$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

Award and This Year’s Key Points (Official)

Award Time/Location: 2025-10-30, American Museum of Natural History, New York. PR NewswireGalien Foundation

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

This Year’s Submissions: Officially, there are 7 categories with 162 candidates in total for 2025. Galien Foundation

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

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

The official press release also notes: This year, the three categories have 16 / 18 / 13 candidates, respectively. PR Newswire

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 JournalsX-MOL

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

Regulatory Milestones: Received FDA **Fast Track** designation for DGC; previously secured IND approval. OncLiveYahoo Finance

Technical Approach: The company emphasizes combining organoid + AI screening and optimization of candidates, with prospective data presented at AACR 2025. en.signettx.com

Nomination Details (Official): Listed as "SIGX1094R – Signet Therapeutics" under the Best Biotechnology Product category for the 2025 Prix Galien USA. PR Newswire

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

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 NewsNew England Journal of Medicine

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 AdministrationReuters

PADCEV®+KEYTRUDA® (Pfizer/Astellas): EV-302/KEYNOTE-A39 confirmed significantly superior OS/PFS vs. chemotherapy, reshaping the treatment landscape for metastatic urothelial carcinoma. Astellas PharmaScienceDirect

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.comGlobeNewswire

CAPVAXIVE™ (Merck): 21-valent pneumococcal conjugate vaccine for adults, covering ~84% of invasive pneumococcal disease serotypes in adults ≥50 years, FDA-approved. Merck.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). GileadReutersThe Washington Post

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

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 NewswireOncLive

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

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 JournalsOncLive

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!!!