developer that recently emerged from the Inception Incubator with a USD 62 million Series A funding, has struck a strategic partnership with Swiss pharmaceutical giant Novartis (NYSE: NVS). The collaboration aims to identify and develop potentially first-in-class therapeutics using Light Horse’s…
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WuXi Biologics Partners with Sino Biopharmaceutical for First-in-Class Monoclonal Antibody Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced a significant research service cooperation agreement with fellow firm Sino Biopharmaceutical Ltd (HKG: 1177). This partnership aims to empower Sino Biopharmaceutical in the development of a first-in-class monoclonal antibody (mAb), with the target currently undisclosed. Comprehensive…
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Henlius Biotech Expands Partnership with Palleon Pharmaceuticals for Autoimmune Disease Treatment
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biotechnology company based in China, has announced an expansion of its alliance with Palleon Pharmaceuticals Inc. This partnership, originally established in June 2022, now includes the US firm in the development and commercialization of a combination therapy using Palleon’s E-602 and Henlius’…
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HighField Biopharmaceutical’s HF50 Receives Tacit Clinical Approval from NMPA for HER-2 Positive Tumors
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Hangzhou-based HighField Biopharmaceutical, a specialist in immuno-oncology biotech focused on targeted lipid-based therapies, has revealed that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its drug candidate HF50. This T-cell redirecting antibody fragment-anchored liposomes (TRAFsomes) product will be tested in clinical trials for HER-2…
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AstraZeneca’s Truqap Meets Primary Endpoint in Phase III Prostate Cancer Study
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UK-based pharmaceutical giant AstraZeneca Inc., (AZ, NASDAQ: AZN) has announced that its Phase III CAPItello-281 study has successfully met its primary endpoint of radiographic progression-free survival (rPFS). The study evaluated the efficacy of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient de novo…
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Biosion Secures Licensing Deal with Aclaris Therapeutics for Global Rights to BSI-045B and BSI-502
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Biosion, a clinical stage biotech company with operations in Delaware, US, and China, has entered into a licensing agreement with US based Acraris Therapeutics, Inc. (NASDAQ: ACRS). The deal grants Acraris exclusive global rights, excluding Greater China, to Biosion’s BSI-045B and BSI-502, further strengthening the two companies’ layout in the…
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TenNor Therapeutics’ Rifasutenizol Shows High Eradication Rate in H. pylori Phase III Study
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China-based TenNor Therapeutics has announced positive results from its Phase III clinical study for rifasutenizol (TNP-2198) in treating Helicobacter pylori (H. pylori) infection. The study successfully met its primary endpoints, showing significant advantages of the rifasutenizol regimen over the bismuth-containing quadruple therapy (BQT), which is the current standard of care.…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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NucMito and Amoytop Biotech Seal Deal for Development and Commercialization of NASH Drug Candidate in Greater China
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NucMito, a pioneering nuclear receptor drug developer headquartered in Xiamen, has entered into a licensing agreement with fellow Chinese firm Xiamen Amoytop Biotech Co., Ltd (SHA: 688278). The agreement, valued at up to RMB 145 million (approximately USD 20.37 million) in upfront and milestone payments, as well as royalties, grants…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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2seventy bio and BMS Discontinue Phase III Trial for Multiple Myeloma Therapy Abecma
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2seventy bio Inc. (NASDAQ: TSVT), a U.S.-based biotechnology company partnered with Bristol-Myers Squibb (BMS, NYSE: BMY) on the development of the chimeric antigen receptor (CAR) T-cell therapy Abecma (idecabtagene vicleucel; ide-cel), has announced the discontinuation of enrollment in a Phase III clinical trial. The trial, known as KarMMa-9, was investigating…
