China Merchants Securities: Haixi New Pharmaceutical (02637) Hx9428 is expected to fill the blue ocean of oral treatment of NAMD

The Zhitong Finance App learned that China Merchants Securities released a research report saying that Haixi Xinyao (02637), an innovative drug for oral fundus disease, is expected to solve clinical treatment pain points. The potential market space is broad, and for the first time, it has a “gain” rating. The bank expects the company to achieve net profit of 1.79/2.07/239 million yuan in 2026-2028, corresponding to a growth rate of 1%/16%/16%.

The main views of China Merchants Securities are as follows:

Oral administration reshapes the management path of chronic fundus disease and accurately cuts into the core pain points of long-term treatment burdens

Currently, the first-line standard treatment for vascular diseases under the eye is vitreous anti-VEGF injection, which limits treatment compliance and real-world efficacy. As an innovative drug for oral small molecule fundus disease, HX9428 can exert a therapeutic effect without intraocular injection. It can cover both eye diseases at the same time, significantly reducing the long-term treatment burden, and is expected to provide a new administration route for the management of chronic fundus disease and fill the gap in the oral treatment market.

Differentiated pharmacologic characteristics of “eye concentration and rapid systematic removal” solve the problem of oral fundus safety from a mechanistic point of view

Hx9428 optimized molecular design based on the MultiSel-opt platform. Preclinical data showed that the half-life of plasma in C57 mice was only 1.7 hours, with basic systemic elimination within 12 hours; however, the ocular half-life reached 19.9 hours, 11.7 times that of plasma, and the 24-hour ocular AUC was 5.1 times that of plasma, achieving selective ocular enrichment. The unique pharmacological characteristics guarantee effective drug concentration under the eyes, greatly reduce the risk of toxicity caused by systemic exposure, and provide core support for the safety of long-term oral administration.

Clinical trials have entered a critical verification period, and China and the US are promoting enhanced catalysis

NAMD, the first indication for Hx9428, has completed a phase I dose climbing study in China. There was no dose-limiting toxicity in the 5 to 40 mg dose range. 13 patients who completed 24 weeks of administration had an average BCVA increase of 5.2 letters, central retinal thickness decreased by an average of 73.3 μm, and no additional anti-VEGF injections were received throughout the process, which initially verified the efficacy and safety of oral administration. Currently, the company is simultaneously promoting three phase II clinical trials: 80 patients have been enrolled in the phase II dose extension study in China, and the phased data is consistent with the phase I trend; the Chinese positive controlled phase II study head-to-head versus intravitreal injections of abacip is the core verification of the clinical value of the product; and the US phase II clinical trial has been approved by the FDA and granted fast-track qualification. DME indications were submitted to CDE in August 2026 for phase IIa applications. Subsequent expansion of indications such as RVO has a continuous pathologic mechanism, and the long-term market ceiling for the product is broad.

The multi-track innovation pipeline is clear, and the value of platform-based R&D is gradually showing

Relying on the dual-track strategy of “cloning helps innovation”, the company built a stable cash flow chassis with 17 approved generic drugs, continued to invest in innovative drug research and development, built the MultiSel-Opt multi-target small molecule R&D platform, and laid out the four high-barrier fields of ophthalmology, oncology, central nervous system, and fibrosis. In addition to the core product HX9428, C019199 targets CSF-1R/DDR1/VEGFR2 multiple pathways, and phase III registered clinical trials have been initiated for recurrent refractory osteosarcoma. The phase Ib study achieved a disease control rate of 73.3% and a median PFS of 181 days, which is superior to the historical level of traditional second-line chemotherapy. HXP089 targets glioblastoma and has good ability to penetrate the blood-brain barrier, and has been approved for the clinical phase. The HXP090 is in the preclinical research stage for idiopathic pulmonary fibrosis, verifying the platform's R&D potential across disease fields.

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