Zhifei Biological (SZ300122) Tuberculosis Vaccine Market Space Calculation Report

Based on collected market data and policy information, I now provide you with a systematic and comprehensive

:

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Zhifei Biological was founded in 2002 and listed on the Growth Enterprise Market (GEM) of the Shenzhen Stock Exchange in September 2010, making it the first private vaccine enterprise to be listed on the GEM. It is an international, full-industry-chain high-tech biological enterprise integrating R&D, production, sales, promotion, distribution, and import and export of vaccines and biological products.

Product Name	Brand Name	Launch Year	Indication	Product Type	Competitive Position
Recombinant Mycobacterium Tuberculosis Fusion Protein	Yika®	2020	Diagnosis of Mycobacterium tuberculosis infection	In-vivo Diagnostic Reagent	Leading in China
Injectable Mycobacterium vaccae	WeiKa®	2019	Prevention of latent Mycobacterium tuberculosis infection	Therapeutic Vaccine	World’s First, Exclusive
Freeze-dried Intradermal BCG Vaccine	-	Clinical Phase	Tuberculosis Prevention	Prophylactic Vaccine	In R&D Pipeline

: In the first three quarters of 2025, Zhifei Biological’s self-developed products achieved revenue of approximately 5.0 (RMB 100 million), accounting for about 10.15% of total revenue, while tuberculosis products accounted for about 10-15% of self-developed products [1][2].

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Based on the World Health Organization’s 2025 Global Tuberculosis Report and data from the Chinese Center for Disease Control and Prevention [3][4]:

Indicator	2024 Data	Change from 2023
Estimated number of new tuberculosis cases	696,000 cases	Down 5.8%
Incidence rate	49 per 100,000	Entered the list of low- and medium-incidence countries for the first time
Estimated multidrug-resistant/rifampicin-resistant tuberculosis	25,000 cases	Account for 7.1% of the global total
Latent tuberculosis infection rate	Approximately 18%	-
Population with latent infection	Approximately 250 million people	-

Core goals of the National Tuberculosis Prevention and Control Plan (2024-2030) [3][4][5]:

Time Node	Target Indicator
2025	Incidence rate reduced to below 50 per 100,000; coverage rate of preventive treatment for close contacts reaches 60%
2030	Incidence rate reduced to below 43 per 100,000; coverage rate of preventive treatment reaches 80%

:

• Jointly released by nine ministries and commissions, with 15 government departments included in the responsibility framework
• The “Tuberculosis-Free Community” pilot program expanded from 36 in 2022 to 790 in 2024 [4]
• The national number of people receiving preventive treatment increased from 22,778 in 2021 to 87,034 in 2024 [4]

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Population Category	Scale	Screening Policy
Close contacts of tuberculosis patients	5 million people	Key screening
HIV-infected individuals	1.2 million people	Routine screening
Diabetic patients	140 million people	Recommended screening
Immunosuppressant users	50 million people	Recommended screening
Dialysis patients	8 million people	Recommended screening
Silicosis patients	6 million people	Key screening
School teachers and students (enrollment/employment)	20 million people	Routine screening
Elderly population (aged 65 and above)	200 million people	Recommended screening
Total	Approximately 430 million person-times/year	-

:

• Unit test price: Approximately RMB 50
• Penetration rate in 2024: Approximately 8%
• Target penetration rate in 2030: Approximately 30%

Year	Penetration Rate	Market Scale (RMB 100 million)	Zhifei Biological’s Accessible Revenue (30% Market Share, RMB 100 million)
2024	8%	17.2	2.6
2027	18%	38.7	11.6
2030	30%	64.5	19.4

According to industry data [6], the competition pattern of the skin test diagnosis market in 2024:

Product	Manufacturer	Market Share	Product Features
TB-PPD	Simcere Xiangrui (Exclusive)	Approximately 84%	Traditional product, included in medical insurance
EC Diagnostic Reagent	Zhifei Biological	Approximately 15%	Next-generation product, not affected by BCG vaccination
BCG-PPD	Chengdu Institute	Approximately 1%	Non-mainstream product

:

• Zhifei Biological’s EC reagent faces fierce competition from Simcere Xiangrui’s TB-PPD (84% market share) [6]
• As a next-generation product, the EC reagent has obvious technical advantages (not affected by BCG vaccination)
• Zhifei Biological’s Xs02 (Phase III clinical trial) may become an iterative product of TB-PPD

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• World’s First
  : The only product globally that has completed clinical research on prevention for populations with latent Mycobacterium tuberculosis infection
• Exclusive Advantage
  : No direct competing products
• Technical Barrier
  : The technology for Mycobacterium vaccae vaccines has high R&D barriers

:

• Population with latent tuberculosis infection: Approximately 250 million people
• Cost per treatment course: Approximately RMB 1,200 (RMB 200 × 6 doses)
• Current treatment rate: Approximately 2%
• Target treatment rate in 2030: Approximately 12%

Year	Treatment Rate	Market Scale (RMB 100 million)	Zhifei Biological’s Accessible Revenue (85% Market Share, RMB 100 million)
2024	2%	60.5	51.4
2027	6%	181.4	154.2
2030	12%	362.9	308.4

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Year	EC Diagnostic Reagent (RMB 100 million)	WeiKa® Vaccine (RMB 100 million)	Total Revenue (RMB 100 million)
2024	2.6	51.4	54.0
2027	11.6	154.2	165.8
2030	19.4	308.4	327.8

Scenario	Diagnostic Penetration Rate	Treatment Rate	WeiKa® Market Share	Total Revenue (RMB 100 million)
Conservative Scenario	20%	8%	80%	206.4
Base Scenario	30%	12%	85%	327.8
Optimistic Scenario	40%	18%	90%	515.7

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Business Type	First Half of 2025 (RMB 100 million)	Revenue Share	Gross Profit Margin
Agent Products	Approximately 43.7	~90%	Approximately 22.6%
Self-Developed Products	Approximately 5.0	~10%	Approximately 80%+
Tuberculosis Products	Approximately 0.5-0.8	10-15% of self-developed products	High gross profit margin

Time Node	Estimated Total Revenue of Zhifei Biological (RMB 100 million)	Tuberculosis Product Revenue (RMB 100 million)	Revenue Share
2024	Approximately 442	Approximately 5-8	Approximately 1-2%
2030 (Base Scenario)	Assumed to maintain current level	Approximately 327.8	Approximately 74%

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• Strong Policy Promotion
  : The National Tuberculosis Prevention and Control Plan (2024-2030) clearly sets a target of 80% coverage rate
• Large Room for Penetration Improvement
  : The current prevention intervention rate is only 2-3%, with a policy target of 80%, representing a growth space of approximately 30 times
• Obvious Technical Advantages
  : EC reagent is a next-generation product, and WeiKa® is a globally exclusive product
• High Gross Profit Margin Feature
  : The gross profit margin of self-developed products is over 80%, significantly higher than that of agent products (~23%)

• Intensified Market Competition
  : TB-PPD still accounts for 84% of the market share, posing challenges to the promotion of EC reagents
• Policy Implementation Below Expectations
  : Local fiscal pressure may affect funding for screening
• Limited Revenue Contribution
  : Tuberculosis products currently account for less than 2% of the company’s total revenue, with limited short-term contribution
• Inventory and Capital Pressure
  : Inventory reached 202 (RMB 100 million) in the first three quarters of 2025, with significant debt pressure [1][2]

Zhifei Biological’s tuberculosis products have

, but their short-term performance contribution is limited:

Time Horizon	Evaluation Conclusion
Short-Term (1-2 Years)	Tuberculosis product revenue is expected to reach RMB 500 million - 1 billion, with limited impact on performance
Mid-Term (3-5 Years)	Driven by policies, it is expected to achieve a revenue scale of RMB 5-10 billion
Long-Term (Over 5 Years)	If policy goals are fully achieved, it can contribute RMB 20-30 billion in revenue

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Zhifei Biological has deployed a complete product matrix of

in the tuberculosis vaccine field. As a world’s first product, WeiKa® has unique competitive barriers. Benefiting from the policy promotion of the national National Tuberculosis Prevention and Control Plan (2024-2030), the long-term market space for tuberculosis products is vast, and Zhifei Biological’s accessible market space is expected to reach approximately by 2030.

However,

, tuberculosis products still contribute little to the company’s performance (accounting for an estimated 1-2% of revenue), and face competitive pressure from competitors such as TB-PPD. The company is still dominated by agency business, and the decline in its HPV vaccine business has brought significant performance pressure.

: It is recommended to pay attention to the progress of penetration rate improvement of tuberculosis products and the increase in the proportion of self-developed products. The tuberculosis business can serve as a key support for the company’s long-term strategic transformation.

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[1] Losses Widen, Market Value Hits 5-Year Low, What’s Wrong with the “Vaccine King”?

[2] “Vaccine Leader” Turns to Debt to Survive, Zhifei Biological Secures RMB 10.2 Billion Syndicated Loan

[3] China Becomes a Low- and Medium-Incidence Tuberculosis Country for the First Time

[4] WHO Report Praises China’s Tuberculosis Preventive Treatment Practice for Contributing to Global Efforts to End Tuberculosis Epidemic

[5] World Tuberculosis Day: Overcoming the “Last Mile” to End Tuberculosis

[6] Announcement of Beijing Leadman Bio-Pharmaceuticals Co., Ltd. Regarding the Reply to the Inquiry Letter from the Shenzhen Stock Exchange