Within a week, the listing applications of a number of pharmaceutical companies for APIs were approved

【Pharmaceutical Network Industry Dynamics】APIs refer to any kind of substance or mixture of substances used in drug manufacturing, which is the upstream of the industrial chain of therapeutic drugs, and is also the basis for
ensuring the supply of drugs and meeting people's drug needs.

In recent years, with the advancement of collection policies, consistency evaluation and drug-related approval, as well as the impact of factors such as the transfer of global orders, the scale of China's API industry is continuing to expand
.

Affected by this, a large number of API companies have also begun to accelerate the promotion of more products to market
.

It is reported that in the past week, many companies have announced that the registration and listing applications of APIs have been approved
.

For example, on September 22, Jimin Credible Group announced that the characteristic API of Avalatopopa maleate developed by the Innovative Technology Drug Research Institute of Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
, a subsidiary of Jiyu Pharmaceutical Technology Co.
, Ltd.
, has been submitted for registration and accepted
by the Drug Evaluation Center (CDE) of the State Drug Administration.

The on-site production of the API was undertaken by Nanjing Hang Seng Pharmaceutical Co.
, Ltd.
, which is the first API project
jointly declared by two subsidiaries of Jimin Credible Group.

On the same day, Northeast Pharmaceutical announced in the evening that the company's recent application for registration of "acetyllevonectine hydrochloride" API passed the approval of the Drug Evaluation Center (CDE) of the State Food and Drug Administration, and received the "Notice of Approval of Chemical API Listing Application"
issued by the State Food and Drug Administration.

On September 16, CR Shuanghe also announced that its wholly-owned subsidiary, Shuanghe Pharmaceutical (Shangqiu) Co.
, Ltd.
(hereinafter referred to as "Shangqiu Shuanghe"), received the "Notice of Approval of Chemical API Listing Application"
issued by the State Food and Drug Administration.

It shows that the API has met the relevant national drug review technical standards, and can be produced and sold to the domestic market after passing the GMP compliance inspection, which is conducive to further enriching the company's product line and enhancing market competitiveness
.

It is worth noting that at present, with the promotion of new policies for medical reform and the impact of factors such as global order transfer, the scale of China's API industry is expanding continuously, and the overseas of pharmaceutical companies' APIs is also accelerating
.

In June, Hunan Huana Pharmaceutical Factory Chiral Drug Co.
, Ltd.
, a wholly-owned subsidiary of Warner Pharmaceutical Co.
, Ltd.
, said that it had received a certificate of registration for APIs issued by the Ministry of Food and Drug Safety (MFDS) of South Korea, which reads: "Ticagrelor"
.

In March, the fluocinolone API produced by Tianjin Tianyao Pharmaceutical Co.
, Ltd.
obtained the CEP certificate (European Pharmacopoeia Applicability Certificate), which is the first time that the API produced by a Chinese enterprise has obtained the CEP certificate
.

According to the data, the CEP certification is the European market access certificate
.

The CEP certification is recognized not only by all EU member states, but also by countries that recognize the status of the European Pharmacopoeia
.

If the API used in the drug to be marketed has obtained CEP, the application for marketing authorization (MAA) can use the certificate directly, and the review authority no longer evaluates
the quality of the API.

In addition, before that, Hanyu Pharmaceutical's octreotide API also received a CEP certificate issued by the European Medicines Quality Agency, which is valid
for five years from March 14, 2022.

Octreotide is an octapeptide derivative of synthetic natural somatostatin whose pharmacological action is similar to that of somatostatin, but lasts longer
.

Industry analysis believes that as far as the domestic API market is concerned, with the implementation of policies such as normalization of collection, consistency evaluation and drug-related approval, the industry concentration continues to increase, as well as the transfer of beneficiary orders, the status of the API industry in the industrial chain is improved, and it is expected that the production and export scale of China's characteristic APIs will continue to expand and grow
in the future.

In this context, API companies are expected to show three major development trends: First, continue to focus on the field of APIs, expand more product pipelines, and accelerate internationalization; The second is to cut into the downstream preparation market and realize the "integration of APIs + preparations"; Third, with its rich large-scale production experience and cost control capabilities, it undertakes more CMO/CDMO orders, improves profitability, and transforms
to CDMO.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.