With the introduction and landing of a series of policy documents to encourage drug innovation and implement priority review and approval, while China's innovative drug industry is booming, the efficiency of review and approval of new drugs at home and abroad is also constantly improving
.
In recent years, a large number of domestic and foreign new drug marketing applications have been approved
.
According to industry statistics, in 2021, the State Food and Drug Administration approved a total of 76 new drugs (excluding new indications and vaccines), including 37 imported new drugs, 12 innovative traditional Chinese medicine drugs, and 27 domestic innovative drugs
.
Since 2022, the State Food and Drug Administration has approved more than 50 new drugs for marketing, including linplisac, serplulimab injection, etc.
, which are mainly concentrated in the field
of anti-tumor drugs, rare disease drugs and other drugs.
Among them, more than 21 models are listed
in China for the first time.
It is worth mentioning that at the end of the year, a number of pharmaceutical companies have recently received good news
on the launch of new drugs.
For example, on December 14, Boehringer Ingelheim announced that China's National Medical Products Administration had approved the marketing application of its rare skin disease innovative drug pesolimab injection (trade name: San Ligzo) for the treatment of generalized pustular psoriasis (GPP) episodes
in adults.
It is understood that pesolimab is the first monoclonal antibody of its kind to block IL-36 receptor activation, filling the huge unmet treatment needs in the field of the disease for a long time, and can quickly, effectively and durably remove pustules and skin lesions from GPP attacks, thereby improving the quality of life of
patients.
On the same day, Heyuan Biotechnology (Tianjin) Co.
, Ltd.
(hereinafter referred to as "Heyuan Bio") also announced that the National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) with Hergilencel injection (proposed) (CNCT19 cell injection, Inaticabtagene Autoleucel)
for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia.
According to public information, Hergilencel injection is the first CAR-T cell therapy product in the field of leukemia treatment in China to be accepted by NDA and is expected to be approved, and it is also the first fully independently developed targeted CD19 CAR-T cell therapy product
in China.
Hergilencel injection has a globally unique CD19 scFv (HI19a) structure and an internationally leading manufacturing process, and the success rate of cell drug production in adult r/r B-ALL registered clinical studies has reached 100%.
At present, the drug has obtained the "breakthrough therapy drug (BTD)" designation of the Center for Drug Evaluation (CDE) of the National Medical Products Administration and the "orphan drug designation" (ODD)
of the US FDA.
In general, behind the accelerated approval of a large number of new drugs, it is inseparable from the support
of a series of favorable policies in China.
In the future, under the influence of favorable policies, as well as the aging of the population and the growth of drug demand, the industry expects that more new drugs will be approved for marketing, bringing more and better treatment options
to patients.
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