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Menarini Group Partners with VisualDx to Enhance BPDCN Identification Using AI/ML Tools
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Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has formed a partnership with US-based VisualDx. This alliance aims to enhance the identification of individuals who may have blastic plasmacytoid dendritic cell neoplasm (BPDCN) by introducing artificial intelligence/machine learning (AI/ML) tools. Understanding BPDCNBPDCN is an aggressive orphan hematologic malignancy with…
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Elevation Oncology Halts EO-3021 Development After Poor Phase 1 Data
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US-based Elevation Oncology, Inc. (NASDAQ: ELEV) has announced the decision to terminate development of EO-3021 following disappointing Phase 1 data, which caused its stock price to plummet 41% before trading. EO-3021’s Background and Licensing DealEO-3021, a Claudin 18.2-targeted antibody drug conjugate (ADC) originated by China’s CSPC Pharmaceutical Group Ltd (HKG:…
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Changchun High & New Technology Industries Receives US Trial Approval for GenSci120 in Rheumatoid Arthritis
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced its subsidiary GenScipt Biotech Corp. receiving approval to initiate a clinical study for its GenSci120 in rheumatoid arthritis (RA) in the United States. This marks a significant step forward in the development of this innovative biologic product for…
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Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
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Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G). This marks the first and only approved therapy specifically targeting this rare kidney disease, which is characterized by a poor…
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Sino Biopharmaceutical’s 2024 Revenue Up 10.2% on Strong Innovative Drug Sales
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) released its 2024 financial report, recording revenues of RMB 28.9 billion (USD 4 billion), marking a 10.2% year-on-year increase. This growth was driven by strong performances across multiple therapeutic areas and the continued expansion of innovative drug sales. Revenue BreakdownInnovative drugs generated RMB 12…
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Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has filed a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast) 0.05% with the US Food and Drug Administration (FDA). The application seeks approval for the topical use of Zoryve in children…
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Sanofi to Acquire DR-0201 for $600 Million to Advance Myeloid Cell Engager
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Sanofi (EPA: SAN, NASDAQ: SNY) announced plans to acquire DR-0201, a bispecific myeloid cell engager (MCE) targeting CD20, through the acquisition of its developer, Dren Bio, Inc. The deal underscores Sanofi’s commitment to expanding its portfolio in autoimmune diseases with a novel therapeutic approach. Deal StructureSanofi will pay an upfront…
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Kexing Biopharm and Hinova Forge Alliance to Expand Global Market Reach
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced this week a strategic alliance with compatriot firm Hinova Pharmaceuticals Inc. (SHA: 688302) to jointly explore and develop overseas markets for their collaborative products. Collaboration DetailsThe partnership between Kexing Biopharm and Hinova Pharmaceuticals is designed to leverage their combined strengths in oncology…
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Kintor Pharmaceutical’s KX-826 Shows Promising Results in Alopecia Phase III Trial
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced positive topline results from the long-term safety Phase III study for its KX-826 (pyrilutamide) in alopecia. The trial met the primary endpoint with statistical significance and demonstrated the drug’s outstanding safety and efficacy. Clinical Trial ResultsAt week 52, patients showed significant improvements in…
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Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its JS212, a bispecific antibody drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). This marks a…
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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
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On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of…
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Paratek Pharmaceuticals to Acquire Optinose for $330 Million
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Paratek Pharmaceuticals and Optinose, Inc. (NASDAQ: OPTN) announced a definitive merger agreement on March 19, 2025. Under the terms of the agreement, Paratek will acquire Optinose, including its approved product XHANCE (fluticasone propionate), an innovative drug-device combination for the treatment of chronic rhinosinusitis (CRS) with or without nasal polyps. Transaction…
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Boji Medical’s Huasheng Transfers Glucosamine Sulfate Capsules Technology to Panlong
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On March 20, 2025, Boji Medical Technology Co., Ltd (known as Boji Biomedicals) (SHE: 300404) announced that its subsidiary, Huasheng Pharmaceutical, has signed a technology transfer contract with Panlong Pharmaceutical. The agreement involves the transfer of technology for “Glucosamine Sulfate Capsules” from Huasheng to Panlong, with a total transfer fee…
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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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Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
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On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients…
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CDE Announces 92nd Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 92nd batch of reference preparations for generic quality and consistency evaluation (GQCE). This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the market. New AdditionsThe latest batch includes 33 new drugs and…
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HutchMed’s 2024 Financial Report Shows Dip in Revenue Amid Oncology Product Growth
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) released its 2024 financial report, revealing a total revenue of USD 630.2 million, marking a 25% year-on-year decline. The oncology/immune business segment reported USD 363.4 million, a decrease of 31% compared to the previous year. Oncology Product PerformanceDespite the overall decline, oncology product sales…
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Servier and Black Diamond Therapeutics Ink Global Deal for BDTX-4933
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French pharmaceutical company Servier and US-based Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) announced a strategic global licensing agreement for BDTX-4933 on March 19, 2025. This collaboration aims to advance the development of BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Drug ProfileBDTX-4933 is uniquely designed by Black Diamond to…
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NMPA Seeks Public Input on Drug Trial Data Protection Measures
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On March 19, 2025, China’s National Medical Products Administration (NMPA) released draft measures and procedures for drug trial data protection, soliciting public opinions until May 18, 2025. The initiative aims to foster drug innovation and meet public medication needs, in line with relevant pharmaceutical regulations. Data Protection FrameworkThe draft measures…
