Sixteen applications for drug registration are to be included in the review

The Drug Review Center of the State Drug Administration announced 16 priority evaluation varieties, including 8 rare disease treatment drugs such as human prothrombin complex, 5 obvious therapeutic advantages such as navuliumab injection, and 2 children's products such as Chloral hydrate/syrup combination packaging. Drug and Rituximab Injection, a major special product. Public information shows that four recombinant human coagulation factor products for injection (specifications are 250IU/bottle, 500IU/bottle, 1000IU/bottle, 2000IU/bottle) of Novo Nord Pharmaceutical Co., Ltd. and human coagulation factor of Nanyue Biopharmaceutical Co., Ltd. (each bottle contains human coagulation factor 200IU), The human prothrombin complexes (each bottle containing human coagulation factor IX 400IU) of Boya Biopharmaceutical Group Co., Ltd. were applied for the registration of rare disease drugs and were included in the priority review procedure. It is understood that human coagulation factor is suitable for the control and prevention of hemophilia A (congenital coagulation factor deficiency) bleeding. Two specifications of Nidanib Ethylsulfonate soft capsules declared by Bringer Ingham Co. were also included in the priority review procedure as applications for registration of rare diseases drugs.

Two specifications of Nidanib Ethylsulfonate soft capsules declared by Bringer Ingham Co. Reporters learned that Nidanib Ethylsulfonate Soft Capsule was approved for market in China in September 2017. The indication is for the treatment of idiopathic pulmonary fibrosis (IPF). This registration declaration is to add a new indication - systemic sclerosis related interstitial lung disease.

This time, two innovative drugs with obvious therapeutic advantages were also announced, namely, the sublingual drops of Artemisia annua pollen allergen declared by Zhejiang Wu Biotechnology Co., Ltd. and the ramazolam Toluene sulfonate for injection declared by Jiangsu Hengrui Pharmaceutical Co., Ltd. It is reported that the registration of sublingual drops of Artemisia annua pollen allergens is classified as the fourth category of therapeutic biological products - allergen products. The drug is mainly used for desensitization treatment of allergic rhinitis (conjunctivitis or asthma) caused by Artemisia pollen allergy. Remazolam toluene sulfonate for injection is a short-acting GABAa receptor agonist suitable for general anesthesia during elective surgery. In addition, Bremesh Squibb's Navulizumab injection (specification 100mg/10ml, 40mg/4ml) and Novartis's Scuchiuqiumab injection have obvious therapeutic advantages, and the BIO-analogue drug rituximab injection developed by Xinda Biopharmaceuticals (Suzhou) Co., Ltd. is regarded as the heavy drug. Specialized varieties are included in the priority review procedure.