[PBF] The company's new kidney disease drug Nephoxil approved for marketing in China

1. Date of occurrence: April 27, 2027
2. Company name: PBF Biotechs Co., Ltd.
3. Relationship with the company: The Company
4. Interlocking shareholding ratio: Not applicable
5. Cause: The company's new kidney disease drug Nephoxil 500mg Capsule has been approved by the National Medical Products Administration (NMPA) of China for registration. It is approved for controlling hyperphosphatemia in adult patients with chronic kidney disease who are receiving dialysis treatment.
6. Countermeasures: Announcement of material information.
7. Other matters to be specified:
(A) The product is a novel oral iron-containing phosphate binder, whose main active ingredient is Ferric Citrate Coordination Complex.
(B) Market status:
According to the China Kidney Disease Data Registration System (CNRDS) and other public information, as of the end of December 2024, the number of dialysis patients in mainland China reached approximately 1.183 million, including 1.027 million hemodialysis patients and 156,000 peritoneal dialysis patients.
According to data announced at the 19th Congress of Critical Care Nephrology and Blood Purification of the Chinese Medical Association in 2025:
(1) Rapid growth in total numbers: From 2013 to 2023, the number of hemodialysis patients grew from about 210,000 to 916,000, a 3.5-fold increase in ten years. In 2024, it further increased to 1.027 million.
(2) Increasing annual new patients: Since 2015, the number of new dialysis patients has stabilized at around 180,000 annually, with a slight increase in 2023, reaching 220,000 in 2024.
(3) Significant rise in prevalence: The prevalence of hemodialysis rose from 255 per million in 2013-2017 to 635 per million in 2023.
(4) Growth is mainly related to expanded medical insurance coverage, aging population, and rising incidence of chronic diseases like diabetes and hypertension.
(C) The company is actively expanding its pharmaceutical market footprint in China to enhance operational performance.
(D) No milestone income is associated with this acquisition of the drug license.
(E) New drug development involves long timeframes, high costs, and no guarantee of success. Investors should judge prudently.