In today’s rapidly evolving pharmaceutical landscape, challenges such as high R&D costs, lengthy development timelines, and intense market competition have become increasingly evident. In new drug development, therapeutic efficacy and time-to-market remain top priorities. Many biotech companies often overlook or are indifferent to commercialization costs at this stage — since the premium pricing of novel drugs can easily offset these expenses. Later-stage process optimization remains a viable option.

However, this traditional understanding is being challenged by regulatory shifts such as China's centralized drug procurement system and the U.S. Affordable Care Act. As technology and business models continue to evolve, so too do the expectations for CMC (Chemistry, Manufacturing, and Controls) during early-stage development. Cost control across the product lifecycle has become an essential consideration.

Founded by a team of experienced pharmaceutical R&D engineers, AeroLyn brings deep technical expertise from globally recognized pharmaceutical companies and leading research institutions. Our core team has over two decades of cumulative experience in new drug discovery, process development, quality assurance, and industrial scale-up. We remain committed to our mission of "innovation-driven development," leveraging cutting-edge technologies to enhance efficiency and reduce costs across the pharmaceutical value chain.

As a technically grounded company, AeroLyn provides end-to-end solutions that support partners from early R&D through to commercialization. We not only focus on streamlining generic drug development but also emphasize optimizing manufacturing processes through technological innovation, significantly reducing production costs. This meticulous attention to detail has enabled us to achieve meaningful results across multiple projects and earn strong recognition from our partners.

Strategic Focus on IND/NDA Projects with Clear Commercial Potential

Currently, AeroLyn is strategically shifting its R&D focus toward IND (Investigational New Drug) and NDA (New Drug Application) projects with clear commercial viability. We firmly believe that true innovation should not remain confined to the lab, but should be translated into real-world clinical applications.

To achieve this, we adopt a collaborative model based on “early engagement, rapid development, and mutual success,” building strong strategic partnerships with biotech startups, pharmaceutical firms, and academic institutions. By identifying promising candidates early and participating in critical development stages, we help clients optimize regulatory pathways, mitigate risks, and accelerate timelines — ultimately increasing the likelihood of successful commercialization.

Our technical platform supports full-cycle drug development, including synthetic route design, formulation optimization, CMC studies, and GMP manufacturing, ensuring every project progresses efficiently along a well-defined path to industrialization.

Building an AI-Driven Smart Management System for Operational Excellence

Faced with increasingly complex R&D and production workflows, traditional management systems can no longer meet the demands of modern enterprises. In response, AeroLyn has integrated AI-powered smart production and management tools into our operations, incorporating advanced technologies such as big data analytics and machine learning into daily production processes.

This system enables real-time monitoring of key production parameters and reduces losses caused by equipment failures through predictive maintenance. Additionally, AI algorithms applied to project management and resource allocation significantly improve decision-making efficiency and precision, saving substantial labor and time costs for the enterprise.

Collaborative Growth and Co-Creation of a New Pharmaceutical Ecosystem

AeroLyn remains firmly committed to the philosophy of "mutual benefit and shared success." We are eager to work hand-in-hand with global partners to explore the future of the pharmaceutical industry together. Whether you're a startup or a large pharmaceutical firm, if you share a vision to change the world, AeroLyn is ready to be your trusted technical partner.

Looking ahead, we will continue to invest heavily in R&D, expand our international collaborations, and continuously enhance our core competitiveness. We firmly believe that only by constantly pushing boundaries and embracing innovation can we truly propel the entire pharmaceutical industry toward a more efficient and sustainable future.。

在全球医药行业持续变革的大背景下，药物研发成本高、周期长、市场竞争激烈等问题日益凸显。新药开发过程中，药效和上市时间表始终是行业的关注重点。然而，许多生物科技企业在早期阶段对商业化成本缺乏明确考量，甚至并不敏感——因为新药的高溢价往往足以覆盖这些支出，未来再进行工艺优化也具备可行性。但这一传统认知正面临挑战。中国的医药集采政策与美国的《平价医疗法案》正在重塑行业格局。随着技术创新和商业模式的演进，新药研发阶段对CMC（化学、制造与控制）的要求不断提升，产品全生命周期的成本控制也成为不可忽视的重要议题。

AeroLyn由一群资深医药研发工程师创立，核心团队成员均来自国际知名制药企业和顶尖科研机构，在新药研发、工艺开发、质量控制及工业化放大方面拥有超过二十年的技术积累与实战经验。我们始终秉持“以技术创新为导向”的发展理念，致力于通过前沿科技手段推动医药行业的效率提升与成本优化。

作为一家具备深厚技术背景的创新型公司，AeroLyn专注于为合作伙伴提供从早期研发到商业化落地的全流程解决方案。我们不仅关注如何高效完成仿制药的研发流程，更注重通过技术创新实现生产工艺的优化，从而显著降低制造成本。这种对工艺细节的极致追求，使我们在多个项目中取得了卓有成效的成果，并赢得了合作伙伴的高度认可。

聚焦IND/NDA商业化研发布局，打造快速转化能力

当前，AeroLyn正将战略重心逐步转向具有明确商业化前景的IND（临床试验申请）和NDA（新药上市申请）项目的研发布局。我们坚信，真正的技术创新不应仅停留在实验室阶段，而应转化为可实际应用于临床的产品。

为此，我们采用“提前介入、快速开发、合作共赢”的合作模式，与多家生物科技公司、制药企业和科研机构建立了紧密的战略合作关系。通过早期识别潜力项目并参与其关键开发节点，我们能够帮助合作伙伴优化申报路径、规避风险、加快进度，从而提升整体项目的成功率和商业化价值。

我们的技术平台涵盖从合成路线开发、制剂优化、CMC研究到GMP生产的全链条支持，确保每一个项目都能高效推进，并具备清晰的产业化路径。

构建AI驱动的智能管理体系，提升运营效率

面对日益复杂的药品研发与生产流程，传统管理模式已难以满足现代企业的高效运营需求。为此，AeroLyn在生产体系中引入AI驱动的智能生产与管理系统，将大数据分析、机器学习等先进技术融入日常生产运营之中。

这套系统不仅能够实时监控生产过程中的各项参数，还能通过预测性维护减少因设备故障导致的损失。同时，在项目管理和资源调配方面，AI算法的应用有效提升了决策效率和资源配置的精准度，为企业节省大量人力与时间成本。

合作共赢，共创医药产业新生态

AeroLyn始终坚持“合作共赢”的发展理念，我们愿意与全球范围内的合作伙伴携手前行，共同探索医药行业的未来发展之路。无论是初创企业还是大型制药公司，只要您怀揣改变世界的梦想，AeroLyn都愿成为您值得信赖的技术伙伴。