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Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
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Mega Lifesciences Secures Exclusive Rights for Bio-Thera’s Bevacizumab Biosimilar in Indonesia
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Thailand-based Mega Lifesciences (BKK: MEGA) has announced an in-licensing agreement with China-based Bio-Thera Solutions (SHA: 688177) for bevacizumab (BAT1706), a biosimilar version of Roche’s (SWX: ROG) Avastin (bevacizumab). According to the agreement, Mega Lifesciences obtains exclusive distribution and marketing rights to the product in Indonesia, while Bio-Thera will handle the…
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Jiangsu Hengrui’s Dalpiciclib Approved for Initial Therapy in HR+, HER2- Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving another indication approval for its drug dalpiciclib (SHR6390). The approval is for use as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
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BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
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Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
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Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has been approved to enter clinical trials for the treatment of cervical cancer in China. The molecule will be assessed in combination with platinum chemotherapy and with or without bevacizumab, as per the Chinese firm’s announcement.…
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Medivir AB Receives Chinese Patent Approval for Liver Cancer Treatment Fostroxacitabine Bralpamide
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Sweden-based Medivir AB (FRA: MVR0) has announced the approval of a patent in China for its fostroxacitabine bralpamide (fostrox) and its use in the treatment of liver cancer. The patent, which remains valid until 2035 with potential for extensions, is a significant milestone for Medivir, considering China’s large population of…
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Grand Pharmaceutical Initiates Phase II STARBURST Study for TLX250-CDx in Indication Expansion
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the indication expansion Phase II STARBURST study for its TLX250-CDx (89Zr-DFO-girentuximab). The imaging agent is licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a 2020 deal valued at up to USD 225 million. The 2020…
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United Imaging Healthcare Acquires Stake in Apactron for High-End Particle Therapy Technology
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Shanghai-based United Imaging Healthcare (UIH, SHA: 688271) has announced an investment of RMB 45 million (USD 6.3 million) to acquire a 4.7% stake in Shanghai Apactron Particle Equipment Co., Ltd., a company specializing in high-end particle therapy technology. This strategic deal is aimed at leveraging Apactron’s expertise in proton therapy…
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Sequanta Technologies Partners with DarkJade Sciences to Establish Organoid Bank and Glioma Project
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Sequanta Technologies, a leading multi-omics research and clinical service provider based in Shanghai, has announced a partnership with DarkJade Sciences, a renowned organoid specialist based in Beijing. The collaboration aims to leverage the respective strengths of both companies to establish an organoid bank, with the first project focusing on glioma…
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Nanjing Leads Biolabs Receives FDA IND Approval for LBL-033 Phase I/II Clinical Trial
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China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial for its pipeline candidate, LBL-033. This anti-MUC16/CD3 bispecific antibody (BsAb) is set to be investigated as a potential…
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TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its bispecific antibody (BsAb), TGI-6. This development marks a significant step forward in the company’s efforts to bring innovative immunotherapies to patients…
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Aosaikang Pharmaceutical’s ASKB589 Shows Promising Results in Solid Tumor Treatment Study
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed the latest results from a Phase I/II study for its Category 1 biologic product candidate ASKB589, which is being assessed as a treatment for solid tumors. The findings were presented at the 15th International Gastric Cancer Association (IGCA) meeting, highlighting the…
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Jiangsu Hengrui Medicine Cancels Licensing Agreement with Mabworks Citing Market Changes
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced its decision to cancel a licensing agreement with compatriot firm Mabworks, along with a related equity investment deal, due to changes in the market landscape. This move signifies that Hengrui Pharmaceuticals will no longer hold exclusive commercialization rights to Mabworks’…
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BeiGene to Showcase Brukinsa Data at ICML, Highlighting Efficacy in Relapsed Follicular Lymphoma
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China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of…
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Fosun Pharma Initiates Phase II Study of HLX26 and Serplulimab Combo for Metastatic CRC
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II clinical study in China for HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, in combination with its programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) for the treatment of metastatic…
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Takeda and HutchMed’s Elunate Study Results Published in The Lancet
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Takeda (TYO: 4502) and HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) have announced that the results of the Phase III FRESCO-2 study for Elunate (fruquintinib) in previously treated metastatic colorectal cancer (mCRC) have been published in The Lancet journal. The global Phase III study, conducted across the US, Europe, Japan,…
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CStone’s Sugemalimab Shows Promising Survival Rates in Stage IV NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the prestigious journal Nature Cancer has published the overall survival (OS) interim analysis from the registrational clinical study GEMSTONE-302. The study evaluates the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab as a first-line treatment for stage IV non-small cell lung cancer (NSCLC). GEMSTONE-302…
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Jiangxi Jemincare’s JYB1907 Receives NMPA Approval for Clinical Study in Solid Tumors
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China-based Jiangxi Jemincare Group has announced that it has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug, JYB1907, a monoclonal antibody (mAb) targeting GARP and TGF-β1, in patients with locally advanced malignant solid tumors. The drug had previously…
