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Hengrui Pharmaceuticals Gets NMPA Green Light for HRS-1738 and HRS-5817 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its two Category 1 chemical drugs, HRS-1738 and HRS-5817, targeting prostate cancer and overweight/obesity respectively. HRS-1738: Prostate Cancer Diagnostic InnovationHRS-1738 is an internally developed radiopharmaceutical designed for in…
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Servier and Black Diamond Therapeutics Ink Global Deal for Solid Tumor Targeted Therapy BDTX-4933
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French pharmaceutical firm Servier has announced a global licensing agreement with US-based Black Diamond Therapeutics (NASDAQ: BDTX) concerning BDTX-4933, a small molecule targeted therapy for solid tumors. The deal underscores a significant collaboration aimed at advancing the treatment landscape for multiple cancer indications. Deal Structure and Financial TermsUnder the agreement,…
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Shanghai Junshi Biosciences’ Loqtorzi Approved in Singapore for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Singapore Health Sciences Authority (HSA) for its Loqtorzi (toripalimab). The anti-PD-1 monoclonal antibody (mAb) is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for recurrent, not amenable to surgery…
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Bayer Inks Licensing Deal for Suzhou Puhe’s PRMT5 Inhibitor, BAY 3713372
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German pharmaceutical giant Bayer (ETR: BAYN) has entered into a licensing agreement with Suzhou Puhe Biopharma Co., Ltd, acquiring global exclusive development, manufacturing, and commercialization rights to the Chinese firm’s MTA-cooperative PRMT5 inhibitor, designated as BAY 3713372. Financial details of the deal were not disclosed. Bayer has enrolled the first…
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AstraZeneca’s Calquence Approved by NMPA for CLL/SLL Treatment
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UK pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a monotherapy. This marks the third…
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Sichuan Huiyu Pharmaceutical Wins Marketing Approvals in Italy, Portugal, Saudi Arabia
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China-based Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553) has announced its its subsidiaries Seacross Pharma (Europe) and Seacross Pharmaceuticals Ltd. receiving a series of marketing approvals for its products in Italy, Portugal, and Saudi Arabia. The approved products include valproate concentrated solution, zoledronic acid, teicoplanin, and plerixafor. Valproate Concentrated SolutionValproate,…
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Merck KGaA Partners with Roche to Commercialize Tepmetko in China
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Germany-based pharmaceutical giant Merck KGaA (ETR: MRK) has entered into a partnership with Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) to commercialize its lung cancer targeted drug Tepmetko (tepotinib) in mainland China. This collaboration aims to leverage the strengths of both companies to bring Tepmetko to more patients in need.…
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Chia Tai Tianqing’s TQB2210 Approved for Advanced Malignant Tumor Study
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Chia Tai Tianqing’s Category 1 drug TQB2210 for clinical study in advanced malignant tumors. This marks a significant step forward for the company in the field of oncology. Drug Profile and InnovationTQB2210 is a human…
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Joint Biosciences’ OVV-01 Receives FDA Fast Track Designation for Soft Tissue Sarcoma Trial
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Shanghai-based Joint Biosciences Ltd., a developer of tumor combined immunotherapies, has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its Phase II study of OVV-01. This recombinant vesicular stomatitis virus (VSV) carrying the NY-ESO-1 tumor-associated antigen is being investigated for the treatment of advanced…
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Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
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Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has obtained Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its liver cancer multi-gene methylation + protein multi-omics screening reagent and supporting analysis software. This recognition highlights the innovative nature of…
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CStone Pharmaceuticals Files for EMA Approval of Sugemalimab for Unresectable Stage III NSCLC
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China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) with the European Medicines Agency (EMA). The application seeks approval for sugemalimab’s use in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not…
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Abbisko Therapeutics and Allist Pharmaceuticals Partner on KRAS-G12C NSCLC Combination Therapy
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has entered into a cooperation agreement with compatriot firm Allist Pharmaceuticals Co., Ltd (SHA: 688578). The alliance aims to study the combination of Abbisko’s investigational ABSK043 and Allist’s glecirasib in patients with KRAS-G12C mutant non-small cell lung cancer (NSCLC). ABSK043: PD-L1 InhibitorABSK043…
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FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
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The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL) to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) regarding its application for the combination of programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab with small-molecule targeted cancer therapy apatinib as a first-line treatment for irresectable…
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Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication for its PD-1 inhibitor Loqtorzi (toripalimab). The drug is now approved for use in combination with bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC),…
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HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received…
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Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
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China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
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Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
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Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan. The drug is approved for treating adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer who have undergone prior chemotherapy. First TROP2-Directed Therapy…
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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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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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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…
