The first generic drug broke out!

Recently, a number of the first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets

More than 60 first copy approvals this year, Qilu, Hengrui, Renfu.

More than 60 first generic drugs involved more than 20 approved import companies and more than 40 domestic companies.

From the perspective of the global sales of the original products, there are many heavy varieties, such as Lingbei/Takeda’s vothiaxetine, Eisai/Mersk’s lenvatinib, Astellas’ Mirabellon, and Boehringer Ingelheim’s Nintanib, etc.

Some of the first imitations approved since 2021

Source: Meinenet MED2.

From the perspective of domestic sales, the sales of 11 varieties in China's urban public hospitals, county-level public hospitals, urban community centers, township health centers (Chinese public medical institutions) and Chinese urban retail pharmacies will exceed 100 million in 2020.

Since 2021, it has been approved for the first domestic enterprises with 2 or more imitations

Source: Meinenet MED2.

Since 2021, Qilu has won 17 generic drugs (all reported for production under the new classification), which is far ahead of other companies.

Hengrui, known as "the first brother of innovative drugs", also has a layout in high-end generic drugs and first generic drugs.

With the title of "King of First Imitation", Chia Tai Tianqing Pharmaceutical won 6 first imitations last year, ahead of other companies

Both Kelun and CSPC have approved more than 10 generic drugs this year, of which 2 are the first generic drugs

16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen.

Some of the first generic drugs that have been reported by companies since 2021

Note: with * is the first report

Source: Mi Nei Net Database

The competition among the three varieties of Shugeng Sodium Gluconate Injection, Aposterol Tablets, and Sacubatril and Valsartan Sodium Tablets is fierce

Sugammadex is the world's first selective relaxation antagonist for reversing neuromuscular blockers developed by Merck.

Apster is a PDE-4 inhibitor developed by Celgene (acquired by Amgen), with global sales of 2.
195 billion U.
S.
dollars in 2020, and import approval in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.

Sacubitril and Valsartan is an angiotensin receptor/enkephalinase inhibitor developed by Novartis.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.

Five varieties of osimertinib mesylate tablets, mabaloxavir tablets, ibrutinib capsules, selepagram tablets, and idoxaban tosylate tablets are exclusively reported for production
.

Osimertinib is a third-generation EGFR-TKI developed by AstraZeneca.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.

Mabaloxavir is an anti-influenza single-dose oral drug with a new mechanism of action jointly developed by Shiono Yoshio/Roche, and is the third batch of clinically urgently needed overseas new drugs
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.

Ibrutinib is the world's first BTK inhibitor developed by Johnson & Johnson/AbbVie.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.

Sleppug is an IP receptor agonist developed by Johnson & Johnson's Actylon.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.

Adoxaban is a new oral anticoagulant drug developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.

Policy and market blessings, the domestic first generic drug competition is becoming increasingly fierce

The first generic drug has always been one of the priorities of the domestic pharmaceutical companies’ R&D layout.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement, domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.

Compared with innovative drugs, the development difficulty and cost of the first generic drugs are lower.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.

In addition, the first generic drug is an extension of corporate strategy and deep cultivation of the field, such as Hengrui, Qilu, and Hausen, which focus on the field of anti-tumor, Zhengda Tianqing, which focuses on the field of liver disease, and Xinli in the field of anticoagulation.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.

At the same time, in recent years, the domestic drug reform policy has also given vigorous advancement in "encouraging the first generic drugs"
.

The first is the reform of the review and approval system
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.

The second is the period of market exclusivity
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.

With the ever-faster review and approval speed, the superposition of the "patent link system" and the introduction of the "first imitation exclusive period", and the deepening of domestic pharmaceutical companies' awareness of drug patents, the competition for first generic drugs will intensify in the future
.

Source: Mi Nei Net Database