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Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
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The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab (RO7082859) and China-based Dizal Pharmaceutical Co., Ltd’s sunvozertinib (DZD9008) are set to enter the priority review process. This marks a significant step forward for both drugs, which are poised to address significant unmet needs in…
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Adagene’s ADG126 Shows Promise in Combination with Anti-PD-1 Therapy
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China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced data for its masked anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy in patients with advanced/metastatic solid tumors. The results, as of January 6, 2023, demonstrate the safety and initial efficacy profiles of ADG126…
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Jiangxi Jemincare’s JMKX003142 Gets FDA Nod for Clinical Study
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China-based Jiangxi Jemincare Group has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its oral drug JMKX003142 in polycystic nephropathy. This marks a significant step forward in the development of a potential new treatment for this chronic kidney condition. Disease Background…
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Pfizer’s Paxlovid Excluded from China’s NRDL Amid Price Dispute
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The National Reimbursement Drug List (NRDL) negotiations have concluded, with Pfizer’s (NYSE: PFE) COVID-19 therapy Paxlovid (nirmatrelvir, ritonavir) notably absent despite widespread anticipation. The National Healthcare Security Administration (NHSA) cited a failure to agree on a price point as the reason for Paxlovid’s exclusion. Industry observers speculated that the NHSA…
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Eli Lilly’s Donanemab Set to Gain Breakthrough Therapy Designation in China
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The Center for Drug Evaluation (CDE) website indicates that US-based Eli Lilly’s (NYSE: LLY) injectable donanemab is set to obtain the breakthrough therapy designation (BTD) status for use in early symptomatic Alzheimer’s disease (AD), including mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease. This marks a significant…
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Suzhou Thery’s Generic Nilotinib Approved by China’s NMPA
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China-based Suzhou Thery Pharmaceutical Inc. has announced that the National Medical Products Administration (NMPA) has approved its generic version of Novartis’s (NYSE: NVS) cancer therapy Tasigna (nilotinib). Thery filed a “4.1 certification” under China’s patent linkage system, directly challenging the validity of Tasigna’s patent. Thery is the first company to…
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Zhifei Biological Products’ BCG Vaccine Filing Accepted by China’s NMPA
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China-based Chongqing Zhifei Biological Products Co., Ltd (SHE: 300122) has announced that its clinical trial filing for an in-house developed therapeutic BCG vaccine has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for bladder…
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Yantai Dongcheng Pharma Gets FDA Go-Ahead for 177Lu-LNC1004 Clinical Trial
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its 177Lu-LNC1004 in advanced fibroblast activation protein (FAP)-positive solid tumors. This marks a significant step in the development of this innovative…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Denmark
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the health regulatory body in Denmark for its generic version of Roche’s Cytovene-IV (ganciclovir). This approval marks another milestone in the global expansion of Poly Pharm’s product portfolio, targeting the treatment of cytomegalovirus retinitis in immunocompromised…
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Jacobio Pharma Doses First Patient in US Phase I/IIa Study for JAB-2485
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China-based Jacobio Pharma (HKG: 1167) has announced that the first patient has been dosed in a Phase I/IIa clinical study being carried out in the United States for its Aurora A inhibitor JAB-2485. The initial indication for the study is general advanced solid tumors, marking a significant step in the…
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Eisai CEO Outlines Ambitions for Alzheimer’s Drug Leqembi After FDA Approval
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Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc’s (NASDAQ: BIIB) novel Alzheimer’s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. According to Naito, the US market eligible to use Leqembi annually currently stands…
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Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
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Luye Pharma’s BA1301 Receives CDE Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This…
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HutchMed’s Sovleplenib Administered to First Patient in Phase II COVID-19 Study
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On January 4, Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) administered its novel, investigational, selective small-molecule inhibitor sovleplenib to the first patient at Huashan Hospital. The Phase II study is focused on severe/critical COVID-19 patients, marking a significant step in the development of this innovative therapy. Mechanism and DevelopmentSovleplenib…
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Salubris Pharmaceuticals Gains NMPA Approval for Phase I Study of SAL0133
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its 3CL protease inhibitor SAL0133 in adult patients with mild to common COVID-19. This marks a significant step forward in the development of…
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Henlius Completes First Dosing in Global Phase III Study for HanSiZhuang in LS-SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced the completion of the first subject dosing in a global Phase III clinical study comparing its programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab) combined with chemotherapy and concurrent radiotherapy to placebo combined with chemotherapy and concurrent radiotherapy in limited stage-small cell lung cancer (LS-SCLC).…
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Boehringer Ingelheim Enrolls First Patient in Phase II/III Study for BI 907828
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German pharmaceutical giant Boehringer Ingelheim has announced the enrollment of the first patient in the Phase II/III Brightline-1 study for its investigational MDM2-p53 antagonist BI 907828. The study is taking place at the West China Hospital and aims to assess the efficacy and safety of BI 907828 compared to doxorubicin…
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Vcanbio’s Stem Cell Therapy VUM02 Accepted for Clinical Trial Review
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) has been accepted for review by the Center for Drug Evaluation. VUM02 is a Category 1 therapeutic biologic product developed to treat patients with…
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CanSino Biologics’ mRNA Vaccine CS-2034 Shows Positive Safety and Immunogenicity Data
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China-based CanSino Biologics (HKG: 6185) has announced positive periodical data from a clinical study assessing the safety and immunogenicity of its COVID-19 mRNA vaccine CS-2034 as a sequential booster in adults aged 18 and above who have already received three doses of inactivated COVID-19 vaccines. The study, which began in…
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Jiangsu Aidea’s ACC007 Approved by NMPA for HIV-1 Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that its Category 1 compound preparation ACC007 (ainuovirine, lamivudine, tenofovir disoproxil) has been approved by the National Medical Products Administration (NMPA) for the treatment of newly treated adult patients with HIV-1 infection. This approval marks a significant step forward in…
