Sino Biopharmaceutical Announces Promising Preliminary Clinical Data for MK-2010/LM-299 at AACR 2026

Key Highlights from the Latest Clinical Development Update

Sino Biopharmaceutical Limited (“Sino Biopharm”, HKEX: 1177) has released a significant voluntary announcement regarding the preliminary clinical data for MK-2010/LM-299, an investigational PD-1/VEGF bispecific antibody. The data were presented at the prestigious American Association for Cancer Research (AACR) Annual Meeting 2026, marking a major milestone for the company’s oncology pipeline.

Key Points from the Announcement

• Innovative Bispecific Antibody: MK-2010/LM-299 is a tetravalent bispecific antibody that simultaneously targets programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). It is developed using an IgG-VHH fusion format with Fc silencing, intended to enhance anti-tumor efficacy while minimizing immune-related side effects. This approach leverages the established clinical benefits of combining PD-1 inhibition and VEGF blockade in treating advanced solid tumors.
• Strategic Partnership with Merck & Co.: In November 2024, LaNova Medicines Limited (“LaNova”), a wholly-owned subsidiary of Sino Biopharm, entered into a global exclusive licensing agreement with Merck & Co., Inc. (MSD, outside the US and Canada). This deal grants MSD exclusive worldwide rights to develop, manufacture, and commercialize LM-299, demonstrating strong validation from a global pharmaceutical leader and potential for substantial milestone and royalty payments to Sino Biopharm.

Clinical Study Results: Safety and Efficacy Data

• Patient Enrollment: The Phase 1/2 study included a total of 112 patients across dose-escalation (n=40) and non-small cell lung cancer (NSCLC) expansion cohorts (n=72). The cohort was heavily pretreated, with 68% having prior therapy, 60% with prior anti-PD-(L)1 treatment, and 26% previously exposed to anti-VEGF therapies.
• Manageable Safety Profile: MK-2010/LM-299 showed a manageable safety profile, with no grade 5 treatment-related adverse events (TRAEs) and only one TRAE leading to discontinuation (in the dose escalation group). In the NSCLC expansion cohort, most TRAEs were low-grade, with Grade 3–4 TRAEs occurring in only 17–27% of patients. Importantly, no treatment-related deaths were reported, and VEGF inhibitor-associated toxicities were generally Grade 3 or below and manageable.
• Promising Efficacy Signals: Early anti-tumor activity was observed, especially in the NSCLC backfill cohort. For previously untreated patients, the unconfirmed overall response rate (ORR) was 55% in the 20 mg/kg Q3W group and 44% in the 30 mg/kg Q3W group. Notably, at 20 mg/kg Q3W in first-line NSCLC treatment, the ORR stood at 55% with grade ≥3 TRAEs in only 17% of patients.
• Pharmacokinetics: The mean estimated half-life of MK-2010/LM-299 ranged from approximately 9.5 to 12.6 days, indicating a dosing schedule suitable for clinical development.

Potential Implications for Shareholders and Share Price

• Positive Clinical Data: The demonstration of both a strong safety profile and promising efficacy in a difficult-to-treat, heavily pretreated NSCLC population positions MK-2010/LM-299 as a potential best-in-class bispecific antibody for major oncology indications.
• Global Licensing Deal: The partnership with Merck & Co. substantially de-risks the development of MK-2010/LM-299 and may provide Sino Biopharm with significant future revenues through upfront, milestone, and royalty payments. This licensing deal also validates the technology and increases the asset’s commercial potential.
• Further Development Supported: The results support continued advancement of MK-2010/LM-299 as both a monotherapy and in combination regimens, expanding future market opportunities.
• Potential Share Price Impact: These developments are highly price sensitive. Positive clinical data, coupled with a strategic partnership with a global pharmaceutical leader, could lead to a re-rating of Sino Biopharm’s shares as investors factor in the increased probability of future commercial success.

Board Composition Update

The announcement also reconfirms the current composition of the Board, which includes six executive directors and five independent non-executive directors, maintaining a strong governance structure.

Disclaimer: This article is a summary and analysis based on a voluntary announcement made by Sino Biopharmaceutical Limited. It is intended for informational purposes only and does not constitute investment advice. Investors are advised to conduct their own due diligence and consult with professional advisers before making any investment decisions.

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