According to a research note from CMSC, HAIXI PHARMA (HKEX: 02637) has a promising oral ophthalmic innovative drug, HX9428, that could address a clinical pain point with substantial market potential. The brokerage initiated coverage with an "Accumulate" rating.

The firm forecasts the company will achieve net profit attributable to shareholders of RMB179 million, RMB207 million, and RMB239 million in 2026, 2027, and 2028, corresponding to growth rates of 1%, 16%, and 16%, respectively.

The key points from CMSC are as follows.

Oral Administration Reshapes Chronic Management of Fundus Diseases, Precisely Targeting the Core Burden of Long-Term Treatment

The current first-line standard treatment for fundus vascular diseases is intravitreal anti-VEGF injection, which has limited treatment compliance and real-world efficacy. As an oral small-molecule innovative drug for fundus diseases, HX9428 can exert therapeutic effects without intraocular injection and can simultaneously cover lesions in both eyes, significantly reducing the long-term treatment burden. It is expected to provide a new drug delivery pathway for chronic management of fundus diseases and fill the blank market for oral treatment.

Differentiated Pharmacokinetic Profile of "Ocular Enrichment and Rapid Systemic Clearance" Addresses the Safety Challenge of Oral Fundus Drugs from a Mechanistic Perspective

HX9428 was optimized based on the MultiSel-Opt platform for molecular design. Preclinical data show that its plasma half-life in C57 mice is only 1.7 hours, with essentially complete systemic clearance within 12 hours and no organ accumulation. In contrast, the ocular half-life reaches 19.9 hours, 11.7 times that of plasma, and the 24-hour ocular AUC is 5.1 times that of plasma, achieving selective ocular enrichment. The unique pharmacokinetic profile ensures effective drug concentration in the fundus while significantly reducing the toxicity risk associated with systemic exposure, providing core support for the safety of long-term oral administration.

Clinical Stage Enters Key Validation Period, Dual-Track Advancement in China and the U.S. Strengthens Catalysts

The first indication for HX9428, nAMD, has completed a Phase I dose-escalation study in China. No dose-limiting toxicity occurred within the 5-40 mg dose range. Among 13 patients who completed 24 weeks of dosing, BCVA improved by an average of 5.2 letters, and central retinal thickness decreased by an average of 73.3 μm, with no additional anti-VEGF injections throughout the period, preliminarily validating the efficacy and safety of oral administration. The company is currently advancing three Phase II trials simultaneously: the China Phase II dose-expansion study has enrolled 80 patients, with interim data consistent with Phase I trends; the China positive-control Phase II study is a head-to-head comparison against aflibercept intravitreal injection, serving as the core validation of the product's clinical value; and the U.S. Phase II trial has received FDA approval and been granted Fast Track designation. For the DME indication, a Phase IIa IND application was submitted to the CDE in August 2026. Subsequent expansion into indications such as RVO has pathological mechanistic continuity, and the product's long-term market ceiling is broad.

Clear Multi-Track Innovative Pipeline with Platform-Based R&D Value Gradually Emerging

Leveraging a dual-track strategy of "generic drugs supporting innovation," the company has built a stable cash flow base with 17 approved generic drugs and continues to invest in innovative drug R&D. It has established the MultiSel-Opt multi-target small-molecule R&D platform, covering four high-barrier areas: ophthalmology, oncology, central nervous system, and fibrosis. In addition to the core product HX9428, C019199 targets multiple pathways including CSF-1R/DDR1/VEGFR2. For relapsed and refractory osteosarcoma, a Phase III registrational clinical trial has been initiated. The Phase Ib study achieved a disease control rate of 73.3% and a median PFS of 181 days, superior to historical levels of traditional second-line chemotherapy. HXP089 targets glioblastoma, possesses good blood-brain barrier penetration, and has been approved to enter clinical trials. HXP090 for idiopathic pulmonary fibrosis is in the preclinical research stage, validating the platform's R&D potential across disease areas.

Risk Factors

Clinical trials may underperform expectations; technological iteration; policy; and model parameter assumptions may not hold, among other risks.