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阿柏西普(Eylea)
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荣昌生物不再坚持自己卖药
Xin Lang Cai Jing· 2025-08-19 09:25
Core Viewpoint - Rongchang Biopharma has entered into an agreement with Santen China to license its proprietary RC28-E injection, granting Santen exclusive rights for development, production, and commercialization in Greater China and several Southeast Asian countries, while retaining global rights outside these regions [1][4]. Group 1: Financial Aspects - Rongchang Biopharma will receive a non-refundable upfront payment of 250 million RMB (approximately 35.5 million USD), with potential milestone payments totaling up to 520 million RMB (approximately 73.5 million USD) for development and regulatory achievements, and up to 525 million RMB (approximately 74.5 million USD) for sales milestones [1]. - The total value of the collaboration is estimated at 1.295 billion RMB (approximately 183.5 million USD), resulting in an investment return rate of 355.76% based on the company's initial investment of 364 million RMB (approximately 51.5 million USD) [5][4]. - As of Q1 2025, Rongchang Biopharma reported cash reserves of 721 million RMB (approximately 102.5 million USD) and a negative operating cash flow of 188 million RMB (approximately 26.6 million USD) [9]. Group 2: Strategic Considerations - The licensing agreement allows Rongchang Biopharma to focus on the more lucrative markets in Europe and the U.S. while transferring the risks and costs associated with the Asian market to Santen China [4][6]. - The RC28-E injection targets eye-related neovascular diseases and is positioned against the leading ophthalmic drug, Eylea, which has a global sales figure of 9.554 billion USD, with a significant portion coming from the U.S. and Europe [6]. - The decision to license rather than build a commercial team in China reflects the company's strategy to mitigate risks associated with high costs and uncertainties in drug commercialization [7]. Group 3: Market Context - Compared to global standards, Chinese biotech assets are generally undervalued, with upfront payments typically 60% to 70% lower and overall transaction sizes 40% to 50% smaller than their global counterparts [2][4]. - The competitive landscape in China is intensifying, with both innovative and biosimilar drugs entering the market, posing challenges for new entrants like Rongchang Biopharma [7].
“半年一针”药械控释疗法,正重构湿性AMD治疗路径
思宇MedTech· 2025-06-16 09:06
Core Viewpoint - The article discusses the advancements in the treatment of neovascular age-related macular degeneration (nAMD) through the development of Duravyu, a drug-device combination product by EyePoint, which aims to reduce the treatment burden associated with frequent injections [2][14]. Group 1: Product Development and Clinical Trials - EyePoint's Duravyu has completed patient recruitment for its Phase III LUGANO study within 7 months, enrolling over 400 subjects, marking a significant step towards commercialization [2]. - The preliminary data from the LUGANO trial is expected to be released in mid-2026, with the LUCIA study results anticipated in the second half of 2026 [2]. - Duravyu aims to provide a "six-month injection" treatment regimen, addressing the frequent injection dilemma faced by nAMD patients [2][14]. Group 2: Challenges in Current Treatments - nAMD is a leading cause of severe central vision loss in the elderly, with current anti-VEGF therapies requiring 6 to 12 injections per year, creating a significant treatment burden [3]. - The pharmacokinetic challenges in the posterior segment of the eye necessitate the development of implantable drug delivery systems (IDDS) to maintain stable drug concentrations [3][8]. Group 3: Duravyu's Mechanism and Advantages - Duravyu utilizes EyePoint's proprietary Durasert technology to deliver vorolanib, a multi-target tyrosine kinase inhibitor, through a biodegradable implant [9][12]. - The product is designed to be injected through a standard syringe, simplifying the procedure and reducing the learning curve for healthcare providers [12]. - The release profile of Duravyu can be finely tuned to ensure sustained therapeutic effects while minimizing the need for additional interventions [12][13]. Group 4: Market Implications and Future Directions - The success of Duravyu could significantly impact EyePoint's valuation and provide a model for the future development of sustained-release formulations in ophthalmology [14]. - The article emphasizes the importance of balancing efficacy, safety, and commercial viability in the design of drug-device combination products like Duravyu [14]. - The ongoing evolution of ocular IDDS is expected to lead to innovative solutions that address the treatment burden of nAMD and improve patient outcomes [13][14].