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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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China Resources Biopharmaceutical Secures RMB 600 Million in Series B Funding
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China Resources Biopharmaceutical Co., Ltd has announced the completion of a Series B financing round, raising RMB 600 million (USD 88.5 million). The funding was led by China Structural Reform Fund, with contributions from China State-owned Enterprise Mixed Ownership Reform Fund, CCB PE, Technology Financial Group, and Guolian Group. The…
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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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Pfizer CEO Denies Licensing Paxlovid to Chinese Generics Firms
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Pfizer Inc. (NYSE: PFE) CEO Albert Bourla, speaking on the sidelines of the JPMorgan Healthcare conference in San Francisco, denied that talks were being held with the Chinese government on potentially licensing Paxlovid (nirmatrelvir, ritonavir) to local generic firms in China. Bourla’s comments countered a report from Reuters that claimed…
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Legend Biotech Receives Nasdaq Notice Regarding Listing Compliance
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Legend Biotech Corporation (NASDAQ: LEGN) announced on January 6, 2023, that it received a notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC indicating that the company is not currently in compliance with Nasdaq’s Listing Rules. The non-compliance is due to the company’s failure to file an…
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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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Changzhou Sifary Medtech Secures Series B Funding for Global Expansion
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Changzhou Sifary Medical Technology Co., Ltd, a China-based platform for the globalization of oral medical instruments, has reportedly raised “hundreds of millions” of renminbi in a Series B financing round. The funding was led by GF Xinde Investment, with contributions from Motianshi Investment and Youshuo Venture Capital. The proceeds will…
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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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VivaVision Biotech Partners with Everads Therapy for Retinal Disease Therapies
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China’s VivaVision Biotech Inc. has announced a collaboration agreement with Israel-based Everads Therapy Ltd to develop safer, more effective, and lasting novel therapies targeting retinal diseases. The partnership aims to leverage the strengths of both companies to advance innovative treatments for these conditions. Collaboration DetailsThe collaboration is designed to safely…
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Shenzhen-Based Rhegen Bio Raises RMB 100 Million in Pre-Series B Round
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Shenzhen-based biotechnology company Rhegen Bio, specializing in mRNA technology, has reportedly raised RMB 100 million (USD 14.7 million) in a pre-Series B financing round. The funding was led by Fer-Capital Investment, with participation from Sequoia Capital China and other existing investors. The proceeds will be used to support clinical trials…
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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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VACSERA in Talks with Sinovac to Establish Integrated Vaccine Plant
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Egypt-based drug firm Holding Company for Biological Products and Vaccines (VACSERA) is reportedly in talks with China-based Sinovac Biotech Ltd (NASDAQ: SVA) to establish an integrated manufacturing plant focused on vaccines, according to a local media source. The proposed facility aims to enhance vaccine production capabilities and address the growing…
