XtalPi Holdings Limited

XtalPi has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for KQTD-126, a potential first-in-class gut-restricted pan-TRK inhibitor for chronic intestinal pain associated with irritable bowel syndrome and inflammatory bowel disease. The candidate is the first program from XtalPi's proprietary pipeline to reach an IND submission since the portfolio was unveiled in the company's recent interim results. In preclinical studies, KQTD-126 achieved pan-TRK inhibition at sub-nanomolar concentrations, with an IC50 below 1 nM, and a gut tissue-to-blood exposure ratio exceeding 1,000 to 1, confining activity to the gastrointestinal tract to limit systemic exposure and avoid the neurological side effects of systemic TRK inhibitors. XtalPi said the compound was designed using its generative and predictive AI models integrated with automated chemistry robots, a closed-loop process of computational design, automated synthesis, screening, and molecular refinement. IBS affects approximately 10% to 15% of the global population, while more than 10 million people live with IBD, and BCC Research projects the global IBS and IBD therapeutics market will reach US$52.6 billion by 2030.

XtalPi announced that Viva-Thera, a biotechnology company it incubated and backs as a strategic shareholder, has nominated a preclinical candidate targeting the membrane-proximal external region of HIV-1 gp41, completing discovery and optimization in seven months by combining Viva-Thera's atomic-resolution structural research with XtalPi's AI drug design and automation platform. Deploying generative AI from the outset, XtalPi navigated a chemical space of approximately 10 million compounds to isolate five validated hits with desirable drug properties and strong antiviral activity, then continuously optimized the leads to reach PCC nomination. The asset targets gp41-mediated membrane fusion at MPER, a region that retains approximately 90% sequence identity across viral strains, opening a path toward a broad-spectrum antiviral with a binding site distinct from those addressed by reverse-transcriptase, integrase, and protease inhibitors. In its public debut, Viva-Thera also reported that its MPER vaccine immunogens elicited antibody levels in rhesus macaques approximately five times those of the conventional HIV immunogen comparator, with antisera retaining substantial inhibition of HIV pseudovirus infection at a 1:1,000 dilution. The company is pursuing HIV prevention and cure through four modalities—vaccines, long-acting small molecules, gene therapy and cell therapy—and its gene-therapy program has completed vector construction, cell-infection experiments and CD4+ T-cell introduction in humanized mice, with live-virus infection and treatment studies in preparation.

Apex Intelligence has completed its angel and angel-plus funding rounds, raising nearly US$50 Million in total. The angel round was co-led by IDG Capital, LinkX Capital and XtalPi, with participation from Decent Capital, SEE Fund, Monad Ventures, and Winsoul Capital, while the angel-plus round was co-led by Zhongguancun Science City Fund, SCGC, and Shanghai Engine Fund. Founded in June 2026, the Beijing-based company is building self-evolving foundation models based on Recursive Self-Improvement, aiming to move AI from an assistive tool to a co-researcher focused on scientific research and discovery. Apex Intelligence said its self-evolving AI system has autonomously produced research of a standard suitable for acceptance at leading AI conferences, comparable to an AI PhD student, and has produced a complete proof of the majorization conjecture, which had remained open for more than three decades. The company was founded by Yongchao Chen, an assistant professor at Tsinghua University's School of Artificial Intelligence, and will visit leading North American universities including Harvard University, MIT, Yale University, and Boston University from September 17 to September 23 for talent recruitment and research collaboration.

The generative AI in pharmaceutical market is projected to grow from $2.43 billion in 2025 to $9.36 billion by 2030, at a compound annual growth rate of 30.9%. The market is expected to reach $3.19 billion in 2026, driven by increased R&D investments, rising chronic diseases, and AI adoption in early-stage drug discovery. A key growth driver is the rise of personalized medicine, with 16 novel personalized therapies approved by the FDA in 2023, up from six the previous year. Leading companies such as Pfizer, Johnson & Johnson, and Roche are active in the space, while Nvidia launched generative AI microservices for drug discovery in March 2024 and Eli Lilly partnered with XtalPi to explore chemical spaces for drug candidates. North America was the largest regional market in 2025, and the report covers global regions including Asia-Pacific, Europe, and the Americas.