STOCK TITAN

TP-03 (lotilaner ophthalmic solution) 0.25% Now Approved in China for the Treatment of Demodex Blepharitis, Triggering a $15M Milestone Payment to Tarsus

(Neutral)
Tags

Tarsus Pharmaceuticals (NASDAQ: TARS) announced a $15 million milestone payment after Grand Pharmaceutical Group obtained NMPA approval in China for TP-03 (lotilaner ophthalmic solution) 0.25% for Demodex blepharitis. The approval covers the Greater China region and triggers agreed patent-related and regulatory milestones.

Under the partnership, Tarsus may receive additional payments for regulatory milestones, China sales thresholds, and tiered royalties tied to TP-03 commercial performance in the region.

Loading...
Loading translation...

Positive

  • $15M milestone payment received upon NMPA approval
  • NMPA regulatory approval for TP-03 in Greater China
  • Potential future revenue via sales thresholds and tiered royalties

Negative

  • None.

News Market Reaction – TARS

-0.59%
1 alert
-0.59% Session close to close
$2.75B Market Cap
1.42K Volume

In the Mar 23 session, TARS declined 0.59%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds a new geographic pillar to the TP-03/XDEMVY story, with China approval and a ...
Analysis

This announcement adds a new geographic pillar to the TP-03/XDEMVY story, with China approval and a $15 million milestone from Grand Pharma building on prior XDEMVY sales of $451.4 million in 2025. It reinforces the global commercialization trajectory highlighted in earlier updates. Investors may watch launch execution in Greater China, additional regulatory milestones, and evolving royalty and sales thresholds tied to this partnership.

Key Figures

Milestone payment: $15 million 2025 XDEMVY sales: $451.4 million Q4 2025 XDEMVY sales: $151.7 million +5 more
8 metrics
Milestone payment $15 million Regulatory approval of TP-03 in China triggers payment from Grand Pharma
2025 XDEMVY sales $451.4 million Full-year 2025 net product sales for XDEMVY
Q4 2025 XDEMVY sales $151.7 million Fourth quarter 2025 net product sales for XDEMVY
Bottles delivered 400,000 bottles Approximate number of XDEMVY bottles delivered in 2025
Payer coverage >90% XDEMVY payer coverage level reported for 2025
Year-end cash $417.3 million Tarsus cash balance at end of 2025
Peak sales potential >$2 billion Management’s cited peak sales potential for XDEMVY
Patients affected 40 million people Estimated people in Greater China affected by Demodex blepharitis

Historical Context

5 past events · Latest: Feb 26 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Feb 26 Investor conferences Neutral -0.5% Announcement of management participation in March 2026 health care conferences.
Feb 23 Earnings and update Positive +7.8% Reported strong 2025 XDEMVY sales, robust cash and pipeline progress.
Feb 18 Board appointment Positive +0.8% Added former Allergan CEO David Pyott to Board of Directors.
Feb 17 Earnings date notice Neutral +0.8% Set date and webcast details for Q4 and full-year 2025 results.
Nov 24 Investor conference Neutral -3.9% Planned fireside chat at BTIG Ophthalmology Day with webcast access.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent history shows strong positive reaction to fundamental updates like earnings, while conferences and routine announcements have produced modest or mixed price moves.

Recent Company History

Over the past six months, Tarsus has highlighted XDEMVY’s commercial growth, with full-year 2025 net product sales of $451.4 million and Q4 sales of $151.7 million, alongside a solid cash position of $417.3 million. Board strengthening and frequent conference participation supported the story, but only the earnings release drove a sizable move (+7.79%). Today’s China approval and $15 million milestone build on that global expansion narrative around TP-03/XDEMVY.

Key Terms

demodex blepharitis, ophthalmic solution, national medical products administration
3 terms
demodex blepharitis medical
"treatment of Demodex blepharitis in the Greater China region"
An inflammatory eye condition caused by tiny mites (Demodex) that live at the base of eyelashes, leading to redness, itching, crusting and chronic eyelid irritation. It matters to investors because it represents a clear clinical need that can drive demand for new drugs, medical devices and diagnostic tests; like a common household pest problem, it can create recurring treatment markets, ongoing clinical development and potential regulatory milestones that affect company value.
ophthalmic solution medical
"TP-03 (lotilaner ophthalmic solution) 0.25%, marketed as XDEMVY"
An ophthalmic solution is a liquid medicine formulated to be placed in the eye, like eye drops, used to treat conditions such as infections, inflammation, pressure changes, or dry eye. Investors track these products because their approval, safety record, manufacturing quality and patent status determine sales potential and competition—think of it like a packaged household remedy whose shelf life, rules and maker reputation affect its market value.
national medical products administration regulatory
"by the National Medical Products Administration (NMPA) of the People's Republic of China"
The National Medical Products Administration is the government agency responsible for reviewing, approving and supervising drugs, vaccines, medical devices and related products. Think of it as the country’s gatekeeper for medical products: its decisions determine whether a product can be sold, how quickly it reaches patients and what safety or labeling requirements apply, so its rulings directly affect a company’s sales prospects, regulatory risk and investor valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

IRVINE, Calif., March 23, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) today announced that a $15 million milestone payment due Tarsus has been achieved following regulatory approval of TP-03 (lotilaner ophthalmic solution) 0.25%, marketed as XDEMVY® in the U.S., by the National Medical Products Administration (NMPA) of the People's Republic of China.

The approval was obtained by Grand Pharmaceutical Group Limited (“Grand Pharma”), Tarsus’ exclusive partner for the development and commercialization of TP-03 for the treatment of Demodex blepharitis in the Greater China region, which includes the People’s Republic of China, Hong Kong, Macau and Taiwan.

“TP-03 is once again the first and only therapy approved to address the root cause of Demodex blepharitis — marking a meaningful advance for the more than 40 million people in the region affected by this disease,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “This approval underscores our commitment to bringing this much-needed treatment to patients worldwide, and we look forward to supporting Grand Pharma as they prepare for launch.”

Under the terms of the agreement with Grand Pharma, Tarsus is eligible to receive the $15 million milestone payment based on regulatory approval in China and patent issuance related to TP-03, both conditions of which have been achieved, as well as further consideration from Grand Pharma upon the achievement of additional TP-03 events. These include additional regulatory milestones, China-based TP-03 sales threshold milestones, and tiered royalties for TP-03 product sales in the Greater China region.

About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of ocular rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease, both of which are in Phase 2.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding achievement of milestone payments due Tarsus and our partners’ ability to commercialize TP-03 in the Greater China region, and the quotations of Tarsus’ management. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the successful commercialization of XDEMVY for the treatment of Demodex blepharitis and the successful development, regulatory approvals and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it could continue to incur significant expenses and potential losses in the future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not ultimately be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus’ products and its product candidates is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, marketing, and distribution capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the potential treatment of ocular rosacea, as well as TP-05 for the potential prevention of Lyme disease, have not been established with precision and may be smaller than estimated, possibly materially; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue from net product sales and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for XDEMVY or its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2025 filed on February 23, 2026, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
akemp@tarsusrx.com

Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
DNakasone@tarsusrx.com


FAQ

What milestone did Tarsus (TARS) achieve on March 23, 2026?

Tarsus achieved a $15 million milestone payment tied to China approval. According to the company, Grand Pharma's NMPA approval of TP-03 and related patent issuance triggered the payment under their partnership agreement.

What approval did TP-03 (lotilaner) receive in China for TARS?

TP-03 received NMPA approval in the People’s Republic of China for Demodex blepharitis. According to the company, approval covers the Greater China region including Hong Kong, Macau and Taiwan via Grand Pharma.

Will Tarsus (TARS) receive additional payments from Grand Pharma after this milestone?

Yes, Tarsus is eligible for further payments tied to additional milestones and sales. According to the company, future consideration includes regulatory milestones, China-based sales thresholds, and tiered royalties on TP-03 sales.

How does the Grand Pharma partnership affect Tarsus' commercialization of TP-03 in Greater China?

Grand Pharma holds exclusive development and commercialization rights in Greater China under the agreement. According to the company, Grand Pharma obtained NMPA approval and will lead launch and local commercialization efforts.

What is the marketed name of TP-03 in the U.S. referenced by TARS?

TP-03 is marketed in the U.S. as XDEMVY. According to the company, the same lotilaner ophthalmic solution, TP-03 0.25%, achieved regulatory approval in China through Grand Pharma.