NMPA
Lisiting Approvals:
1. On October 12, according to the official website of the NMPA, Betta Pharmaceutical's Class 1 chemical drug befatinib mesylate capsule (trade name: Semena) was approved for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) replacement mutations. Befatinib is the third representative of the cutaneous growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
2. On October 9, according to the official website of CDE, Bebetter Med's Class 1 new drug biristalat for injection (BEBT-908 for injection) was declared for marketing, and the presumed indication is adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL) who have received at least two prior systemic therapies. Birisristal for injection is a first-in-class HDAC/PI3K dual-target anti-cancer drug introduced by Bibet Biopharma from Curis in 2012.
3. On October 10, according to the official website of CDE, CSPC Pharmaceutical Group's Class 4 generic Ilaprazole enteric-coated tablets were declared for marketing, which is intended to be used for duodenal ulcer and reflux esophagitis. This is the first generic drug of ilaprazole enteric-coated tablets to be declared for marketing. The original product of ilaprazole enteric-coated tablets was developed by Livzon Group, and the terminal sales of the hospital in 2022 will be about 1.2 billion yuan.
4. On October 11, according to the official website of CDE, Karyopharm Therapeutics and Antengene's selinexor tablets were declared for marketing for the treatment of relapsed/refractory diffuse large B-cell lymphoma. Selinexor is an orally selective nuclear export protein (XPO1) inhibitor.
5. On October 12, according to the official website of CDE, the 3 generic drugs niergoline tablets jointly developed by Jiangxi Dasheng Medicine and Visum Pharma were declared for marketing, and the predicted indication was cerebrovascular-related diseases. This is the seventh domestic nicergoline tablets to be declared for marketing, after Kunshan Rotam Reddy's Pharmaceutical's nicergoline tablets passed the consistency evaluation and was the first in China to pass the evaluation.
6. On October 17, according to the official website of the NMPA, AstraZeneca's eculizumab (Soliris) was approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Eculizumab is the world's first approved complement inhibitor that inhibits the uncontrolled activation of the immune system by inhibiting terminal complement.
7. On October 18, according to the official website of the NMPA, Macitentan tablets from East China, Nanjing Chia Tai Tianqing and Puji Biotech were approved for marketing, and the three companies jointly won the first generic of macitentan tablets. Macitentan is an endothelin receptor antagonist, which was first developed by Actelion Pharmaceuticals and approved by the FDA in 2013, and is the first oral formulation approved for pulmonary hypertension.
8. On October 19, according to the official website of the NMPA, Bristol-Myers Squibb's (BMS) deuterated colacitinib tablets were approved for marketing for the treatment of moderate to severe plaque psoriasis. This product is also the first TYK2 inhibitor approved for marketing in China. In addition to psoriasis, deuterated colecitinib has been developed to treat a variety of immune diseases such as psoriatic arthritis, scalp psoriasis, systemic lupus erythematosus, and inflammatory bowel disease.
9. On October 19, according to the official website of the NMPA, Pfizer's ritlecitinib capsule (trade name: Lefunuo) was approved for marketing for adolescents aged 12 years and older and adults with severe alopecia areata who are suitable for systemic treatment. Litexitinib tosylate is a kinase inhibitor that irreversibly inhibits the JAK3 and tyrosine kinase families.
10. On October 17, according to the official website of CDE, Xuanzhu Bio's Class 1 new drug piroctinib tablets were declared for marketing, and pirobusinib is used as a single d...
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