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CDE Drafts Proposal on Generic Drug Studies for Varieties without Reference Preparations
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The Center for Drug Evaluation (CDE) has released a Notice on the “Generic Study for Varieties with no Reference Preparations” (draft proposal), outlining the filing material and technical requirements for such products. This move aims to address the unique historical legacy issue in the development process of generic drugs in…
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Mural Health Partners with Clinflash to Enhance Patient Payments in Clinical Trials
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US-based Mural Health has announced a strategic partnership with China-based Clinflash, both companies specializing in providing patient-focused services and solutions during the clinical trial process. This collaboration will see Mural Health leveraging Clinflash’s specialist IT capabilities to expand the capacity and global market reach of patient payments for clinical trials.…
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Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy. HX009’s Clinical…
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Clover Biopharmaceuticals Partners with Kyuan Trade for Commercial Launch of AdimFlu-S (QIS) in China
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China-based Clover Biopharmaceuticals Ltd (Clover; HKG: 2197) has announced the establishment of a commercial partnership with Keyuan Xinhai (Beijing) Medical Products Trading Co., Ltd (Kyuan Trade). The strategic alliance aims to prepare for the commercial launch of AdimFlu-S (QIS), the only imported quadrivalent seasonal influenza vaccine approved for use in…
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Minghui Pharmaceutical Initiates First-in-Human Trial for IGF-1R Antibody Fusion Protein MHB018A
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China-based Minghui Pharmaceutical Inc. has announced the commencement of a first-in-human Phase Ia trial for its pipeline candidate, MHB018A. This novel fusion protein combines a humanized single domain IGF-1R antibody with a human Fc fragment, and the study aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers. MHB018A: A…
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Shanghai Ark Biopharmaceutical Partners with WuXi STA for Commercial Supply of Ziresovir
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China’s Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has entered into a partnership with WuXi STA, a subsidiary of WuXi AppTec, for the commercial supply of ziresovir, a novel treatment for respiratory syncytial virus (RSV) infections. Ziresovir: A First-in-Class RSV Fusion InhibitorZiresovir, a first-in-class small molecule RSV fusion (F) protein inhibitor,…
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China’s NMPA and NHC Tighten Regulations on Tramadol Compound Preparations
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The National Medical Products Administration (NMPA) and National Health Commission (NHC) have released a notification regarding the regulation of tramadol compound preparations and other substances. Effective from July 1, 2023, manufacturers without designated qualifications and production demand plans are prohibited from manufacturing tramadol compound preparations, eptazocine, or perampanel. Additionally, an…
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Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as…
