重新定义眼底疾病治疗

Redefining ocular fundus disease treatment Haixi Pharma (Haixi) is an innovation-oriented, commercial-stage pharmaceuticalcompany that integrates R&D, production and sales capacities.Ithas a diversifiedproduct portfolioin the largest and fastest-growing therapeutic areas in China,with 15 approved generic products and 4 innovative products under development.Notably,HXP056isa potential world’s first oral therapy for the treatment of ocular Target PriceHK$280.00Up/DownsideCurrent PriceHK$178.90 China Healthcare Jill WU, CFA(852) 3900 0842jillwu@cmbi.com.hk HXP056,potentially the world’s first oral drug for retinal diseases. Internally developed by Haixi, HXP056isa potential world’s first oral therapyfor the treatment of ocular fundus diseases. Haixi has already completedpatient enrollment of Phase 1 study onwet age-related macular degeneration(wAMD)in China, with a Phase 2 dose expansion trial initiated in 4Q25.Thereare substantial opportunities for oral therapies in global ocular fundus diseasemarket. Globally, ~19.6–39.2mn patients are affected by wAMD, ~48.5mnpatients havediabetic macular edema (DME)and ~28.6mn patients are living Benchen HUANG, CFAhuangbenchen@cmbi.com.hk withretinal vein occlusion (RVO), according toWHO. Theimmense medical needsfrom ocular fundus diseasescontinues to drive the emergence ofinnovativetherapies,with anti-VEGF agents obtaining absolute marketdominance. However, intravitreal injection of anti-VEGF agents as a route of C019199,a novel multi-mechanism immuno-modulator. As the mostadvancedclinical-stage candidate in Haixi’s innovative drug pipeline,C019199 is an innovative multi-mechanism immuno-modulator targetingCSF-1R/DDR1/VEGFR2.Haixi has posted a Phase III clinical trial ofC019199 as a monotherapy for treating osteosarcoma in China in May 2026 Source: FactSet Generic drugs as cash cow to support innovation.Haixiuses its genericdrug business as a financial engine to support innovation. The rapid, self-generated cash flowsfrom generics ensure consistent capital support for Initiate at BUY. Our TP of HK$280.00is based on a 10-year DCF model withWACC of 13.2% and terminal growth of 2.0%. We forecast Haixi’s revenue togrow by19.1%/ 17.7%/ 16.6%YoY andnet profit toincrease by18.9%/ Contents Investment thesis...........................................................................3HXP056–potentially the world’s first oral drug for retinal diseases.........................................................................................................5 Substantial opportunities for oral therapies inglobal ocular fundus diseasemarket.............................................................................................................................5HXP056 shows encouraging preclinical profile........................................................11 C019199–a novel multi-mechanism immuno-modulator.........15 Overview of C019199...................................................................................................15Market opportunity for C019199.................................................................................16Clinical development plan of C019199......................................................................17 Generic drugs as cash cow to support innovation....................26 A growing list of approved generic drugs................................................................26A rich pipeline of generic drug candidates...............................................................33 Competitive strengths and strategies of Haixi...........................35 Robust, scalable and sustainable product portfolio and pipeline..........................35Strong commercialization capabilities......................................................................36Excellent R&D team and product development platforms......................................36Optimized production capacity supported by in-house and external facilities....37 Financial analysis.........................................................................40Valuation........................................................................................42Investment risks............................................................................43Appendix: Company profile.........................................................44 Investmentthesis HXP056–potentiallytheworld’sfirst oral drug for retinal diseasesInternally developed by Haixi, HXP056is a potential world’s first oraltherapy for thetreatment of ocular fundus diseases. Haixi has already completed patientenrollment of There are substantial opportunities for oral therapies in global ocular fundus diseasemarket. Driven by global population aging and the rising prevalenceof chronic diseasessuch as diabetes, the global patient pool with ocular fundus diseases is substantial andexpanding. Globally,~19.6–39.2mn patients are affected by wAMD, ~48.5mn patients haveDME and ~28.6mn patients are livi