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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…
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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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Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD
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Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US FDA to conduct a Phase I clinical study for its EXG102-031. The study will assess the safety, tolerability, and vision improvement potential of this once-administered gene therapy in patients with wet age-related macular degeneration (wAMD).…
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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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Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its Comirnaty bivalent vaccine has been approved as a normal import vaccine in Macau. The vaccine is authorized for use as a booster shot in individuals aged 12 and above. Partnership and DevelopmentFosun Pharma is partnered with…
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HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy HG004. The company plans to initiate a global, multi-center clinical study for the drug, a single-administered, non-adeno-associated virus serotype 2 (non-AAV2) gene replacement therapy, targeting retinopathy associated…
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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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Tianjin-Based Protein T Raises RMB 100 Million in Series A Financing
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Tianjin-based biotech Protein T, focused on multi-omics research, has reportedly raised close to RMB 100 million (USD 14.7 million) in a Series A financing round. The sole investor was Shanghai Dinghui Baifu Wealth Management. The proceeds will be used to facilitate Protein T’s business expansion, strategic layout, and the translation…
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Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its ASC10, an oral double prodrug antiviral, to evaluate its potential as a treatment for monkeypox. This approval marks a significant step in expanding the therapeutic applications of…
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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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CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 2.2 chemical octreotide long-acting injection in acromegaly. This marks a significant step forward in developing more convenient treatment options for patients with this rare…
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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…
