Qilu, Yangzijiang and Kelun are leading the way!

On January 30, 2022, the "14th Five-Year Plan for the Development of the Pharmaceutical Industry" was released.
The data shows that during the "13th Five-Year Plan" period, 964 of 278 varieties passed the quality and efficacy consistency evaluation of generic drugs
.
For this plan, the industry interprets it as "welcoming the era of innovative drugs"
.
So, what about generic drugs? Under the tone of the "14th Five-Year Plan", where are the opportunities for generic drug project approval? Industry Competition Landscape Chemical Drug Classification Reform Brings Two Opportunities for Generic Drugs The chemical drug registration classification reform launched in 2015 has the greatest impact on the industry.
Expired original research products, after the first generic drugs are on the market, enjoy the same price treatment as the patent expired original research drugs, which is expected to segment the market opportunities for patent expired original research drugs; Sexual evaluation (including deeming) will have the opportunity to divide
.
After all, the consistency evaluation of chemical generic drugs advocates the opportunity for new entrants to divide up the original stock market
.
The centralized procurement rules are online, and the opportunity to "realize" adds three conditions Beginning in 2019, the centralized procurement rules will be launched
.
The initial investment of enterprises without knowing the bidding rules finally came to fruition - the more products that manufacturers put in, the more intense the price competition and the lower the price
.
The "realization" of the two opportunities mentioned above must also meet three conditions: 1) The product enters the centralized procurement; 2) The product of the manufacturer must be approved before the deadline for the centralized procurement registration; 3) The cost of the product must be low enough and low To be able to win the bid but also have a profit
.
This means that only companies with strong R&D strength in generic drugs, able to obtain approval before the deadline for centralized procurement registration, and well-controlled production costs can win the opportunity - but whether they can win profits depends on the winning bid price and the cost of production.
Obtained market size
.
The distribution of TOP10 generic drug companies Stronger pharmaceutical R&D and production capabilities
.
The top ten domestic generic drug companies are Qilu Pharmaceutical, Yangzijiang, Kelun Pharmaceutical, Chia Tai Tianqing, CSPC, Jiangsu Hansen, Fosun Pharmaceutical, Jiangsu Hengrui, Huahai Pharmaceutical and Beite Pharmaceutical
.
The group headquarters of the top ten domestic generic drug companies are mainly from Hebei, Shandong, Jiangsu, Shanghai, Zhejiang and Sichuan, and no company with group headquarters in Beijing or Guangdong has been squeezed into the top ten
.
The best-performing enterprise in Guangdong is Dongyang Sunshine, with a total of 11 national centralized procurement bids for products
.
"14th Five-Year Plan" engine Which areas have great potential? According to the goals of the 14th Five-Year Plan, implement major national strategies such as the coordinated development of the Beijing-Tianjin-Hebei region, the development of the Yangtze River Economic Belt, the construction of the Guangdong-Hong Kong-Macao Greater Bay Area, and the integrated development of the Yangtze River Delta, and promote the rational distribution and orderly distribution of the pharmaceutical industry nationwide.
transfer
.
At present, the Yangtze River Delta has a good foundation for generic drugs, and generic drugs in other regions still have great potential for development
.
Which ten key support cities? The "14th Five-Year Plan" hopes to focus on supporting about 10 cities with good pharmaceutical innovation foundation and concentrated scientific and technological resources, connecting with international innovation resources, attracting innovative enterprises to gather, and developing into the main engine of new industrial kinetic energy
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Give full play to the technological spillover effect of the innovation highland, drive the coordinated development of surrounding areas, and form a high-level pharmaceutical industry cluster with complementary regional resources and deep integration of industrial chains
.
Can Beijing, Guangzhou and Shenzhen be among the 10 cities? Are cities in Guangdong more willing to invest in medical equipment? Can the original drug production resources in these cities be considered to develop drug-device combination products together with local devices? Combination products of medicine and equipment belong to the scope of the chemical medicine technology research project of the "14th Five-Year Plan"
.
Target? Short board area? Economic globalization has encountered adverse currents, and the reshaping of the industrial chain and supply chain has been accelerated.
At present, the industrial ecology of the coordinated development of large and medium-sized pharmaceutical manufacturing enterprises in China has not yet been formed, and the industrial concentration is not high.
The operating income of the top 100 enterprises in 2020 will account for more than 30%
.
In terms of supply security, the ability to respond to major public health events needs to be enhanced.
Enterprises are less motivated to develop drugs for rare diseases and children's drugs, and there are still supply risks for small varieties of drugs.

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In terms of manufacturing level, the quality control level of generic drugs, excipients, packaging materials and other fields still needs to be improved, and the green production and layout of APIs still need to be solved
.
The "14th Five-Year Plan" expects that by 2025, the industrial chain and supply chain will be stable and controllable: the advantages of large-scale and systematic pharmaceutical manufacturing have been further consolidated, a number of key common technologies for industrialization have made breakthroughs, and positive results have been achieved in key areas to supplement shortcomings.
A group of key enterprises with industrial ecological leadership and driving ability in subdivided fields; supply guarantee capacity continues to increase: major disease prevention and treatment drugs, protective materials and diagnosis and treatment equipment are in sufficient supply, and the medical reserve system has been improved; The supply of medicines is stable, and the guarantee capability of a batch of medicines for children and rare diseases urgently needed in clinical practice has been enhanced; the manufacturing level has been systematically improved: the quality management of medicines throughout the life cycle has been strengthened, and the number of generic medicines that have passed the consistency evaluation has been further increased; enterprises are green, digital, and The level of intelligent development has been significantly improved, the level of safety technology and management has been effectively improved, and the ability to manage and control production safety risks has been significantly enhanced
.
Six Project Opportunities For domestic generic drug companies, the opportunities may come from the following six aspects: 01.
Products that may not be centrally sourced - shortage of essential drugs, children's drugs, and emergency medicines may be included in online purchases , enterprises can consider the products on the national shortage drug list and the key monitoring list of clinically necessary and vulnerable drugs
.
02.
Expired drugs whose clinical needs have not been met on the "Catalogue of Encouraged Generic Drugs" should pay attention to the generic development of such products: if there are many generic manufacturers, they will face centralized procurement
.
The number of imitation manufacturers of projects with ordinary technical difficulty will be more, which will lead to intensified competition
.
03.
Preparations in the Pediatric Hospital Undertake the generic drug project of the preparations produced in the Pediatric Hospital according to the company's own GMP production conditions
.
At present, such projects mainly lack the approval process, and the products produced can only be sold in the pediatric hospital, not outside the hospital.

.
04.
Dosage forms for which consistency evaluation cannot be initiated.
Since only oral solid preparations and injections can initiate consistency evaluation, product approvals for which consistency evaluation cannot be initiated will not be affected by consistency evaluation.
It can be considered that the number of approved companies is small and has market potential.
's products
.
The imitation of dosage forms that do not start the consistency evaluation is expected to snatch the market of the original manufacturers, because according to the policy, after the 3 manufacturers have passed the consistency evaluation, the manufacturers that have not passed the consistency evaluation cannot be sold in the terminal of medical institutions
.
In addition, the "14th Five-Year Plan" encourages qualified enterprises to take the lead in carrying out the consistency evaluation of other dosage forms other than oral solid preparations and injections
.
However, if there is no supporting technical guidance document, even if the enterprise studies it, it is very likely to face the same situation as the injection, and it will not be accepted or will not be reviewed and approved even if it is accepted
.
05.
Preparations using only niche excipients and packaging materials The developed preparation products must, but only have imported pharmaceutical excipients and packaging materials, in order to meet the requirements of generic drug consistency evaluation and preparation internationalization
.
The biggest difficulty of this type of project is: if it is too niche auxiliary materials and packaging materials, the market scale is not large, and the development willingness of auxiliary materials and packaging materials enterprises is not high.
Usually, the development of auxiliary materials and packaging materials is promoted under the needs of project research and development
.
06.
Complex preparations Complex preparations have the characteristics of high selectivity, long-term sustained and controlled release, etc.
, including: injections such as microspheres, oral preparations such as sustained and controlled release, and multi-particulate systems, transdermal, implanted, inhaled, and oral dissolving film administration systems, drug-device combination products,
etc.
The development of these products still has to face centralized procurement, but compared with ordinary preparations, relatively few manufacturers have overcome complex preparations
.
Among them, the current centralized procurement data of sustained and controlled release dosage forms show that the leading enterprises have basically conquered this technology, and the cost is controllable
.