Recently, Porton Pharma has achieved a significant capacity breakthrough at its GMP manufacturing facility in Fengxian, Shanghai, China, further enhancing its production capabilities and technological strength in new modality areas such as peptide and oligonucleotide drugs. This upgrade represents an important step in Porton's commitment to becoming a leading global CDMO company.

lEnhancing Service Capabilities to Meet Market Demand

As the core GMP production site of Porton in the Yangtze River Delta region, the Shanghai Fengxian manufacturing site covers an area of 100 mu. It is equipped with versatile reactors ranging from 10 to 6,300 liters, providing a total production capacity of nearly 100 cubic meters. This capacity supports the batch production of ~100 kg APIs. We are committed to delivering efficient and flexible API production services for small molecule drugs, peptides, and oligonucleotides, covering the entire drug lifecycle, including PCC, toxicology approval, IND, PV, NDA, and commercialization. Additionally, we have received approval for several APIs.

With the growing demand for new modalities in the global biopharmaceutical industry, Porton has actively invested resources to expand its service capacity in this cutting-edge field. In 2024, three GMP production workshops for peptides, oligonucleotides, and payload linkers have been put into operation in Porton Fengxian Manufacturing site. These workshops are equipped with advanced lyophilizers, preparative reverse-phase liquid chromatography, and other state-of-the-art equipment. Notably, the payload-linker area is even equipped with various types of isolators, which meet the OEB5 requirements for the production of highly potent compounds. This setup enables operations such as crystallization, filtration, drying, lyophilization, and packaging.

The Porton Fengxian Manufacturing site adheres to the Group's unified quality management system and rigorously follows international standards, ensuring that all GMP activities comply with regulations set by the NMPA, USFDA, EMA, and other authorities. In 2023, two APIs successfully passed NMPA inspections. As of September 2024, the site had completed over 35 customer quality audits and multiple regular NMPA inspections.

lYears of Accumulated Expertise

As one of the leading CDMO companies, Porton Pharma has consistently prioritized technological innovation and excellent service. The upgrade and expansion of the Shanghai Fengxian manufacturing site is an important manifestation of the company's long-term commitment to its innovative development strategy. With the rise of new molecular technologies, Porton will continue to enhance its technical capabilities and industry influence, remaining dedicated to creating sustainable value for customers through outstanding service and cutting-edge technologies.

Porton Pharma eagerly looks forward to collaborating with customers to create a healthier future, enabling the public's early access to good medicines.