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HighTide Therapeutics Doses First Patient in Phase IIb Study for HTD1801 in NASH
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Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a Phase IIb clinical study for its pipeline candidate HTD1801 in non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled study is designed to assess the histological improvement of HTD1801 compared with placebo in subjects with NASH and…
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MSD Submits Initial Quotation for Molnupiravir in China Amid New COVID-19 Rules
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Under new rules specifically for the launch of COVID-19 therapeutics in China, US-based Merck Sharp & Dohme (MSD, NYSE: MRK) has proactively submitted the initial quotation and materials for its molnupiravir, the world’s first oral COVID-19 therapy. The Tianjin Medical Purchasing Center has publicized the quoted price at RMB 1,500…
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Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA
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China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and Drug Administration (FDA) for its CFI-402257, a best-in-class inhibitor of threonine tyrosine kinase (TTK, also known as Mps1). The designation was granted for the drug’s potential as a treatment for adult patients with ER+/HER2- advanced…
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Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…
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Yiling Pharmaceutical’s BIO-008 Accepted for Review by China’s NMPA
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for BIO-008, an in-house developed Category 1 biologic being developed to treat advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development…
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Luye Pharma Launches Named Patient Program for Lurbinectedin in Hong Kong
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China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program (NPP) in Hong Kong, enabling access to lurbinectedin (LY01017), an RNA polymerase II inhibitor used to treat patients with relapsed small-cell lung cancer (SCLC). The program will provide immediate access to the drug for SCLC…
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Innovent Biologics Doses First Patient in Phase III Study for Mazdutide
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed in the multi-center, randomized, double-blind, placebo-controlled Phase III DREAMS-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being assessed for safety and efficacy in treating Chinese…
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Cosunter’s COVID-19 Drug GST-HG171 Shows Superior Efficacy in Trial
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated trial (ITT) for its Category 1 product GST-HG171/ritonavir in COVID-19 patients. The randomized, controlled trial was designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients and included a test…
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Fosun Foundation Donates COVID-19 Therapy Azvudine to Rural China
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The Fosun Foundation, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Henan Genuine Biotech Co., Ltd have announced the donation of RMB 100 million (USD 14.76 million) worth of the oral COVID-19 therapy azvudine to 180 counties in middle and western rural China. The donation will be…
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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…
