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Akeso Biopharma’s Ebronucimab NDA Accepted for Review by China’s NMPA
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China-based Akeso Biopharma (HKG: 9926) has announced that the National Medical Products Administration (NMPA) has accepted two New Drug Application (NDA) filings for its proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor ebronucimab. The applications are for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, as well as heterozygous familial hypercholesterolemia…
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Eikon Therapeutics Inks Licensing Deals and Raises Funds for Drug Pipeline Expansion
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US biotech company Eikon Therapeutics has announced three in-licensing deals this week, one of which includes a partnership with China-based Impact Therapeutics. The agreement grants Eikon exclusive rights to co-develop, manufacture, and commercialize PARP1 inhibitors, including IMP1734, in markets outside of Greater China. The financial details of the licensing fee…
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Sino Biopharmaceutical’s Subsidiary invoX Completes Additional Investment in pHion Therapeutics
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The UK-based invoX Pharma Ltd, a wholly-owned subsidiary of China’s Sino Biopharmaceutical Ltd (HKG: 1177), has revealed the completion of a second tranche of investment in the Belfast-based company pHion Therapeutics. Specific details regarding the first or second tranche of investment and invoX’s current stake-holding in pHion have not been…
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Ucello Therapeutics Secures RMB 150 Million in Series A+ Financing for CAR-T Cell Therapy
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Ucello Therapeutics, a developer of allogeneic universal chimeric antigen receptor (CAR)-T cell therapies based in Chengdu, has reportedly raised RMB 150 million (USD 21.2 million) in a Series A+ financing round. The funding was led by Juke Investment, with contributions from Guozhong Capital and Penglai Capital, as well as existing…
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Eversana Forms Strategic Alliance with China Resource Pharmaceutical for Healthcare Expansion
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US-based commercial services provider Eversana has announced a strategic alliance with China Resource Pharmaceutical Commercial Group. The collaboration aims to expand access to healthcare solutions, including both drugs and devices, with a focus on global products entering the Chinese market and domestic companies expanding into overseas markets. Enhancing Healthcare Innovation…
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Adcendo ApS Expands Partnership with Duality Biologics for Two Additional ADCs
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Denmark-based Adcendo ApS has announced the expansion and exercise of options to two additional antibody drug conjugates (ADCs) within an existing deal with China’s Duality Biologics. This move follows Adcendo’s initial licensing agreement in January 2023, which granted access to Duality’s DITAC (Duality Immune Toxin Antibody Conjugates) linker-payload platform for…
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Jiangsu Hengrui Medicine’s SHR-1905 and SHR7280 Receive NMPA Clinical Trial Approvals
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drugs, SHR-1905 and SHR7280. SHR-1905 will be assessed for the treatment of chronic sinusitis with nasal polyps, while SHR7280 is intended for controlled superovulation in…
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Brii Biosciences Initiates Phase I Study for BRII-297 in Australia
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China’s Brii Biosciences (HKG: 2137) has announced the first patient dosing in a Phase I clinical study assessing the safety, tolerability, and pharmacokinetics of its BRII-297 in healthy subjects in Australia. This marks a significant step in the development of the drug candidate, which is being closely watched for its…
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AIM Vaccine’s Omicron BA.5 mRNA Vaccine Shows 73.16% Efficacy in China Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has revealed the protective efficacy of its Omicron BA.5 mRNA vaccine, LVRNA012, based on a trial conducted on the China mainland. The study, which aimed to assess the protective efficacy, safety, and immunogenicity of LVRNA012 as a booster shot in individuals aged 18…
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Coherus and Junshi Biosciences Await FDA Decision on Toripalimab After Inspection
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US-based Coherus Biosciences Inc., (NASDAQ: CHRS) has disclosed that the US FDA has recently completed the long-awaited pre-licensing inspection of its partner Junshi Biosciences Ltd’s (HKG: 1877, SHA: 688180) manufacturing site for toripalimab in China. The inspection resulted in “three observations” from the FDA, which Coherus described as “readily addressable.”…
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Betta Pharmaceuticals’ Befotertinib Approved by China’s NMPA for EGFR-Mutated NSCLC
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has…
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Antengene’s Xpovio Combination Therapy Approved for Reimbursement in Australia for R/R MM
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has revealed that Australia’s Pharmaceutical Benefits Scheme (PBS) will reimburse the firm’s Xpovio (selinexor) plus bortezomib and dexamethasone combination therapy for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM), specifically for those who have previously received one other therapy. This…
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Amoytop Biotech and Fosun Pharmaceutical Ink Licensing Deal for Pegfilgrastim in China
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced a licensing agreement with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), granting Fosun exclusive promotion and marketing rights to Amoytop’s pegfilgrastim (Y shape) in mainland China. As part of the deal, Fosun is paying RMB 63 million (USD…
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HighField Biopharmaceuticals Presents Promising HF1K16 Data at ASCO Annual Meeting
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Hangzhou-based biotech HighField Biopharmaceuticals has revealed the publication of an abstract at this year’s American Society of Clinical Oncology (ASCO) annual meeting, showcasing preliminary data from a Phase Ia trial for its lead pipeline candidate, HF1K16. The trial, which focused on refractory metastatic cancer patients, indicated that HF1K16 was well…
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Luzhu Biotechnology’s Herpes Zoster Vaccine LZ901 Concludes Phase II Study
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading maker of human vaccines and therapeutic biologics, has announced the successful conclusion of a Phase II clinical study for its herpes zoster vaccine, LZ901. The drug demonstrated statistically and clinically meaningful data, along with a good safety profile. The company is…
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CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug tildrakizumab, which will be used to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Tildrakizumab: A Humanized Monoclonal Antibody for PsoriasisTildrakizumab…
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Cutia Therapeutics Lists on HKEX with HKD527 Million IPO for Dermatology Therapies
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has successfully made its initial public offering (IPO), issuing 21.3 million shares at a price of HKD24.75 per share, raising a total of HKD527 million (USD 67.3 million). Company Background and Focus on Skin DiseasesFounded in 2019, Cutia is dedicated to the research…
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CSPC Pharmaceutical’s AlaMab Therapeutics Presents Positive ALMB-0168 Data at ASCO
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, AlaMab Therapeutics Inc., will present preliminary positive data from a Phase I clinical study of its pipeline candidate ALMB-0168 at the American Society of Clinical Oncology (ASCO) annual meeting. ALMB-0168 is a monoclonal antibody (mAb) that targets connexin…
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Betta Pharmaceuticals Secures Exclusive Rights to C4 Therapeutics’ CFT8919 in Greater China
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an exclusive licensing agreement with US firm C4 Therapeutics Inc., (NASDAQ: CCCC) focusing on the development and commercialization of C4’s preclinical stage CFT8919 in Greater China, including Hong Kong SAR, Macau SAR, and Taiwan. CFT8919 is an orally bioavailable BiDAC degrader…
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Lynk Pharmaceuticals Secures RMB 200 Million in Series C1 Financing Round
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China-based Lynk Pharmaceuticals Co., Ltd has successfully raised RMB 200 million (USD 28.3 million) through a Series C1 financing round. The investment was led by China Grand Prosperity Investment, with participation from Tailong VC and LIANDO. The proceeds from this funding round will be utilized to accelerate the clinical development…
