공시 • May 05
Xtalpi and Pharmaengine Achieve Enrollment Milestone for Pep08 and Initiate Second Synthetic Lethality Program XtalPi (2228.HK), an AI- and robotics-powered innovation platform, announced dual breakthroughs in its strategic partnership with PharmaEngine (4162.TWO). PEP08, a next-generation PRMT5 inhibitor discovered via XtalPi's platform, has successfully begun enrollments in a Phase I solid tumor trial, achieving a new clinical milestone. Built upon the success of PEP08 at the drug discovery stage, the two companies initiated a second project, targeting a different undisclosed synthetic lethality mechanism. PEP08 received clinical clearance in June 2025 and is currently in Phase I evaluation for solid tumors in Australia and the Taiwan region. The enrollment milestone underscores XtalPi's ability to deliver differentiated molecules with strong drug-like properties, while demonstrating the program's steady clinical advancement. Leveraging XtalPi's integrated quantum physics-, AI-, and robotics-powered platform, PEP08 was designed to overcome the dose-limiting hematological toxicities seen with first-generation PRMT5 inhibitors. The molecule exploits an innovative MTA-cooperative binding mode to specifically target MTAP-deleted tumors—a genomic alteration found in 10-15% of all human cancers, with higher frequencies observed in NSCLC, pancreatic cancer, glioblastoma, and more. Preclinical data presented at 2025 AACR show PEP08 achieving superior efficacy compared to other clinical-stage MTA-cooperative PRMT5 inhibitors across multiple MTAP-deleted tumor models, supporting a potential best-in-class profile. Driven by the success of PEP08 at the drug discovery stage, the partnership expanded into a second project. By combining PharmaEngine's deep oncology expertise with XtalPi's AI and robotics molecular design engine, the duo aims to capture additional market share in the synthetic lethality space. Synthetic lethality is widely recognized as challenging yet highly promising frontier in oncology. According to Globocan and industry data, the global market is expected to grow from $4,200 million to $17,600 million by 2033, at a 17.3% CAGR. In recent years, several early-stage licensing deals in this space have exceeded $1,000 million, further underscoring the immense clinical value and commercial appetite for this category. The clinical advancement of PEP08 and the ongoing collaboration of the second project serve as a dual validation of XtalPi's AI+robotics discovery engine. By repeatedly meeting rigorous benchmarks in complex target spaces, XtalPi has built a reproducible innovation model that turns deep know-how into high-value clinical assets. Underpinned by a milestone-sharing structure, this model tightly aligns the platform's evolution with clinical success, quickly translating biological insights into tangible impact for partners and patients around the world. 공시 • Apr 19
XtalPi Holdings Limited, Annual General Meeting, May 20, 2026 XtalPi Holdings Limited, Annual General Meeting, May 20, 2026, at 15:00 China Standard Time. Location: multi-functional meeting room, 3/f, second phase, of the international biomedical industrial park, no. 2 hongliu road, futian district, shenzhen China 공시 • Mar 13
XtalPi Holdings Limited to Report Fiscal Year 2025 Results on Mar 25, 2026 XtalPi Holdings Limited announced that they will report fiscal year 2025 results at 4:00 PM, China Standard Time on Mar 25, 2026 공시 • Sep 09
Xtalpi Inc. Announces Pep08 Receives Regulatory Clearances to Initiate Phase 1 Clinical Trials in Solid Tumor XtalPi Inc. has announced that PEP08, a next-generation PRMT5 inhibitor candidate developed through its AI drug discovery collaboration with PharmaEngine, Inc. has received regulatory clearances to initiate Phase 1 clinical trials in solid tumors. Approvals include Australia'sHuman Research Ethics Committee (HREC), recognized by the Australian Therapeutic Goods Administration (TGA), and the food and drug authority of the Taiwan region (TFDA). This milestone triggered a payment to XtalPi under the partnership agreement. PRMT5 (Protein Arginine Methyltransferase 5) is a validated synthetic lethality target in tumors harboring homozygous MTAP deletion, which is related to poor prognosis and present in 10-15% of human cancers, including small cell lung cancer (NSCLC), mesothelioma, pancreatic cancer, glioblastoma multiforme (GBM), head and neck cancer, esophageal cancer, and bladder cancer. While PRMT5 inhibition offers a potent mechanism for targeted therapy, first-generation inhibitors face significant challenges in selectivity, resulting in dose-limiting toxicities and unmet medical needs. Leveraging its integrated drug discovery platform that combines quantum physics, AI, and large-scale robotic experiments, XtalPi partnered with PharmaEngine's scientific team to conduct de novo drug design. The AI platform generated a multi-million compound library for PRMT5, identifying novel lead series with exceptional potential and selectivity. Following iterative optimization through quantum physics and AI-powered ADMET screening, PEP08 emerged as the preclinical candidate (PCC) and advanced through IND-enabling studies by PharmaEngine. As a second-generation PRMT5 inhibitor with a novel scaffold, PEP08 demonstrates superior activity and selectivity. Its MTA-cooperative binding mode stabilizes a ternary complex with PRMT5, enabling highly selective target inhibition. This mechanism drives potent synthetic lethality efficacy against MTAP-deleted tumor cells while minimizing off-target effects on normal cells, highlighting significant therapeutic potential. Preclinical studies revealed PEP08's markedly improved safety profile compared to first-generation PRMT5 inhibitors, alongside favorable blood-brain barrier penetration and overall developability characteristics. The compound achieved robust in vivo efficacy across multiple animal models. Compared to other clinical-stage second-generation candidates, PEP08 exhibits potential best-in-class properties and compelling combination therapy opportunities. PharmaEngine presented these findings at the 2025 American Association for Cancer Research (AACR) Annual Meeting. PEP08's successful regulatory clearance and milestone achievement underscore XtalPi's platform-driven innovation capabilities and mark a pivotal advancement in its partnership with PharmaEngine. XtalPi remains committed to empowering partners to discover novel drug candidates addressing complex targets, accelerate the development of competitive pipeline projects, and deliver transformative medicines to patients worldwide. 공시 • Sep 04
XtalPi Holdings Limited has completed a Follow-on Equity Offering in the amount of HKD 2.653338 billion. XtalPi Holdings Limited has completed a Follow-on Equity Offering in the amount of HKD 2.653338 billion.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 285,920,000
Price\Range: HKD 9.28
Transaction Features: Subsequent Direct Listing 공시 • Aug 30
XtalPi Holdings Limited has filed a Follow-on Equity Offering in the amount of HKD 2.653338 billion. XtalPi Holdings Limited has filed a Follow-on Equity Offering in the amount of HKD 2.653338 billion.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 285,920,000
Price\Range: HKD 9.28
Transaction Features: Subsequent Direct Listing 
