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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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CDE Issues Trial Rules for NMPA Drug Review Timekeeping Suspension
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The Center for Drug Evaluation (CDE) has released the “NMPA Drug Review Timekeeping Suspension and Resumption Management Specifications” (trial rules), which take immediate effect. The document outlines six specific cases of timekeeping suspension and corresponding operations for resumption. Suspension and Resumption Cases ApplicabilityThe document applies to the registration application of…
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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.…
