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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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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 (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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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…