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Kelun-Biotech's ASCO 2025 Breakthroughs: A Paradigm Shift in Oncology and a Catalyst for Explosive Growth

Victor HaleFriday, May 23, 2025 5:48 am ET

24min read

The American Society of Clinical Oncology (ASCO) 2025 Annual Meeting has cemented Kelun-Biotech's position as a transformative force in oncology, with its six presented clinical studies demonstrating unprecedented efficacy and safety profiles across multiple tumor types. These data not only redefine treatment paradigms but also unlock a valuation upside that could position the company as a leader in precision oncology. Investors ignoring this opportunity may miss a once-in-a-decade catalyst for growth.

The Rise of Sac-TMT: A TROP2 ADC Shattering Efficacy Barriers

At the core of Kelun-Biotech's breakthrough is Sac-TMT, a first-in-class TROP2-targeting antibody-drug conjugate (ADC). In the OptiTROP-Lung03 Phase 3 trial, Sac-TMT delivered a staggering 45.1% objective response rate (ORR) in EGFR-mutant NSCLC patients after progression on standard therapies, versus just 15.6% for docetaxel. Median progression-free survival (PFS) of 6.9 months versus 2.8 months for the comparator is a game-changer, particularly given Sac-TMT's superior safety profile (56% grade ≥3 adverse events vs. 71.7% for docetaxel).

Sac-TMT's first global approval for EGFR-mutant NSCLC in China underscores its clinical primacy. But its potential extends further. In the Phase 2 OptiTROP-Breast05 trial, Sac-TMT achieved a 70.7% ORR in first-line TNBC, outperforming all existing therapies. Crucially, its efficacy held even in PD-L1-negative subgroups, dismantling the notion that checkpoint inhibitors alone dominate immuno-oncology.

Note: Kelun-Biotech's stock (KLBX) has already surged 35% YTD on anticipation of these data. Investors should note this is just the beginning.

Tagitanlimab: A PD-L1 Pioneer in Neglected Cancers

Kelun's anti-PD-L1 antibody tagitanlimab has similarly disrupted overlooked markets. In nasopharyngeal carcinoma (NPC), a deadly cancer with limited options, the Phase 3 NPC study showed tagitanlimab combined with chemotherapy doubled median PFS (NR vs. 7.9 months) and achieved an 81.7% ORR—results that led to its first global approval for first-line NPC in China. With NPC's global incidence rising in Asia and Africa, this represents a $2B+ addressable market.

In combination studies, such as the OptiTROP-Lung01 trial pairing tagitanlimab with Sac-TMT in NSCLC, the duo delivered a 59.3% ORR and a 15-month median PFS, with manageable toxicity. This synergy hints at a future where ADCs and checkpoint inhibitors become foundational in immuno-combination regimens.

KL590586: A Precision Tool for Rare but Deadly Cancers

Kelun's RET inhibitor KL590586 (licensed to Ellipses Pharma as EP0031) is carving a niche in ultra-rare cancers like medullary thyroid carcinoma (MTC). In a Phase 1 study, 63% of MTC patients achieved an objective response, with 100% disease control—a critical win in a space dominated by limited therapies. With FDA Fast Track designation and global Phase 2 trials underway, this drug could redefine treatment for RET-driven cancers, including NSCLC and thyroid malignancies.

Strategic Alliances Fueling Global Dominance

Kelun's partnerships amplify its reach. The MSD collaboration—where Sac-TMT is now in 14 global Phase 3 trials—ensures access to markets beyond China. Similarly, Ellipses Pharma's licensing of KL590586 accelerates penetration into the U.S., EU, and Middle East. These alliances de-risk development and create a pipeline that rivals Big Pharma's oncology portfolios.

The Investment Case: Valuation at a Crossroads

Kelun's NMPA approvals and global regulatory momentum (e.g., priority review for Sac-TMT in HR+/HER2- BC) signal rapid commercialization. With $2.3B in peak sales potential across its lead assets, the company's current valuation lags far behind its growth trajectory.

Consider this:
- Sac-TMT's EGFR-NSCLC indication alone addresses a market of ~100,000 patients annually.
- KL590586 targets a $500M+ market in RET-driven cancers.
- Tagitanlimab's NPC approval secures a high-margin niche with minimal competition.

Kelun's P/S ratio of 3.2x trails peers at 5.5x+, indicating significant upside as its drugs hit markets.

Conclusion: A Paradigm Shift with a Price Tag

Kelun-Biotech's ASCO 2025 data are not incremental—they are paradigm-shifting. By delivering superior efficacy, safety, and first-in-class approvals, the company has set a new standard for oncology. With partnerships unlocking global markets and a pipeline targeting $3B+ in addressable revenue, the stock is primed for multi-year growth.

For investors: The time to act is now. Kelun's data are too compelling to ignore, and its valuation is still undervalued relative to its potential. This is a rare opportunity to invest in a company poised to redefine cancer treatment—and profit handsomely from it.

Investors should execute immediately to capitalize on this inflection point before broader market recognition drives prices higher.

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