Lianhe Aigen Deepens Domestic Collaboration, Achieving Key Substantive Breakthrough in CRDMO Business

Recently, the Drug Marketing Authorization Application for an innovative drug API, jointly developed by Lianhe Aigen and a key domestic pharmaceutical partner, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the Lianhe Aigen's first successful domestic eCTD electronic submission. This significant progress not only signifies a crucial step towards the commercialization of the collaborative project but also marks a milestone breakthrough for the company in the small-molecule CRDMO sector and the domestic innovative drug API field, representing a substantive achievement in our deep collaboration with domestic clients.

Collaborative Efforts to Unlock the Full CMC Chain

As an enterprise dedicated to Contract Research, Development, and Manufacturing Organization (CRDMO) services, Lianhe Aigen has long focused on the process development and large-scale production services of innovative drug APIs, continuously building integrated CMC service capabilities. Relying on a mature process R&D platform, a comprehensive quality management system, and a professional regulatory technical team, the company was deeply involved in the full-process development of this project in collaboration with our domestic client.

During the project's advancement, multiple departments—including R&D, production, quality, and regulatory affairs—worked closely together and coordinated efficiently with our partner. Together, we overcame a series of technical challenges, such as process scale-up, impurity profiling, stability studies, and the compilation of regulatory dossiers. The company steadily completed the transition from laboratory process development to commercial production and accumulated a high-quality, comprehensive set of pharmaceutical research data, laying a solid foundation for the smooth submission of the marketing application.

Capability Advancement: Securing a New High Ground in Regulatory Submissions

The mature development of the innovative drug industry chain relies on the support of professional CRDMO capabilities. Currently, as domestic innovative drug R&D continues to accelerate, there is a growing demand for integrated services encompassing API process development, compliant manufacturing, and regulatory submissions. The successful acceptance of this marketing application not only fully validates the company's comprehensive strength in undertaking domestic regulatory projects for innovative drug APIs but also marks a substantive breakthrough for us in the domestic innovative drug CMC service sector.

At the same time, the successful implementation of this project further enriches the company's pipeline of innovative drug API projects and continuously consolidates our competitive advantages in the small-molecule innovative drug CRDMO field, laying a solid foundation for undertaking more high-quality domestic innovative drug development projects in the future.

Deepening Collaboration for the Journey Ahead

Looking back, the achievement of every collaborative milestone embodies the dedication of all our employees to pursue perfection and overcome difficulties, vividly interpreting the company's development philosophy of "Empowering Global Innovative Drugs, Contributing to Human Health."

Looking to the future, the company will continue to root itself in the core CRDMO track, continuously iterate our process development and large-scale production capabilities, and constantly improve our domestic and international drug regulatory service systems. Taking this domestic collaboration breakthrough as a new starting point, we will continue to expand deep cooperation with domestic innovative pharmaceutical enterprises, undertake more innovative drug development projects, and help more candidate drugs smoothly advance through the regulatory process. We are committed to accelerating the translation of innovative achievements into clinical applications and contributing to the high-quality development of the pharmaceutical industry.