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"In the next three years, the increase in patented drugs with expiration risks, coupled with the transfer of overseas outsourcing industries, is an opportunity for
China's API enterprises.
" Previously, many insiders of the China Chamber of Commerce for Import and Export of Medicines and Health Products said so
.
APIs are active pharmaceutical ingredients
that directly exert pharmacological effects on the human body.
Through the formulation of various excipients, APIs are finally produced into finished drugs
in various dosage forms such as tablets, capsules, and injections.
Therefore, the API industry occupies a very important position
in the pharmaceutical industry chain.
China is a major producer and exporter of APIs, and since 2020, affected by the epidemic, the demand for APIs at home and abroad has been strong, and the demand for some APIs has rebounded
.
Under the background that the prospect of the API market is still generally optimistic in the industry, many pharmaceutical companies have increased their layout
.
For example, Xintiandi plans to issue 33.
36 million new shares and is expected to raise 585 million yuan, mainly for the construction project of API with an annual output of 120 tons, the construction project of the R&D center and the supplementary working capital
.
The IPO project of Keyuan Pharmaceutical, which intends to be listed on the Growth Enterprise Market, has been submitted for registration, and the company has raised 35,000.
00 yuan this time, mainly used for the technical transformation project of the API comprehensive production line, the green intelligent flexible production line project of pharmaceutical raw materials, the construction of research institutes, drug research and development projects and supplementary working capital projects, and the company will be listed on
the Growth Enterprise Market of the Shenzhen Stock Exchange.
Recently, a number of local pharmaceutical companies have also reported the good news that API products have been approved for marketing at home and abroad, including Zhongsheng Pharmaceutical, HannStar Pharmaceutical, Jinyao Pharmaceutical, Sinopharm Modern, etc
.
On October 27, Zhongsheng Pharmaceutical issued an announcement that the API brofenac sodium of Xianqiang Pharmaceutical, a wholly-owned subsidiary, was approved for marketing
by the State Food and Drug Administration.
Bromofenac sodium is a non-steroidal anti-inflammatory drug for ophthalmology, with good anti-inflammatory activity, analgesic effect and safety, and the sales of the drug have shown a year-on-year growth trend
in recent years.
According to the Intranet database, from 2019 to 2021, the sales of brofenac sodium eye drops were 95.
2 million yuan, 106 million yuan and 135 million yuan
, respectively.
Zhongsheng Pharmaceutical said that the approval of brofenac sodium API for marketing will enrich the company's ophthalmic API product pipeline and help the company expand the sales of
this variety.
Shanyu Pharmaceutical announced on October 27 that the API of atosiban acetate from its wholly-owned subsidiary of Hanyu Wuhan was approved for marketing
by the State Food and Drug Administration.
The API of this product is used in the production of atosiban acetate injection, the clinical specifications of atosiban acetate injection are 0.
9ml: 6.
75mg and 5ml: 37.
5mg, and the indications are for pregnant women in the following conditions to delay the impending premature birth: regular contractions of at least 30 seconds each time, ≥ 4 times
every 30 minutes.
Cervical dilation 1~3cm (new maternal 0~3cm) and uterine softness/thinning ≥50%.
Age ≥ 18
.
24 to 33 full weeks
gestation.
The fetal heart rate is normal
.
Sinopharm Modern announced on the evening of October 17 that recently, the company's wholly-owned grandson company Jiangsu Wichida Pharmaceutical's API dapoxetine hydrochloride was approved for marketing
by the State Food and Drug Administration.
Dapooxetine hydrochloride is a selective serotonin reuptake inhibitor that is primarily indicated for on-demand treatment
of premature ejaculation (PE) in men aged 18 to 64 years.
Tianjin Pharmaceutical announced on the evening of October 26 that the company received the CEP certificate (European Pharmacopoeia Applicability Certificate)
issued by the European Drug Quality Agency for isoleucine and leucine APIs.
According to the PDB database, the global market sales of isoleucine preparations in 2021 were 2.
270 billion US dollars, corresponding to the consumption of APIs of 274 tons; in 2021, the global market sales of leucine preparations were 2.
277 billion US dollars, corresponding to the consumption of APIs was 439 tons
.
Jinyao Pharmaceutical said that the two APIs obtained CEP certificates, marking that they can be sold in the European market and other regulated markets that recognize CEP certificates, which will have a positive impact on
the company's further expansion into the international market.
It is reported that since the beginning of this year, four varieties of APIs under Jinyao Pharmaceutical have obtained CEP certificates
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.