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The implementation of the centralized procurement policy is like a "tiger" going down the mountain, completely subverting the pattern of China's generic drug industry
In the face of centralized procurement, generic drug companies are like stepping into the Colosseum.
Sooner or later, the golden sign of China's second largest pharmaceutical market in the world will surely attract the coveting of more and more global generic drug giants with cost and experience advantages
what to do? There are three questions to answer: 1.
Judging from the winning bids of the fifth batch of centralized procurement, centralized procurement is not just a game between multinational original research drug companies and local generic drug companies.
01 Teva opened and entered the game strongly
01 Teva opened and entered the game stronglyThe emergence of the world's largest generic drug company and Israeli generic drug giant Teva attracts attention
Judging from the fifth batch of selected varieties, there are 2 varieties of Teva that have entered the collection, namely Alfacalcidol soft capsules and Bendamustine Hydrochloride for injection
Judging from the list of candidates to be selected, Teva has a strong momentum in centralized procurement, and all the two varieties shortlisted for centralized procurement have won the bid
Alfacalcidol soft capsules were developed and produced by Danish Leo Pharmaceuticals.
Data from Meinenet shows that the sales of alfacalcidol have been relatively stable in recent years
At present, there are 8 domestic manufacturers of alfacalcidol soft capsules
Judging from the winning bid of Alfacalcidol soft capsules, Zhengda Pharmaceutical won the bid with the lowest price of 18.
In addition, the bendamustine hydrochloride for injection (Treanda) acquired by Teva in May 2011 also won the bid in this centralized procurement
Bendamustine hydrochloride for injection was developed by Cephalon and was approved for marketing in the United States in March 2008
It is worth noting that the bendamustine hydrochloride for injection of Jianjin Pharmaceutical, a domestic generic drug company that won the bid together with Teva, was included in the priority review in July 2020.
Teva's layout in China is not only in the field of generic drugs
Larry said that from a global perspective, the title of a generic drug giant does not prevent Teva from becoming an innovative pharmaceutical company
.
“Although generic drugs account for a large proportion of revenue, the proportion of specialty drugs revenue cannot be underestimated
.
" Damustine), is Teva's first real special drug product in China
.
Teva’s second innovative drug, Antaitan® (deuterated tetrabenazine tablets), was also approved in May 2020 for the treatment of chorea associated with Huntington’s disease (HD) and adult tardive dyskinesia (TD).
)
.
On the one hand, it successfully unlocked the generic drug business of "centralized procurement", and on the other hand, the special drug layout of two innovative products launched in China.
Whether Teva will continue to "open up" in the Chinese market in the future is worth looking forward to
.
02 Indian God of Medicine, and then enter the centralized procurement
02 Indian God of Medicine, and then enter the centralized procurementIn fact, Indian generic drug companies entered the market earlier than Teva
.
India, known as the "World Pharmacy", undertakes 20% of the global generic drug production every year
.
Over the years, generic drug companies from India are entering China, the world's second largest market, through various forms
.
The breakers appeared at the time of 4+7 centralized procurement and expansion in 2019
.
The bid price of 10mg olanzapine tablets under Dr.
Reddy's laboratory, a well-known Indian pharmaceutical company, was 6.
19 yuan/tablet
.
In the quotation for Olanzapine tablets, Dr.
Reddy became one of the three lowest-quoted pharmaceutical companies at a price of 6.
23 yuan/tablet (10mg), which was 35.
8% lower than the bid price of "4+7" and higher than Qilu Pharmaceutical's 2.
48 yuan/tablet, which is lower than Hausen Pharmaceutical
.
Dr.
Reddy’s winning bid price is about 55% lower than the previous national lowest quotation.
“Although the price reduction is so large, the purchase contract and zero sales cost after the 4+7 expansion can still ensure the company’s profitability”, Dr.
Reddy experiment CEO Erez Israeli pointed out: "Although the price of olanzapine tablets is very low, the sales volume will be larger, so the company still has room for profit, in fact, the net profit is higher
.
"
Previously, Indian pharmaceutical companies have been trying to enter the centralized drug procurement of China.
Dr.
Reddy’s selection of olanzapine also proved this possibility for subsequent Indian pharmaceutical companies
.
Israeli stated that Dr.
Reddy has achieved a "milestone victory" in the national expansion of 4+7 volume procurement, which also made Dr.
Reddy "the first Indian generic drug company to win a new round of national procurement in China.
" Company"
.
Some domestic pharmaceutical companies who participated in the bidding said that the appearance of Indian pharmaceutical companies in centralized procurement means that the Indian "tiger" has officially entered the Chinese pharmaceutical market.
This also means that in the future pharmaceutical market, the price of the pharmaceutical market will enter a price.
Descending channel
.
In addition to Dr.
Reddy, in the fifth batch of centralized procurement, Indian pharmaceutical companies once again won the bid
.
Sun Pharmaceuticals, the world's fourth-largest generic drug company, won the bid for bicalutamide tablets, quoting 195.
16 yuan/box, and the lowest unit price was 6.
97 yuan, which was a 75% decrease compared to the previous highest effective declaration price of 27.
88 yuan
.
03 World pharmacy, running into China
03 World pharmacy, running into ChinaIn fact, it is not surprising that Indian generic drug companies have appeared on the shortlist and selected list of China's centralized procurement
.
In the past, it was extremely difficult for Indian generic drugs to enter the Chinese market
.
According to data, from April 2017 to March 2018, India’s pharmaceutical exports amounted to US$17.
3 billion, of which 60% were exported to the European and American markets, but the Chinese market only accounted for 1% of exports
.
With the advancement of China's drug review reform and the opening of policies, the entry of Indian generic drugs into China has been accelerated
.
Whether it is the "Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs" in April 2018, which clearly promotes the internationalization of the generic drug industry and encourages overseas companies to establish R&D centers and production bases in China; or "4+7" in December of the same year.
"In the pilot program, the imported generic drugs corresponding to the products that have been marketed by the original research manufacturers in China or Japan will likely be approved first.
This allows Indian generic drugs with clinical value and price competitive advantages to accelerate imports and win the domestic market.
Machine
.
In June 2019, the China-India Drug Regulatory Exchange Conference was held in Shanghai
.
At the exchange meeting, the two parties conducted extensive exchanges on topics such as the relevant regulations, policies and technical requirements for the registration of imported drugs in China and India, overseas inspection and compliance guidelines for drugs, Chinese drug bidding procurement policies and procedures, and China-India pharmaceutical industry cooperation
.
At this point, India's generic drug giants have begun to "gear up their hands" for entering the Chinese market
.
From the perspective of the layout of Indian pharmaceutical companies entering the Chinese market, it is one of the shortcuts to seize the market with price advantages through centralized procurement
.
Of course, the way Indian pharmaceutical companies deploy the Chinese market does not stop there
.
Take Sun Pharmaceuticals, which has just won the bid in the fifth batch of centralized procurement, as an example.
As the world's fourth largest generic drug company, it has continued to deploy in China in recent years
.
In August 2019, Sun Pharmaceuticals and CMS reached a cooperation agreement, granting CMS the exclusive right to develop and commercialize 7 generic drugs in mainland China.
The license is valid for the first time the product is marketed in the region.
Twenty years from now
.
After the completion of this cooperation, Sun Pharmaceuticals has authorized 8 generic drugs to Kangzhe Pharmaceuticals, and the total drug market value is as high as 1 billion U.
S.
dollars
.
"China has more than 65% of the global generic drug market, which provides important opportunities for generic drug companies, and cooperation with Chinese companies also allows Sun's generic drugs to gain a foothold in the Chinese market
.
" The person in charge of Sun Pharmaceuticals Zeng said
.
At the second CIIE in November of the same year, AstraZeneca and Sun Pharmaceuticals signed a cooperation agreement, which will be responsible for the introduction and promotion of various oncology products of Sun Pharmaceuticals in China
.
Sun Pharmaceuticals said that the cooperation with AstraZeneca will also help more Chinese patients and doctors to use Sun Pharmaceuticals products
.
In addition to business cooperation, establishing a sole proprietorship or joint venture in China for localized development is also a common choice for Indian generic drug companies
.
According to incomplete statistics, a number of global generic drug giants from India, including Arabindo and Dr.
Reddy, entered the Chinese market
.
Dr.
Ruidi entered China as early as 2000, and established a joint venture with Canada's Longdeng Group to establish Kunshan Longdeng Ruidi Pharmaceutical Co.
, Ltd.
(KRRP), which is located in Kunshan Economic and Technological Development Zone
.
Since then, Dr.
Ruidi has also completed production in China and established Dr.
Ruidi (Wuxi) Pharmaceutical Co.
, Ltd.
in Wuxi
.
In 2018, Arabindo reached a cooperation with Luoxin Pharmaceutical to jointly establish a joint venture company in China and jointly invest in R&D and production systems to introduce products in the respiratory field
.
In July 2019, Cipla Europe and Jiangsu Chuangnuo Pharmaceutical jointly invested US$30 million to establish a joint venture company to build a production base for inhalation products; Sihuan Pharmaceutical and Strides Pharmaceutical Sciences established a joint venture company to engage in drug registration and sales.
.
In January 2020, Longxiang Pharmaceutical's pharmaceutical preparation project with a total investment of US$200 million was started in Taizhou.
After it was completed and put into production, it will produce about 200 million injections (bottles) per year, with an annual output value of about 1.
6 billion yuan, and a profit and tax of 538 million yuan.
The products are planned to be sold to the US and EU markets
.
Longxiang Pharmaceutical Taizhou Co.
, Ltd.
is a Chinese company invested and established by Arabindo in October 2019.
This is also the second project invested by Arabindo in China after the cooperation with Luoxin Pharmaceutical
.
04 How to fight back and forth with local pharmaceutical companies
04 How to fight back and forth with local pharmaceutical companiesThe massive entry of Indian pharmaceutical companies will undoubtedly have an impact on China's generic drug industry
.
India’s generic drugs have been recognized by the world’s strictest drug regulation, including the United States.
The “low-cost and effective” Indian generic drugs are gradually opening the door to the Chinese market.
Some analysts pointed out that the entry of Indian generic drug companies will undoubtedly make domestic drug companies The competition intensifies
.
For today's Chinese generic drug companies, on the one hand, they have to face changes in policies such as centralized procurement and medical insurance negotiations, and on the other hand, they have to face pressure from multinational original research drug companies
.
In the future, it will also face the impact from overseas generic drug companies
.
Where is the way out for Chinese generic drug companies?
Is the generic drug business bigger and stronger, and an international route for generic drugs to go overseas?
Among the world's TOP10 generic drug companies, India has five seats, and none of them are from China! Who will be the integrator? As mentioned in the article, the main source of business income for global TOP-level generic drug companies is the US market
.
Whether it is the half-year protection system for the first generic drugs, or the encouragement of hospital pharmacies and pharmacies to use generic drugs, the US market has broad market and policy benefits for generic drugs
.
From the price point of view, comparing the prices of generic drugs in China and the United States, you will find that taking clopidogrel 75mg tablets as an example, the price of generic drugs in the United States is 0.
3 US dollars per tablet (approximately RMB 1.
97).
The price of the first bid was 3.
18 yuan/piece, and the lowest price of CSPC in the second expansion was 2.
44 yuan/piece
.
Obviously, if domestic generic drugs cannot reduce costs and sell them at lower prices, they will not be able to go overseas on a large scale and compete with top generic drug companies on the same stage
.
Of course, there are more generic drug companies that choose to embark on the road to innovation and determine the production of generic drugs and innovative drugs with high-tech barriers as the company's R&D direction
.
When the national centralized procurement and medical insurance negotiations become normal; when the original research drug accelerates into China, biotech gradually enters the harvest period; when the core product loses its bid, Xinlitai transfers two generic drugs for 84 million yuan to better focus on innovation Drug research and development; when the established pharmaceutical companies represented by Hengrui, Qilu, and Yangzijiang embark on the road of combining high imitation and innovation.
.
.
Undoubtedly, innovation is the eternal theme.
"A good strategic layout is something that generic drug companies in the process of innovation and transformation should pay particular attention to.
" There is a point of view
.