Shisi Pharmaceutical Group (02005) obtained drug production registration approval for four products from the State Drug Administration

Zhitong Finance App News, Shisi Pharmaceutical Group (02005) issued an announcement. The group has obtained drug production registration approval from the China National Drug Administration for the following four products, all of which fall under Class 4 chemicals, and are deemed to have passed the consistency evaluation.

one. Sodium citrate blood filter replacement solution (5000ml): This product is mainly used as a replacement solution for continuous renal replacement therapy (CRRT) using topical citrate anticoagulation. It is especially suitable for patients who are contraindicated to use heparin for systemic anticoagulation and increased risk of bleeding.

Compared with mainstream clinical split citrate solutions (bicarbonate replacement solution with independent sodium citrate anticoagulants), the clinical advantages of this product are obvious, and the market prospects are broad. The Group is actively deploying large-capacity injections such as hemofiltration replacement solutions and peritoneal dialysis solutions, and the product portfolio is being further improved.

II. Benidipine hydrochloride tablets (4mg): This product is mainly used to treat essential hypertension and angina pectoris.

The Group has built a complete matrix of high blood pressure products, covering second-generation and third-generation calcium channel blockers, primes, alpha blockers, and a variety of single-tablet compound preparations, as well as venous emergency antihypertensive drugs used in intensive care units (ICU). Among them, the Group's Benidipine hydrochloride tablet 8mg specification has been approved for marketing and has won the 11th batch of national procurement. With the approval of its 4mg specification, it can fully meet the initial small-dose treatment requirements for hypertension, forming a complete dose gradient of “initial titration of 4 mg + maintenance treatment of 8 mg”.

III. Polyvinyl Alcohol Eye Drops 1.4% (0.4ml: 5.6mg): This product is mainly used as a lubricant to prevent or treat irritating symptoms such as dry eyes, foreign body sensation, eye fatigue, etc., or to improve dry eye symptoms.

Polyvinyl alcohol eye drops are packaged in a single dose and do not contain preservatives. They are OTC products for office workers with visual fatigue, long-term screen viewing, and eye surface sensitivity as an immediate relief for dry eyes. The Group strategically lays out the ophthalmology medicine sector with a single-dose, preservative-free dosage form. It has built a product matrix including anti-infection, anti-allergy, eye pressure reduction, artificial tears, and eye anti-inflammatory, forming a dual-channel layout for in-hospital prescription drugs and retail OTC.

IV. Fatty Lactic Amino Acids (17) Glucose (19%) Injection (1540ml and 1026ml): This product is mainly used for adult patients who are unable or dysfunctional or are prohibited from ingesting nutrients oral/intestinal.

This product is a complex preparation with three chambers for parenteral nutrition. It has high process barriers and is mainly used for intravenous nutritional support for adult patients after surgery, tumors, and ICU. The two specifications of 1540ml and 1026ml approved this time can meet the individualized clinical use needs of patients with different body weight and energy needs.

The Group has a systematic layout of parenteral nutrition product platforms, covering premixed three-chamber all-in-one formulations, nutrients, vitamins, trace elements and electrolyte supplements. It was approved to further improve the high-end intravenous nutrition product matrix and form a collaboration with basic infusion, amino acid, and fat milk series, which has a positive effect on expanding the hospital perioperative period and critical nutrition market.