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Henlius’ Serplulimab Phase III Study Approved in Spain for LS-SCLC
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy…
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Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include the treatment of cytomegalovirus retinitis…
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Kangtai Biological Completes Phase III Clinical Data Analysis for COVID-19 Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the completion of the analysis of key Phase III clinical data for its in-house developed COVID-19 inactivated vaccine (Vero cells). The study assessed the vaccine’s efficacy and safety in a global, multi-center, randomized, double-blind, placebo-controlled trial. Study DetailsThe Phase…
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Fapon Biotech Partners with Roche Diagnostics at China International Import Expo
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China-based biotech Fapon Biotech Inc. has announced a partnership with Swiss major Roche Diagnostics at the 5th China International Import Expo (CIIE). The collaboration aims to deepen cooperation in the field of raw material product technical services and molecular diagnostics. The two companies plan to fully integrate their respective resources…
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China’s Jiangsu Bioda Gains NMPA Approval for Innovative Artificial Blood Vessel
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The National Medical Products Administration (NMPA) has granted marketing approval to China-based Jiangsu Bioda Life Science Co Ltd’s innovative artificial blood vessel. This marks a significant milestone in the development and commercialization of advanced medical devices in China. Product ProfileThe artificial blood vessel is primarily composed of PET thread and…
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Visen Pharmaceuticals Publishes Phase III Data for Lonapegsomatropin in Growth Hormone Deficiency
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Visen Pharmaceuticals, a China-based joint venture between Denmark-headquartered Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has published primary data from a pivotal Phase III study for its lonapegsomatropin, also known as TransCon hGH, a once-weekly long-acting growth hormone. The study evaluated the efficacy and safety of lonapegsomatropin in…
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RongCan Biotech Raises Pre-Series A Funding for mRNA Therapeutics Development
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China-based nucleic acid-based therapeutics developer RongCan (Shanghai) Biotech Co., Ltd has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round led by a “reputational healthcare fund.” The proceeds will be used to accelerate product research and development (R&D), team building, and clinical studies for leading pipelines.…
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Lee’s Pharmaceutical Reports Q3 2022 Financials with 8.8% Revenue Growth
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has released its Q3 2022 financial report, recording HKD 1.036 billion (USD 132.4 million) in revenues, up 8.8% year-on-year (YOY). The growth was driven by strong sales of Bredinin (mizoribine), treprostinil, and interferon α2b, which offset declines in some outpatient and surgical drugs.…
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Marinus Pharmaceuticals Collaborates with Tenacia Biotechnology for Ganaxolone
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Pennsylvania-based pharma company Marinus Pharmaceuticals Inc. (NASDAQ: MRNS) has entered into a collaboration and supply agreement with China-based Tenacia Biotechnology (Shanghai) Co., Ltd. Under the agreement, Tenacia will receive exclusive development and commercialization rights to certain formulations of Marinus’s ganaxolone in mainland China, Hong Kong, Macau, and Taiwan. The deal…
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Mirati Therapeutics Sues InventisBio Over Trade Secret Misappropriation
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US-based Mirati Therapeutics (Nasdaq: MRTX) is reportedly suing China-based InventisBio Co., Ltd (SHA: 688382) over allegations of trade secret misappropriation. According to a security exchange notice from InventisBio, Mirati has filed a lawsuit in the Shanghai Intellectual Property Court, requesting an injunction, damages, and confirmation of ownership of certain patents.…
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Bio-Heart Bio to Launch Clinical Study for Rapamycin Drug-Eluting Balloon in Japan
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China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced that it will initiate a clinical study in Japan for its rapamycin drug-eluting balloon, aimed at treating in-stent restenosis. This marks a significant step in the company’s efforts to expand its presence in the Japanese market and address a…
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Bio-Heart Bio Receives Ethical Approval for Iberis RDN System in Hainan
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China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced receiving ethical approval from Ruijin Hospital’s Hainan branch for its Iberis multi-electrode renal radiofrequency denervation (RDN) system. The company is on the brink of applying for clinical emergence use with the Hainan Medical Products Administration and Hainan’s health commission.…
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BeiGene’s Brukinsa Receives EC Approval for CLL Treatment
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China-based biotech BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving marketing approval from the European Committee (EC) for a new indication of its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved across the region to treat adult patients with treatment-naïve (TN) or relapsed/refractory…
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Zhangjiang AI New Drug R&D Alliance Expands with New Members
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The Zhangjiang AI New Drug R&D Alliance has welcomed new participants, including Regor Therapeutics, Roche, Hengrui Pharmaceuticals, Wuxi Biologics, LianBio, Baidu, Ainnocence, Galixir, Nutshell Therapeutics, Infinite Intelligence Pharma, and more. This expansion marks a significant step in enhancing the collaborative research efforts within the alliance. Alliance OverviewThe joint effort, initiated…
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Subtle Medical Secures Series B Funding for AI-Powered Medical Imaging
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Subtle Medical, an Artificial Intelligence (AI)-empowered medical imaging company based in Guangdong, has reportedly raised “tens of millions” of US dollars in a Series B financing round. The round was led by Eastern Bell Capital and Primavera Venture Partners, with contributions from Fusion Fund, 3E Bioventures, Banyan Pacific Capital, Delta…
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Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Three New Drugs
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical trial approvals for three in-house developed drug candidates: HRS-1780, HRS-1358, and SHR-7367. These approvals mark significant milestones in the company’s pipeline development, positioning Hengrui to advance innovative treatments for chronic kidney disease and advanced malignant tumors. HRS-1780 ProfileHRS-1780 is an…
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Rainsure Scientific Secures Series C1 Funding for Digital PCR Development
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Rainsure Scientific, a Suzhou-based developer of digital PCR instruments and RUO detection kits, has reportedly raised “tens of millions” of renminbi in a Series C1 financing round led by Qiaodao Investment Fund. The proceeds will be used to further develop and commercialize the company’s innovative molecular diagnostics products. Company ProfileFounded…
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CSPC Pharma’s rhTNK-tPA Accepted for Review by NMPA for Stroke Indication
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that a supplementary market filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA) has been accepted for review by the National Medical Products Administration (NMPA). The new indication filing is for the drug’s use as a thrombolytic therapy…
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Asia Pacific Medical Group Secures Series A Funding for Hospital Expansion
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Private healthcare group Asia Pacific Medical Group (APMG) has raised “hundreds of millions” of renminbi in a Series A financing round. The round was led by IDG Capital and the People’s Insurance Company of China (PICC), with participation from GL Capital. The proceeds will be used for the late phase…
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Haisco’s HSK31858 Gains Ethical Approval for Phase II Study in NCFBE
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its drug candidate HSK31858 obtained ethical approval at the First Affiliated Hospital of Guangzhou Medical University. The in-house developed Category 1 drug will be assessed for its efficacy and safety in a multi-center, randomized, double-blind, placebo-controlled Phase II study…
