Abbisko Cayman Limited Announces Landmark Phase 3 Results for Pimicotinib Published in The Lancet

Hong Kong, March 9, 2026 – Abbisko Cayman Limited (Stock Code: 2256) has made a significant announcement that is likely to attract investor attention and could impact share performance. The company’s subsidiary, Abbisko Therapeutics Co., Ltd., revealed that the results from its global Phase 3 MANEUVER study for pimicotinib (ABSK021) have been published in the prestigious international medical journal The Lancet. This event marks a major milestone in the company’s journey and highlights its growing international recognition for clinical research quality.

Key Points for Investors

• Global Phase 3 Study Results Published: The MANEUVER study of pimicotinib, a novel, oral, highly selective and potent small-molecule CSF-1R inhibitor developed in-house by Abbisko, was published on March 5, 2026, in The Lancet. Publication in such a high-impact journal significantly raises the profile of Abbisko’s research and adds credibility to its clinical data.
• Study Design and Patient Population: The MANEUVER study was a global, multicenter trial that enrolled 94 patients across more than 30 clinical centers worldwide, with over half the participants from outside China. This diversity strengthens the generalizability of the results and supports potential global market adoption.
• Clinical Impact: Pimicotinib demonstrated significant efficacy and a generally favorable safety profile for the treatment of tenosynovial giant cell tumor (TGCT), a rare and locally aggressive neoplasm. This positions pimicotinib as a promising new therapeutic option for patients with symptomatic TGCT, especially where surgical resection may lead to functional limitations or severe morbidity.
• Regulatory Milestones:
  • Pimicotinib received approval from the China National Medical Products Administration (NMPA) in December 2025 for treating adult patients with symptomatic TGCT where surgery is not ideal.
  • A New Drug Application (NDA) has been formally accepted by the U.S. Food and Drug Administration (FDA), signaling potential near-term entry into the key U.S. market.
  • Additional regulatory applications are under review in other markets, indicating a global commercial strategy.
  • Outside China, pimicotinib has been granted Breakthrough Therapy Designation by the US FDA and PRIME Designation by the European Medicines Agency (EMA), both of which can accelerate development and review timelines.
• Commercialization Partnership: In December 2023, Abbisko entered into an agreement with Merck, granting Merck global commercialization rights for pimicotinib. Merck’s involvement brings significant commercialization expertise and resources, increasing the likelihood of global market penetration and revenue generation.

Implications for Shareholders and Potential Investors

• The publication of positive Phase 3 results in a world-leading journal and regulatory progress in multiple regions are likely to be price-sensitive events. These developments increase the probability of successful commercialization and potential future revenue streams.
• The company cautions that, while these milestones are significant, there is no guarantee that pimicotinib will ultimately be successfully commercialized. Shareholders are advised to exercise caution in trading the company’s shares given the inherent risks in drug development and commercialization.
• The high level of international academic recognition, strong clinical data, and strategic partnership with Merck position Abbisko favorably within the competitive oncology and rare disease space.

About Abbisko Therapeutics

Founded in April 2016 and headquartered in Shanghai, Abbisko Therapeutics is an oncology-focused biopharmaceutical company. It is dedicated to discovering and developing innovative medicines to address unmet medical needs in China and globally. The company has an extensive pipeline centered on precision oncology and immuno-oncology, leveraging the expertise of seasoned industry veterans from multinational pharmaceutical companies.

Forward-Looking Statements

This article contains forward-looking statements regarding Abbisko Cayman Limited’s business and product development. Actual results may differ materially from those expressed or implied. Investors should exercise caution in relying on these statements, which are current only as of the date made. Abbisko is under no obligation to update or revise these statements as a result of new information or future events.

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