Luokang Bio 2025 Revenue Reaches 6.667 Billion Yuan, Up 16.5% YoY, Overseas Revenue Doubles as Globalization Enters Harvest Phase

How AI and globalization strategies are driving Fuhong Hanlin’s overseas revenue doubling

On the evening of March 20, Fuhong Hanlin released its 2025 annual performance report. The financials show that the company achieved total revenue of approximately 6.667 billion yuan, a year-on-year increase of 16.5%; global product revenue contributed about 5.775 billion yuan, up 17.0%. More notably, in terms of profit, the company recorded a total profit of about 827 million yuan. Despite a significant 35.4% year-on-year increase in R&D expenses to approximately 2.49 billion yuan (mainly for innovation transformation), profitability remained stable, thanks to “continued volume growth of core product commercialization” and “significant increase in overseas commercialization profits.”

Among these, “overseas product profits” reached approximately 93.9 million yuan. This data indicates that Fuhong Hanlin’s globalization strategy has entered a harvest period, with overseas markets gradually shifting from investment to profit contribution, becoming a new engine driving performance growth.

International expansion flourishes, overseas markets enter a harvest period

By 2025, Fuhong Hanlin’s internationalization strategy achieved a key breakthrough, once again highlighting the leap from “product going abroad” to “global operations,” becoming a bright spot in the financial report. As of the end of the reporting period, the company had 10 products and 40 indications approved and launched in about 60 countries and regions worldwide, including 7 products launched overseas, benefiting over 1 million patients globally. This successfully realized “Internationalization Loop 1.0,” accelerating toward the “Globalization 2.0 era.”

Core product exports have yielded fruitful results, with several products breaking into international markets. Notably, HLX11 (pembrolizumab injection) was approved by the U.S. FDA in November 2025, becoming the first and only biosimilar of pembrolizumab approved in the U.S., filling a market gap; HLX14 (desulmonab injection) successfully gained access to European and American markets, becoming the first “Chinese” desulmonab, with two products marketed under the brand names BILDYOS® and BILPREVDA®, covering all indications of the original drug, providing more treatment options for the aging population worldwide.

The progress of自主创新产品 Hans Zhuang® (srlulirumab injection) in international markets is particularly notable. This product not only became the first anti-PD-1 monoclonal antibody approved in the EU for extensive small cell lung cancer but also added indications in multiple regions, with approvals in over 40 countries and regions, and inclusion in the medical insurance lists of 7 EU countries.

Meanwhile, Fuhong Hanlin’s overseas collaborations and capacity layout have been upgraded simultaneously. In 2025, the company actively engaged in licensing collaborations, reaching new agreements with well-known international pharmaceutical companies such as Dr. Reddy’s, Eisai, and Sandoz, granting global or regional commercialization rights for products like HLX15 (daratumumab), Hans Zhuang®, and HLX13 (ipilimumab). The company also demonstrated strategic flexibility by proactively optimizing agreements with some partners for specific regions (such as parts of Southeast Asia) to seek better global commercial arrangements.

In terms of capacity, multiple production lines at Songjiang Base (I) and (II) passed pre-approval GMP inspections by the U.S. FDA and the EU in 2025, ensuring stable global supply. Additionally, Fuhong Hanlin’s self-built clinical operations team has been able to advance research in nearly 30 countries/regions, marking a shift from solely manufacturing and supply to covering the entire chain of clinical development and regulatory registration.

Continuous innovation and pipeline expansion into high-value areas

While accelerating globalization, Fuhong Hanlin has not relaxed its investment in innovation. The financial report shows that in 2025, R&D expenses reached 2.492 billion yuan, a year-on-year increase of 651 million yuan or 35.4%. The core focus is on innovative drug R&D and pipeline expansion, demonstrating the company’s firm commitment to transforming from a “biological similar drug leader” to an “innovative biopharmaceutical company.”

The ongoing empowerment of R&D platforms provides strong support for translating innovative results into products. Relying on platforms like HAI Club (AI-driven) and Hanjugator (ADC development), in 2025, several innovative projects entered clinical stages. For example, HLX22 (HER2 monoclonal antibody) completed the first patient dosing in multiple global phase III trials, and synergized with the imported HLX87 (HER2 ADC), focusing on first-line breast cancer treatment, further enriching the company’s oncology pipeline. Multiple combination therapy trials for HLX43 (PD-L1 ADC) received approval, with phase II/III clinical trials for advanced or metastatic squamous non-small cell lung cancer launched in the U.S., some of which are expected to support registration applications. The promising clinical data in NSCLC, esophageal squamous carcinoma, and other solid tumors lay a solid foundation for subsequent commercialization.

Fuhong Hanlin continues to expand its innovative pipeline through a dual approach of自主研发 (independent R&D) and licensing. In 2025, the company introduced several high-potential assets, including SIRPα-Fc fusion protein (HLX701), HER2 ADC (HLX87), and IL-1R3 monoclonal antibody (HLX109). As of the financial report date, the pipeline includes over 50 early-stage innovative assets and about 10 R&D platforms, covering monoclonal antibodies, multi-specific antibodies, ADCs, fusion proteins, and small molecules, forming a complete innovation chain from early R&D to clinical advancement and commercialization, providing strong momentum for long-term development.

Outlook 2026: Deepening global presence and delivering innovation

Looking ahead to 2026 and beyond, Fuhong Hanlin has outlined clearer global goals, continuing to deepen its global layout and innovation R&D as dual main lines.

In terms of globalization, the company plans to advance more products into mainstream markets such as Europe and the U.S., including applications for Hans Zhuang® in the U.S. and approvals for HLX11 in the EU. By 2030, it aims to have over 15 products launched in Europe and the U.S., further expanding its global market share.

In innovation R&D, the focus will be on accelerating the clinical and commercial progress of core assets. Key clinical trials for HLX43 are expected to start in 2026, and more innovative molecules like HLX48 (EGFR×cMet ADC) will submit clinical trial applications, with promising results expected to accelerate commercialization.

Domestically, Fuhong Hanlin will continue to deepen its focus on breast cancer treatment, building a comprehensive product matrix with Hanquyou®, HannaiJia®, and the newly included Huatuoning®, covering early adjuvant to late-stage treatment, further consolidating its leadership in this field.

2025 has been a landmark year for Fuhong Hanlin, not only delivering a steady growth in financial performance but also successfully crossing the critical threshold from “Made in China” to “Global Brand.” By elevating “internationalization” to “globalization” and embedding “innovation” into its corporate DNA, Fuhong Hanlin is gradually building a unique global competitive edge. In the current reshaping of the global biopharmaceutical landscape, Fuhong Hanlin’s practices provide a valuable reference model for Chinese innovative drug companies’ global development.