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Betta Pharmaceuticals Enrolls First Patient in BPI-442096 Phase I Study for Solid Tumors
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China-based Betta Pharmaceuticals (SHE: 300558) announced that the first subject has been enrolled in a Phase I clinical study of BPI-442096 for advanced solid tumors. The multi-center trial, which includes dosage escalation and expansion phases, will assess the safety, tolerability, and preliminary efficacy of BPI-442096, and determine the maximum tolerated…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
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Ascentage Pharma Launches Olverembatinib Named Patient Program with Tanner Pharma
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China-based Ascentage Pharma (HKG: 6855) announced the launch of a Named Patient Program (NPP) for its drug olverembatinib in partnership with US-based Tanner Pharma Group. The program aims to provide access to the drug in over 100 countries and regions where it is not yet commercially available. Drug ProfileOlverembatinib is…
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Sirnaomics’ STP705 Receives Approval for Liver Cancer Trial in Taiwan
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced that it has received approval from the Ministry of Health and Welfare of Taiwan to conduct a Phase I clinical study of its therapeutic candidate STP705 for advanced liver cancer. Drug ProfileSTP705 is a siRNA (small interfering RNA) therapeutic that leverages…
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GenFleet Therapeutics’ GFH018 Receives CTA Approval for Two Clinical Trials in China
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Shanghai-based biotech company GenFleet Therapeutics announced that two clinical trial applications (CTAs) for its drug candidate GFH018 have been approved in China. GFH018 is a small molecule designed to specifically target and inhibit TGF-ß R1. Clinical Trial Details SignificanceThe TGF-ß signaling pathway is a key target for multiple solid tumors.…
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NMPA Approves Genuine Biotech’s Azvudine for COVID-19, Fosun Pharma Inks Licensing Deal
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China’s National Medical Products Administration (NMPA) has conditionally approved HeNan Genuine Biotech Co., Ltd’s azvudine for the treatment of COVID-19 infection. The drug, originally approved in July 2021 for adult HIV-1 patients with high viral loads, can now be used to treat ordinary COVID-19 adult patients. Licensing AgreementShanghai Fosun Pharmaceutical…
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Chinese Pharmacists Association Releases Draft VBP Drug Management Guidelines for Public Feedback
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The Chinese Pharmacists Association (CPA) has released the “National Volume-based Procurement (VBP) Drug Management Expert Consensus for Medical Institutions,” a draft proposal open for public feedback until March 31, 2022. The document provides guidance on standardizing, homogenizing, normalizing, and institutionalizing the implementation of the national VBP drug policy. Key Guidelines…
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3D Medicines Files IPO Prospectus for Hong Kong Listing
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China-based oncology specialist 3D Medicines has published its initial public offering (IPO) prospectus with the Hong Kong Stock Exchange (HKSE), though the issuance amount and price have yet to be disclosed. Company ProfileFounded in 2014, 3D Medicines has a product pipeline that includes envafolimab, a programmed-death ligand 1 (PD-L1) inhibitor…
