Recently, Fosun Pharma announced that the drug registration application of aripiprazole oral solution developed by its holding subsidiary Fosun Pharmaceutical Industry and its holding subsidiary Jinzhou Aohong Pharmaceutical has been accepted by the State Food and Drug Administration for the treatment of schizophrenia
in adults and adolescents over 15 years old.
The new drug is a chemical drug independently developed by Fosun Pharma and is intended to be mainly used for the treatment of schizophrenia
.
As of July 2022, the cumulative R&D investment in the new drug was approximately RMB3.
71 million (unaudited
).
According to public information, aripiprazole is a dopamine system stabilizer, a third-generation antipsychotic drug, jointly developed
by Bristol-Myers Squibb and Japan's Otsuka Pharmaceutical.
In 2002, the original drug was approved for marketing in the United States, and in 2006, it was approved to enter China
.
Compared with a generation of antipsychotics, aripiprazole has fewer side effects, is simple to take, increases medication adherence, and makes the condition more stable
.
At present, similar products that have been listed in China mainly include Boss Qing of Chengdu Kanghong Pharmaceutical Group Co.
, Ltd.
, An Lufan ® of Zhejiang Otsuka Pharmaceutical Co.
, Ltd.
, and Pag ® of Jiangsu Enhua Pharmaceutical Co.
, Ltd
.
Among them, the main production and listing enterprise of aripiprazole oral solution in China is Kanghong Pharmaceutical, which accounts for a relatively large market, occupying about 47.
67% of the market; It is followed by Otsuka Pharmaceutical, Shanghai Shangyao Zhongxi Pharmaceutical, and Enhua Pharmaceutical
.
According to the IQVIA database, sales of similar products in China will reach about 1.
046 billion yuan in 2021
In fact, since the expiration of the aripiprazole patent, the major generic drug companies in order to seize the strategic heights of the aripiprazole generic drug market in the fight against each other, the field is also ushering in more and more new entrants
.
For example, in the near future, in addition to the acceptance of Fosun Pharma's application for registration, on August 15, Shanghai Pharmaceutical also announced that the aripiprazole oral solution of Shanghai Shangpharm Sinopharm Sinopharm Co.
, Ltd.
, a subsidiary of the company, received the "Drug Registration Certificate"
issued by the State Drug Administration.
At present, in addition to the original pharmaceutical company Otsuka Pharmaceutical, there are more than 15 domestic enterprise layouts, of which there are more ordinary tablet approvals, followed by oral collapse tablets
.
It is reported that fosun pharma's oral solution dosage form has been approved by 5 enterprises, namely Sichuan Otsuka Pharmaceutical, Shangyao Zhongxi Pharmaceutical, Changzhou Siyao Pharmaceutical, Wante Pharmaceutical (Hainan), and Kanghong Pharmaceutical
.
It is worth mentioning that aripiprazole was approved by the FDA in 2009 for irritability in children with autism, although in China, only sichuan Otsuka Pharmaceutical's aripiprazole oral solution for tic disorders and autism indications was approved for listing
on July 19 this year.
However, the industry expects that the major pharmaceutical companies that will lay out aripiprazole in the future will also begin to accelerate breakthroughs in this indication and continue to benefit more patients
.
