China Merchants Securities: Abbisko (2256.HK, Buy) Enters First Year of Commercialization and Numerous Clinical Catalysts

Pimitespib:$ABBISKO-B (02256.HK)$Expected to receive several milestone payments in 2026, along with the start of continuous commercial revenue

Following a comprehensive success in the global MANEUVER Phase III trial, the company successfully launched the commercial rollout of the drug in China by the end of December last year. The new drug application (NDA) for the US market was accepted in January 2026. Merck Germany will initiate commercialization, and they will announce their fiscal 2025 results on March 5th. We will wait for Merck to provide more numerical guidance on the commercial ramp-up post-launch of Pemigatinib.

Ipatasertib: More clarity on timeline for completion of pivotal Phase III trial

For the China-based clinical development of this asset, the first patient was enrolled (FPI) in June 2025 in its domestic pivotal Phase III study. The company expects to complete enrollment of the last patient (LPI) in the second half of 2026, followed by the release of primary data from the second-line liver cancer patient population around the first half of 2027. After the primary data (objective response rate) matures, the company will prepare to submit a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) in China and anticipates launching the drug in the second half of 2027 or in 2028. Regarding the global Phase III MRCT clinical development plan for this asset, the company has successfully completed discussions with the U.S. FDA. Future plans may include combination therapy with Tecentriq and Avastin as the first-line standard treatment for liver cancer.

The company will initiate more Phase I clinical studies in 2026 while diversifying further into non-oncology fields.

The company is preparing to launch multiple Phase I clinical trials targeting pan-KRAS, CDK4/2 selective small molecule inhibitors, CDK4 (capable of penetrating the central nervous system), GIPR small molecules, STAT6, and others. We believe the company is actively leveraging cutting-edge breakthroughs in structural biology and protein-protein interactions, while also using artificial intelligence to design more novel drugs. In terms of early platform development and pipeline, there will be a focus on highly selective small molecules with high neuro-permeability, as well as exploring additional oral small molecule pipelines in metabolism/cardiovascular and immune-inflammatory areas.

Maintain增持rating:We believe that short-term fundamentals are currently undervalued by the market. We reiterate our增持rating, with the target price unchanged.

$ABBISKO-B (02256.HK)$

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