Ping An Securities: Abbisko-B (2256.HK) – Pemigatinib Receives Marketing Approval in Canada, Global Commercial Value Begins to Materialize

Notices:

On June 22, 2026, pemigatinib officially received marketing approval from Health Canada, marking the second global approval following its launch in China and signaling the beginning of the drug’s global commercial value realization phase.$ABBISKO-B (02256.HK)$

In addition, regulatory review processes for pemigatinib in the United States and numerous other countries worldwide are actively progressing.

Ping An View:

Pemigatinib has received approval for marketing in Canada, marking the beginning of its global commercial value realization.In December 2025, pemigatinib (Bejiemai) was approved for marketing in China. In March 2026, the first prescription in China was issued, addressing the long-unmet systemic treatment needs of patients with tenosynovial giant cell tumor (TGCT). Based on results from the global Phase 3 MANEUVER study and long-term follow-up data, the U.S. FDA accepted the company’s New Drug Application (NDA) for pemigatinib in TGCT patients in January 2026. On June 9, 2026, the company announced it had received a payment of USD 13.52 million from Merck, comprising the milestone payment tied to the first prescription of Bejiemai (pemigatinib) in China and the Q1 2026 sales royalty. On June 22, 2026, pemigatinib officially received marketing approval from Health Canada, representing the second global approval following its Chinese approval and signifying the start of its global commercialization phase. Additionally, regulatory reviews for pemigatinib in the U.S. and other countries worldwide are ongoing. In December 2023, the company entered into an out-licensing agreement with Merck for pemigatinib, with total potential transaction value up to USD 605.5 million. The company received upfront and option exercise payments totaling USD 155 million in 2024 and 2025, granting Merck exclusive global commercial rights to pemigatinib.

The pivotal registrational clinical trial of epagotinib, an FGFR4 inhibitor, is progressing smoothly in China, while its global clinical development is being advanced in parallel.Epagotinib is a highly selective, orally administered FGFR4 inhibitor independently developed by the company. In prior clinical studies, whether used as monotherapy or in combination therapy for patients with advanced hepatocellular carcinoma (HCC) exhibiting FGFR19 overexpression, epagotinib demonstrated favorable safety and significant antitumor activity. Currently, the global Phase 1 clinical trial of epagotinib in FGF19-overexpressing HCC has dosed its first patient in the U.S., and the drug previously received Fast Track designation from the FDA. In March 2026, epagotinib was granted Orphan Drug Designation by the European Medicines Agency (EMA), which is expected to further accelerate its global development. Regarding progress in China, the pivotal registrational Phase 2 clinical trial of epagotinib as monotherapy in second-line HCC treatment has been initiated across more than 50 clinical centers nationwide and is advancing smoothly. Additionally, the company continues to explore the potential of epagotinib combined with various standard targeted-immunotherapy regimens as first-line treatment for advanced HCC.

The company maintains a robust pipeline of early-stage programs focused on innovative and cutting-edge therapeutic areas.At this year’s AACR Annual Meeting, the company presented preclinical and translational research findings from six early-stage programs, including the Pan-KRAS inhibitor ABSK211, the fourth-generation EGFR inhibitor ABK-EGFR-1, the CDK-selective inhibitor ABK-CDK4, the PRMT5-MTA cooperative inhibitor ABSK131, and a study utilizing ctDNA technology to elucidate resistance mechanisms to the FGFR2/3 inhibitor ABSK061. Among these, ABSK211 demonstrated potent in vitro activity, broad mutation coverage, and combination therapy potential in preclinical studies; ABK-EGFR-1 targets the C797S resistance mutation to address challenges arising from third-generation EGFR inhibitor resistance; ABK-CDK4 exhibits high selectivity and brain-penetrant properties, offering a potential therapeutic option for patients with brain metastases.

Maintain 'Recommended' rating.The company’s core product pemigatinib has already been approved for marketing in China and Canada for TGCT treatment, while its FGFR4 inhibitor for liver cancer has entered registrational clinical trials, and early-stage pipeline programs continue to advance steadily. Considering that pemigatinib has just entered the initial phase of commercial scale-up, with gradually increasing market penetration, and given the USD 13.52 million milestone payment from Merck confirmed in June 2026—with future milestone payments dependent on global regulatory approvals and commercial sales performance—we have adjusted our revenue forecasts for 2026 and 2027 accordingly, now estimating revenues of RMB 348 million and RMB 446 million (previously RMB 623 million and RMB 664 million, respectively), and introducing a new 2028 revenue forecast of RMB 591 million. Moreover, the company’s long-term core competitiveness—including the clinical value advantage of its lead products, its differentiated early-stage innovative pipeline, and its capability in out-licensing collaborations—remains unchanged. We maintain a 'Recommended' rating.

Risk Warning:Risks include slower-than-expected drug approval timelines, weaker-than-anticipated sales ramp-up following new drug launches, intellectual property-related risks, and risks arising from changes in government policies.

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