Shisi Pharmaceutical Group (02005): Peritoneal dialysis solution (bicarbonate-G 1.5%) (2000ml) obtained drug production registration approval

Zhitong Financial App News, Shisi Pharmaceutical Group (02005) announced that the Group has obtained drug production registration approval from the China National Drug Administration for peritoneal dialysis solution (bicarbonate-G 1.5%) (2000ml), which is considered to have passed the consistency evaluation. It is mainly used for peritoneal dialysis in patients with chronic renal failure, and is used when hypermagnesemia has not been fully improved.

Peritoneal dialysis solution (bicarbonate-G 1.5%) is the Group's first type of dialysis solution packaged in a double chamber bag. It uses a bicarbonate buffer system. The double chamber bag structure can isolate and store different components and mix them before use. The production process is difficult and the technical barriers are high. This product has better biocompatibility, is beneficial to protect peritoneal function, reduce the risk of peritonitis, and is suitable for patients with abnormal liver function and metabolic acidosis. This product is an emerging upgraded variety in the field of peritoneal dialysis. The number of domestic approved companies is limited, and the competitive pattern is good. Compared with traditional lactate preparations, there is room for differentiated pricing. As clinical awareness increases, there is broad market penetration space.

The Group's strategic layout is in the field of renal replacement therapy, and its products cover peritoneal dialysis solutions, hemofiltration replacement solutions, etc. As an important treatment for end-stage nephropathy, peritoneal dialysis has the convenience of home operation and flexible schedule. It can complement and be used sequentially with hemodialysis to prolong the patient's life cycle, and the clinical needs are rigid and sufficient. Compared with hemodialysis, the penetration rate of the domestic peritoneal dialysis market has a lot of room for improvement, and the growth prospects are broad. Up to now, the Group has formed a leading domestic peritoneal dialysis solution product matrix, covering multiple technical routes and polyglucose concentration specifications for conventional lactate, low calcium lactate, and bicarbonate, and is one of the companies with the most complete peritoneal dialysis solution product line layout in China. Relying on the Group's mature infusion technology platform, the support system for dialysate production is perfect, and the quality advantages are outstanding.