MIRXES-B (02629) was officially included in the Hang Seng Composite Index and the Stock Connect program on September 8, 2025. Given its unique technological edge and significant growth potential in the Chinese market, the company is expected to attract substantial southbound capital inflows, providing additional upward momentum for its stock price. Founder Securities forecasts the company's revenue for 2025–2027 at $27 million, $41 million, and $75 million, respectively, representing year-on-year growth of 30.84%, 55.14%, and 81.32%. The firm initiated coverage with a "Recommend" rating.

Key highlights from Founder Securities' analysis include:

**Pioneer in Global Gastric Cancer Early Screening with First-Mover Advantage** MIRXES-B's flagship product, GASTROClear, is the world's first and only molecular diagnostic IVD product approved for gastric cancer screening. It has been commercialized in markets such as Singapore and Thailand and has received the U.S. FDA's "Breakthrough Device" designation, validating its technological leadership and clinical value. With over a decade of R&D expertise in miRNA technology and a robust patent portfolio (27 granted patents and 63 pending applications), the company holds a strong competitive position in the non-invasive cancer early screening market, particularly in Asia, where gastric cancer prevalence is high.

On October 9, 2025, the company announced that GASTROClear had obtained Class III medical device registration approval from China's NMPA. In H1 2025, revenue from its "Early Detection and Precision Multi-Omics" segment surged 50% YoY to $10.5 million, driven primarily by GASTROClear and LUNGClear. The company is poised to benefit from commercialization efforts in key markets, including China, Japan, and the U.S., with strong market penetration expected to sustain growth.

**Clear Product Pipeline and Platform-Driven Growth** Leveraging its mature miRNART-qPCR technology platform, MIRXES-B has built a diversified pipeline ranging from commercialized products to preclinical research. Beyond GASTROClear (gastric cancer) and LUNGClear (lung cancer), the company is advancing screening products for CRC-1 (colorectal cancer), LV-1 (liver cancer), BC-1 (breast cancer), and the multi-cancer screening CADENCE project. This scalable R&D model allows the company to replicate GASTROClear's success across other products, accelerating development cycles and creating new growth drivers.

**Near-Term Catalysts** LUNGClear has been commercialized as an LDT service in Southeast Asia and Japan. CRC-1 is progressing rapidly, with prototype completion and Southeast Asian LDT commercialization expected in H2 2025, followed by IVD clinical trials in China and Singapore in 2026.

**Long-Term Potential** Pipeline products targeting liver cancer (LV-1) and breast cancer (BC-1) are in early development, while the multi-cancer screening CADENCE project has launched large-scale clinical studies, offering long-term growth potential.

**Integrated Capabilities Strengthen Competitive Edge** MIRXES-B has established end-to-end capabilities, including two cGMP-compliant production facilities in Singapore and China with an annual capacity of approximately 590,000 tests. This integrated model ensures product quality, stable supply, and cost efficiency, with gross margin rising 18.8 percentage points YoY to 67.8% in H1 2025, laying a solid foundation for profitability.

**Investment Recommendation** As a pioneer in gastric cancer early screening, MIRXES-B is well-positioned to maintain its industry leadership. The NMPA approval of GASTROClear marks a major commercialization milestone and unlocks China's vast gastric cancer screening market, serving as a key near-term catalyst.

**Risk Factors** Potential risks include intensifying competition, delays in clinical trials or regulatory approvals, slower-than-expected market expansion, pricing pressures post-launch, and broader systemic risks.