Overseas income "doubles," but it can't hide the hardships of Chinese innovative drugs going global

Why is Doubling Overseas Revenue Still a Challenge for Going Global?

On March 20, Junshi Biosciences announced its 2025 performance: last year, it achieved operating revenue of 6.667 billion yuan, a year-on-year increase of 16.5%; during the same period, the company’s net profit reached 827 million yuan. Junshi Biosciences has achieved consecutive growth in revenue and net profit for three years.

“Doubling overseas revenue” became the most eye-catching line in the financial report. According to the report, in 2025, Junshi Biosciences’ overseas product revenue exceeded 200 million yuan, with a year-on-year growth of 100%, which is not a large base but still a significant breakthrough. Additionally, Junshi Biosciences received 45.7 million yuan from the licensing and R&D service income of Trastuzumab and Surufatinib.

Trastuzumab performed steadily, achieving overseas sales of 155 million yuan, a year-on-year increase of 32%. Although Surufatinib only achieved overseas sales of 52.8 million yuan, it showed a remarkable year-on-year growth of 1327%, reflecting the expected growth trend of innovative products. In February 2025, the combination therapy of Surufatinib for extensive-stage small cell lung cancer was approved in the EU, and there should be significant progress in sales in Europe last year.

In 2026, Junshi Biosciences’ overseas market should continue to expand rapidly. In the second half of 2025, the biosimilars of Dexamethasone and Pertuzumab received approvals from regulatory authorities in the U.S., EU, and UK, with products blooming in overseas markets. Last year, Dexamethasone generated 9.83 million yuan in revenue for Junshi Biosciences. Moreover, this year, Surufatinib is applying for indications for squamous and non-squamous non-small cell lung cancer and esophageal squamous carcinoma in Europe.

After five years of going global, Junshi Biosciences’ dream of conquering the global market is becoming clearer, yet the reality remains less rosy than ideal: this financial report showcases the latest breakthroughs in overseas markets but also reveals the harsh realities of the international pharmaceutical market.

The Harsh Reality of Domestic Biologics Going Global

Junshi Biosciences began its international expansion earlier than most of its peers. In July 2020, its first biosimilar, Trastuzumab “Hanquyou,” successfully entered the EU market. By 2021, “Hanquyou” generated 40.6 million yuan in revenue. As of now, “Hanquyou” has been approved for sale in over 50 countries and regions globally and has entered the healthcare systems of multiple countries, including China, the UK, France, and Germany. The PD-1 Surufatinib “Hanshuang” has been approved in over 40 countries and regions.

These figures demonstrate the extensive overseas layout of Junshi Biosciences. However, after five years, it has only achieved 200 million yuan in overseas product revenue. From 2023 to 2025, the overseas sales of “Hanquyou” were 69.5 million, 118 million, and 155 million yuan respectively, with growth rates gradually slowing. If not for the addition of Surufatinib “Hanshuang,” it would have been challenging for Junshi Biosciences to achieve the feat of “doubling overseas product revenue” in 2025.

This stark disparity between investment and output is a true reflection of the challenges faced by Chinese biotech companies going global. The international market is not a land of opportunity; Chinese innovative drugs are not guaranteed to be snatched up the moment they go abroad.

Public reports indicate that global sales revenue for four leading PD-(L)1 monoclonal antibodies will reach $50 billion by 2025. However, many PD-1 products, especially those developed by numerous Chinese companies, face significant difficulties in going global, and even if they are approved overseas, they can only enter niche markets such as nasopharyngeal carcinoma, making it impossible to reach the mainstream market.

Junshi Biosciences is one of the few companies daring to target major indications, opting for small cell lung cancer for Surufatinib, making it the only anti-PD-1 monoclonal antibody approved for the treatment of extensive-stage small cell lung cancer in the EU, creating a competitive landscape distinct from leading PD-(L)1 products.

Additionally, Junshi Biosciences is exploring indications for Surufatinib in lung cancer and gastrointestinal tumors and adjusting its overseas cooperation strategy. In February of this year, Junshi Biosciences announced a revision of its agreement with Indonesian pharmaceutical company KGbio, retaining the partnership for Surufatinib in Indonesia while transferring other rights in Asia, the Middle East, and Africa to the multinational pharmaceutical company Abbott. At the same time, Junshi Biosciences is partnering with Eisai to jointly expand the market for Surufatinib in Japan for indications such as small cell lung cancer.

At this point, Surufatinib can be considered to have just taken its first step into the overseas market. If all goes well, this product is expected to have significant market potential. Junshi Biosciences has set a goal: Surufatinib should become the next domestically produced innovative drug with annual global sales exceeding 10 billion yuan.

Although Junshi Biosciences is progressing slowly from biosimilars to innovation, it is making steady progress step by step.

Is the U.S. Biosimilars Market About to Open Up?

For Junshi Biosciences, 2026 is a year that must not be taken lightly; the most important thing is to maintain the market position of several biosimilars.

In 2025, Junshi Biosciences’ key revenue pillar, “Hanquyou,” had global sales revenue of 2.965 billion yuan, a year-on-year increase of 5.5%, which is much lower than before. Fortunately, other products are filling the gap: the Rituximab biosimilar contributed 590 million yuan in sales revenue for Junshi Biosciences last year.

From Junshi Biosciences’ operating results, the market environment for biosimilars is far from what was initially imagined. Domestically, they must face the inevitable arrival of biosimilar centralized procurement, and overseas they must contend with fierce competition and overcome numerous barriers to brand drugs. The FDA has disclosed that the market share of its approved biosimilars compared to branded drugs is less than 20%.

It is worth mentioning that Junshi Biosciences’ shift has been timely, as it has been strengthening its innovative drug pipeline in recent years. Last year alone, Junshi Biosciences invested 2.492 billion yuan in R&D, a year-on-year increase of 35.4%. The company allocated significant resources to new drug development, resulting in a mere 0.8% increase in net profit last year. Junshi Biosciences must maintain a delicate balance between R&D investment and product revenue, and the strategy of “using biosimilars to support innovative drugs” will need to continue for some time.

Among Junshi Biosciences’ pipeline, the PD-L1 ADC (HLX43) is the most notable, currently showing positive efficacy signals in non-small cell lung cancer, gynecological tumors, esophageal squamous carcinoma, and other solid tumors, and is expected to become a highly regarded BIC product. Additionally, clinical trials for HER2 monoclonal antibodies and HER2 ADC for gastric cancer and breast cancer are ongoing.

Currently, biosimilars may be on the verge of new opportunities in the U.S. market. In October last year, the FDA sought public opinion on clinical efficacy comparative studies for biosimilars, which is expected to simplify the approval process for biosimilars and increase market supply, allowing patients to choose more cost-effective biosimilars. In March this year, the FDA released another draft, proposing to no longer require mandatory pharmacokinetic bridging studies comparing the proposed biosimilar to U.S. reference drugs and foreign reference drugs. The FDA emphasized that this could save biosimilar developers up to 50% of PK research costs, equivalent to about $20 million.

These policy trends bring new hope to biopharmaceutical companies like Junshi Biosciences that are bravely venturing overseas. At the end of last year, Junshi Biosciences’ clinical trial application for the biosimilar of Nivolumab was approved by the U.S. FDA. If the new FDA policies are implemented smoothly, they will alleviate significant cost pressures and commercial expansion barriers for Junshi Biosciences.

Written by: Yang Xixia

Edited by: Jiang Yun, Jia Ting

Operation: Li Muzi

Illustration: Visual China

Disclaimer: This is original content from Jian Shi Ju. Please do not reproduce without permission.