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Sun Pharma Loses VBP Bid for Bicalutamide in China Due to Quality Failures
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The Shanghai Medical Products Administration (SMPA) has revoked the winning bid of India-based Sun Pharmaceutical Industries Ltd. for its prostate cancer drug bicalutamide in the fifth round of China’s national volume-based procurement (VBP) program. This decision follows random inspections that revealed Sun Pharma’s product failed to meet import drug regulations…
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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for First-Line NSCLC Treatment
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for furmonertinib. The third-generation epidermal growth factor receptor (EGFR) inhibitor is now approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR…
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Dakang Medical Secures RMB 400M in Series E Round for Hemodialysis Center Expansion
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Dakang Medical (DiaCare Medical), a Beijing-based provider of blood purification chain medical services, has reportedly raised RMB 400 million (USD 59.7 million) in a Series E financing round, the largest deal in the segment. The round was led by Jiangxi Ganjiang New District Development and Investment Group Co., Ltd, with…
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Ascentage Pharma’s APG-5918 Receives FDA Approval for First-in-Human Study
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Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a first-in-human clinical study of its embryonic ectoderm development (EED) inhibitor APG-5918. The study will assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced…
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Luzhu Bio Files for Hong Kong IPO After RMB 4.42 Billion Valuation
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Beijing Luzhu Biotechnology Co., Ltd, a leading developer of human vaccines and therapeutic biologics, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange, with CICC as the sponsor. The Chinese firm previously secured a Series C financing round that valued the company at RMB 4.42…
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Youwe Bio’s Series B Financing to Advance Microneedle Technology Commercialization
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China-based Youwe (Zhuhai) Biotechnology Co., Ltd, a developer of soluble microneedle transdermal drug delivery technology, has reportedly raised close to RMB 100 million (USD 14.9 million) in a Series B financing round. Cenova Ventures was the sole investor. The proceeds will be used for the commercialization of soluble microneedle technology…
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NHSA Updates NRDL with Focus on Expert Review and Simplified Renewals
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The National Healthcare Security Administration (NHSA) has released the “2022 National Reimbursement Drug List (NRDL) Adjustment Work Plan” along with relevant documents. This official update to the draft proposal issued on June 13th outlines the full details and processes for this year’s NRDL update. List Adjustment ScopeThe scope of the…
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Ascletis Pharma Doses First Patient in China’s Phase II Trial for HIV-1 Treatment with ASC22
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the dosing of the first patient in its Phase II clinical trial for ASC22 (envafolimab) in combination with anti-retroviral therapy (ART) for the immune restoration and functional cure of human immunodeficiency virus 1 (HIV-1) infection. This trial marks a significant step forward in…
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Jixing Pharmaceuticals’ Aficamten Receives CDE Approval for Phase III HCM Study
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China-based Ji Xing Pharmaceuticals announced receiving approval from the Center for Drug Evaluation (CDE) to initiate a Phase III clinical study for its aficamten (CK-3773274) in symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This study is part of the global multi-center SEQUOIA-HCM trial. Drug Profile and MechanismAficamten is a next-generation cardiac myosin…
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BDgene Advances CRISPR-Based BD111 for Herpes Keratitis with IND Filing
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Shanghai BDgene Technology Co., Ltd has completed efficacy and preliminary safety studies for BD111, its CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK). The company plans to file for Investigational New Drug (IND) approval and was awarded orphan drug designation (ODD) status in the US last week.…
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MicroPort NeuroTech Lists in Hong Kong with $43.3 Million IPO
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MicroPort NeuroTech Limited has successfully completed its initial public offering (IPO) on the Hong Kong Stock Exchange, issuing 13.7 million shares at HKD 24.64 (USD 3.40) per share, raising a total of HKD 340 million (USD 43.3 million). This milestone underscores the company’s significant valuation of USD 1.75 billion upon…
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Bayer’s Kerendia Approved by China’s NMPA for Diabetic Kidney Disease
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The National Medical Products Administration (NMPA) has approved Bayer’s (ETR: BAYN) Category 1 drug Kerendia (finerenone) for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. This approval marks a significant advancement in the treatment of diabetic kidney disease, offering a new option to slow disease progression…
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Hengrui Medicine’s SHR3680 Approved for High Burden Metastatic Prostate Cancer
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China’s Hengrui Medicine Co., Ltd. (SHA: 600276) announced that its Category 1 drug SHR3680 has received conditional approval from the National Medical Products Administration (NMPA) via priority review procedures. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. Mechanism and AdvantagesSHR3680…
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Legend Biotech Collaborates with Trinity College Dublin on CAR-T Therapies for Solid Tumors
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has formed a partnership with Trinity College Dublin and Saint James’s Hospital in Ireland to develop 3D models for exploring chimeric antigen receptor T-cell (CAR-T) therapies in solid tumors. This collaboration, focusing on lung, colorectal, and gastric cancers, aims to create three types of…
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AnchorDx and West China Hospital Collaborate on Lung Cancer Early Diagnosis
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Guangzhou-based AnchorDx and West China Hospital of Sichuan University have entered into a transfer agreement for their joint patent on methylation molecular markers for detecting benign and malignant pulmonary nodules. This collaboration aims to enhance the early diagnosis of lung cancer and improve the diagnostic rate of fiberoptic bronchoscopy. Collaboration…
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Akeso Biopharma’s Cadonilimab Approved for Cervical Cancer Treatment
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China-based biotech company Akeso Biopharma (HKG: 9926) announced that its self-discovered bispecific antibody (BsAb) cadonilimab (AK104) has received conditional market approval from the National Medical Products Administration (NMPA). The drug is indicated for the treatment of recurrent or metastatic cervical cancer that has failed previous platinum-based chemotherapy. Drug Profile and…
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Humanwell Healthcare Wins NMPA Approval for RFUS-144 in Pain Management
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 drug RFUS-144, designed to relieve pain and itching. This marks a significant step forward in the company’s efforts to develop innovative therapies for…
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LaNova Medicines Secures Series B Funding to Advance Oncology Pipeline
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China-based LaNova Medicines has successfully closed a Series B financing round, raising an undisclosed sum to support its ongoing research and development efforts. The round was co-led by Qiming Venture Partners, Summer Capital, and Taikun Fund, with participation from the Shanghai Biomedicine Fund. The funds will be dedicated to advancing…
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GenFleet Collaborates with BioLineRx to Develop Motixafortide for Pancreatic Cancer in China
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China-based GenFleet Therapeutics has entered into a collaboration with Israel’s BioLineRx Ltd (NASDAQ: BLRX) to advance the development of motixafortide, a C-X-C chemokine receptor type 4 (CXCR4) inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC) in China. This partnership underscores GenFleet’s commitment to bringing innovative oncology therapies to Chinese…
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Henlius and Palleon Partner on HER2-Targeted Antibody-Sialidase Fusion Protein
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a strategic partnership with US-based Palleon Pharmaceuticals Inc. to jointly develop and commercialize two bifunctional antibody-sialidase fusion proteins. This collaboration leverages Palleon’s innovative Enzyme-Antibody Glyco-Ligand Editing (EAGLE) platform, designed to enhance antitumor immunity by removing immunosuppressive sialic acids from tumor and immune…
