科伦博泰披露2026年中期业绩演示，商业化收入翻倍并转盈但缺少可交易超预期增量

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Introduction & Market Context
Kelun-Biotech (HKEX:6990) presented its interim results for the first half of 2026 on August 17, showcasing a fundamental business transformation as the Chinese biopharmaceutical company shifts from a research-driven model to a commercial-stage enterprise. The presentation revealed that commercialization revenue more than doubled year-over-year to reach RMB 657 million, now accounting for 67% of total revenue, while the company swung to profitability with adjusted net profit of RMB 479 million.
Trading at $522.5 following the announcement, up 0.38% from the previous close, Kelun-Biotech’s stock has delivered a 33% year-to-date gain as investors respond to the company’s commercial momentum. With a market capitalization of $15.86 billion, the company has established itself as a prominent player in China’s biotechnology sector.
Financial Performance Highlights
The company’s first-half financial results demonstrated both the progress and investment required in its commercial transition. As illustrated in the following revenue and margin overview, total revenue reached RMB 978.3 million for H1 2026, representing a modest 2.9% increase from the prior year period, but the composition changed dramatically.
Commercialization revenue from pharmaceutical product sales jumped 112% year-over-year to RMB 657 million, while revenue from license and collaboration agreements contributed RMB 309.8 million. This shift in revenue mix reflects the company’s evolution from relying primarily on partnership income to generating sustainable commercial sales.
Gross profit increased 11.7% to RMB 736.9 million, with gross margin expanding to 75.36%, demonstrating strong operational efficiency. Most significantly, the company reported net profit of RMB 388 million compared to a loss of RMB 145 million in H1 2025, and adjusted net profit of RMB 479 million versus an adjusted loss of RMB 69 million in the prior year period.
However, the commercial scale-up required substantial investment. Research and development expenses climbed 25.7% to RMB 768.4 million as the company advanced multiple late-stage clinical programs. Sales and distribution expenses more than doubled, rising 118.3% to RMB 390.6 million, reflecting the rapid expansion of the commercialization team and market access activities.
Integrated Capabilities and Strategic Position
The presentation emphasized Kelun-Biotech’s positioning as an integrated biopharmaceutical company with comprehensive drug development capabilities. As shown in the company overview below, the firm operates three proprietary technology platforms spanning biologics, antibody-drug conjugates (ADCs), and small molecules.
The company highlighted its distinction as one of the first movers in ADC development in China, with over a decade of accumulated experience. Notably, Kelun-Biotech became the first China-based company to establish an ADC collaboration with a top-ten global biopharmaceutical multinational, specifically MSD (Merck Sharp & Dohme), which serves as both the second-largest shareholder and a major strategic partner.
As of June 30, 2026, the company employed approximately 2,300 full-time staff, including roughly 900 in research and development, 550 in manufacturing and quality management, and 800 in commercialization—the latter nearly doubling year-over-year to support market expansion.
The company’s operational scale encompasses 30+ pipeline assets, with 10+ in clinical stages, 4 products on market covering 8 indications, and 3 new drug applications submitted covering 2 products.
Commercialization Success and Market Access
The company’s commercial performance centered on four marketed products, led by its flagship ADC sac-TMT (also known as SKB264 or MK-2870, branded as 佳泰莱®). The following chart illustrates the approved indications and commercial performance:
Sac-TMT has secured approval for four indications: second-line or later triple-negative breast cancer (TNBC), third-line EGFR-mutated non-small cell lung cancer (NSCLC), second-line EGFR-mutated NSCLC, and second-line or later HR+/HER2- breast cancer. Additional products include tagitanlimab (A167) for nasopharyngeal carcinoma, trastuzumab botidotin (A166) for HER2+ breast cancer, and cetuximab (A140) for colorectal cancer.
The presentation highlighted significant progress in market access, with three indications of sac-TMT and cetuximab passing the comprehensive review by experts for inclusion in China’s 2026 National Reimbursement Drug List (NRDL). This milestone positions sac-TMT as the only TROP2 ADC and the only domestic ADC for TNBC and NSCLC covered under national insurance.
Geographic reach expanded substantially, with the company now covering 30 provinces, over 300 cities, and more than 2,000 hospitals across China. The commercialization team of 800+ professionals, nearly double the prior year, achieved extensive grassroots coverage of top-tier hospitals in high-potential districts.
Management attributed the commercial momentum to two key drivers: expert recognition of high-quality clinical data leading to guideline recommendations, and comprehensive enhancement of drug accessibility through insurance coverage, hospital access channels, and sales force expansion.
Clinical Pipeline Development
The company’s clinical development strategy spans multiple therapeutic areas, with a particular focus on oncology ADCs and novel drug conjugates. The comprehensive pipeline matrix below illustrates the breadth of clinical activities:
The pipeline includes assets across all development stages, from Phase 1 through marketed products, targeting lung cancer, breast cancer, gastrointestinal cancers, and other solid tumors, as well as non-oncology indications including asthma and COPD.
Sac-TMT remained the centerpiece of clinical development, with the presentation detailing an extensive global program. As shown in the following development overview, the asset has evolved from late-line monotherapy to first-line combination therapy, from advanced disease to neoadjuvant settings, and from lung and breast cancer to multiple other tumor types.
In collaboration with MSD, sac-TMT is being evaluated across 17 global Phase 3 clinical studies spanning breast cancer (4 studies), lung cancer (5 studies), gastrointestinal cancer (1 study), gynecological cancers (6 studies), and genitourinary cancer (1 study). The TroFuse-005 study in endometrial cancer met its primary endpoints, representing a significant milestone for the global program.
Key Clinical Data Readouts
The presentation featured detailed efficacy data from multiple pivotal studies of sac-TMT. The most significant new data came from the OptiTROP-Lung05 study in first-line PD-L1-positive NSCLC, presented at the 2026 ASCO Annual Meeting. As illustrated in the following chart:
The combination of sac-TMT plus pembrolizumab demonstrated a hazard ratio of 0.35 for progression-free survival (95% CI: 0.26-0.47) and 0.55 for overall survival (95% CI: 0.36-0.85) compared to pembrolizumab alone. The objective response rate was 28.3 percentage points higher with the combination (70.2% vs 42.0%). Median PFS was not reached for the combination arm versus 5.7 months for pembrolizumab monotherapy, while median OS was not reached versus 14.5 months.
The safety profile showed higher grade ≥3 treatment-emergent adverse events with the combination, primarily driven by expected hematologic events from sac-TMT, but discontinuation rates due to adverse events were similar between arms with no treatment-related deaths attributed to sac-TMT.
Additional pivotal study data across multiple indications demonstrated consistent efficacy. The following chart summarizes results in second-line EGFR-mutated NSCLC, second-line or later TNBC, third-line EGFR-mutated NSCLC, and second-line or later HR+/HER2- breast cancer:
Across these indications, sac-TMT demonstrated hazard ratios ranging from 0.30 to 0.49 for progression-free survival and 0.33 to 0.63 for overall survival compared to standard chemotherapy, with manageable safety profiles and no unexpected safety signals.
Beyond sac-TMT, the presentation highlighted progress with lunbotinib fumarate (A400), a next-generation RET inhibitor. As shown in the Phase 2 pivotal study data below:
In treatment-naïve RET-fusion positive NSCLC patients, lunbotinib achieved a median PFS that was not reached, with 1-year and 2-year PFS rates of 71.6% and 59.9%, respectively. The confirmed objective response rate reached 81.3%. In previously treated patients, median PFS was 27.5 months with a CORR of 87.1%. The drug demonstrated a well-tolerated safety profile with only two patients (1.2%) discontinuing due to treatment-related adverse events.
Strategic Partnerships and Global Expansion
The company’s global expansion strategy centers on strategic partnerships that provide validation, capital, and market access. The following illustration shows the company’s key collaborations:
MSD represents the most significant partnership, serving as the second-largest shareholder and leading 17 global Phase 3 studies for sac-TMT outside Greater China. The collaboration also includes multiple other ADC assets such as SKB410/MK-3120 and SKB571/MK-2750.
Additional partnerships include Ellipses Pharma for global rights to lunbotinib (excluding Greater China and parts of Asia), Windward Bio for SKB378 in asthma and COPD (global rights except Greater China and parts of Southeast and West Asia), and Crescent Biopharma for SKB105 (ex-Greater China rights).
Management articulated a vision to "expand global footprint by improving our capabilities in ex-China market," with long-term goals of leveraging out-licensing collaborations to learn from partners’ expertise, explore diversified international pathways, promote international multi-center registrational studies, and establish a global commercialization system.
Pipeline Strategy and Innovation
The presentation detailed a multi-pronged pipeline strategy extending beyond traditional cytotoxin-based ADCs. As illustrated in the oncology ADC and novel drug conjugate platform overview:
The company is developing novel drug conjugates with single payloads including radioisotope-based, immuno-agonist-based, degrader-based, synthetic lethality-based, and novel cytotoxin-based approaches. Additionally, dual-payload drug conjugates combine mechanisms such as cytotoxin plus cytotoxin, immuno-agonist plus cytotoxin, degrader plus cytotoxin, and DDR inhibitor plus cytotoxin.
The clinical-stage cytotoxin-based ADC portfolio includes eight assets beyond the two approved products (sac-TMT and trastuzumab botidotin), targeting various tumor-associated antigens and designed to be differentiated from and complementary to approved ADCs in indications, efficacy, and safety profiles.
2026 Year-to-Date Achievements
The presentation summarized key accomplishments across commercialization, pipeline development, and capital markets through the first half of 2026:
Commercialization milestones included passing the 2026 NRDL expert review for three indications, expanding to 30 provinces and 2,000+ hospitals, and building a commercial team of 800+ professionals. Pipeline achievements encompassed multiple new indication applications for sac-TMT, initiation of numerous Phase 2 studies for pipeline assets, and receipt of breakthrough therapy designation from China’s NMPA for first-line PD-L1-positive NSCLC.
In capital markets, the company completed an H-share follow-on offering raising approximately $350 million, obtained approval from the Hong Kong Stock Exchange to remove the "B" suffix from its stock code, and gained inclusion in the MSCI Global Standard Indexes, FTSE Global Equity Index Series, and Hang Seng family of indexes.
Forward-Looking Strategy
Management outlined a five-pillar strategy to become a world-class biopharmaceutical company. The approach focuses on advancing differentiated pipelines targeting indications with significant unmet medical needs, innovating through optimized payload-linker strategies and novel drug conjugate designs, enhancing end-to-end drug development and commercialization capabilities, expanding global footprint through strategic partnerships, and optimizing the operational system.
For the commercial products, management detailed specific strategies by disease area. In lung cancer, the focus is on advancing sac-TMT into second-line EGFR-mutant NSCLC and expanding to first-line driver-gene-negative NSCLC, with expectations that first-line approval could reshape the treatment landscape and establish a new standard of care. In breast cancer, the strategy emphasizes advancing ADC adoption in second-line and later treatment for TNBC and HR+/HER2- breast cancer while strengthening differentiated positioning. For other tumors, particularly colorectal cancer, the goal is improving gene-testing rates to unlock growth potential for EGFR monoclonal antibodies.
Management expressed confidence that full-year 2026 commercialization revenue should at least double from 2025 levels and indicated the company could exceed that target. The outlook depends heavily on continued sac-TMT momentum through additional indication approvals, broader reimbursement coverage, increased hospital penetration, and sales force expansion. Near-term catalysts include potential approval of sac-TMT’s first-line TNBC and first-line PD-L1-positive NSCLC applications, as well as the expected launch of lunbotinib in China during the first half of 2027.
While R&D expenses increased substantially in the first half, management indicated that research spending should remain relatively stable in the second half with only modest potential growth, suggesting the company is moving toward a more balanced investment profile as commercialization revenue scales.
The presentation portrayed a company at an inflection point, transitioning from a pure research and development organization to a two-engine model combining collaboration income and commercial sales, with management indicating that break-even or profitability on a sustained basis could be achievable in 2026 or 2027.
Full presentation:
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