With the acceleration of new drug approval and review, new drugs at home and abroad are accelerating into the marketing period
.
It is reported that since November, a number of pharmaceutical companies have released the news
that Class 1 new drugs have been approved for marketing.
Hengrui/Yingli Pharmaceutical's blockbuster Class 1 new drug was approved for marketing
On November 9, the State Food and Drug Administration (NMPA) conditionally approved the marketing of Linperlisib, a Class 1 innovative drug (trade name: Intarui), of Shanghai Yingli Pharmaceutical, through the priority review and approval process, which is suitable for adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
According to the data, Linplisset is a selective inhibitor of the δ isoform (PI3Kδ) of phosphatidylinositol-3-kinase, which is developed by Shanghai Yingli Pharmaceutical, and Hengrui Pharmaceutical made an equity investment of US$20 million (accounting for 6.
67% of the total share capital) in Yingli Pharmaceutical in February 2021, and obtained the joint development rights and exclusive commercialization rights
of Linpliser in the Greater China region.
This is the first highly selective PI3Kδ inhibitor approved for marketing in China, and it is also the first innovative drug
approved for marketing in the BD field of Hengrui Pharmaceutical.
The Class 1 new heart failure drugs introduced by Jinxing Pharmaceutical were declared for marketing
On November 4, the CDE website showed that the application for omec amtiv mecarbil sustained-release tablets submitted by Mistar Pharmaceutical/Cytokinetics has been accepted for the treatment of heart failure (HFrEF)
with reduced ejection fraction.
It is understood that omecamtiv mecarbil is a pioneering selective small molecule myocardial myosin activator under investigation, aiming to increase the number of active actin-myosin transverse bridges in each cardiac cycle, thereby enhancing impaired myocardial contractility
in heart failure (HFrEF) patients with reduced ejection fraction.
The drug was introduced by Cytokinetics, which has the development and commercialization authority in Greater China for omecamtiv mecarbil, a proposed indication for heart failure (HFrEF) with reduced ejection fraction, from Cytokinetics, which received $70 million in commitment funding and is eligible for additional milestone payments
of up to $330 million from Cytokinetics.
Luye Pharmaceutical's new drug for Class 1 depression was approved
On November 3, the State Medical Products Administration approved the marketing of Class 1 innovative drug Toludi venlafaxine hydrochloride sustained-release tablets (trade name: Ruoxinlin) declared by Shandong Luye Pharmaceutical Co.
, Ltd.
According to public information, the antidepressant effect of toludi venlafaxine hydrochloride (ansufaxine hydrochloride sustained-release tablets, LY03005) may be related to
the enhancement of the 5-HT and NE effects of the central nervous system by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE).
The drug is an innovative drug independently developed and has independent intellectual property rights in China, which is suitable for the treatment
of depression.
The industry expects that in the future, under the background of policy support for innovation, enterprises increasing research and development, and introducing new drugs, more and more Class 1 new drugs will be approved for clinical trials and marketing in China, which will achieve breakthroughs in the field of major diseases and benefit more patients
.
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