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The first generic drug has exploded! Hengrui, Kelun... 57 first-class generic drugs were approved

 Last Update: 2022-10-20
 Source: Internet
 Author: User

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The news of the approval of the first generic drug continues! Recently, Ke Lun, Shutai God, and Renfu have successively won the first imitation
.
Since the beginning of this year, 57 first-class generic drugs have been approved in China, involving 38 enterprises
.
Among the 57 first generic drugs, Kelun and Hengrui led the way, with 7 and 6 first generic drugs approved respectively; There are as many as 19 injections and 13 oral regular-release dosage forms; In 2021, the terminal sales scale of the generic drugs involved in the 9 first generic drugs in China's public medical institutions exceeded 1 billion yuan, of which 5 were the first imitations
of new dosage forms.

57 first-class generic drugs approved for marketing! Injections dominate the screen and the 3 major 100 billion markets are targeted

In the just-concluded golden autumn September, domestic pharmaceutical companies won a total of 9 first generic drugs (including the first imitation of dosage form, the same below), including Renfu Pharmaceutical's oxycodone hydrochloride sustained-release tablets and clobazam tablets, Simcere Pharmaceutical's edoxaban tosylate tablets, Kelun Pharmaceutical's brimonidine timolol eye drops and ceftriaxone sodium / sodium chloride injection for injection, Shutaishen's compound polyethylene glycol (3350) electrolyte powder and compound polyethylene glycol (3350) electrolyte oral solution, Jiangxi Yiyou Pharmaceutical's brohexine hydrochloride granules, Henan Taifeng Biologics Idecalcidol softgels
.

According to the author's statistics, in the first three quarters of 2022, a total of 57 first-time generic drugs were approved for marketing in China, involving 38 companies, and March and April were the peak periods of approval, with 11 and 10 first-time generic drugs approved for listing respectively, and February was the trough period, and the particles were not collected
.

In the first three quarters of 2022, the first generic drug was approved in China

The 57 first generic drugs cover 13 therapeutic categories, mainly focusing on digestive and metabolic drugs (13), nervous system drugs (9), cardiovascular and cerebrovascular drugs (7).

According to data from Intranet, in 2021, the sales scale of terminal digestive system and metabolic drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) will exceed 170 billion yuan, and the sales scale of neurological drugs and cardiovascular and cerebrovascular system drugs will exceed
100 billion yuan.

In terms of dosage form, as many as 19 injections among the 57 first generic drugs; There are 13 oral regular-release dosage forms, including as many as 12 ordinary tablets; There are 8 oral liquid agents, involving oral solutions and oral emulsions; There are 5 extended-release controlled-release dosage forms; 2 eye drops, chewable tablets, oral collapse tablets, inhalants, etc.
; There are 1 granule, powder, patch, gel, etc
.

According to data from Intranet, the sales scale of terminal western medicine injections in China's public medical institutions will exceed 620 billion yuan in 2021, a year-on-year increase of 10%, and the market share will approach 60%; The sales scale of a variety of dosage forms achieved rapid growth, with pastes rising by 40.
66%, gels and suppositories by more than 28%, inhalants by 26.
75% year-on-year, and solutions by 24.
66%
year-on-year.

8 varieties of more than 1 billion, 5 new dosage forms are eye-catching

The first generic drug has always been a contested place for soldiers, and the first imitation of large varieties is the focus of
attention in the industry.

Among the 57 first generic drugs, 9 of the generic drugs involved in the first generic drugs will have a terminal sales scale of more than 1 billion yuan in China's public medical institutions in 2021, including tacrolimus, ceftriaxone, valsartan amlodipine, compound polyethylene glycol electrolyte, brohexin, iopromide, ondansetron, levetiracetam, etc
.
Among them, the sales scale of tacrolimus exceeded 5.
5 billion yuan, the sales scale of ceftriaxone exceeded 3.
7 billion yuan, the sales scale of valsartan amlodipine exceeded 2 billion yuan, and the sales scale of compound polyethylene glycol electrolyte exceeded 1.
7 billion yuan
.

Among the 9 first generic drugs, in addition to iopromide injection, ceftriaxone sodium / sodium chloride injection for injection, levetiracetam sodium chloride injection, valsartan amlodipine tablets (II), compound polyethylene glycol (3350) electrolyte oral solution, compound polyethylene glycol (3350) electrolyte powder, brihexine hydrochloride granules, tacrolimus sustained-release capsules, ondansetron oral dissolving film and other 5 products are the first imitation
of the new dosage form.

Compound polyethylene glycol electrolyte is the first-line drug for chronic constipation, and the terminal sales scale of public medical institutions in China will exceed 1.
7 billion yuan in 2021, a year-on-year increase of 41.
63%, and Shutaishen occupies more than 30% of the market share
.
The compound polyethylene glycol (3350) electrolyte oral solution approved for marketing by Shutaishen fills the gap in the domestic polyethylene glycol (3350) drug market, and the compound polyethylene glycol (3350) electrolyte is the first polyethylene glycol special drug
for children to treat children's constipation in China.

Sales of terminal compound polyethylene glycol electrolyte in public medical institutions in China (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

Bromhexine is a commonly used phlegm drug for respiratory diseases, and the terminal sales scale of public medical institutions in China exceeded 1.
4 billion yuan in 2021, and Jiangxi Yiyou Pharmaceutical continued to lead
the market share.
The brohexine hydrochloride granules approved for marketing by Jiangxi Yiyou Pharmaceutical Co.
, Ltd.
provide a safe and effective new dosage form for children's drugs in China, filling the domestic gap
.

Sales of terminal brohexine in public medical institutions in China (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

Tacrolimus is the core basic immunosuppressant after transplantation, and tacrolimus capsules, ointments, injections, eye drops, sustained-release capsules and granules have been listed in China, and the terminal sales scale of public medical institutions in China will exceed 5.
5 billion yuan in 2021, a year-on-year increase of 11.
59%.

Hengrui Pharmaceutical's tacrolimus sustained-release capsules are the first imitation in China, and compared with the traditional tacrolimus immediate-release capsules, it can make the blood concentration more stable, significantly improve the compliance of transplant recipients, and improve the quality
of life of patients.

Sales of tacrolimus terminal in public medical institutions in China (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

Ondansetron is a commonly used clinical central antiemetic drug, the domestic market preparations are mainly ondansetron hydrochloride tablets, capsules, oral collapse tablets and injection, in 2021 in China's public medical institutions terminal sales scale of more than 1.
2 billion yuan, a year-on-year increase of 20.
80%.

As the first imitation in China, Hengrui Pharmaceutical's ondansetron oral dissolving membrane has the characteristics
of fast dissolution, convenient administration and high patient compliance compared with the traditional oral preparation of ondansetron.

Sales of Ondansetron terminals in public medical institutions in China (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

Hengrui and Kelun lead the way in competing for the annual "first imitation champion"

In the first three quarters of 2022, Kelun Pharmaceutical had a total of 7 first-time generic drugs approved for marketing, while Hengrui Pharmaceutical had 6 first-time generic drugs approved for marketing, and the two companies jointly competed for the annual "first-class generic champion"; Eight companies, including Qilu Pharmaceutical, Yangtze River Pharmaceutical, Renfu Pharmaceutical, Puli Pharmaceutical, Shutaishen, Xi'an Libang Pharmaceutical, Weigao Termo, and Hanmei Pharmaceutical, each had 2 first-class generic drugs approved for marketing
.

Since the beginning of this year, Kelun Pharmaceutical has had 16 generic drugs approved for marketing
.
Among them, 7 varieties are the first imitation + first in China to be evaluated, including brimonidine timolol eye drops, ceftriaxone sodium / sodium chloride injection for injection, tripagliptin succinate tablets, gadolinol injection, sildenafil citrate oral collapse tablets, medium and long chain fat emulsion / amino acid (16) / glucose (36%) injection, medium and long chain fat emulsion / amino acid (16) / glucose (30%) injection, etc
.
With the gradual realization of the generic drug pipeline laid out in the early stage, the company's product cluster advantages have been further strengthened
.

The approval of Kelun Pharmaceutical's first generic drug in the first three quarters of 2022

As the "first brother of innovative drugs" in China, Hengrui Pharmaceutical innovates and imitates both, and the Class 1 new drug revilutamide tablets approved for marketing this year are the first domestic AR inhibitors, and the 10 approved generic drugs are also remarkable
.
Among the 10 generic drugs, there are as many as 6 first-class generic drugs, including tacrolimus sustained-release capsules, diquafosoxol sodium eye drops, gadolinol injection, ondansetron oral dissolving film, acetaminophen mannitol injection, nimodipine oral solution; In addition, omega-3 fatty acid ethyl ester 90 softgels are the second in China, and medium and long chain fat emulsion/amino acid (16)/glucose (16%) injection is the third in China
.

The approval of Hengrui Pharmaceutical's first generic drug in the first three quarters of 2022

epilogue

With the continuous advancement of policies such as volume procurement and medical insurance negotiation, the pharmaceutical industry has accelerated the reshuffle, and the R&D strategies of domestic pharmaceutical companies have also been adjusted.

Under the increase of relevant encouragement policies, the research and development of new dosage forms of generic drugs, children's drugs, rare diseases, etc.
has gradually become a trend
.

Source: Intranet database, company announcement

Note: Intranet's "Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 9, if there are any omissions, welcome to correct!

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