Porton's End-to-End CMC Development Accelerates Market Approval for Innovative ALK Inhibitor Dirozalkib (Xuanfeining) Tablets

Dirozalkib is indicated for the treatment of patients with ALK-positive, locally advanced, or metastatic non-small cell lung cancer (NSCLC) who have not previously received ALK inhibitor therapy.

Dirozalkib is a next-generation ALK inhibitor with a unique structural design that enhances its inhibitory activity against drug-resistant sites. Clinical trial results demonstrate that Dirozalkib exhibits superior activity against multiple drug-resistant sites associated with first-generation and certain second-generation ALK inhibitors. Compared to currently available drugs, Dirozalkib shows a higher objective response rate and a better safety profile in treating patients with ALK-positive, locally advanced, or metastatic NSCLC.

Additionally, Dirozalkib can cross the blood-brain barrier and is effective against brain metastases. It also has significantly fewer side effects than comparable products, underscoring its strong safety profile. This combination of efficacy and safety is expected to make it more readily accepted by both physicians and patients, highlighting its substantial clinical and commercial value.

As the sole CDMO service provider for the active pharmaceutical ingredient (API) of Dirozalkib, Porton leverages its end-to-end capabilities to accelerate the commercialization process of this innovative blockbuster drug significantly. Porton provides comprehensive CMC solutions across the entire development process, beginning with the Phase I clinical trial and building a critical foundation for the successful submission and approval of the New Drug Application (NDA).

During the R&D phase, Porton conducted in-depth optimization of the initial process, achieving key breakthroughs in multiple production steps. These efforts improved overall yield, reduced costs, and enhanced product quality and process stability.

In production, Porton efficiently completed multiple batches, including clinical, pivotal clinical, and process validation batches, while ensuring continuous compliance and stable operations throughout.

On the regulatory side, Porton provided comprehensive pharmaceutical and quality research services precisely aligned with NDA submission requirements. In parallel, Porton’s expertise in crystal form research and catalyst optimization, combined with outstanding performance in quality control, cost management, and customer service, earned high recognition from XuanZhu Biopharm.

As a global CDMO, Porton is committed to providing end-to-end CMC solutions to its clients from process route exploration and optimization to pilot-scale and commercial production, as well as quality research and CMC registration support. Looking ahead, Porton will continue to strengthen its collaboration with XuanZhu Biopharm through full lifecycle management (LCM) to further enhance production efficiency, reduce overall costs, and provide a solid foundation for Dirozalkib to secure a competitive position in the market. Additionally, Porton will continue meeting the growing API demand for this drug post-launch, helping it fully unlock its clinical and commercial value.

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