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Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA
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China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced…
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Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…
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Gaoling Medical Secures Funding for Infrared Thermotherapy Technology
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Gaoling Medical, a Hangzhou-based developer of systemic infrared thermotherapy technology, has raised an undisclosed amount of money through a strategic financing round led by Huaxia Hengtian. The company’s technology integrates neurobiology, bioenergetics, and medical immunology, focusing on improving core body temperature to address sub-health conditions and various diseases. Therapeutic Applications…
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Yiling Pharmaceutical’s BIO-008 Accepted for Review by China’s NMPA
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for BIO-008, an in-house developed Category 1 biologic being developed to treat advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
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Sino Biopharmaceutical Secures Rights to Biosimilar of Amgen’s Xgeva in China
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary CP Pharmaceutical Qingdao has entered into a five-year cooperation agreement with compatriot firm Shandong Boan Biotechnology Co., Ltd. Under the agreement, CP Qingdao has obtained exclusive commercialization rights to LY06006/BA6101, a biosimilar version of US major Amgen’s (NASDAQ: AMGN)…
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CanSino Biologics to Issue GDRs on SWX Swiss Exchange to Boost Globalization
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced plans to issue an undisclosed amount of Global Depository Receipts (GDRs) on the SWX Swiss Exchange. The move is part of the company’s strategy to accelerate its globalization efforts, building on multiple emergency use authorizations (EUAs) and conditional approvals for its…
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Luye Pharma Launches Named Patient Program for Lurbinectedin in Hong Kong
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China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program (NPP) in Hong Kong, enabling access to lurbinectedin (LY01017), an RNA polymerase II inhibitor used to treat patients with relapsed small-cell lung cancer (SCLC). The program will provide immediate access to the drug for SCLC…
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Innovent Biologics Doses First Patient in Phase III Study for Mazdutide
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed in the multi-center, randomized, double-blind, placebo-controlled Phase III DREAMS-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being assessed for safety and efficacy in treating Chinese…
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Cosunter’s COVID-19 Drug GST-HG171 Shows Superior Efficacy in Trial
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated trial (ITT) for its Category 1 product GST-HG171/ritonavir in COVID-19 patients. The randomized, controlled trial was designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients and included a test…
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Fosun Foundation Donates COVID-19 Therapy Azvudine to Rural China
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The Fosun Foundation, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Henan Genuine Biotech Co., Ltd have announced the donation of RMB 100 million (USD 14.76 million) worth of the oral COVID-19 therapy azvudine to 180 counties in middle and western rural China. The donation will be…
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Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
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The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab (RO7082859) and China-based Dizal Pharmaceutical Co., Ltd’s sunvozertinib (DZD9008) are set to enter the priority review process. This marks a significant step forward for both drugs, which are poised to address significant unmet needs in…
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China Resources Biopharmaceutical Secures RMB 600 Million in Series B Funding
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China Resources Biopharmaceutical Co., Ltd has announced the completion of a Series B financing round, raising RMB 600 million (USD 88.5 million). The funding was led by China Structural Reform Fund, with contributions from China State-owned Enterprise Mixed Ownership Reform Fund, CCB PE, Technology Financial Group, and Guolian Group. The…
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Adagene’s ADG126 Shows Promise in Combination with Anti-PD-1 Therapy
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China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced data for its masked anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy in patients with advanced/metastatic solid tumors. The results, as of January 6, 2023, demonstrate the safety and initial efficacy profiles of ADG126…
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Pfizer CEO Denies Licensing Paxlovid to Chinese Generics Firms
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Pfizer Inc. (NYSE: PFE) CEO Albert Bourla, speaking on the sidelines of the JPMorgan Healthcare conference in San Francisco, denied that talks were being held with the Chinese government on potentially licensing Paxlovid (nirmatrelvir, ritonavir) to local generic firms in China. Bourla’s comments countered a report from Reuters that claimed…
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Legend Biotech Receives Nasdaq Notice Regarding Listing Compliance
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Legend Biotech Corporation (NASDAQ: LEGN) announced on January 6, 2023, that it received a notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC indicating that the company is not currently in compliance with Nasdaq’s Listing Rules. The non-compliance is due to the company’s failure to file an…
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Jiangxi Jemincare’s JMKX003142 Gets FDA Nod for Clinical Study
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China-based Jiangxi Jemincare Group has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its oral drug JMKX003142 in polycystic nephropathy. This marks a significant step forward in the development of a potential new treatment for this chronic kidney condition. Disease Background…
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Pfizer’s Paxlovid Excluded from China’s NRDL Amid Price Dispute
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The National Reimbursement Drug List (NRDL) negotiations have concluded, with Pfizer’s (NYSE: PFE) COVID-19 therapy Paxlovid (nirmatrelvir, ritonavir) notably absent despite widespread anticipation. The National Healthcare Security Administration (NHSA) cited a failure to agree on a price point as the reason for Paxlovid’s exclusion. Industry observers speculated that the NHSA…
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Eli Lilly’s Donanemab Set to Gain Breakthrough Therapy Designation in China
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The Center for Drug Evaluation (CDE) website indicates that US-based Eli Lilly’s (NYSE: LLY) injectable donanemab is set to obtain the breakthrough therapy designation (BTD) status for use in early symptomatic Alzheimer’s disease (AD), including mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease. This marks a significant…
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Changzhou Sifary Medtech Secures Series B Funding for Global Expansion
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Changzhou Sifary Medical Technology Co., Ltd, a China-based platform for the globalization of oral medical instruments, has reportedly raised “hundreds of millions” of renminbi in a Series B financing round. The funding was led by GF Xinde Investment, with contributions from Motianshi Investment and Youshuo Venture Capital. The proceeds will…
