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]

资料显示，天演药业公司(纳斯达克股票代码:ADAG)是平台驱动并拥有自主平台产出的临床产品开发阶 段的生物制药公司,公司致力于发现并开发以原创抗体为基石的新型癌症免疫疗法。借助计算生物学和 人工智能相结合的强大平台,公司研制出高安全性和有效性的新型抗体,为更多癌症患者带来了福音。公 司的抗体发现引擎——"动态精准抗体库"(Dynamic Precision Library),正在推动天演药业的产品管线开发, 致力于打造潜在的全球创新或同类最佳型产品。 本文源自：市场资讯 作者：行情君 据交易所数据显示，12月16日，天演药业(ADAG)盘中上涨14.37%，截至22:38，报1.91美元/股，成交 18.18万美元，总市值9002.07万美元。 财务数据显示，截至2024年12月31日，天演药业收入总额10.32万美元，同比减少99.43%；归母净利 润-3342.41万美元，同比减少76.41%。 ...

本文源自：市场资讯 作者：行情君 据交易所数据显示，12月16日，天演药业(ADAG)开盘上涨8.98%，截至22:30，报1.82美元/股，成交 16.72万美元，总市值8577.89万美元。 财务数据显示，截至2024年12月31日，天演药业收入总额10.32万美元，同比减少99.43%；归母净利 润-3342.41万美元，同比减少76.41%。 资料显示，天演药业公司(纳斯达克股票代码:ADAG)是平台驱动并拥有自主平台产出的临床产品开发阶 段的生物制药公司,公司致力于发现并开发以原创抗体为基石的新型癌症免疫疗法。借助计算生物学和 人工智能相结合的强大平台,公司研制出高安全性和有效性的新型抗体,为更多癌症患者带来了福音。公 司的抗体发现引擎——"动态精准抗体库"(Dynamic Precision Library),正在推动天演药业的产品管线开发, 致力于打造潜在的全球创新或同类最佳型产品。 ...

Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, ...

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]

Core Insights - Adagene Inc. has initiated a Phase 2 clinical trial for muzastotug in combination with KEYTRUDA for patients with microsatellite stable colorectal cancer, with the first patient dosed in October 2025 [1][2] - The trial aims to confirm the optimal dosing for a subsequent Phase 3 trial, with completion anticipated in early 2027 and potential updates expected in 2026 [1][2] Phase 2 Clinical Trial Details - The trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with up to 30 patients per arm [1][4] - The primary endpoint is overall response rate (ORR), while secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [4] Phase 1b/2 Trial Findings - In the Phase 1b/2 trial, 67 patients were treated with muzastotug, showing an ORR of 17% for the 10 mg/kg cohort and 29% for the 20 mg/kg cohort [3][4] - The median duration of response for the 10 mg/kg cohort was 6.2 months, while the median overall survival for the 10 mg/kg cohort was 19.4 months [5] Safety Profile - Muzastotug has been safely dosed at 20 mg/kg with less than 20% Grade 3 adverse events and no discontinuations, indicating a favorable safety profile compared to first-generation anti-CTLA-4 therapies [2][5] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [7][8] - The company's lead program, ADG126 (muzastotug), targets regulatory T cells in the tumor microenvironment and is part of a broader pipeline leveraging its SAFEbody technology [9]

Core Viewpoint - Adagene Inc. has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Adagene for the fiscal year ending December 2025 is projected at -$0.65 per share, unchanged from the previous year [9]. - Over the past three months, the Zacks Consensus Estimate for Adagene has increased by 7.2%, reflecting a positive trend in earnings estimates [9]. Zacks Rating System - The Zacks rating system is based solely on a company's changing earnings picture, which is tracked through EPS estimates from sell-side analysts [2]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has shown a strong track record, with Zacks Rank 1 stocks averaging a +25% annual return since 1988 [8]. - Adagene's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11]. Market Dynamics - Changes in earnings estimates are strongly correlated with near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [5]. - Rising earnings estimates and the subsequent rating upgrade for Adagene suggest an improvement in the company's underlying business, which could lead to increased buying pressure and a higher stock price [6].

Core Insights - Adagene Inc. announced an amendment to its collaboration and license agreement with Exelixis, allowing Exelixis to utilize Adagene's SAFEbody technology platform for developing an antibody-drug conjugate (ADC) targeting a solid tumor [1][2] Company Overview - Adagene is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, leveraging computational biology and artificial intelligence [5] - The company has established strategic collaborations with global partners to utilize its SAFEbody precision masking technology [5] Technology and Innovation - The SAFEbody technology enables antibodies or ADCs to remain "invisible" until they reach the tumor microenvironment, which enhances therapeutic index and minimizes toxicity to healthy cells [3][6] - Adagene's lead SAFEbody candidate, ADG126, is currently in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with a Phase 2 trial expected to start before the end of 2025 [4][7] Clinical Development - ADG126 targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment and is being studied in combination with anti-PD-1 therapy [7] - The SAFEbody platform is validated for various antibody-based therapeutic modalities, including Fc empowered antibodies and bi/multispecific T-cell engagers [7]

Summary of Adagene Inc. Conference Call Company Overview - **Company**: Adagene Inc. - **Industry**: Biotechnology, specifically focused on antibody generation and protein engineering Key Points and Arguments SAFEbody® Platform and ADG126 - Adagene utilizes AI for protein engineering and antibody generation, leading to the development of novel antibodies, including ADG126, a masked anti-CTLA-4 antibody [2][3] - ADG126 binds to a different epitope than first-generation anti-CTLA-4 antibodies (ipilimumab and tremelimumab), resulting in up to 10 times stronger antibody-dependent cellular cytotoxicity (ADCC) [2] - The proprietary masking technology of ADG126 allows for a significantly expanded therapeutic window, addressing the high dose-dependency and toxicity issues associated with anti-CTLA-4 therapies [3][4] Target Indication: Microsatellite Stable Colorectal Cancer (MSS-CRC) - MSS-CRC accounts for 95% of all colorectal cancer cases, presenting a significant unmet medical need as current immunotherapies have not been effective in this subgroup [5][6] - Adagene is focusing on patients without liver metastasis, which represent roughly one-third of MSS-CRC patients, equating to over 10,000 patients in the U.S. [26] - The combination of ADG126 with Keytruda (pembrolizumab) has shown a confirmed response rate of 29% in phase 1B trials, with a median overall survival of 19 months, outperforming standard care options [10][12][32] Clinical Development and Regulatory Path - A randomized phase 2 trial is set to begin before the end of 2023, testing two dose levels of ADG126 in combination with Keytruda [22][18] - The primary endpoint for the phase 2 trial will be the response rate, which will inform the pivotal phase 3 trial [18][19] - The FDA has indicated that a control arm may not be necessary for the phase 2 trial, recognizing the ineffectiveness of PD-1 and CTLA-4 monotherapies in the targeted setting [41][42] Financial Position and Collaborations - Adagene had approximately $63 million in cash at the end of June 2025, with a runway extending into 2027 due to a recent equity investment from SNOWPEA [27][28] - SNOWPEA has committed to invest up to $25 million, with the first tranche of $17 million already received, supporting the phase 2 trial [28] - The collaboration with SNOWPEA includes a phase 1/2 trial evaluating a novel combination involving ADG126, potentially expanding its addressable market [29] Competitive Landscape and Future Outlook - Adagene is well-positioned within the global biotech landscape, leveraging its Chinese heritage and global clinical trial capabilities [37][38] - The company is utilizing AI to enhance antibody design and decision-making processes, positioning itself as a disruptor in the biotech space [39] - Future data readouts and updates on clinical trials are anticipated, with a focus on durability and response rates from ongoing studies [30][32] Additional Important Points - The incidence of grade 3 adverse events in the high-dose cohort of ADG126 is less than 20%, with no grade 4 or 5 events reported, indicating a favorable safety profile [11][33] - The collaboration with SNOWPEA not only validates Adagene's technology but also enhances its clinical development capabilities [34]

Summary of Adagene Inc. Conference Call Company Overview - **Company**: Adagene Inc. - **Industry**: Biopharmaceuticals, specifically focused on antibody therapies for cancer treatment - **Key Technologies**: NEObody™, SAFEbody®, POWERbody™ Current Pipeline - **Lead Program**: ADG126, a novel masked anti-CTLA-4 antibody - **Mechanism**: Enhanced antibody-dependent cellular cytotoxicity (ADCC) and improved therapeutic index due to proprietary masking technology - **Dosing**: Currently dosing patients at 20 mg/kg every six weeks, up from an initial 10 mg/kg every six weeks [3][8] SAFEbody® Technology - **Mechanism**: Protease-sensitive masking technology that activates in the tumor microenvironment, requiring high levels of specific proteases and target expression [4][8] Collaboration with Sanofi - **Investment**: Sanofi made an equity investment of up to $25 million, with $17 million received at signing [5][6] - **Collaboration**: Expanded partnership includes a trial collaboration for a phase 1B/2 study evaluating a bispecific antibody in combination with ADG126 in solid tumors, targeting over 100 patients [6] Clinical Data and Safety - **Safety Profile**: Low discontinuation rate due to toxicity, allowing patients to receive multiple treatment cycles [9][10] - **Response Rates**: - 20 mg/kg cohort shows a response rate in the high 20% range - Median overall survival of 19 months compared to standard care's 10-12 months [12][10] - Confirmed overall response rate (ORR) at 29% for the 20 mg/kg cohort [12] Future Data Expectations - **Next Data Update**: Expected in early 2026 for phase 1B data set in combination with Keytruda [11] FDA Alignment - **Phase 2 Trial Design**: Randomized trial with two dosing levels (10 mg/kg and 20 mg/kg) to identify optimal dose for future phase 3 trials [13][15] Treatment Landscape - **Potential Impact**: If ADG126 shows a response rate above 20%, it could be clinically differentiated from current standard care, which has a median overall survival of 10-12 months [17][18] Pipeline Beyond ADG126 - **Other Programs**: ADG138, a double masker HER2/CD3 engager, is IND-ready and shows strong preclinical activity [22][24] Major Catalysts - **Upcoming Data**: More mature data from phase 1B expected in early 2026, including potential triplet combination data [26] - **Business Development**: Ongoing discussions for additional trial collaborations following positive data presentations [26] Financial Position - **Cash Position**: $63 million at the end of June, increased by $17 million from Sanofi investment, funding operations into 2027 [27]