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Specialised Therapeutics to Commercialize Akeso’s PD-1 Inhibitor Penpulimab in APAC
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Singapore-based Specialised Therapeutics Asia Pte Ltd (ST) has been appointed to handle the commercialization of the programmed death-1 (PD-1) inhibitor, Anniko (penpulimab), in Australia, Singapore, and South-East Asia. The drug is developed by the joint venture (JV) CTTQ-Akeso (Shanghai) Biomed Tech Co., Ltd, a partnership between Akeso Inc. (HKG: 9926)…
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Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
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China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its biosimilar version of Roche’s Avastin (bevacizumab) has been accepted for review by Brazil’s National Health Surveillance Agency (ANVISA). Luye’s Biosimilar Approval and Global OutlookLuye’s biosimilar bevacizumab was approved in China in 2021 to treat indications…
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Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
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CStone Pharmaceuticals Reduces Ayvakit Price to Boost Accessibility in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a lower recommended price for its precision medicine drug Ayvakit (avapritinib) in an effort to alleviate the financial burden on patients and enhance drug accessibility. The new prices for the 100mg and 300mg versions of the drug are now set at RMB 17,207…
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Hangzhou Baikai Biomedical and Leads Biolabs Partner to Develop Innovative ADCs
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China-based Hangzhou Baikai Biomedical Co., Ltd and Leads Biolabs Inc. have announced a partnership aimed at developing multiple novel antibody-drug conjugates (ADCs). The collaboration combines the expertise of both companies to advance the development of innovative cancer treatments. Financial details of the partnership have not been disclosed. Baikai Bi’s ADC…
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Cuban-Chinese Biotechnology Center Showcases Drug and Vaccine Progress to Cuban Delegation
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Researchers from Cuba and China at the Yongzhou joint biotechnology innovation center in China’s Hunan Province recently presented updates on their drug and vaccine development projects to a diplomatic delegation from Cuba. Established in 2021, the bi-national institution has a robust pipeline that encompasses cancer, neurology, and infectious diseases, including…
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Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
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The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig (ponatinib) is on track to obtain priority review status for the treatment of specific leukemia conditions in China. These include chronic myeloid leukemia (CML) that is resistant or intolerant to previous medications, recurrent or refractory…
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Yiling Pharmaceutical’s XY0206 Advances to Phase III Trial for FLT3-ITD AML
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication). XY0206: A Promising Multi-Target Tyrosine Kinase InhibitorXY0206…
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TYK Medicines Secures FDA Approval for Next-Generation TKI Clinical Trial
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China-based TYK Medicines, Inc. has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed next-generation tyrosine kinase inhibitor (TKI). This marks a significant step forward in the development of the company’s pipeline, with a separate clinical trial filing for…
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Yantai Dongcheng Pharmaceutical Gets Singapore Regulatory Approval for 177Lu-LNC1004 Phase I Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving the green light from the regulatory body in Singapore to initiate a Phase I clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets fibroblast activation protein (FAP) and is under development to treat FAP-positive advanced solid tumors. This…
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Scorpion Therapeutics and Pierre Fabre Collaborate on NSCLC Therapies STX-721 and STX-241
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US-based Scorpion Therapeutics Inc. has formed a collaboration and license deal with France-based Pierre Fabre, focusing on the co-development of Scorpion’s two potential therapies for non-small cell lung cancer (NSCLC), STX-721 and STX-241. Under the agreement, Pierre Fabre will be granted exclusive development and commercialization rights to these molecules in…
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Haisco Pharmaceutical Gets CDE Approval for HSK38008 Prostate Cancer Clinical Study
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug, HSK38008 oral preparation, in the treatment of prostate cancer. HSK38008: An Androgen Mutant AR-V7 Oral Degradation AgentHSK38008 is an androgen mutant…
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Yiling Pharmaceutical’s G201-Na Receives CDE Approval for Phase Ia Study in Prostate Cancer Treatment
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a single-center, randomized, double-blind, placebo-controlled, dosage escalation Phase Ia study. The study will assess the safety, tolerability, and pharmacokinetics of G201-Na in healthy adult males in China. G201-Na: A Small…
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Mabwell’s 9MW2821 ADC Shows Positive Signals in Solid Tumor Clinical Data
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data demonstrated positive therapeutic signals in multiple solid tumors and exhibited a good safety profile at the recommended Phase II dosage (RP2D). Mechanism of Action and Pharmaceutical…
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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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Evopoint Biosciences Partners with Merck for Phase Ib/II Study Combining XNW5004 and Keytruda
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China-based Evopoint Biosciences has announced a collaboration agreement with US major Merck Sharp & Dohme (MSD, NYSE: MRK). The agreement will permit Evopoint to conduct a Phase Ib/II clinical study assessing the combination of the EZH2 inhibitor XNW5004 with MSD’s anti-PD-1 drug Keytruda (pembrolizumab) in advanced solid tumors. XNW5004: A…
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CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…
