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Guangdong Zhongsheng Pharma Initiates Phase IIb Study for ZSP1601 in NASH
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the first subject enrollment in a Phase IIb clinical study for its Category 1 drug ZSP1601, targeting non-alcoholic steatohepatitis (NASH). The study, set to be conducted across over 30 centers in China, will involve subjects stratified into randomized groups based…
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Novartis’s Iptacopan on Track for Priority Review Status in China for PNH Treatment
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China’s Center for Drug Evaluation (CDE) website has indicated that Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan is likely to receive priority review status for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH). This potential award highlights the fact that iptacopan is a clinically urgently needed innovative drug addressing a…
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Novo Nordisk’s Semaglutide for Weight Loss Accepted for Review by China’s NMPA
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Denmark-headquartered Novo Nordisk (NYSE: NVO) has announced that its market filing for the glucagon-like peptide-1 (GLP-1) analogue semaglutide has been accepted for review by the National Medical Products Administration (NMPA) in China, with the targeted indication being weight loss. Semaglutide’s Mechanism and Existing ApprovalsSemaglutide, a subcutaneous injection version of a…
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Qilu Pharmaceutical Gains Temporary FDA Approval to Import Cisplatin Amid US Shortage
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Qilu Pharmaceutical, a China-based firm, has benefited from the effects of drug shortages in the United States. According to a notice on the US FDA website, Qilu has been temporarily authorized to import the chemotherapy drug cisplatin to the US market, despite its product not being officially approved. Timing and…
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CStone Pharmaceuticals and Blueprint Medicines’ Ayvakit Wins FDA Approval for ISM Treatment
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Partners CStone Pharmaceuticals (HKG: 2616) and Blueprint Medicines have announced that the US FDA has approved Ayvakit (avapritinib), a tyrosine kinase inhibitor, for the treatment of adults with indolent systemic mastocytosis (ISM). ISM is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ…
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Sirnaomics Initiates Phase I Clinical Trial for Anticoagulant Drug Candidate STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the first systemic dosing of a Phase I clinical trial for its leading RNAi drug candidate, STP122G, an anticoagulation treatment. STP122G, developed using Sirnaomics’ GalNAc RNAi delivery platform technology GalAhead, targets Factor XI and has broad applicability across various disease indications, including the potential…
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CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
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China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug maralixibat (CAN108). The drug is approved to treat pruritus due to cholestasis in patients with Alagille Syndrome (ALGS) aged 1 year and above. Understanding Alagille Syndrome…
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Innovent Biologics Partners with Merck KGaA to Test KRAS Inhibitor Combo in NSCLC
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China-based Innovent Biologics (HKG: 1801) has announced a clinical study and supply agreement with German pharmaceutical giant Merck KGaA (NYSE: MRK). The collaboration aims to explore the combination of Innovent’s KRAS G12C inhibitor, IBI351, and Merck’s Erbitux (cetuximab) in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS…
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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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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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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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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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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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BeiGene’s Brukinsa Receives Canadian Approval for Chronic Lymphocytic Leukemia
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China-based BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), has received the latest indication approval in Canada for the treatment of chronic lymphocytic leukemia (CLL). This approval marks the fourth total approved Canadian indication for Brukinsa, following earlier approvals…
