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Sciwind Biosciences Initiates Phase III Trial for Ecnoglutide in Type 2 Diabetes
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Hangzhou-based Sciwind Biosciences Co., Ltd has announced the first subject dosing in a Phase III clinical study for its ecnoglutide (XW003), a novel, long-acting glucagon-like peptide-1 (GLP-1) analog, in adult patients with type 2 diabetes in China. The trial marks a significant milestone in the development of this innovative therapy,…
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Beijing HSA Sets Price for Hainan Simcere’s COVID-19 Therapy SIM0417
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Beijing’s municipal Healthcare Security Administration (HSA) bureau has released details of the initial quote and Chinese market price for Hainan Simcere Pharmaceutical Co., Ltd’s recently approved small-molecule COVID-19 therapy, SIM0417. The drug will be launched at RMB 750 (USD 111) per box, with an ex-factory price including tax (or CIF…
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Qilu Pharmaceutical’s Biosimilar Lucentis Accepted for Review by China’s CDE
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China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of Novartis’ (NYSE: NVS) Lucentis (ranibizumab) has been accepted for review by the Center for Drug Evaluation (CDE) in China. Qilu’s biosimilar is the most advanced version of Lucentis currently under development, positioning the company to…
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RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of…
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Luye Pharma Gains CDE Approval for Goserelin Acetate Microspheres Clinical Study
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China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its goserelin acetate sustained-release microspheres for injection (LY01022, three-month long-acting dosage form). The drug will be evaluated for treating prostate and breast cancers that are suitable for…
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Enkang Pharma Secures Series B Funding for DRIPs-Targeted Cancer Therapy
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Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd, a developer of DNA replication-initiation proteins (DRIPs)-targeted drugs, has reportedly raised “tens of millions” of renminbi in a Series B financing round. The round was solely led by CHER AMI Investment, with proceeds earmarked for new drug research and development. EN002 Gel: First-in-Class Cancer…
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CARsgen and Roche Partner on Clinical Study for Gastric Cancer Treatment
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation agreement with Swiss pharmaceutical giant Roche. The partnership will focus on a clinical study assessing the combination of CARsgen’s Claudin18.2 (CLDN18.2)-targeted monoclonal antibody (mAb) AB011 with Roche’s PD-L1 therapy Tecentriq (atezolizumab) alongside standard chemotherapy for…
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Zennova Pharmaceuticals Completes Phase 1 of Chengdu Manufacturing and R&D Center
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Zennova Pharmaceuticals Group, a contract manufacturing organization (CMO) with operations in New Jersey, US, and Chengdu, China, has completed Phase 1 construction on a manufacturing site and R&D center in Chengdu, Sichuan province. The 300,000 square foot facility includes a multi-dosage formulation center, warehousing, and administrative buildings, marking a significant…
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Tigermed Completes Acquisition of Croatia-Based CRO Marti Farm
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China-based Contract Research Organization (CRO) Tigermed (SHE: 300347, HKG: 3347) has announced the completion of its acquisition of Croatia-based Marti Farm. The deal, which strengthens Tigermed’s operational presence in Europe, adds local-level expertise to its global portfolio. Financial details of the transaction were not disclosed. Marti Farm: Services and CapabilitiesBased…
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Haisco’s Prostate Cancer Drug HSK38008 and DPP-4 Inhibitor HSK7653 Accepted for Review
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the clinical trial filing for its Category 1 chemical drug HSK38008 oral preparation has been accepted for review by the National Medical Products Administration (NMPA). Additionally, the NMPA has accepted Haisco’s market filing for its Category 1 chemical HSK7653, according…
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RemeGen and Allist Partner to Assess ADC and EGFR Inhibitor Combination in NSCLC
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China-based RemeGen Ltd (HKG: 9995) and Allist Pharmaceuticals Inc. (SHA: 688578) have announced a clinical cooperation agreement to evaluate the safety, tolerability, efficacy, and pharmacokinetics of RemeGen’s antibody drug conjugate (ADC) RC108 in combination with Allist’s epidermal growth factor receptor (EGFR) inhibitor furmonertinib. The collaboration aims to assess the potential…
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HealZen Therapeutics Gains NMPA Approval for HZ-A-018 Clinical Study in Autoimmune Diseases
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Hangzhou-based HealZen Therapeutics has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate HZ-A-018 in recurrent multiple sclerosis (RMS) and neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step forward in exploring new treatment options for these…
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Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) BPI-D0316 has been accepted for review by the Center for Drug Evaluation (CDE). The company is seeking approval for BPI-D0316 in first-line treatment of locally advanced…
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Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE
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China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its zorifertinib, an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations (L858R and Exon 19Del), has been accepted for review by the Center for Drug Evaluation (CDE). Zorifertinib is indicated for the treatment…
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Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong provincial Medical Products Administration bureau for its Jext pre-filled adrenaline auto-injector pen. The product is now permitted to be imported into the Greater Bay Area (GBA) as a clinically urgently needed product. Product Details and…
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Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib…
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CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
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The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to obtain priority review status, with the drug in line for conditional approval. HL-085 is being developed to treat advanced melanoma with NRAS mutations in patients previously treated with immunotherapy. The investigational MEK inhibitor is undergoing…
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NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies
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The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered COVID-19 small-molecule therapies: SIM0417 from Hainan Simcere Pharmaceutical Co., Ltd, and VV116 from Shanghai JunTop Biosciences Co., Ltd. JunTop is a joint venture (JV) between Junshi Biosciences and Vigonvita Life Sciences Co., Ltd. SIM0417: Next-Generation…
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JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
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Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by its US subsidiary VITRAC Therapeutics, LLC for its small molecule aurora A kinase (AURKA) inhibitor VIC-1911. The molecule is being assessed both as a monotherapy and in combination with sotorasib for the treatment of KRAS…
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Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab
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Akeso Inc. (HKG: 9926) has announced receiving the first installment of USD 300 million as part of an upfront fee paid by US-based Summit Therapeutics Inc. (NASDAQ: SMMT) under the firms’ December 2022 licensing deal for the bispecific antibody (BsAb) ivonescimab. The initial payment includes USD 274.9 million in cash…
