In -depth report of the antibiotic industry in 2024： antibiotics intermediate, obvious variety differentiation, and continuous industrial upgrading

Antibiotic industry chain and intermediate related target

At present, the main categories of antibiotic drugs in China include cephalosporins, penicillin, macrolactone, carbonicochide, etc. The first three types of production process routes are mainly biological fermentation paths, that is, corn, soybeans, etc.Coccus, penicillin industrial salt, thiocyanicate and other core intermediates, and further synthesize antibiotic drugs.Carbon moldynes are mainly prepared by synthetic 4-AA intermediates, and then carbon moldyne drugs are obtained by adding side chains.

Industry policy: Development and Reform Commission restricts production capacity entry

On August 27, 2019, the National Development and Reform Commission reviewed and approved the "Industrial Structure Adjustment Guidance Catalog (2019)", and was released on October 30.The above catalogs are mainly divided into three categories of industrial structure adjustment guidance: (1) encouraging class; (2) limited classes; (3) elimination class.Among them, newicillin industrial salt, 6-amino penic acid (6-APA), chemical method production 7-amino cephalotic acid (7-ACA), chemical method production 7-amino-3-deodoxide cephalosporin acid(7-ADCA) production devices such as penicillin V, aminoininin, hydroxylinoin, and cephalosporin C fermentation are included in the restricted class.On July 14, 2023, the National Development and Reform Commission issued the "Industrial Structure Adjustment Guidance Catalog (2023, Draft for Soliciting Opinions)", and passed in December 2023 and implemented in February 2024.

National Development and Reform Commission: For new projects that are restricted categories, investment is prohibited.The investment management department does not approve or approve, and all financial institutions shall not issue loans. Natural resources, construction, ecological environment, water conservancy, market supervision, fire protection, customs and other departments shall not go through relevant procedures.Anyone who violates the regulations shall be held accountable for investment and financing construction.For the existing production capacity that belongs to the restrictions, it allows enterprises to take measures and upgrades within a certain period of time. Financial institutions continue to support support according to the principle of credit.

Restriction policy: The Health and Health Commission restricts abuse rather than disable, and the demand is still rigid

In order to control the further enhancement of bacterial tolerance, the Ministry of Health in 2011 conducted a special rectification of clinical application of antibacterial drugs in the country. In 2012, the "Administrative Measures for Clinical Application of Antibacterial Drugs" was promulgated., Price and other factors, are divided into three levels: non -restricted use, restricted use and special use level.The essence of the "restriction order" policy is to restrict antibacterial drugs that are not abused rather than disabled, and antibacterial drugs are as important categories in my country's pharmaceutical market, and the market has rigid demand.

The demand for the antibiotics market is stable, and the scale increases smoothly

The demand for the antibiotics market is stable, and the scale has increased smoothly.From the perspective of the terminal market, the market size of global antibiotic agents is more than $ 50 billion, and the domestic antibiotic market size is close to 200 billion yuan.The domestic market has declined since 2017 due to the implementation of restricted measures such as antibiotic drug grading management.Antibiotic products and markets mature, but due to rigid demand for clinical treatment of antibiotics, we expect the industry to maintain a steady growth.

Cephalosporin and penicillin are the main antibiotic varieties, accounting for over 70%

Cephalosporin and penicillin are the main antibiotic varieties.Antibiotic varieties are mainly divided into two categories: & beta; -lide and non-& beta; -Nramide, of which & beta; many varieties of lactide; wide clinical applications, subdivisions include cephalosporin, penicillin, carbonite, carbonite, carbonite, and carbonite, carbonite, and carbonite, and carbonite.Moralne, oxygen cephalosporin, etc.; Non-& beta; -lidamum subdivision includes macrolactone, amino glycoside, tetracycline, chloramphenicol, etc.From the perspective of antibiotic varieties, cephalosporin and penicillin antibiotics are the most important varieties. According to PDB data cephalosporin+penicillin 2022 sample hospital sales accounted for 56%.

6-APA: A Mo Xilin and other important antibiotics of antibiotics

As an important type of penicillin antibiotics, amoxicillin is composed of two parts, 1) "Mother Core", that is, 6-APA (6-APA). This part is the key part of penicillin antibacterial activity; 2) The side chain connected to the parent nucleus can stabilize the mother nucleus and increase the ability of disease -destructive bacteria by changing the structure of the side chain.At the same time, it can also expand the antibacterial spectrum, increase acid resistance, so that it can be taken orally, and to a certain extent reduces the possibility of crowd allergies.6-APA: As the mother nucleus of penicillin molecules, it is an important intermediate to produce semi-synthetic penicillin amoxicillin and ammonia crickets (sodium).

6-APA: The industry has entered high barriers, and the production capacity of head enterprises is concentrated

The industry has entered high barriers.6-APA generally uses biological fermentation method integration production. According to data released by the Indian Chemical Pharmaceutical Industry Society, the total domestic 6-APA output in 2019 is 36,700 tons, and the export is 0.24 million tons.Due to the large investment in production links, large sewage treatment volume, and high environmental protection requirements, the national "Industrial Structure Adjustment Guidance Catalog" restricts new enterprises to enter the industry, so the 6-APA industry has a higher barriers to enter the barriers.The capacity concentration of head enterprises is high.At present, the demand for the 6-APA market is about 30,000 tons/year. The largest domestic production capacity of domestic enterprises is the federal pharmaceutical. The production capacity is about 18,000 tons/year, and the production capacity of Wikida is about 7,000 tons/year (the official website is 9,000 tons/year), Sichuan -Ning's biological output is about 6,700 tons/year.

6-APA: The price of factors such as raw material costs is increased, and the competition pattern is relieved

The price of 6-APA has been fluctuating before, and the price has continued to increase since 2020, mainly in the following factors: 1) the cost of raw material costs.The market prices of corn and soybean oil that produced 6-APA's main fermentation raw materials for biological methods have risen, bringing the production costs to gradually increase.2) Increase the cost of manufacturing.The short -term suspension caused by public health prevention and control has brought about rising manufacturing costs, and in some periods to actively reduce the manufacturing costs caused by market demand to increase.3) Optimization of competition pattern.Due to the stricter of environmental protection requirements and the continuous improvement of environmental protection costs in recent years, the competition pattern brought by the withdrawal of the original capacity has been relieved.

6-APA: The demand of downstream terminal products is of rigid demand, and the proportion of out-of-hospital markets continues to increase

6-APA's main terminal product Amoxicillin is one of the most commonly used anti-inflammatory antibacterial drugs. It has a wide range of channels. It is sold in hospitals, pharmacies and online pharmacies in hospitals.From the perspective of the channels, the sales of Amoxicillin in the hospital market in 2020 have declined. Amoxicillin was selected in the second batch of collection and began in April 2020. The price of the collection in the collection is about 33%compared with the declared price.However, the decline in Amoxicillin is less than cephalosporin drugs. The main reason is that Amostalin has a large proportion of non -hospital sales markets. The proportion of retail sales of pharmacy has continued to increase. In 2021, sales exceeded the sales level in 2019, which is 7.14 from 2020, which is 7.14 from 2020.%, The proportion of out -of -hospital markets accounted for 60.15%.

6-APA: Benefiting from the increase in the unit price of sales, the gross profit margin is steadily increased

6-APA's gross profit margin is steady and rising: taking Sichuan-Ning's biological income and cost structure as an example, the gross profit margin dropped to less than 30%in 2019 was mainly affected by the fluctuation of the unit price of sales, and the gross profit margin from 2020-2021 rose to about 30%, 2022H1 2022H1As the unit price of 6-APA sales increased, the gross profit margin increased to more than 40%.At present, the market price of the 6-APA is still maintaining a good level. We expect the company's 6-APA business gross profit margin to perform well in 2023.

6-APA: The cost end has risen, and the price increase of raw materials is the core reasonAhmedabad Investment

The cost side has been improved due to the factors of raw material price increases: taking the cost structure of the biological cost of Chuanning, the cost of the company's 6-APA unit rose from 92.17 yuan/kg in 2019 to 124.22 yuan/kg of 2022H1, and the unit cost of unit cost in 2020-2022The changes were 0.47%, 15.03%, and 16.62%, respectively.

Cost splitting: 6-APA unit cost central materials and manufacturing costs are the main part. The proportion of raw materials in the unit cost is more than 60%, and the manufacturing costs are more than 30%.In the past three years, the cost of 6-APA units has risen mainly due to the rise in raw materials (2020-2022h1, respectively +5.6%,+11.0%,+13.6%) and the improvement of manufacturing costs (2020-2022h1, respectively -7.4%,+26.4%,+22.9%, respectivelyTo.The raw materials are mainly affected by the rise in the price of raw materials such as corn, soybean cake powder, soybean oil, and soybean oil; the manufacturing cost is related to the short -term stop work caused by public health prevention and control and some periods to actively adjust production capacity according to market demand.

Analysis of 6-APA in the industry 6-APA in recent years

At present, the heads of the 6-APA industry mainly include federal pharmaceuticals, Sichuan-Ning Bio, and National Medicine Wittada. In addition, Sinoccal Disman and Changsheng Pharmaceutical also have certain production capacity but are based on their own use. They are basically not exported.In recent years, the output of 6-APA in the first three companies has a total of about 30,000 tons, and the total export volume is 18-19,000 tons.

Penicillin industrial salt: antibiotic intermediate with extensive use

Peloxycin industrial salt includes penicillin G potassium salt, sodium salt, V potassium salt, etc., and penicillin G potassium salt is the raw medicine for all penicillin and some cephalosporin antibiotics. It can be used to synthesize 6-APA, 7-ADCA (cephalosporin, cephalosporin, before cephalosporin,), 7-ACCA (cephalosporite front body), GCLE and other intermediates or directly produce penicillin potassium, sodium penicillin, and potassium clavanateHyderabad Wealth Management. It is a key part of the antibiotic industry. It is extremely important in the antibiotic industry as the antibiotics industry.The bridge effect.

Penicillin industrial salt: domestic companies meet most global production capacityNagpur Investment

The current demand for global penicillin industrial salt is about 60,000 tons/year to 70,000 tons/year.The production capacity of penicillin G potassium salts in my country has gradually increased from one of the three points of the world's total production capacity in the early 1990s to most of the world's production capacity.At present, there are many domestic production enterprises. According to the data of the Foresight Industry Research Institute, the production capacity of the stone medicine group is 18,000 tons, and the production capacity of Henan Huaxing is 12,000 tons.In addition, companies in the industry include North China Pharmaceuticals, Federal Pharmaceuticals, State Pharmaceutical Weichida, and Chuanning Bio.About 50%of the lower reaches of penicillin G potassium are used as raw materials for 6-APA and nearly 30%are used for export.Since 2020, the market price of penicillin G potassium has continued to rise, and it is still at a high level.

Penicillin g potassium salt: higher prices have brought about sales unit price and gross profit margin increase

Taking Chuanning's biological income and cost structure as an example, the company's penicillin G potassium salt business has benefited from the higher product prices since 2020, and the unit price and gross profit margin of sales have increased.32.35%and 47.01%.Price rise is related to factors such as the impact of public health prevention and control, the increase in raw materials cost, and the rise in manufacturing costs.

Penicillin g potassium salt: The cost end is similar to 6-APA, and raw materials and manufacturing costs increase

The cost side has been improved due to the factors of raw material price increases: taking the cost structure of the biological cost of Chuanning as an example, the cost of penicillin G potassium salt units rose from 54.39 yuan/kg in 2019 to 78.86 yuan/kg of 2022H1, 2020-2022 unit unitsThe range of cost changes was 0.47%, 15.03%, and 16.62%, respectively.

Cost splitting: The proportion of raw materials in the cost of penicillin G potassium salt units accounted for about 60%, and the manufacturing cost was 30-40%.The cumulative increases of raw materials and manufacturing costs were 39.1%and 62.4%compared with 2019, respectively.Raw materials are mainly affected by the rise in market prices of major fermentation raw materials in corn, soybean cake powder, soybean oil; manufacturing costs are related to the short -term stop work caused by public health prevention and control and actively adjusting production capacity according to market demand.

India: The PLI plan tries to reduce dependence on Indian ingredients, but the total investment is limited

Proposal institution: The Department of Pharmaceuticals, which is established under the Ministry of Chemicals & Frtilizers.Background: Since 2020, in order to ensure the resistance of external impact, strengthen drug safety, and improve the domestic production capacity of key raw materials and high -value products, the Indian Pharmaceutical Bureau has launched three production linked inspiration plans, PLI) to motivate domestic and Indian domestic participants to strengthen investment and production of these products categories, involving: 1) Incentives for Materials Drug Production Links (PLI 1.0);) Grand Pharmaceutical Park Plan.In terms of government fund investment, the investment of the PLI plan of the raw medicine drug and the large pharmaceutical park plan is limited, and the core of the funding is planned to the pharmaceutical PLI plan.

PLI 1.0: involved 53 dependence on imported raw materials and drug categories

Background: India has previously relying on imports. According to the previous disclosure of Indian government departments, India's imported raw materials are mainly due to economic considerations.In fiscal 2018-19, raw medicines account for 63%of the total imports of Indian drugs.To this end, the Pharmaceutical Safety Commission established by the Indian Pharmaceutical Bureau has compiled the detailed information of India's imported raw materials and determined 53 53 raw materials that are seriously dependent on imports.

The fermentation and chemical synthesis are involved. The single variety subsidy is limited and distributed in six years

Objective: Realize the self -reliance of key raw medicines and reduce import dependence. On March 20, 2020, the Indian government approved the "PLI Plan" to promote key raw materials (KSM)/drug intermediate (DI) and activityDrug composition (API) is produced in India.The plan determines 41 Eligible Products, which covers the aforementioned 53 substances.41 qualified products are involved in the direction of fermentation and chemical synthesis, and qualified manufacturers will receive economic rewards.However, from the perspective of the overall subsidy subsidy of the raw and drug, the single variety subsidy is limited and the score is issued. The core investment is completed by the enterprise.

Chuanning Bio: The middle of the middle body fermentation capacity industry, the strategic layout of synthetic biology

The company currently has three categories of intermediate varieties, and the fermentation capacity is at the forefront of the industry: penicillin has 10,000 tons of production capacity, and large ringlodes and cephalosporins are 3,000 tons of fermentation capacity.Strategic layout synthetic biology help industrial upgrading.In recent years, the company has vigorously deployed the synthetic biology field through the "biological fermentation" and "synthetic biological" two -wheel drive strategy.The company's layout advantage in the field of synthetic biology can be summarized as the following three aspects: 1) Underworld raw materials: high -quality and low -cost raw material supply and supporting facilities; 2) front -end research and development: Establish a Mengshi Research Institute and actively build a platform;There are 10,000 tons of production capacity and rich experience accumulation; the geographical advantages of newly built Gongliu base are obvious.

Federal Pharmaceutical: Antibiotic Full Industry Chain Lottery, vertical integration and innovation transformation continues to advance

The layout of the entire industry chain has continued to advance.The company has an intermediate-the entire industrial chain in the antibiotic field-the raw and drug-preparation, especially in the field of semi-synthetic penicillin. In terms of intermediate 6-APA/penicillin G potassium salt production capacity exceeds 20,000 tons, semi-synthetic penicillin and the production capacity of the drug production capacity alsoAt the level of 20,000 tons and the capacity utilization rate, the company has deployed amoxicillin capsules and potassium of amoximelin cavate in the downstream preparations to complete the layout of the entire industry chain and through its own intermediate and raw and drug advantages.Pioneering preparation market.It is worth noting that the company's export proportion of semi -synthetic penicillin intermediate in recent years has reduced the trend, the overall value chain has shifted downstream, and the vertical integration of industrial upgrading has continued to advance.

R & D and innovation accelerate.In 2023, the company's R & D investment was 808 million yuan, a year -on -year increase of 36.2%.At present, there are 39 new products in the company's development, of which 19 are one type of new drugs.Progress of the corresponding varieties of research and development and listing will continue to improve the company's competitiveness and creativity.

(This article is for reference only, does not mean any investment advice of our investment. If you need to use the relevant information, please refer to the original report.)

Kanpur Investment