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Yiling Pharmaceutical’s G201-Na Accepted for Review by China’s NMPA for Prostate Cancer
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for G201-Na, a Category 1 chemical being developed to treat prostate cancer requiring androgen castration, 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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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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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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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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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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China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030
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The National Health Commission (NHC), Ministry of Education, Ministry of Civil Affairs, and six other bureaus have released the “Accelerating the Eradication of Cervical Cancer Action Plan.” The initiative seeks to establish a multi-bureau network focused on driving cervical cancer prevention and control mechanisms with the goal of eradicating the…
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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…
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InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023
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Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune diseases, has announced the latest data for its pan-fibroblast growth factor receptor (FGFR) inhibitor gunagratinib (ICP-192) in cholangiocarcinoma at the ASCO-GI 2023 meeting. The findings highlight the drug’s potential in treating this challenging form of…
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Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for its Cosela (trilaciclib) at the Jilin Cancer Hospital. This milestone marks the official clinical application of the first-in-class CDK4/6 inhibitor in China. Drug Background and DevelopmentTrilaciclib, discovered by US biotech G1 Therapeutics Inc., was in-licensed…
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Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive,…
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HutchMed Signs Licensing Deal with Takeda for Global Fruquintinib Development
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced a licensing deal with Japanese firm Takeda Pharmaceutical Co., Ltd (TYO: 4502, NYSE: TAK) to further the global development, commercialization, and manufacturing of fruquintinib in markets outside mainland China, Hong Kong, and Macau. Under the agreement, HutchMed will receive up…
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Legend Biotech’s Carvykti Meets Primary Endpoint in CARTITUDE-4 Phase III Study
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Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) as a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard…
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BeiGene’s Brukinsa Approved by FDA for Chronic Lymphocytic Leukemia
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In a separate announcement, BeiGene also noted that the Medicines…
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BMS’s Opdivo Approved in China for Neoadjuvant Therapy in Urothelial Carcinoma
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US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for its programmed death-1 (PD-1) inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use as a neoadjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection. This marks the…
