Tianfeng Securities: Pimicotinib approved for marketing, officially entering commercialization phase for Abbisko Therapeutics-B (02256.HK)

Event:The highly selective CSF-1R small molecule pimicotinib has been approved for marketing to treat adult patients with symptomatic tenosynovial giant cell tumor (TGCT), for whom surgical removal might lead to functional limitations or severe complications.$ABBISKO-B (02256.HK)$

The first self-developed innovative drug product, pimicotinib, has been approved for marketing, demonstrating BIC potential

Pimicotinib is the company’s first approved self-developed innovative drug product with good efficacy and safety. The MANEUVER Phase III study showed that after 25 weeks of treatment with pimicotinib, the ORR was 54.0% (vs. 3.2% for placebo). From a long-term efficacy perspective, at a median follow-up of 14.3 months, the ORR in patients receiving pimicotinib increased to 76.2%; by week 49, patient clinical outcome assessments (COAs) continued to improve with good safety, and relative joint mobility improved by 23.9% from baseline by week 73. Patients in the control group who switched to pimicotinib also achieved clinical benefits, with an ORR of 64.5% at a median follow-up of 8.5 months and improvements in COAs. Currently, there are few drugs globally approved for treating TGCT; the approved drug pexidartinib achieved an objective response rate (ORR) of 39% at week 25 but may pose risks of mixed and cholestatic hepatotoxicity, resulting in an FDA 'black box warning'; Ono Pharmaceutical's Vimseltinib had an ORR of 40% at week 25. Pimicotinib shows no cholestatic hepatotoxicity and has a higher ORR, offering dual advantages of efficacy and safety over existing drugs (non-head-to-head comparison).

The therapeutic value of pimicotinib has been recognized by multinational corporations (MNCs), and its global commercialization process is accelerating

In addition to being approved in China, pimicotinib has received Breakthrough Therapy Designation (BTD) from the US FDA and Priority Medicines (PRIME) status from the European EMA (similar to BTD), with developments progressing smoothly in both the US and Europe. Globally, there are approximately 400,000 cases of TGCT. In 2023, the company signed an exclusive licensing agreement with Merck for pimicotinib, granting Merck commercial rights in China. In April 2025, Merck exercised its option to obtain global commercial rights for a fee of $85 million. The total transaction amount could reach up to $605.5 million, deepening the partnership.

ABSK043's preliminary clinical data shows a balance of efficacy and safety, with combination therapies targeting nearly half of the NSCLC market

The oral PD-L1 inhibitor ABSK043 has FIC potential and has demonstrated antitumor efficacy comparable to approved PD-L1 antibodies in multiple preclinical models. ABSK043 is specifically designed for combination therapy and is currently undergoing three Phase II clinical trials in combination with Furmonertinib, Grelerac, and ABSK061.

EGFR mutations are the most common driver gene mutations in NSCLC. Although third-generation EGFR-TKIs have become the standard first-line treatment for EGFR-mutated advanced NSCLC, previous studies suggest that for patients with EGFR mutations combined with high PD-L1 expression, the efficacy of third-generation EGFR-TKIs is inferior to that observed in patients with low or negative PD-L1 expression. In patients with PD-L1<50% and PD-L1≥50%, the mPFS for the Osimertinib group was 23.6 months and 10.2 months, respectively. Furthermore, combinations of PD-(L)1 antibodies with EGFR-TKIs have been limited by severe toxicity. In a Phase Ib clinical trial of Durvalumab combined with Osimertinib as a first-line treatment for EGFR mutant NSCLC, treatment-related toxicities were significant, with 82% of patients experiencing Grade 3 or higher adverse events, including an ILD incidence rate of up to 38%.

Phase II clinical data for ABSK043 in combination with Furmonertinib showed that among 21 patients with EGFR mutations and PD-L1 positivity who had previously been treated for advanced NSCLC (17 patients received third-generation EGFR-TKIs), the DCR reached 71%, ORR was 25%, and no DLT or ILD was observed. The most common TEAEs were Grade 1-2, with no Grade 4 or 5 TEAEs observed. These positive results provide a solid foundation for the ongoing dose-expansion phase of this combination therapy in first-line treatment for EGFR-mutant and PD-L1-positive NSCLC.

Several key assets are approaching milestones, marking the company’s entry into a new phase of intensive catalysts

The company boasts a rich pipeline with over 10 oncology products in clinical stages. Pan-KRAS inhibitor ABSK211 is expected to enter clinical trials in 2026, while development of other drugs like FGFR4 inhibitor ABSK011 is proceeding smoothly.

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