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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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CDE Releases 66th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 66th batch of chemical generic reference preparations, adding 27 new specifications and updating information for 33 previously published specifications. The document is open for public feedback until January 20, 2023. Details of the ReleaseThe latest batch includes 27 new specifications, expanding…
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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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China Meheco Keyi Pharma’s Ganciclovir Loses VBP Bid After Inspection Failure
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The national drug alliance procurement office has released a notification indicating that China Meheco Keyi Pharma Co., Ltd’s ganciclovir failed a production site inspection. As a result, the company will lose its tender within the fifth volume-based procurement (VBP) round. The Hubei Medical Products Administration bureau has suspended the manufacturing…
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NMPA Releases 63rd Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) has released the 63rd batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 42 new specifications, involving 16 injectables and modifications to 18 existing specifications. The release aims to enhance the quality and consistency of generic drugs in the…
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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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NMPA Approves Expanded Production for COVID-19 Symptom Treatments
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The National Medical Products Administration (NMPA) has approved filings from multiple companies to expand manufacturing and capacity for a range of medications used to treat symptoms caused by COVID-19 infection. The approved products include ibuprofen tablets, ibuprofen granules, ambroxol hydrochloride sodium chloride injection, compound codeine phosphate solution (II), and acetylcysteine…
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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 Optimizes Medical Insurance Policies for COVID-19 Treatment
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The National Healthcare Security Administration (NHSA), Ministry of Finance, National Health Commission, and Chinese Center for Disease Control and Prevention have released a Notice on “Optimizing Relevant Medical Insurance Policies for Treatment Expenses of Patients with Novel Coronavirus Infection after Implementation of ‘Class B and Class B Management’”. The guidelines…
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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…
