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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…
