Shanghai Henlius Biotech Announces Major Amendments to License Agreements with Abbott and KGBio for HANSIZHUANG

Key Developments in Licensing Strategy

Shanghai Henlius Biotech, Inc. (“Henlius”) has announced significant amendments to its licensing arrangements for HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody. These changes involve the company’s agreements with PT Kalbe Genexine Biologics (“KGBio”) and Abbott Products Operations AG (“Abbott”), impacting the commercialization and market reach of HANSIZHUANG across multiple regions.

Highlights of the Announcement

• Termination of KGBio License in Multiple Territories: Henlius has reached an amicable agreement with KGBio to terminate KGBio’s exclusive license rights for HANSIZHUANG in all regions except Indonesia. KGBio will transfer any marketing authorizations obtained for HANSIZHUANG in these terminated territories to a third party designated by Henlius. Henlius will pay KGBio up to US\$33.75 million in milestone payments, depending on transfer progress, and regulatory milestones will be adjusted accordingly. Commercial sales milestone payments and royalties will now only apply to Indonesia.
• Expansion of Abbott License: On the same date, Henlius amended its agreement with Abbott, expanding Abbott’s exclusive commercialization rights for HANSIZHUANG to cover additional territories in Asia, the Middle East, Africa, and Eastern Europe (42 countries/regions in total). The updated agreement includes extra regulatory milestone payments of up to US\$46 million and commercial sales milestone payments of up to US\$80 million, tied to achievements in these new regions.
• Conditions Precedent: These amendments will only become effective once certain conditions are fulfilled, notably the full execution of the termination agreement with KGBio, transfer of relevant rights and confirmations, and Henlius acquiring necessary rights to grant Abbott the expanded license.
• Strengthening Global Market Reach: This restructuring allows Henlius to leverage Abbott’s global commercialization capabilities, particularly in the newly added regions, which is expected to enhance the international presence and recognition of HANSIZHUANG.
• Product Background: HANSIZHUANG is approved for several indications in China and globally, including various types of lung and esophageal cancers. It has also been granted Orphan-drug Designation in the US, EU, Switzerland, South Korea, and other markets. Worldwide sales for monoclonal antibody drugs targeting PD-1 reached approximately US\$45.7 billion in 2024, highlighting the significant market opportunity.
• Strategic Rationale: Through the termination with KGBio and expanded partnership with Abbott, Henlius aims to accelerate overseas market penetration and better commercialize HANSIZHUANG internationally.

Potential Price-Sensitive and Shareholder-Relevant Information

• Significant Milestone Payments: The agreements with Abbott and KGBio involve substantial potential milestone payments (up to US\$46 million regulatory + US\$80 million commercial from Abbott; up to US\$33.75 million to KGBio), which could materially impact Henlius’s financial results.
• Expanded Commercialization Footprint: The expanded licensing territory to include 42 new countries/regions with Abbott, and the shift from KGBio to Abbott in most territories, substantially increases the potential market for HANSIZHUANG and may drive future revenue growth.
• Change in Territory Control: The strategic handover from KGBio to Abbott (except Indonesia) centralizes commercialization under a single, globally recognized partner, which may enhance execution and market access.
• Regulatory Progress: In December 2025, HANSIZHUANG’s application for gastric cancer treatment was accepted for priority review by China’s National Medical Products Administration (NMPA), signaling potential for new indications and further market expansion.

Company Backgrounds

• Abbott: A wholly-owned subsidiary of Abbott Laboratories (NYSE: ABT), a global player in diagnostics, medical devices, nutrition, and pharmaceuticals.
• KGBio: A holding subsidiary of PT Kalbe Farma Tbk (IDX: KLBF), Indonesia’s largest pharmaceutical company.

Conclusion and Investor Takeaways

The announced amendments represent material changes to Henlius’s licensing and commercialization strategy for HANSIZHUANG, positioning the company for greater global reach and potential revenue from expanded territories and milestone payments. The reallocation of rights to Abbott, a strong global partner, and the substantial financial terms involved are likely to be viewed as positive developments by investors and could have a significant impact on the company’s future performance and share price.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult professional advisors before making any investment decisions. The information is based on public announcements and may be subject to change or further updates.

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