Henlius Expands Sandoz Partnership in Up to $322 Million Biosimilars Deal
Shanghai Henlius Biotech, Inc. (“Henlius”) has significantly expanded its partnership with Sandoz, entering a strategic collaboration covering up to 10 monoclonal antibody (mAb) and antibody-drug conjugate (ADC) biosimilar candidates in a deal that could generate up to US$322 million in upfront payments, development and commercial milestones, and option fees.
Under the agreement announced August 17, Henlius and Sandoz have finalized collaboration terms for three initial biosimilar products, while Sandoz has also obtained an option for an additional asset. Henlius expects the total amount invoiced under the initial arrangements to reach as much as US$100.5 million in 2026. (Henlius)
Henlius’ official announcement
Three Initial Biosimilar Candidates
The initial portfolio spans oncology, cardiovascular disease and autoimmune disorders, giving Sandoz access to biosimilar opportunities across several major therapeutic areas.
HLX05-N — Cetuximab Biosimilar
The first asset, HLX05-N, is Henlius’ proposed biosimilar to cetuximab, an anti-EGFR monoclonal antibody used in the treatment of certain colorectal and head and neck cancers.
Under the agreement, Sandoz receives exclusive registration and commercialization rights for HLX05-N in the United States, Canada, European Union, United Kingdom, Switzerland, Japan, Australia and New Zealand, as well as semi-exclusive rights in certain Asian markets.
Cetuximab represents a substantial commercial opportunity as the global market for the reference product continues to transition toward biosimilar competition. Reuters reported that global sales of cetuximab were approximately US$1.7 billion in 2025, citing IQVIA data. (Reuters)
HLX16 — Evolocumab Biosimilar
The second program, HLX16, is a proposed biosimilar to evolocumab, the PCSK9 inhibitor marketed as Repatha.
Sandoz will receive worldwide exclusive rights outside China for HLX16. The program is currently in the early stages of development.
Evolocumab is one of the largest commercial opportunities in the portfolio. According to Reuters, the reference product generated approximately US$6.6 billion in global sales in 2025. (Reuters)
Belimumab Biosimilar
The third confirmed asset is a proposed belimumab biosimilar, targeting the reference biologic marketed as Benlysta for autoimmune diseases including systemic lupus erythematosus.
Sandoz will receive worldwide exclusive rights outside China for the program. Like HLX16, the belimumab biosimilar remains in early development.
Global sales of belimumab reached approximately US$2.5 billion in 2025, according to IQVIA data cited by Reuters, highlighting the commercial potential of the program. (Reuters)
Option on Recombinant Human Hyaluronidase
In addition to the three biosimilar candidates, Sandoz has obtained an option for HLXTE-HAase1001, a recombinant human hyaluronidase.
Hyaluronidase technology can be used to facilitate the subcutaneous administration or co-formulation of biologic medicines, potentially providing a route to more convenient administration for selected therapies.
The inclusion of HLXTE-HAase1001 expands the collaboration beyond conventional biosimilar antibodies and gives Sandoz the opportunity to add another technology asset to the partnership. (Henlius)
Henlius to Lead Development and Manufacturing
The strategic collaboration is structured around a division of responsibilities that leverages the respective strengths of the two companies.
Henlius will be responsible for:
- Product development
- Manufacturing
- Commercial supply
- China rights
Sandoz will be responsible for:
- Registration outside China
- Commercialization outside China
- Market access and commercialization activities across its international network
The collaboration is designed as a multi-product portfolio framework, allowing the two companies to work together from early-stage development through regulatory submission, manufacturing, launch and lifecycle management. (Stock Titan)
For Henlius, the arrangement provides a way to leverage its integrated biologics development and manufacturing capabilities while using Sandoz’s established global commercial infrastructure to accelerate international market access.
For Sandoz, the agreement adds multiple potential biosimilar products to its pipeline at a time when the global biologics market is entering a major wave of loss of exclusivity.
Deal Could Reach $322 Million
The financial terms underscore the scale of the expanded relationship.
Henlius is eligible to receive up to US$322 million through a combination of upfront payments, development and commercial milestones, and option fees. The company expects up to US$100.5 million to be invoiced in 2026 based on the initial arrangements. (Henlius)
Reuters reported that the initial three-product agreement includes up to US$77 million in upfront payments, with additional development milestones of up to US$160 million and commercial milestones of up to US$77 million. (Reuters)
The difference between the initial three-product economics reported by Reuters and Henlius’ broader US$322 million potential reflects the additional option-related economics and the broader strategic collaboration structure.
Builds on 2025 Ipilimumab Partnership
The expanded agreement builds on a relationship that began in April 2025, when Henlius and Sandoz signed an agreement covering HLX13, Henlius’ proposed ipilimumab biosimilar.
Under that agreement, Sandoz received exclusive commercialization rights for HLX13 in the United States, 42 European countries and regions, Japan, Canada and Australia. Henlius was eligible for US$31 million in upfront payments and up to US$270 million in milestone payments, for a potential total of US$301 million. (Henlius)
HLX13 has since advanced into international clinical development. In June 2026, Henlius announced that the first patient had been dosed in the United States in the international Phase 1 study HLX13-HCC102, following first dosing in China. (Henlius)
The new portfolio agreement therefore represents a substantial expansion from a single oncology biosimilar partnership into a broader platform collaboration spanning multiple biologics and potentially ADC-related products.
A Broader Globalization Strategy for Henlius
The deal is another example of Henlius’ strategy of partnering with global pharmaceutical companies to bring China-developed biologics into international markets.
Rather than building a commercial infrastructure independently in every major market, Henlius can retain its core strengths in biologics R&D, development and manufacturing, while relying on established multinational partners for registration, market access and commercialization.
The approach is consistent with the company’s broader globalization strategy of “Developed in China, Access for the World.” (Henlius)
For Sandoz, meanwhile, the partnership provides access to a growing pipeline of biologics developed by a Chinese company with an established manufacturing and development platform. The three initial targets—evolocumab, belimumab and cetuximab—also represent commercially significant reference products whose markets could become increasingly attractive as patent and regulatory exclusivity barriers fall.
What the Deal Means for the Biosimilar Market
The expanded Henlius-Sandoz agreement highlights the increasingly important role of China-based biopharmaceutical companies in the global biosimilar ecosystem.
The deal also illustrates a shift in partnering strategy. Instead of licensing individual late-stage assets one at a time, multinational companies are increasingly forming portfolio-level collaborations that provide access to multiple programs and allow partners to participate earlier in development.
For Henlius, the agreement potentially provides a significant source of non-China revenue while reducing the burden of building an international commercialization organization. For Sandoz, it offers a pipeline of potentially differentiated biosimilars that can be integrated into its global portfolio.
With up to 10 mAb and ADC biosimilar candidates potentially covered, the latest agreement could ultimately prove much larger than the four assets currently identified.
Bottom line: Henlius’ expanded partnership with Sandoz marks a significant step in the globalization of Chinese-developed biosimilars. The combination of Henlius’ development and manufacturing capabilities with Sandoz’s global commercialization platform creates a potentially powerful model for bringing more affordable biologic therapies to patients worldwide.
