This year, driven by the bullish market for innovative drugs in Hong Kong stocks, the Hang Seng Healthcare Index (800804) surged from 2,331.02 points at the beginning of the year to a yearly high of 4,726.41 points in September, marking a cumulative increase of 102.76%. Subsequently, due to technical factors and external influences, the index entered a downward correction phase, declining 19.06% from its peak as of December 22. During this period, many high-performing stocks with strong innovation capabilities and solid fundamentals, including ABBISKO-B (02256), were affected.

Among the top performers in this year’s biotech rally, ABBISKO-B saw its stock price soar by 370.95% at its peak. Although the stock has retreated amid sector-wide fluctuations, the recent approval of its core drug, pimicotinib (branded as Beijieme®), in China has emerged as a major value catalyst.

**Breakthrough Commercialization of a "Billion-Dollar Molecule"** On December 22, ABBISKO announced that China’s National Medical Products Administration (NMPA) approved Beijieme® (pimicotinib capsules) based on positive global Phase III MANEUVER study data. Beijieme® is the first self-developed systemic treatment for tenosynovial giant cell tumor (TGCT) in China and a key asset in ABBISKO’s differentiated R&D pipeline.

The approval marks the first step in the global commercialization of this potential first-in-class (FIC)/best-in-class (BIC) drug, addressing an unmet medical need in TGCT treatment. Notably, the NDA review process was completed in just over six months without supplementary requirements, reflecting the drug’s robust clinical data and regulatory confidence.

**Strong Clinical Validation** At the European Society for Medical Oncology (ESMO) 2025 conference, ABBISKO presented long-term efficacy and safety data from the MANEUVER study. Results demonstrated durable tumor response and sustained clinical improvement in TGCT patients, with a safety profile consistent with prior analyses. These findings reinforced pimicotinib’s therapeutic potential and supported its regulatory approval.

As the first China-developed CSF-1R inhibitor, pimicotinib has received breakthrough therapy designations in the U.S., EU, and China. Beyond TGCT, it holds promise for other indications like chronic graft-versus-host disease (cGVHD). Its blockbuster potential was underscored by a high-value licensing deal with Merck in late 2023, including a $70 million upfront payment and an $85 million option exercise in April 2024. The total deal value could reach $606 million, highlighting Merck’s confidence in ABBISKO’s innovation.

**Market Potential and Competitive Edge** Pimicotinib targets TGCT patients ineligible for surgery, a rare disease with an incidence of 43 per million. While competitor pexidartinib (marketed by Daiichi Sankyo) carries a black-box warning for liver toxicity, it generated ¥5.3 billion in 2023 revenue. Pimicotinib’s superior safety and efficacy profile positions it for rapid market penetration and expansion into additional indications.

CMB International Securities projects peak global sales of $1.5 billion for pimicotinib, citing its best-in-class potential.

**Strengthening the Innovation Pipeline** With pimicotinib’s approval, ABBISKO is poised to generate stable cash flow to fuel its R&D efforts. The company’s pipeline includes 22 globally competitive assets, such as epagocitinib (ABSK011), a potential FIC FGFR4 inhibitor, and other FIC/BIC candidates like ABSK043 (PD-L1 inhibitor), ABSK141 (KRAS G12D inhibitor), and ABSK061 (FGFR2/3 inhibitor). Recent milestones across these programs underscore ABBISKO’s innovation momentum.

**Shareholder Value and Valuation Upside** ABBISKO stands out among Hong Kong-listed biotech firms for its commitment to shareholder returns, including a HK$200 million share buyback program in March. Year-to-date, the company has repurchased 10.23 million shares for HK$84.67 million.

Compared to peers like Akeso (39.07x P/S) and Ascentage Pharma (49.16x P/S), ABBISKO’s current P/S ratio of 13.38x suggests significant upside, given its robust pipeline and commercialization progress.

As pimicotinib enters the market, ABBISKO transitions into a commercial-stage biopharma, with potential to accelerate global expansion and unlock further value.