Adagene FY Conference Summary Company Overview - **Company**: Adagene (NasdaqGM:ADAG) - **Focus**: Development of immuno-oncology drugs, specifically targeting microsatellite stable colorectal cancer (MSS-CRC) with low response rates to current therapies [2][3] Key Points and Arguments Drug Development and Efficacy - **Lead Compound**: ADG126, a masked anti-CTLA-4 antibody, is being developed in combination with KEYTRUDA (pembrolizumab) for late-line MSS-CRC without liver metastases [3][4] - **Response Rates**: ADG126 has shown a response rate between 15% and 30% depending on dosage, with a median overall survival of 20 months in the lowest dose cohort [3][5] - **Safety Profile**: The discontinuation rate is less than 10%, with no grade 4 or 5 adverse events reported, indicating a favorable safety margin [5][15] Market Opportunity - **Target Population**: Approximately 10,000 patients in the U.S. represent the MSS-CRC without liver metastases, a challenging tumor type for immuno-oncology agents [12] - **Historical Context**: Current standard of care has a median overall survival of 10-14 months, highlighting the need for more effective treatments [2][11] Collaboration and Funding - **Sanofi Investment**: Sanofi committed to an equity investment of up to $25 million, with the first tranche of $17 million received at $2 per share. This funding supports the ongoing phase 2 trial of ADG126 [6][7] - **Trial Collaboration**: Sanofi will evaluate ADG126 in combination with their bispecific PD-1 IL-15 in over 100 patients with solid tumors [6][7] Competitive Landscape - **CTLA-4 Mechanism**: CTLA-4 therapies like Yervoy (ipilimumab) and Imjudo (tremelimumab) generate close to $4 billion in revenues, indicating a robust market for effective CTLA-4 inhibitors [8][9] - **Differentiation**: ADG126 is positioned as a safer alternative with a better safety margin compared to existing CTLA-4 therapies, which have shown high toxicity [10][76] Future Developments - **Upcoming Data**: Updates on ADG126's efficacy and safety are expected in the coming months, including data from triplet combinations and a phase 2 trial in neoadjuvant colorectal cancer patients [20][23] - **Regulatory Pathway**: Plans for a randomized phase 3 trial focusing on overall survival as the primary endpoint are in discussion with the FDA [62][73] Additional Important Insights - **Combination Potential**: ADG126 is seen as a versatile partner for various combinations beyond PD-1, including potential combinations with VEGF and TGF inhibitors [36][38] - **Strategic Partnerships**: The company aims to pursue more licensing deals and trial collaborations to expand its market reach and evaluate novel regimens [23][24] This summary encapsulates the critical insights from the Adagene FY Conference, highlighting the company's strategic direction, drug development progress, and market potential in the oncology space.

Core Insights - Adagene Inc. is participating in two upcoming healthcare conferences, the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026, and the Leerink Global Healthcare Conference from March 8-11, 2026 [1][2] - The company recently presented at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, with a webcast available for viewing [3] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology to address unmet patient needs in cancer treatment [4] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to enhance the safety and efficacy of antibody therapeutics [5] - The lead clinical program, muzastotug (ADG126), is a masked anti-CTLA-4 SAFEbody with FDA Fast Track designation, currently in Phase 1b/2 and Phase 2 studies targeting microsatellite stable metastatic colorectal cancer [6]

Company Overview - Adagene Inc. (NASDAQ:ADAG) specializes in developing monoclonal antibody drugs for cancer treatment, currently trading at $2.49 with a target price of $1.67, indicating a potential downside of 33.08% [1][5] - Adicet Bio, Inc. (NASDAQ:ACET) focuses on gamma delta T cell therapies, trading at $8.44 with a discounted cash flow valuation of $7.15, reflecting a potential downside of 15.29% [2][5] Market Sentiment - The market sentiment towards both Adagene and Adicet Bio is cautious, as evidenced by the negative growth potential reflected in their stock prices [3][5] - Despite the innovative nature of their cancer treatment approaches, investment analysts remain wary due to inherent risks and uncertainties in the biotechnology sector [4][5] Industry Context - The biotechnology industry is characterized by high-risk, high-reward dynamics, with companies often facing challenges in clinical trials, regulatory approvals, and market adoption [4]

Core Insights - Adagene Inc. announced an update on its ongoing Phase 1b/2 study of muzastotug in combination with pembrolizumab for patients with microsatellite stable metastatic colorectal cancer (MSS CRC), with data expected in Q1 2026 [1][6] - The company reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025, which is anticipated to provide sufficient runway until late 2027 [1][3] 2025 Key Accomplishments - The company demonstrated a favorable safety profile for muzastotug at doses 10-20 times higher than first-generation CTLA-4 inhibitors, with encouraging overall response rates and durable responses [5] - Muzastotug received FDA Fast Track designation for use in combination with KEYTRUDA for adult patients with MSS CRC without current or active liver metastases [5] - Adagene secured a strategic investment of up to $25 million from Sanofi to support the randomized Phase 2 study of muzastotug [5] - Collaborations were established with Third Arc Bio for developing next-generation T cell therapies and with Exelixis for advancing a third masked ADC against a solid tumor target [5] 2026 Objectives - The company aims to provide a data update from the ongoing Phase 1b/2 study, including results from 41 patients in the 10 mg/kg cohort and 26 patients in the 20 mg/kg cohort [6] - Complete enrollment of the randomized Phase 2 dose-optimization study with muzastotug, aligned with FDA Project Optimus [6] - Share results from a clinical trial collaboration with Roche evaluating muzastotug in combination with atezolizumab and bevacizumab for liver cancer [6] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [8] - The company's lead clinical program, muzastotug, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in Phase 1b/2 and Phase 2 studies [10]

Group 1 - The core point of the article highlights the significant stock price increases of several Chinese concept stocks, with notable gains in the biotechnology and education sectors [1] Group 2 - Brain Rejuvenation Technology (RGC) saw a price increase of 40.44%, closing at 30.770 with a trading volume of 37.2475 million [1] - Burning Stone Medical (BNR) experienced a rise of 32.20%, closing at 41.060 with a trading volume of 4.0811 million [1] - Four Seasons Education (FEDU) increased by 30.21%, closing at 10.000 with a trading volume of 3.6878 million [1] - 707 Cayman Holdings (JEM) rose by 26.58%, closing at 0.2505 with a trading volume of 5.0629 million [1] - Tianyan Pharmaceutical (ADAG) increased by 20.12%, closing at 2.030 with a trading volume of 1.1583 million [1]

Core Insights - Adagene Inc. (ADAG) received Fast Track designation from the FDA for its lead immuno-oncology candidate, muzastotug (ADG126), in combination with Merck's Keytruda for treating adult patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC) without active liver metastases [1][6] - Following the announcement, ADAG shares increased by 13.8% [1][7] - The Fast Track designation aims to expedite the development and review of therapies for serious diseases with unmet medical needs [2] Company Overview - Muzastotug is a next-generation anti-CTLA-4 antibody developed using proprietary SAFEbody masking technology, which may improve survival and quality of life compared to conventional therapies [5][7] - The ongoing phase II study has primary and secondary endpoints focused on overall response rate, duration of response, progression-free survival, and overall survival [6][8] - A phase III study is planned to start in 2027, contingent on continued positive clinical results [8] Market Performance - Over the past year, ADAG's shares have declined by 6.9%, contrasting with a 16.3% rise in the industry [4] - The Fast Track designation allows for more frequent interactions with the FDA and potential rolling reviews of future marketing applications [8]

Core Viewpoint - Tianyan Pharmaceuticals (ADAG) has experienced a significant stock price increase of 14.37% on December 16, reaching $1.91 per share, with a total market capitalization of $90.02 million, despite reporting a substantial decline in revenue and net profit for the fiscal year ending December 31, 2024 [1]. Financial Performance - The total revenue for Tianyan Pharmaceuticals is reported at $103,200, reflecting a year-over-year decrease of 99.43% [1]. - The net profit attributable to the parent company is reported at -$33.42 million, which represents a year-over-year decrease of 76.41% [1]. Company Overview - Tianyan Pharmaceuticals is a biopharmaceutical company listed on NASDAQ under the ticker ADAG, focused on the development of clinical products driven by its proprietary platform [1]. - The company aims to discover and develop novel cancer immunotherapies based on original antibodies, utilizing a powerful platform that combines computational biology and artificial intelligence [1]. - The company's antibody discovery engine, known as the "Dynamic Precision Library," is advancing the development of its product pipeline, with the goal of creating potentially innovative or best-in-class products globally [1].

Core Viewpoint - Tianyan Pharmaceutical (ADAG) is a clinical-stage biopharmaceutical company focused on developing novel cancer immunotherapies based on original antibodies, utilizing a powerful platform that combines computational biology and artificial intelligence [1]. Financial Performance - As of December 31, 2024, Tianyan Pharmaceutical reported total revenue of $103,200, representing a year-over-year decrease of 99.43% [1]. - The company recorded a net loss attributable to shareholders of $33.4241 million, a decline of 76.41% compared to the previous year [1]. Market Activity - On December 16, Tianyan Pharmaceutical's stock opened with an increase of 8.98%, reaching $1.82 per share by 22:30, with a total trading volume of $167,200 and a market capitalization of $85.577 million [1]. Company Overview - Tianyan Pharmaceutical is listed on NASDAQ under the ticker symbol ADAG and is dedicated to discovering and developing innovative cancer immunotherapies [1]. - The company's antibody discovery engine, known as the "Dynamic Precision Library," is driving the development of its product pipeline, aiming to create potentially global innovative or best-in-class products [1].

Core Insights - The FDA has granted Fast Track Designation to Adagene's muzastotug in combination with Merck's KEYTRUDA® for treating adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without active liver metastases, highlighting the potential of this therapy to meet an unmet medical need [1][2][3] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence to create innovative therapies [4][7] - The company employs its proprietary SAFEbody technology to enhance the safety and efficacy of antibody therapies by targeting the tumor microenvironment while minimizing systemic toxicity [6][7] Clinical Development - Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody designed to overcome Treg resistance in tumors, showing promising efficacy and safety in heavily pretreated patient populations [2][3] - The ongoing Phase 2 trial will evaluate muzastotug in combination with pembrolizumab, with a focus on late-line patients with MSS CRC without liver metastases [5][7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), while the Phase 3 trial will focus on overall survival (OS) as the primary endpoint [5] Future Plans - Adagene plans to share updated topline Phase 1b/2 clinical data in the coming months and is preparing for a registration trial set to begin in 2027 [3][5]

Core Insights - Adagene Inc. and Third Arc Bio, Inc. have entered into a licensing agreement for the use of Adagene's SAFEbody technology platform to develop masked CD3 T cell engagers targeting unique tumor-associated antigens [1][2] - Adagene will receive an upfront payment of $5 million and potential milestone payments totaling up to $840 million, along with royalties on end-user sales [1] - Adagene retains a no-cost option to develop and commercialize the candidate molecules in Greater China, Singapore, and South Korea [1] Company Overview: Adagene - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [3] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology [3][4] - Adagene's lead clinical program, ADG126 (muzastotug), is currently in Phase 1b/2 and Phase 2 studies, targeting CTLA-4 in regulatory T cells within the tumor microenvironment [5] Technology Insights - The SAFEbody technology is designed to enhance safety and tolerability of antibody therapeutics by activating antibodies specifically in the tumor microenvironment, minimizing off-target toxicity [4] - Adagene's Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, contributing to a differentiated pipeline of immunotherapy programs [4] Company Overview: Third Arc Bio - Third Arc Bio is a clinical-stage biotech company developing multifunctional antibodies aimed at precisely activating or inhibiting T cells [7] - The lead program, ARC101, is a bispecific T cell engager currently in Phase 1 trials for solid tumors expressing CLDN6 [8] - Third Arc Bio's platforms include the ARCStim Platform for solid tumors and the ARCTag Platform for precision immune regulation [7]