KOSDAQBiotech & Pharma476060

Onconic Therapeutics

₩15,750▼ 1.07%2026-10-02 close
Market Cap
₩713.4B
Turnover
₩2.7B
Volume
170K
Shares out.
45.4M
PER
30.1×
PBR
8.4×
EPS
₩546
Dividend Yield
0.00%

PER, EPS, PBR and BPS are calculated in-house from the last 4 quarters (2025Q3–2026Q2) · Dividend yield is based on ₩0 per share · Prices as of the 2026-10-02 close

01

Report overview

Zacuvo Growth Continues, Overseas Approvals in Focus

Onconic Therapeutics continues to post profits on the back of expanding domestic prescriptions for its self-developed drug Zacuvo (zastaprazan), while overseas approval progress in China and India and clinical advances in its oncology pipeline Nesuparib stand out as the next things to watch.

  1. 1

    Domestic prescription sales for Zacuvo have set a new quarterly record every quarter since its October 2024 launch, reaching KRW 25.6 billion in Q2 2026.

  2. 2

    Consolidated 2025 revenue reached KRW 53.4 billion with operating profit of KRW 12.6 billion, turning around from a loss the prior year.

  3. 3

    NMPA approval in China through partner Livzon Pharmaceutical Group is in the final review stage, while India granted the company's first overseas marketing approval in August 2026.

  4. 4

    A Phase 3 IND for expanding Zacuvo's indication to H. pylori eradication therapy in Korea was approved in September 2026.

  5. 5

    Oncology candidate Nesuparib has received US FDA orphan drug designations in pancreatic cancer, gastric cancer, and small cell lung cancer, highlighting pipeline value.

02

Business structure

Onconic Therapeutics was established in 2020 after in-licensing an acid-related gastrointestinal drug candidate and an oncology candidate from Jeil Pharmaceutical, and listed on KOSDAQ under the technology special listing track in December 2024.

Its core revenue driver is Zacuvo tablet (zastaprazan), Korea's 37th domestically developed new drug and a P-CAB (potassium-competitive acid blocker) treatment for gastroesophageal reflux disease.

Zacuvo was approved in April 2024 and launched domestically in October of that year, currently holding approvals for erosive GERD and gastric ulcer. Domestic distribution and marketing are handled jointly with parent company Jeil Pharmaceutical and Dong-A ST under a co-promotion agreement.

Overseas business is structured through licensing deals, with Livzon Pharmaceutical Group as the China partner and additional partners across a total of 27 countries including India, Latin America, and Southeast Asia.

In the domestic P-CAB market, the company entered as a later mover behind HK inno.N's K-CAB (tegoprazan) and Daewoong Pharmaceutical's Fexuprazan.

In oncology, the company is developing Nesuparib (JPI-547), a synthetic lethal dual PARP/Tankyrase inhibitor candidate, in Phase 2 trials across four solid tumor types: pancreatic, ovarian, endometrial, and gastric cancer.

Revenue is composed of domestic Zacuvo prescription sales plus overseas licensing milestones and royalties, with the timing and scale of the latter being a key driver of quarterly earnings volatility.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩9.4B₩1.1B11.8%
2025Q3₩19.2B₩8.3B43.3%
2025Q4₩15.6B₩1.6B10.3%
2026Q1₩23B₩4.6B20.0%
2026Q2₩24.4B₩2.8B11.4%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2023₩21.1B₩2.2B₩1.7B10.6%—−290.7%
2024₩14.8B-₩4.8B-₩8.1B−32.3%−14.4%8.7%
2025₩53.4B₩12.6B₩15.8B23.6%21.9%5.1%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-04

04

Earnings analysis

Consolidated 2025 revenue reached KRW 53.39 billion with operating profit of KRW 12.62 billion (23.6% operating margin), marking a clear turnaround from 2024's revenue of KRW 14.84 billion and an operating loss of KRW 4.80 billion.

Net income attributable to owners also improved from a loss of KRW 8.09 billion in 2024 to a profit of KRW 15.78 billion in 2025.

In 2023, the company posted revenue of KRW 21.06 billion and operating profit of KRW 2.23 billion, though total equity stood at a negative KRW 19.69 billion, reflecting a capital impairment situation prior to listing.

On a quarterly basis, Q2 2025 revenue was KRW 9.43 billion with operating profit of KRW 1.11 billion, while net income attributable to owners registered a small loss of KRW 156 million.

Q3 2025 showed a sharp improvement with revenue of KRW 19.21 billion, operating profit of KRW 8.32 billion, and net income of KRW 9.40 billion, reflecting the combined effect of expanding Zacuvo prescriptions and recognition of overseas milestones.

Q4 2025 revenue was KRW 15.58 billion with operating profit of KRW 1.61 billion, a lower operating margin than Q3, illustrating the quarter-to-quarter variability tied to milestone recognition timing.

Into 2026, Q1 revenue reached KRW 22.98 billion with operating profit of KRW 4.59 billion, and Q2 revenue hit KRW 24.40 billion with operating profit of KRW 2.79 billion — revenue has set a new record each quarter, though operating margin has fluctuated.

Over the trailing four quarters from Q3 2025 through Q2 2026, net income attributable to owners totaled KRW 24.25 billion, indicating a rapidly expanding profit base on an annualized basis.

05

Industry analysis

Korea's domestic P-CAB class GERD treatment market recorded prescription sales of KRW 368.5 billion in 2025 according to UBIST, up 28.7% from KRW 286.4 billion in 2024, with HK inno.N's K-CAB holding the incumbent position while Daewoong Pharmaceutical's Fexuprazan and Onconic Therapeutics' Zacuvo compete as later entrants.

The domestic acid-suppressant market is in a structural growth phase as prescriptions shift from traditional PPIs to P-CABs, and Zacuvo continues to set new quarterly prescription records and expand share even in its second year on the market.

Overseas, China is estimated to be the world's largest single-country GERD treatment market at roughly KRW 6 trillion, and is seen as still in an early formation stage for P-CAB-class drugs, suggesting greater growth potential than the domestic market.

Onconic Therapeutics secured Livzon Pharmaceutical Group, the leading player in China's PPI segment, as its local partner, giving it access to an established distribution network.

In oncology, PARP inhibitors are already established as standard therapy in several indications, and Nesuparib is attempting to differentiate itself through a dual PARP/Tankyrase inhibition mechanism.

The case of a domestically developed new drug simultaneously pursuing overseas clinical trials and approvals while attempting global commercialization is drawing attention within Korea's broader biotech industry.

06

Outlook

In a February 2026 disclosure, the company presented a 2026 target of KRW 111.8 billion in revenue and KRW 26.5 billion in operating profit, aiming for roughly double the growth of 2025 results.

First-half 2026 results showed revenue of KRW 47.3 billion and operating profit of KRW 7.4 billion, up 154.3% and 174.1% year-over-year respectively, indicating progress toward that target.

In overseas business, NMPA approval in China through partner Livzon Pharmaceutical Group is in the final review stage, and the company has stated it expects approvals in both China and India by the end of 2026.

India granted local manufacturing and sales approval for erosive GERD treatment through the CDSCO in August 2026, marking the company's first overseas marketing approval, with royalty income expected once local sales begin.

Domestically, a Phase 3 IND for expanding the indication to H. pylori eradication therapy was approved in September 2026, with a trial involving 414 patients set to proceed, while a Phase 3 trial for the same indication is also underway in China.

For the oncology pipeline, Phase 1b data for Nesuparib in pancreatic cancer was presented at ASCO in May 2026, and further disclosure of endometrial and gastric cancer trial results could advance licensing discussions.

The company has described its strategy as reinvesting stable Zacuvo revenue into research and development of follow-on new drug candidates.

07

Valuation

PER
30.1×
PBR
8.4×
ROE
33.5%
EPS
₩546
BPS
₩1,951
Dividend per share
₩0

Onconic Therapeutics turned from a loss in 2024 to a profit in 2025, and has continued into 2026 with revenue setting new quarterly records each period, reflecting an earnings recovery phase.

The stock's earnings-based valuation level can be interpreted as reflecting the valuation structure typically seen in the early stage of an earnings turnaround, and the share price trades well above book value per share, placing it in a range with a significant premium to net asset value.

The company does not pay dividends, so dividend-related metrics are not meaningful here.

Valuation reflects not only domestic Zacuvo prescription revenue but also progress on overseas approvals in China and India, as well as the clinical and potential licensing prospects of the oncology pipeline Nesuparib, meaning the assessment could shift depending on whether upcoming approval and milestone events materialize.

Kiwoom Securities, in a May 2026 report, raised its target price from KRW 19,000 to KRW 30,000, citing the incorporation of value from Zacuvo's China pipeline and the Nesuparib pipeline.

Sangsangin Investment & Securities, in a July 2026 report, stated that value recognition for Zacuvo and Nesuparib was accelerating and presented a Buy rating with a target price of KRW 21,000.

PER, EPS, PBR and BPS are all calculated in-house (the same method as Naver and Toss) · Dividend yield = cash dividend per share from DART filings (supplemented by KRX) ÷ current price · As of 2026-09-04

08

Bull factors

Sustained High-Speed Domestic Prescription Growth

Zacuvo has set a new quarterly prescription record every quarter since its October 2024 launch, with Q2 2026 prescription sales reaching KRW 25.6 billion, up 20.6% from Q1. Monthly prescription figures have also grown rapidly, from KRW 3.7 billion in June 2025 to roughly KRW 9.7 billion in July 2026.

The fact that growth has not slowed even in the second year since launch is a key strength of the domestic business.

Overseas Approval Progress and Milestone Inflows

In August 2026, India's CDSCO granted the company's first overseas marketing approval for erosive GERD treatment.

In China, NMPA approval through partner Livzon Pharmaceutical Group is in the final review stage, and a milestone of roughly KRW 1.5 billion was secured following first-patient dosing in a Phase 3 H. pylori eradication trial.

Given licensing agreements spanning 27 countries, additional approval and milestone events have the potential to occur sequentially.

Rising Visibility of the Oncology Pipeline

Nesuparib has received US FDA orphan drug designations in pancreatic cancer, gastric cancer, and small cell lung cancer, underscoring recognized medical need.

Phase 1b pancreatic cancer data was presented at ASCO in May 2026, and additional disclosure of endometrial and gastric cancer trial results could lead to licensing discussions. The structure of funding oncology drug development through Zacuvo revenue is cited as a potential source of follow-on growth.

09

Bear factors

Revenue Concentration in a Single Product

A substantial portion of current revenue stems from domestic Zacuvo prescriptions and related milestones, reflecting high dependence on a single product. The follow-on pipeline candidate Nesuparib remains in Phase 2 trials, meaning commercialization is likely to take considerable time. Any slowdown in Zacuvo's growth could have an outsized effect on overall results.

Intensifying Competition and Overseas Approval Uncertainty

The domestic P-CAB market remains competitive, with HK inno.N's K-CAB and Daewoong Pharmaceutical's Fexuprazan holding incumbent positions.

Regarding NMPA approval in China, the company has stated it expects approval within the year, but overseas approval processes always carry the possibility of schedule delays or changed conditions. If the timing of full-scale overseas revenue is delayed, growth projections may need to be revised.

Quarterly Earnings Volatility

Operating profit was KRW 8.3 billion in Q3 2025 but dropped sharply to KRW 1.6 billion in Q4, illustrating significant quarter-to-quarter variability tied to milestone recognition timing.

This stems from the non-recurring nature of overseas licensing income, making it difficult to judge the overall growth trend from any single quarter's results.

10

Risk factors

Regulatory Approval Risk

Overseas marketing approvals in China, India, and Mexico, as well as domestic and international Phase 3 trials for indication expansion, are all subject to timing and conditions that depend on regulatory review outcomes.

The H. pylori eradication trial is at the stage of starting a 414-patient study following IND approval in September 2026, and results will take time to confirm. If approvals are delayed or granted conditionally, the timing of related milestone payments could also be pushed back.

Competitive Landscape Risk

In the domestic P-CAB market, HK inno.N's K-CAB and Daewoong Pharmaceutical's Fexuprazan have already secured a broad prescription base, meaning Zacuvo, as a later entrant, must continue expanding its share. Competition from local generics and rival brands is also expected in overseas markets. Intensifying competition could slow prescription growth rates.

Governance and Ownership Risk

The stake held by largest shareholder Jeil Pharmaceutical is understood to have declined from roughly 53% at the time of listing to around 45% subsequently, and there is an ongoing structure of related-party transactions including technology fee settlements and co-promotion agreements with the parent company.

Changes in the parent's stake or in the terms of related-party transactions are factors that could affect minority shareholder interests.

11

What to watch next

  1. Around November 2026

    Check the Q3 quarterly report disclosure for continued Zacuvo prescription growth and any recognition of overseas milestones.

  2. During Q4 2026

    Confirm whether the company's targeted timeline for NMPA approval in China (within the year) is actually achieved.

  3. H2 2026 through 2027

    Monitor whether local sales commence in India following CDSCO approval and when related royalty income begins to materialize.

  4. Sequentially from September 2026 onward

    Track the progress of the domestic 414-patient Phase 3 H. pylori eradication trial and the Phase 3 quadruple-therapy trial in China.

  5. At each clinical data disclosure

    Watch for additional Nesuparib clinical data disclosures in endometrial and gastric cancer, and whether these lead to progress in licensing discussions.

12

Overall view

Onconic Therapeutics turned from a loss in 2024 to a profit in 2025 on the back of rapid domestic prescription growth for Zacuvo, and has continued setting new quarterly revenue records into 2026.

However, quarterly operating profit has shown considerable variance depending on the timing of overseas milestone recognition, making it difficult to draw firm conclusions from any single quarter's results.

In overseas business, following its first marketing approval in India, NMPA approval in China is in the final review stage, with the company stating it expects approval within the year.

The oncology pipeline Nesuparib has drawn attention as a potential follow-on growth driver, having secured multiple FDA orphan drug designations, though it remains in Phase 2 trials and will require time before commercialization.

The competitive landscape in the domestic P-CAB market and uncertainty around overseas approval timelines remain factors that warrant balanced consideration.

Future earnings and valuation assessments are likely to hinge on whether Zacuvo's domestic prescription growth continues, progress on overseas approvals and commercialization in China and India, and the outcome of upcoming Nesuparib clinical data disclosures.

13

Sources

  1. Korea Exchange (KRX) — Prices · Market Cap · Volume
  2. FSS electronic disclosure system (DART) — Financial statements · Dividend filings
Show 18 more articles and sources
  1. view.asiae.co.kr
  2. fintechtimes.co.kr
  3. mt.co.kr
  4. geconomy.co.kr
  5. fintechtimes.co.kr
  6. apsk.co.kr
  7. pharm.edaily.co.kr
  8. view.asiae.co.kr
  9. insightkorea.co.kr
  10. etoday.co.kr
  11. newstown.co.kr
  12. dart.fss.or.kr
  13. valueline.co.kr
  14. zdnet.co.kr
  15. comp.fnguide.com
  16. m.thinkpool.com
  17. kr.investing.com
  18. thevc.kr

Report written 2026-09-05 · Data as of 2026-09-04

This content is AI analysis of market data and web search results, provided for information only. It is not a solicitation or recommendation to invest. Investment decisions and their consequences are the investor's own responsibility. Data may be delayed or contain errors.