NMPA
1. On June 1, NMPA official website revealed that Ethyl Icosapentate soft capsule, Class 5.1 chemical drug from Ceclor Pharmaceutical, a subsidiary of Yiteng, had been approved for marketing for reducing the TG level of adult patients with severe VHTG (≥500mg/dL). The drug, a monomolecular prescription drug containing highly purified active ingredient IPE developed by Amarin, has been approved for marketing by FDA under the brand name Vascepa, and Yiteng has the right to develop and commercialize in Greater China.
2. On June 2, NMPA official website revealed that CANbridge's Class 5.1 chemical drug Maralixibat Oral Solution (Code: CAN108) had been approved for marketing for treating cholestatic pruritus in patients aged 1 year and above with Alagille syndrome. CAN108 is an oral, once-a-day IBAT inhibitor developed by Mirum Pharmaceuticals.
20. On June 2, NMPA official website revealed that GSK's Class 5.1 chemical drug Dolutegravir Dispersible Tablet (brand name: Tivicay) had been approved for marketing for treating pediatric HIV-1 infection. Dolutegravir (brand name: Tivicay), an HIV integrase inhibitor, can block HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells.
3. On June 2, NMPA official website revealed that Qilu Pharmaceutical's Class 4 chemical drug Apremilast Tablet had been approved for marketing for treating adult patients with moderate to severe plaque psoriasis who meet the indications of phototherapy or systemic therapy, which is the second generic drug of Apremilast approved for marketing in China. Apremilast is an oral small molecule PDE4 inhibitor, originally developed by Amgen.
4. On June 2, NMPA official website revealed that Yangtze River's Class 3 chemical drug Peramivir Injection had been approved for marketing for treating influenza A and B. The original peramivir, a cyclopentane anti-influenza virus drug originally developed by Biocryst Pharmaceuticals, was approved by the FDA in 2014, which is the only anti-influenza injection approved by the FDA.
5. On June 5, NMPA official website revealed that the new indication of Ustekinumab Injection (brand name: Stelara, specification: 45mg/0.5ml/injection) from Janssen, a subsidiary of Johnson & Johnson, had been approved for treating the moderate and severe plaque psoriasis in children and adolescents aged 6 and above (weighing 60 kg to 100 kg) who have insufficient or intolerable response to other systemic treatments or phototherapy. The drug has been approved for treating the moderate to severe plaque psoriasis in adults before. Ustekinumab is a fully humanized "double-targeted" IL-12 and IL-23 inhibitor.
6. On June 13, NMPA official website revealed that the third indication of AstraZeneca's Eculizumab Injection (brand name: Soliris) had been approved for treating the refractory gMG adult patients with anti-AChR antibody positive. The two indications approved before are PNH and aHUS. Eculizumab Injection is a C5 complement inhibitor.
7. On June 26, NMPA official website revealed that AstraZeneca's Class 5.1 chemical drug Dapagliflozin And Metformin Hydrochloride Extended-Release Tablet (brand name: XigduoXR) had been approved for marketing for treating T2D. XigduoXR, a compound formulation of SGLT2 inhibitor/metformin hydrochloride sustained release tablet, was approved for marketing by FDA in October 2014. Its another indication is T2D complicated with chronic kidney disease with moderate renal dysfunction (estimated eGFR is 45-59mL/min/1.73m2).
8. On June 26, NMPA official website revealed that the new indication of Hengrui Pharmaceuticals' Class 1 chemical drug Dalpiciclib Isetionate Tablets (R&D code: SHR6390) had been approved for combining aromatase inhibitor as the initial treatment for locally advanced or metastatic breast cancer with HR positive and HER2 negative. The dru...
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