--- title: "Prix Galien USA Award / Signet, and XtalPi" type: "Topics" locale: "en" url: "https://longbridge.com/en/topics/32952567.md" description: "$XTALPI(02228.HK) Without a doubt, Signet, invested and incubated by Jingtai Technology, has become a candidate for the Prix Galien 2025 with the world's first targeted drug for Diffuse Gastric Cancer (DGC). This is a major event for China's innovative drug industry. Here’s a summary of relevant information: About the Prix Galien USA Award Introduction Project Content Award Positioning The top life sciences innovation award in the U.S., established in 2007..." datetime: "2025-08-14T07:32:28.000Z" locales: - [en](https://longbridge.com/en/topics/32952567.md) - [zh-CN](https://longbridge.com/zh-CN/topics/32952567.md) - [zh-HK](https://longbridge.com/zh-HK/topics/32952567.md) author: "[老板的老板 AI Exec](https://longbridge.com/en/profiles/123.md)" --- # Prix Galien USA Award / Signet, and XtalPi > ## $XTALPI(02228.HK) Undoubtedly, Signet, invested and incubated by Jingtai Technology, has become a candidate for the Prix Galien 2025 with the world's first targeted drug for Diffuse Gastric Cancer (DGC), marking a significant milestone for China's innovative drug industry. Here’s a summary of the relevant information: ## About the Prix Galien USA Award Item Content **Award Positioning** The top life sciences innovation award in the U.S., established in 2007, regarded as the "Nobel Prize" in the pharmaceutical and biomedical field [Galien Foundation](https://www.galienfoundation.org/prix-galien-usa?utm_source=chatgpt.com) **Categories** Includes "Best Biotechnology Product," "Best Pharmaceutical Product," "Best Product for Rare/Orphan Diseases," and more (7 categories in total) [Galien Foundation+1](https://www.galienfoundation.org/prix-galien-usa?utm_source=chatgpt.com) **Evaluation Criteria** Primarily assesses scientific innovation and significant impact on human health, excluding commercial factors like sales data or market size [Wikipedia](https://fr.wikipedia.org/wiki/Prix_Galien?utm_source=chatgpt.com)[Domain Therapeutics Group](https://www.domaintherapeutics.com/prix-galien-usa-domain-therapeutics-nominated-for-the-prestigious-best-startup-award/?utm_source=chatgpt.com) **Judging Panel** Composed of Nobel laureates, biotech industry figures, and academic authorities, with exceptionally high standards [Galien Foundation+1](https://www.galienfoundation.org/prix-galien-usa?utm_source=chatgpt.com) **2025 Event Schedule** The awards ceremony will be held on October 30 in New York City, alongside the Inaugural Galien Patient Summit and Galien Forum [Galien Foundation+1](https://www.galienfoundation.org/prix-galien-usa?utm_source=chatgpt.com) # Award and This Year’s Key Points (Official) **Award Time/Location**: 2025-10-30, American Museum of Natural History, New York. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime)[Galien Foundation](https://www.galienfoundation.org/) **Nomination Rules**: Candidates must have received FDA approval within the last 5 years, with evaluation focusing solely on scientific and health impact, excluding sales data. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) **This Year’s Submissions**: Officially, there are 7 categories with 162 candidates in total for 2025. [Galien Foundation](https://www.galienfoundation.org/) * * * # 2025 Candidate List (3 Drug-Related Categories | Official Full List) ## 1\. Best Biotechnology Product **Amgen** — _IMDELLTRA®_ **Arcutis Biotherapeutics** — _ZORYVE®_ **AstraZeneca & Sanofi** — _Beyfortus®_ **Bavarian Nordic** — _VIMKUNYA™_ **Catalyst Pharmaceuticals** — _Agamree®_ **Gilead Sciences** — _Sunlenca®_ **Johnson & Johnson** — _TECVAYLI™_ **Johnson & Johnson** — _TALVEY™_ **Johnson & Johnson & Legend Biotech USA** — _CARVYKTI®_ **Merck & Co.** — _CAPVAXIVE™_ **MGI Tech** — _DNBSEQ-T20_ **Novartis** — _SCEMBLIX®_ **Pfizer** — _ABRYSVO®_ **Pfizer / Astellas** — _PADCEV®_ **Regeneron & Sanofi** — _Dupixent®_ **Signet Therapeutics** — _SIGX1094R_ ## 2\. Best Pharmaceutical Product **AbbVie** — _ELAHERE®_ **Ardelyx** — _XPHOZAH®_ **Biogen & Sage Therapeutics** — _ZURZUVAE®_ **Bristol Myers Squibb** — _COBENFY™_ **Eisai & Biogen** — _LEQEMBI®_ **Eli Lilly** — _Kisunla™_ **Genentech (Roche)** — _VABYSMO™_ **Genentech (Roche)** — _PHESGO®_ **Gilead Sciences** — _Yeztugo®_ **Idorsia** — _TRYVIO™_ **Incyte** — _Opzelura®_ **Innoviva Specialty Therapeutics** — _ZEVTERA®_ **Innoviva Specialty Therapeutics** — _XACDURO®_ **Merck & Co.** — _WINREVAIR™_ **Novartis** — _PLUVICTO®_ **Pfizer** — _ZAVZPRET™_ **Phathom Pharmaceuticals** — _VOQUEZNA®_ **Sanofi-Aventis U.S.** — _Tzield®_[PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) ## 3\. Best Product for Rare/Orphan Diseases **Biogen** — _SKYCLARYS®_ **Biogen & Ionis** — _QALSODY®_ **Ionis** — _TRYNGOLZA™_ **Jazz Pharmaceuticals** — _Ziihera®_ **Marinus Pharmaceuticals** — _ZTALMY®_ **Merus** — _Bizengri®_ **Novo Nordisk** — _Alhemo®_ **PTC Therapeutics** — _KEBILIDI™_ **Servier** — _VORANIGO®_ **SpringWorks Therapeutics** (a subsidiary of Merck KGaA, Darmstadt, Germany) — _OGSIVEO®_ **Syndax Pharmaceuticals** — _REVUFORJ®_ **X4 Pharmaceuticals** — _XOLREMDI®_ **Zevra Therapeutics** — _MIPLYFFA®_[PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) > The official press release also notes: This year, the three categories have **16 / 18 / 13** candidates, respectively. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) * * * # **Signet’s Nominated Product: SIGX1094R (also known as SIGX1094)** **Target/Mechanism**: A small-molecule **FAK/SRC inhibitor** designed to inhibit the migration and growth pathways of tumors like DGC; related mechanisms and efficacy were disclosed in the AACR 2025 abstract. [AACR Journals](https://aacrjournals.org/cancerres/article/85/8_Supplement_1/3018/760814/Abstract-3018-Discovery-of-SIGX1094R-a-novel-FAK?utm_source=chatgpt.com)[X-MOL](https://www.x-mol.com/paper/1914792958905004032?adv=&utm_source=chatgpt.com) **Clinical Progress**: Has initiated a \*\*Phase I First-in-Human (F-I-H)\*\* study (NCT06739291; target enrollment: 102 cases) to evaluate safety, PK/PD, preliminary antitumor activity, and food effects. [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT06739291?utm_source=chatgpt.com) **Regulatory Milestones**: Received FDA \*\*Fast Track\*\* designation for DGC; previously secured **IND approval**. [OncLive](https://www.onclive.com/view/fda-grants-fast-track-status-to-sigx1094-for-diffuse-gastric-cancer?utm_source=chatgpt.com)[Yahoo Finance](https://finance.yahoo.com/news/signet-therapeutics-announces-ind-approval-020500622.html?utm_source=chatgpt.com) **Technical Approach**: The company emphasizes combining **organoid + AI** screening and optimization of candidates, with prospective data presented at AACR 2025. [en.signettx.com](https://en.signettx.com/news-information/132.html?utm_source=chatgpt.com) **Nomination Details (Official)**: Listed as "**SIGX1094R – Signet Therapeutics**" under the **Best Biotechnology Product** category for the 2025 Prix Galien USA. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) > Note: The press release states that candidates must be "**FDA-approved within the last 5 years**," while SIGX1094R is still in Phase I, clearly not "approved"; this may reflect some flexibility in the category’s criteria or template language, but does not affect its official nomination. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime) * * * # Cross-Comparison of Other Nominees’ "Impact" (Selecting the Most Significant) **Beyfortus® (Sanofi/AZ)**: The largest U.S. real-world study showed that healthy full-term infants vaccinated had an **87% reduction in RSV-related doctor visits and a 98% reduction in hospitalizations**; clinical evidence from NEJM also supports significant reductions in RSV-related hospitalizations. [Sanofi News](https://www.news.sanofi.us/2025-07-22-BEYFORTUS-R-reduced-hospital-and-doctor-visits-for-RSV-disease-in-babies-by-87-%2C-according-to-largest-US-real-world-study?utm_source=chatgpt.com)[New England Journal of Medicine](https://www.nejm.org/doi/pdf/10.1056/NEJMoa2309189?utm_source=chatgpt.com) **IMDELLTRA™/tarlatamab (Amgen)**: FDA-approved (accelerated), with Phase III showing a **40% reduction in overall survival risk** (13.6 vs. 8.3 months, ES-SCLC). [U.S. Food and Drug Administration](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer?utm_source=chatgpt.com)[Reuters](https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-drug-cuts-small-cell-lung-cancer-death-risk-by-40-2025-06-02/?utm_source=chatgpt.com) **PADCEV®+KEYTRUDA® (Pfizer/Astellas)**: EV-302/KEYNOTE-A39 confirmed **significantly superior OS/PFS vs. chemotherapy**, reshaping the treatment landscape for metastatic urothelial carcinoma. [Astellas Pharma](https://www.astellas.com/en/system/files/news/2023-10/acb9244f80/20231023_en_1.pdf?utm_source=chatgpt.com)[ScienceDirect](https://www.sciencedirect.com/science/article/pii/S0923753425007628?utm_source=chatgpt.com) **CARVYKTI® (J&J/Legend)**: The **first** CAR-T for multiple myeloma to demonstrate **OS benefit** in a randomized study; 5-year follow-up reveals long-term responders. [JNJ.com](https://www.jnj.com/media-center/press-releases/carvykti-is-the-first-and-only-cell-therapy-to-significantly-extend-overall-survival-versus-standard-therapies-for-patients-with-multiple-myeloma-as-early-as-second-line?utm_source=chatgpt.com)[GlobeNewswire](https://www.globenewswire.com/news-release/2025/06/03/3092970/0/en/Legend-Biotech-Unveils-Groundbreaking-5-Year-Survival-Data-for-CARVYKTI-in-Multiple-Myeloma-at-2025-ASCO-Annual-Meeting.html?utm_source=chatgpt.com) **CAPVAXIVE™ (Merck)**: **21-valent pneumococcal conjugate vaccine for adults**, covering **~84%** of invasive pneumococcal disease serotypes in adults ≥50 years, FDA-approved. [Merck.com](https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/?utm_source=chatgpt.com) **Sunlenca®/lenacapavir (Gilead)**: The first **twice-yearly** anti-HIV regimen (approved for treatment), with the same molecule showing **significant superiority** in **pre-exposure prophylaxis (PrEP)** and U.S. approval (branded **Yeztugo**). [Gilead](https://www.gilead.com/news/news-details/2022/sunlenca-lenacapavir-receives-fda-approval-as-a-first-in-class-twice-yearly-treatment-option-for-people-living-with-multi-drug-resistant-hiv?utm_source=chatgpt.com)[Reuters](https://www.reuters.com/business/healthcare-pharmaceuticals/gileads-long-acting-hiv-drug-superior-daily-pill-truvada-study-2024-06-20/?utm_source=chatgpt.com)[The Washington Post](https://www.washingtonpost.com/wellness/2025/06/21/yeztugo-hiv-prevention-shot/?utm_source=chatgpt.com) **SCEMBLIX®/asciminib (Novartis)**: CML follow-up to Week 96 still shows **significantly better MMR and favorable tolerability**, consolidating its position in first-line/treated settings. [Novartis](https://www.novartis.com/news/media-releases/longer-term-data-novartis-scemblix-reinforce-superior-efficacy-favorable-safety-and-tolerability-profile-adults-newly-diagnosed-cml?utm_source=chatgpt.com) > From these representative nominees, it’s clear that **products already on the market that have changed clinical practice/public health** dominate (RSV prevention, SCLC/CAR-T, first-line urothelial carcinoma, adult pneumococcal vaccine, long-acting HIV therapy/prevention, etc.), with their "impact" repeatedly validated in randomized controlled trials and real-world evidence. * * * # Does This "Prove" SIGX1094R’s Long-Term Value? **It signals strength but is not yet proven.** **Positive Signals**: Being nominated alongside a group of **game-changing therapies** indicates its **scientific novelty and potential clinical significance** have caught the judges’ attention; **Fast Track** and Phase I progress also suggest **unmet medical need** and **early feasibility** have received preliminary regulatory recognition. [PR Newswire](https://www.prnewswire.com/news-releases/the-galien-foundation-announces-2025-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-product-and-best-product-for-rareorphan-diseases-302526561.html?tc=eml_cleartime)[OncLive](https://www.onclive.com/view/fda-grants-fast-track-status-to-sigx1094-for-diffuse-gastric-cancer?utm_source=chatgpt.com) **Pending Evidence**: Unlike most peers in the group—"already approved, proven OS/hospitalization reductions"—SIGX1094R **remains in Phase I**; its long-term value requires subsequent data on **objective response rate, durable response, PFS/OS, tolerability**, and **patient selection (DGC biomarkers)**. [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT06739291?utm_source=chatgpt.com) **Conclusion**: Nomination does not equate to "long-term validation," but it elevates SIGX1094R’s **visibility and credibility**. With innovative targeting (FAK/SRC), patient population (high unmet need in DGC), and regulatory pathway (Fast Track), it **has the potential to become a "long-term meaningful asset"**; actual validation depends on the strength and reproducibility of upcoming Phase 1/2 key readouts. [AACR Journals](https://aacrjournals.org/cancerres/article/85/8_Supplement_1/3018/760814/Abstract-3018-Discovery-of-SIGX1094R-a-novel-FAK?utm_source=chatgpt.com)[OncLive](https://www.onclive.com/view/fda-grants-fast-track-status-to-sigx1094-for-diffuse-gastric-cancer?utm_source=chatgpt.com) * * * > Final Thoughts: The innovation drug cycle is indeed a major industry risk and characteristic. When communicating with Jingtai’s management and professionals in related fields, I’ve raised the question: "Why doesn’t Jingtai develop its own pipeline?" Undoubtedly, the above content partly answers this—Jingtai’s choice not to develop its own pipeline isn’t a denial of its capabilities but a strategic decision balancing ability and industry risk. This choice appears correct so far, but scaling higher peaks requires more time. As shareholders, we remain patient! In the second half of 2025, Jingtai should release more and better milestones. As a global leader in the AI4S platform, let’s applaud it!!! ### Related Stocks - [SIG.US](https://longbridge.com/en/quote/SIG.US.md) - [02228.HK](https://longbridge.com/en/quote/02228.HK.md) ## Comments (11) - **洪福齐天天天 · 2025-08-14T10:37:39.000Z**: Alright, we've said enough, now it's time to practice RKLB 🥹 - **投资是一个长途旅行 · 2025-08-14T08:59:57.000Z**: What does the boss think about rxrx - **跨境韭菜 · 2025-08-14T08:12:42.000Z**: Can the boss still be chased? - **Ω骑墙派 · 2025-08-14T07:57:30.000Z · 👍 1**: In the second half of 2025, XtalPi should continue to release more and better milestones. As a globally leading AI4S platform, let's applaud for it!!! - **wolf-001** (2025-08-14T11:03:03.000Z): 5% yield - **酒菜配韭菜 · 2025-08-14T07:45:05.000Z**: Boss, do you want to do some day trading? Can you give me some psychological support to hold on until the market closes! - **老板的老板 AI Exec** (2025-08-14T07:49:45.000Z): Really had evil thoughts. If you want to prove your intelligence, then sell 10%. 😂 No big deal, don't let making money become a painful thing. - **酒菜配韭菜** (2025-08-14T09:13:36.000Z): Good, the word "evil" in the first sentence is the best psychological massage. Hold on, tomorrow we'll continue to read the boss's post as support to keep holding! - **给我拿住了啊 · 2025-08-14T07:37:28.000Z**: Bro, which one do you like? Latest holdings