In February, in terms of drug review and approval, domestically, the anti-PD-L1 monoclonal antibody Adebrelimab from Hengrui Pharmaceuticals was approved for marketing, and the Class 3 chemotherapy Limaprost tablets from Sino Biopharm were approved for marketing, targeting common diseases in the middle-aged and elderly.
1. On February 20, the NMPA official website revealed that Class 3 chemical drug Limaprost Tablets (brand name: Keliton) from Sino Biopharm was approved for marketing in the field of analgesia and microcirculation treatment. Limaprost Tablets are the only small-molecule drug with clear indications for the treatment of lumbar spinal stenosis in the clinical manual, and are the first drug in China to address the pathological mechanism of lumbar spinal stenosis, with the dual effects of improving neural blood flow microcirculation disorders and improving neurological function, as the basic drug for the whole management of lumbar spinal stenosis.
2. On February 20, NMPA official website revealed that Nitisinone capsules as well as oral suspension of Sobi Pharmaceuticals were approved for marketing for the treatment of hereditary tyrosinemia type I (HT-1) in adults and pediatric patients (of any age) and for the indication of combining tyrosine and phenylalanine dietary restrictions. Nitisinone, developed by Orphan BiovitrumAB of Switzerland, is a reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase.
3. On February 20, the NMPA official website revealed that the Upadacitinib Sustained Release Tablets from AbbVie were approved for marketing fourth indication for the treatment of adult patients with moderately severe active ulcerative colitis (UC) who have responded poorly to one or more tumor necrosis factor (TNF) inhibitors or who are intolerant or contraindicated. Upadacitinib is a self-developed JAK1 inhibitor by AbbVie, and its enzymatic activity and cellular assay results show that it inhibits JAK1 with higher potency than JAK2, JAK3 and TYK2.
4. On February 20, the NMPA official website revealed that Amphotericin B Liposome for Injection (brand name: AmBisome) from Gilead. was approved for marketing for the treatment of invasive fungal diseases. AmBisome targets s variety of fungi including Candida, Aspergillus, Trichoderma and Cryptococcus fungi, with an overall response rate of up to 90% against Candida and rare drug resistance.
5. On February 20, the NMPA official website revealed that Human Coagulation Factor IX from Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. was approved for marketing. The approved indication is for the prevention and treatment of bleeding caused by human coagulation factor IX deficiency (hemophilia B). Hemophilia is a rare recessive hereditary bleeding disorder that can be classified into two types, hemophilia A and hemophilia B, which are both caused by mutations in the corresponding coagulation factor genes. Among them, hemophilia B is caused by a deficiency of coagulation factor IX.
6. On February 20, the CDE official website revealed that X842, which was co-developed by Shanghai Pharmaceuticals's wholly-owned subsidiary Shanghai Sine Pharmaceutical Laboratories Co., Ltd., was submitted and processed as a marketing application for the treatment of reflux esophagitis. X842 is a next-generation potassium competitive acid blocker (P-CAB) orally administered drug. In October 2021, Shanghai Pharmaceuticals acquired the exclusive contract manufacturing and industrial marketing rights for X842 in China for all indications from Sinorda Biomedicine for a transaction amount not exceeding RMB 690 million.
7. On February 20, the CDE official website revealed that the indication of the first-in-class drug Tegoprazan Tablets from Luoxin Pharmaceuticals was submitted and processed for marketing, with the new indication of duodenal ulcer. Tegoprazan is the first self-developed potassium competitive acid blocker (P-CAB) in China. In October 2015, Luoxin Pharmaceuticals entered into an agreement w...
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