Henlius Sets Five-Year Plan Targeting Biosimilar Market as Overseas Revenue Doubles

As biosimilars enter a dense period of patent expirations, Henlius disclosed its globalization 2.0 operating blueprint at an open day held on September 8, 2026. The company was recently added to the Shanghai-Hong Kong Stock Connect and the Hong Kong Stock Connect southbound trading list.

Zhu Jun, executive director and chief executive officer of Henlius, said overseas biosimilar revenue will double every year over the next three years. Cao Ping, chief business development officer and senior vice president, said that as patents on multiple originator drugs expire, biosimilars will see rapid global growth, and the company has proposed a five-year plan targeting this hundred-billion-yuan market.

According to an IQVIA report published in 2025, 118 biologics in the United States market will lose patent protection between 2025 and 2034, representing a market opportunity of approximately USD234 billion. Cao Ping, citing another set of industry data, calculated that the originator drug market size covered by unauthorized biosimilar pipelines is approximately USD92.3 billion; assuming intense price competition after patent expiration, even if the overall market size declines by 50% within five years, approximately USD46 billion would remain. Henlius's first-half 2026 financial report shows revenue of RMB3.588 billion, up 27.3% year on year; overseas product sales revenue was RMB105 million, up 159.4% year on year; overseas product profit was RMB59.5 million, more than four times that of the same period in 2025. Overseas product sales revenue still accounts for less than 3% of the total.

Biosimilars ramp up quickly after originator patents expire, capturing 70% to 80% of market share within four years. The cost of developing biologics in China is about 60% of that in the United States.

Darius Panaligan, chief commercial officer of Henlius's international market, said Henlius will advance global expansion in three steps: establishing direct access to the United States market from 2026 to 2027, expanding into the European Union and other high-value markets from 2028 to 2030, and becoming a global biopharmaceutical leader after 2030. The company has built core international market capabilities covering commercial alliances, affiliated commerce, market access, commercial strategy and medical affairs, and has formulated differentiated strategies for North America, Europe, Latin America, Asia-Pacific, and the Middle East and Africa.

Henlius has obtained regulatory approvals for multiple products in multiple regions globally: four products approved by the US FDA, five by the European Commission, and eight by China's NMPA. Cao Ping said that in the industry, the success rate of biosimilars from clinical trials to approval is low, and several leading international companies have failed due to CMC issues, while Henlius maintains a 100% success rate of approval upon filing. The pertuzumab biosimilar Hanbeiyou is the world's first and only domestically developed pertuzumab biosimilar approved in the three major markets of China, the United States, and Europe. The cetuximab biosimilar HLX05-N has received Phase I clinical trial approval from the US FDA and China's NMPA, and completed first patient dosing in China in July 2026; no similar product has yet been approved for marketing in the United States or Europe.

Yuan Jijun, chief scientific officer of Henlius, said the company has expanded an innovation platform matrix covering multiple modules including immune cell engagers, antibody-drug conjugates, multispecific antibodies, and AI-assisted drug design. To date, multiple products developed on the Tri-TCE platform and ADC platform have entered Phase I clinical studies. The ADC platform is simultaneously advancing internal and external collaboration on novel mechanism toxin discovery and site-specific conjugation technology; the multispecific antibody pipeline is expanding into non-oncology areas such as autoimmune diseases, thyroid eye disease, and inflammatory bowel disease. Through its self-developed HAI Club artificial intelligence platform, the company has deeply integrated the entire process from target discovery to preclinical candidate compound confirmation. The company aims to achieve only 12 to 16 months from project initiation to PCC, and only 10 to 12 months from PCC to IND, and continues to push innovative molecules into clinical stages at a rate of about 10 projects per year.

According to disclosures at the event, multiple innovative molecules entered clinical trials in the first half of 2026, including the next-generation T cell engager HLX3902 in prostate cancer, the tetra-specific T cell engager HLX3901 developed on a proprietary platform, the cMETxEGFR bispecific ADC HLX48, and the KAT6A/B small molecule inhibitor HLX97, among others, all of which have entered first-in-human trials.