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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…
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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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Zai Lab and Novocure’s TTFields Device Shows Survival Benefit in Lung Cancer Study
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Shares in Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) and its partner Novocure (NASDAQ: NVCR) surged yesterday after the companies revealed positive results from the Phase III LUNAR study. The study assessed the efficacy of the TTFields electrical field medical device in combination with immunotherapy for patients with…
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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…
