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Blue Shield Pharma’s LD013 CAR-T Therapy Approved for Clinical Trials
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China-based Blue Shield Biotech’s in-house developed LD013, an autologous chimeric antigen receptor (CAR)-T cell therapy, has obtained clinical trial approval from the National Medical Products Administration (NMPA). The intended indication is recurrent refractory ovarian cancer, a condition that poses significant challenges in treatment and management. Mesothelin as a TargetMesothelin (MSLN)…
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Biomed Union Raises RMB 200M in Series B Round for Diagnostic Products
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Biomed Union (formerly known as Shanghai Biomed-union Biotechnology Co., Ltd), a tumor molecular diagnostic technology and cellular technology specialist based in Zhejiang, has reportedly raised close to RMB 200 million (USD 27.5 million) in a Series B financing round. The round was led by Kequan Fund in the Anji County…
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Yaguo Technology Secures Series A+ Funding for Airway Management Devices
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Yaguo Technology Co., Ltd, an airway management and respiratory therapy device maker based in Beijing, has reportedly raised “tens of millions” of renminbi in a Series A+ financing round. The round was led by Weifang Zhongke Haichuang Equity Investment Partnership, with contributions from Beijing Jinke Huiyu Venture Capital Partnership. The…
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Novatim Immune Therapeutics Raises RMB 500M in First Financing Round
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China-based tumor immunotherapy developer Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has reportedly raised close to RMB 500 million (USD 68.9 million) in its first financing round. The round was led by Kequan Fund in the Anji County Economic Development Zone. The proceeds will be used for core product clinical studies,…
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Pulnovo Medical Raises ‘Tens of Millions’ in New Financing Round
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Pulnovo Medical, a pulmonary hypertension (PH) medical device maker based in Wuxi, has reportedly raised “tens of millions” of US dollars in another financing round. The round was led by Yuanbio Venture Capital, with participation from OrbiMed, Cenova Ventures, Lilly Asia Ventures, Gaorong Capital, Huihe Capital, and GC&H Investments. The…
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Akeso Biopharma Completes Enrollment for AK112 Phase III Study
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China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small…
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Eccogene Gains FDA Approval for Phase I Study of ECC5004
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Shanghai-based Eccogene has announced receiving approval from the US FDA to initiate a Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) targeting type 2 diabetes mellitus (T2DM), in healthy participants and subjects with T2DM. GLP-1 Mechanism and…
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BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
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China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have…
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Dartsbio Licenses Potential First-in-Class BsAb DS005 to Duality Biologics
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China-based Dartsbio Pharmaceuticals, Ltd has announced a licensing deal with Duality Biologics, a novel modality drug developer operating out of the United States and China. The agreement grants Duality Biologics global rights to Dartsbio’s in-house developed, potential first-in-class bispecific antibody (BsAb) DS005 to develop a new antibody drug conjugate (ADC).…
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Fosun Pharma Terminates Equity Transfer Deal with OncoCare Medical
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the termination of an equity transfer deal with OncoCare Medical Pte. Ltd. The decision follows the inability to fulfill all preconditions for the transaction within the agreed period. Deal OverviewIn June this year, Fosun Pharma had agreed to…
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Antengene’s CD73 Inhibitor ATG-037 Greenlit for Phase I Study by NMPA
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China-based Antengene Corporation Limited (HKG: 6996) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study assessing its ATG-037, a small molecule inhibitor of CD73, in patients with locally advanced or metastatic solid tumors. This marks a significant step forward in the development…
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Sino Medical Sciences’ Non-Compliant Balloon Catheter Approved by NMPA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the National Medical Products Administration (NMPA) for its non-compliant balloon dilation catheter. This approval marks a significant step forward in the company’s efforts to enhance cardiovascular treatment options. Product ProfileThe non-compliant balloon dilation catheter is now…
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Hengrui’s Pyrotinib Granted Breakthrough Therapy Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA: 600276) pyrotinib has been granted breakthrough therapy designation (BTD) status for use in combination with trastuzumab plus docetaxel in recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive in…
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NMPA Approves Humanwell’s Generic Clobazam for Lennox-Gastaut Syndrome
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China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version (oral suspension) of Sanofi’s clobazam (trade name: Frisium) has been approved by the National Medical Products Administration (NMPA) to be assessed in a clinical study as a combination therapy for seizures in patients with Lennox-Gastaut syndrome (LGS) two years of age and…
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NMPA Approves Luye Pharma’s LY03005 for Depression Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that its Category 1 chemical drug LY03005 has been approved by the National Medical Products Administration (NMPA) for the treatment of depression. This marks a significant milestone in the company’s efforts to address the growing need for effective depression treatments. LY03005 ProfileLY03005…
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Shanghai SMPA Suspends HEC’s Linagliptin Procurement Over Patent Infringement
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The Shanghai Sunshine Medical Procurement All-in-One (SMPA) platform has revealed that it has suspended the procurement qualifications for HEC Group’s linagliptin (5mg × 7 boxes). HEC’s product is a generic version of German major Boehringer Ingelheim’s (BI) Trajenta. The decision was taken to ensure that intellectual property (IP) rights are…
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Shanghai Pharmaceuticals Gets NMPA Clearance for Sublingual Rasagiline
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its rasagiline (sublingual delivery) to treat primary Parkinson’s disease (PD) as a monotherapy and patients with drug end fluctuation combined with levodopa. This marks a significant step forward in the development…
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Baidu Health Partners with Shanghai Epiprobe for Cancer Early Screening
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China Internet giant Baidu’s Health Internet Hospital unit has announced a partnership with Shanghai Epiprobe Biotechnology Co., Ltd. The collaboration aims to enhance the promotion and popularization of universal cancer early screening in clinics. No financial details were disclosed. Partnership ObjectivesThe partnership will leverage the respective strengths of both companies…
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Pharmaniaga Partners with JD.com to Enter China Market
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Malaysia-based pharma company Pharmaniaga Berhad (Pharmaniaga) is planning to bring its products into mainland China through a partnership with JD.com, one of China’s largest e-commerce platforms. The company has signed a memorandum of understanding (MoU) with JD.com subsidiary JDMAS Commerce Sdn Bhd to commercialize its over-the-counter (OTC) products, with plans…
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Eli Lilly’s Peresolimab and LOXO-783 Gain Tacit Clinical Trial Approvals in China
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approvals to two investigational drugs from US-based Eli Lilly (NYSE: LLY): peresolimab, a PD-1 agonist, and LOXO-783, a PI3Kα H1047R inhibitor. These approvals pave the way for further clinical development of the drugs in China. Peresolimab: Targeting…
