CSTONE Pharmaceuticals Co., Ltd. 2025 Annual Report Summary

Stock Code: 300765 Stock Abbreviation: XinNuoWei Announcement No.: 2026-018

I. Important Reminders

This summary of the annual report is derived from the full annual report. To fully understand the company’s operating results, financial condition, and future development plans, investors should carefully read the full annual report published through the media designated by the China Securities Regulatory Commission.

All directors attended the board meeting that reviewed this report.

Deloitte Huayong Certified Public Accountants (Special General Partnership) issued an unqualified opinion on the company’s financial statements for the year.

Non-standard audit opinion indication

□ Applicable √ Not applicable

The company was not profitable at listing and has not yet achieved profitability.

□ Applicable √ Not applicable

The profit distribution plan or capital reserve conversion plan approved by the board of directors for the reporting period.

□ Applicable √ Not applicable

The company plans not to distribute cash dividends, not to send bonus shares, and not to convert capital reserves into share capital.

The profit distribution plan for preferred shares approved by the board of directors for this reporting period.

□ Applicable □ Not applicable

II. Basic Company Information

1. Company Overview

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2. Main Business or Product Introduction During the Reporting Period

(1) Main Business of the Company

The company focuses on the research, development, production, and commercialization of biopharmaceuticals, functional raw materials, and health foods. Relying on large-scale, standardized production systems and strict quality control, it continuously consolidates its competitive advantage in the global functional raw materials market; meanwhile, it accelerates transformation into an innovative biopharmaceutical enterprise, with key layouts in antibody drugs, ADCs, and mRNA vaccine platforms, steadily advancing biopharmaceutical pipeline research and industrialization. During this reporting period, the company strictly followed relevant laws, regulations, and regulatory requirements, focusing on core business development and steadily promoting various operational activities. The detailed business activities during the reporting period are as follows:

1. Biopharmaceuticals

The company specializes in the research, development, production, and sales of innovative biopharmaceuticals such as antibody drugs, ADCs, and mRNA vaccines, covering treatment areas including tumors, autoimmune diseases, and infectious diseases, forming an integrated industry chain of “R&D, manufacturing, and commercialization.” In 2025, biopharmaceutical revenue was 256.9329 million yuan. After the approval and listing of Enlongsubab monoclonal antibody injection (Enshuxing?) and Omalizumab injection (Enyitan?) in 2024, market development proceeded in an orderly manner, quickly entering the commercialization stage, becoming a new growth point for the company’s 2025 biopharmaceutical revenue. In January 2026, the company’s controlling subsidiary Jushi Biotech and its affiliates CSPC Group and Zhongqi Pharmaceuticals signed a “Strategic Cooperation and Authorization Agreement” with AstraZeneca, collaborating on innovative peptide drug discovery and long-acting delivery platform. Jushi Biotech will receive an initial payment of $420 million and is entitled to receive milestone payments, sales milestones, and licensing fees based on the actual pipeline authorized.

In 2025, the company invested 1,036.011 million yuan in R&D, an increase of 193.81 million yuan from the previous year, up 23.01%. The company has numerous ongoing projects, with over ten key drugs in clinical or late-stage development by the end of 2025, including Uscnumab injection and Patuzumab injection, which have submitted listing applications. Several projects are in critical clinical trial phases, which are expected to become future drivers of performance growth.

In 2025, the company’s drug registration and approval work progressed steadily, achieving multiple research milestones. Nine products obtained clinical trial approval in China; four products received FDA approval for clinical trials; two ADC products entered Phase III clinical trials. In January 2025, SYS6010 was granted breakthrough therapy designation; in February 2025, Omalizumab injection (trade name: Enyitan?) for moderate to severe persistent allergic asthma was approved, marking the second approved indication in China.

During this period, the company accelerated product development driven by innovation. Patuzumab injection completed lock-up and achieved expected results; DP303c injection completed key clinical trial enrollment; several other products advanced to critical clinical stages, promising breakthroughs in related disease treatments. Other pipeline projects also progressed simultaneously, establishing a competitive R&D system; multiple key clinical data have been published, enhancing global academic influence. Details of the biopharmaceutical business are provided in Appendices 1 to 8.

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Note: Omalizumab injection was approved for listing in September 2024, indicated for adults and adolescents (12 years and above) with chronic spontaneous urticaria unresponsive to H1 antihistamines. In February 2025, a new indication was approved.

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(2) Functional Raw Materials and Health Foods

The company’s functional raw materials and health foods mainly include caffeine, acarbose, anhydrous glucose raw materials, Guowei Kang vitamin C chewables, and vitamin B complex chewables. In 2025, sales revenue from these products reached 1,857.4151 million yuan.

Caffeine is a xanthine alkaloid compound, a central nervous system stimulant that temporarily relieves drowsiness and restores energy. It is mainly used as an additive in functional foods and beverages and as a pharmaceutical raw material, with applications expanding into cosmetics and daily chemical products. Globally, China, India, and Germany are major caffeine suppliers, with China being the primary producer. CSPC Innovation is the world’s largest producer of synthetic caffeine, supplying major international beverage companies like Coca-Cola, Pepsi, and Red Bull.

Acarbose and anhydrous glucose are used as pharmaceutical and functional food raw materials. Acarbose, an α-glucosidase inhibitor, effectively manages post-meal blood sugar levels in diabetics and pre-diabetics by delaying carbohydrate absorption. Anhydrous glucose is widely used in pharmaceuticals, available as oral liquids or intravenous injections as nutritional supplements. In the food industry, it can be used as a sweetener, reducing agent, or component in culture media.

To meet diverse consumer health needs, the company offers a comprehensive range of health supplements supporting key health areas such as immune enhancement, bone density improvement, antioxidant effects, mineral supplementation, and relief of visual fatigue. Guowei Kang series products target consumers of all ages, covering multiple categories, with advanced formulations, refreshing taste, and convenient intake, effectively supplementing vitamins, boosting immunity, suitable for daily health, work alertness, outdoor use, etc. The “Guowei Kang?” trademark has been recognized as a “China Well-Known Trademark.”

(2) Brand Operation Status

The company’s main products include:

Biopharmaceuticals: Enlongsubab injection (Enshuxing?), Omalizumab injection (Enyitan?), etc.

Functional raw materials and health foods: Caffeine, acarbose, Guowei Kang vitamin C chewables, etc.

In 2025, the company focused on developing the biopharmaceutical sector, achieving multiple research milestones. Its biopharmaceutical products mainly target tumors, autoimmune diseases, and infectious diseases, including lung, breast, cervical, and gastric cancers, as well as psoriasis. As of now, Jushi Biotech has numerous ongoing projects, with Enlongsubab and Omalizumab approved in 2024. By the end of 2025, over ten key drugs are in clinical or late-stage development.

The company entered the functional raw materials and health foods sector early, accumulating rich R&D experience and customer resources. With high brand recognition, advanced manufacturing processes, and strict quality control, it has strong market competitiveness. Recently, the company has consolidated its position in caffeine products, expanded into niche products like monoethylcocamine and doxophylline, and leveraged manufacturing advantages to explore new markets and profit drivers, such as urea pyrimidine products. The company also launched a broad health supplement portfolio supporting key health needs, with the “Guowei Kang?” trademark recognized as a China Well-Known Trademark. Its health supplement sales network covers nearly 200 chain pharmacies nationwide.

(3) Industry Overview

1. Biopharmaceuticals

2025 marks the final year of the “14th Five-Year” biological economy development plan, with profound industry changes underway. The biopharmaceutical industry is shifting from policy dependence to a mature model driven by both policy guidance and market forces, with the bio-economy becoming a key driver of high-quality development. As a strategic emerging industry vital to public welfare, economic growth, and national security, supported by national technological and industrial policies, the industry faces unprecedented development opportunities.

In recent years, both global and Chinese pharmaceutical markets have shown significant growth, with forecasts indicating continued rapid expansion over the next decade. According to Frost & Sullivan, the global pharmaceutical market grew from $1.3245 trillion in 2019 to $1.542 trillion in 2024, with projections reaching $2.0639 trillion by 2030 and $2.6493 trillion by 2035. The compound annual growth rate (CAGR) from 2024 to 2030 is 5.0%, and from 2030 to 2035 is 5.1%. Driven by aging populations, increased healthcare spending, technological advances, and supportive government policies, China’s biopharmaceutical market is also expanding rapidly, expected to grow from RMB 1,629.7 billion in 2024 to RMB 2,129.7 billion in 2030 and RMB 3,103.4 billion in 2035, with CAGRs of 4.6% and 7.8%, respectively.

Jushi Biotech operates across multiple subfields including antibody drugs, ADCs, and mRNA vaccines, leveraging core platforms in antibody engineering, ADC, and mRNA vaccine development to establish differentiated positions in oncology, autoimmune diseases, and other areas, forming a complete R&D-to-industrialization capability. Innovation remains the core competitive advantage; future progress in technology will continue to underpin biopharmaceutical R&D, with ongoing efforts to deepen exploration in antibody therapies and related fields.

2. Functional Raw Materials and Health Foods

According to the latest data from the National Bureau of Statistics, by the end of 2025, China’s population aged 65 and above reached 223.65 million, an increase of 3.42 million from the previous year, accounting for 15.92% of the total population. The aging trend is becoming more prominent. With the continuous promotion of the “Healthy China” strategy, consumer health awareness is rising, and demand for functions such as alertness, physical strength, and immune regulation is increasing. The health industry is entering an unprecedented golden period, with market size expanding and demand for functional raw materials and health foods steadily rising. The company offers a comprehensive health supplement portfolio supporting key health areas like immunity, bone density, and antioxidation, providing consumers with full-spectrum health protection.

(4) Industry Position

Biopharmaceuticals: In 2024, the company expanded into biopharmaceuticals by increasing its stake in Jushi Biotech. It focuses on innovative therapies targeting differentiated pathways, with strong capabilities in antibody drugs, ADCs, and mRNA vaccines. With a competitive edge of “innovation + scale + internationalization,” it has become a leading domestic enterprise in antibody and ADC innovation drug industrialization, providing safe, effective, and accessible biotherapies globally. It is among the first domestic companies to commercialize mRNA vaccines and has a complete pipeline of ADCs and antibody drugs, integrating innovation, clinical translation, large-scale manufacturing, and international commercialization.

Functional raw materials and health foods: CSPC Innovation has long focused on high-quality caffeine research and production, supplying functional beverage additives. Frost & Sullivan data shows that from 2020 to 2024, the company maintained its position as the world’s largest synthetic caffeine producer, exporting to over 60 countries and regions. Its stable product quality, cost advantages from large-scale production, and supply chain system have established strong partnerships with global beverage giants like Coca-Cola, Pepsi, and Red Bull. The company is also one of China’s largest certified acarbose raw material producers, with a sales network covering nearly 200 chain pharmacies nationwide. The “Guowei Kang?” trademark has been recognized as a China Well-Known Trademark.

3. Key Financial Data and Indicators

(1) Major Financial Data and Indicators for the Past Three Years

Does the company need to retrospectively adjust or restate previous years’ financial data?

□ Yes √ No

(Unit: Yuan)

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(2) Major Quarterly Financial Data

(Unit: Yuan)

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Are the above financial indicators or their totals significantly different from the related financial indicators disclosed in the company’s quarterly or semi-annual reports?

□ Yes √ No

4. Share Capital and Shareholder Information

(1) Top 10 Shareholders and Shareholders with Voting Rights Restored, and Shareholdings

(Unit: Shares)

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Participation of shareholders holding more than 5% and the top 10 shareholders, as well as the top 10 unrestricted circulating shareholders in securities lending and borrowing activities.

□ Applicable √ Not applicable

Changes in shareholding due to securities lending/return by the top 10 shareholders and the top 10 unrestricted circulating shareholders.

□ Applicable √ Not applicable

Does the company have arrangements for differences in voting rights?

□ Yes √ No

(2) Preferred Shareholders and Top 10 Preferred Shareholdings

The company had no preferred shareholders during the reporting period.

(3) Ownership and Control Relationship Diagram Between the Company and the Actual Controller

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5. Bonds Outstanding as of the Date of Approval of the Annual Report

□ Applicable √ Not applicable

III. Major Events

None

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