# EDGAR Filing Document

**Accession Number:** 0001818838
**File Stem:** 0001104659-25-110830
**Filing Date:** 2025-11
**Character Count:** 7571
**Document Hash:** df18d6c46f39cbae8c713bc75def6427
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-110830.hdr.sgml**: 20251113

**ACCESSION NUMBER**: 0001104659-25-110830

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20251113

**FILED AS OF DATE**: 20251113

**DATE AS OF CHANGE**: 20251113

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Adagene Inc.
- **CENTRAL INDEX KEY:** 0001818838
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** E9
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39997
- **FILM NUMBER:** 251475331

**BUSINESS ADDRESS:**
- **STREET 1:** 4F, BUILDING C14, NO. 218, XINGHU STREET
- **STREET 2:** SUZHOU INDUSTRIAL PARK
- **CITY:** JIANGSU
- **STATE:** F4
- **ZIP:** 00000
- **BUSINESS PHONE:** 86-512-87773632

**MAIL ADDRESS:**
- **STREET 1:** 4F, BUILDING C14, NO. 218, XINGHU STREET
- **STREET 2:** SUZHOU INDUSTRIAL PARK
- **CITY:** JIANGSU
- **STATE:** F4
- **ZIP:** 00000

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 6-K**

**REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-<br> 16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934**

**For the Month of November 2025**

**Commission File Number: 001-39997**

**Adagene Inc.**

**4F, Building C14, No. 218**

**Xinghu Street, Suzhou Industrial Park**

**Suzhou, Jiangsu Province, 215123**

**People's Republic of China**

**+86-512-8777-3632**

**(Address of principal executive offices)**

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F x Form 40-F ¨

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **Adagene Inc.** | **Adagene Inc.** |
|  | By: | /s/ Peter Luo |
|  | Name: | Peter Luo |
|  | Title: | Chief Executive Officer |
| Date: November 13, 2025 |  |  |

---

**EXHIBIT INDEX**

---

| |
|:---|
| **Exhibit** |
| [99.1](tm2531147d1_ex99-1.htm) [Press release titled Adagene Announces Licensing Agreement with Third Arc Bio for Development of Two Masked CD3 T Cell Engagers Utilizing SAFEbody<sup>®</sup> Technology](tm2531147d1_ex99-1.htm) |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm2531147d1_ex99-1img001.jpg)

**Adagene Announces Licensing Agreement with Third Arc Bio for Development of Two Masked CD3 T Cell Engagers Utilizing SAFEbody<sup>®</sup> Technology**

SAN DIEGO, CA, SUZHOU, China, and SPRING HOUSE, PA, November 13, 2025 -- Adagene Inc. ("Adagene") (Nasdaq: ADAG) and Third Arc Bio, Inc. ("Third Arc Bio"), today announced a licensing agreement under which Third Arc Bio will utilize Adagene's SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to research, develop and commercialize two candidate molecules worldwide. Adagene will receive an upfront payment of $5 million and is eligible to receive development and commercial-based milestones of up to $840 million (if all milestones and conditions are achieved) as well as royalties on end-user sales. In addition, Adagene has a no-cost option to develop and commercialize these candidate molecules in Greater China, Singapore and South Korea.

Peter Luo, Ph.D., Chief Executive Officer of Adagene said, "Our SAFEbody technology allows activation of an antibody when it reaches the tumor microenvironment. The resulting wider therapeutic index from improved safety allows for higher dosing and potentially better efficacy, as seen from the data we continue to generate with muzastotug. We're thrilled that Third Arc Bio will be utilizing our SAFEbody technology for a portion of their exciting pipeline programs."

"Our agreement with Adagene will allow Third Arc Bio to advance highly innovative molecules with a superior therapeutic index and help build on our growing portfolio of novel CD3- and CD28-targeting T cell engagers," said Peter Lebowitz, M.D., Ph.D., Chief Executive Officer of Third Arc Bio. "Adagene's SAFEbody® technology expands the reach of our ArcStim Platform to additional novel targets."

**About Adagene**

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody precision masking technology in multiple approaches at the vanguard of science.

Adagene's lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on microsatellite stable (MSS) colorectal cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T cell engagers.

![](tm2531147d1_ex99-1img001.jpg)

For more information, please visit: <u>https://investor.adagene.com</u>.

Follow Adagene on <u>WeChat, LinkedIn</u> and X.

SAFEbody is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

**About Third Arc Bio**

Third Arc Bio is a clinical stage biotech company developing multifunctional antibodies that generate immune synapses to precisely activate or inhibit T cells. The lead program ARC101, is a bispecific T cell engager currently being evaluated in a Phase 1 trial for cancer patients with solid tumors expressing CLDN6. The company's drug development engine delivers superior biologics optimized to create best-in-class T cell engagement by leveraging novel technologies that power a pipeline of high value therapeutics. The Third Arc Bio platforms include a solid tumor ARCStim Platform and an immunology & inflammation (I&I) ARCTag Platform that offers precision immune regulation to achieve superior efficacy and safety. To learn more, visit <u>www.thirdarcbio.com</u>.

**About ARC101**

ARC101 is a potential best-in-class T cell engager that targets solid tumors expressing CLDN6. ARC101 exhibits high specificity with no off-target binding, avoids other Claudin family proteins, and has potent cytotoxicity, a long half-life and optimal biophysical properties. ARC101 is currently in Phase 1 studies <u>NCT06672185</u>, to assess its safety, tolerability, pharmacokinetics and antitumor activity in patients with advanced cancer.

**Adagene Investor Contacts:**

Raymond Tam

<u>raymond_tam@adagene.com</u>

Corey Davis, Ph.D.

LifeSci Advisors LLC

212-915-2577

<u>cdavis@lifesciadvisors.com</u>

**Adagene Media Contact:**

Lindsay Rocco

Elixir Health PR

862-596-1304

<u>lrocco@elixirhealthpr.com</u>

**Third Arc Bio Contacts:**

Peg Rusconi, Deerfield Group<br> <u>peg.rusconi@deerfieldgroup.com</u>

Amanda Jonhson, Deerfield Group

<u>amanda.johnson@deerfieldgroup.com</u>