重新定义眼底疾病治疗

Redefining ocular fundus disease treatment Target PriceHK$280.00Up/Downside56.5%Current PriceHK$178.90 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 ocularfundusdiseases,possessing substantial market opportunities.We initiatecoverage on Haixi with a BUY rating anda TP of HK$280.00. 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 livingwithretinal vein occlusion (RVO), according toWHO. Theimmense medicalneedsfrom 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 ofadministrationhas letto poor patient adherence. Researches(source 1;source 2)found a decrease of 45% regarding injection frequency from Year1 to Year 2, with the fear of intravitreal injection as the leading cause (29.6%)of non-adherence. As a result,non-invasive treatment, such as oral drugs,represents onemajor R&D route of next-gentreatment for ocular fundusdiseases. The global R&D pipeline of non-invasive therapies for retinaldiseasesremains relatively limited,with Haixi’s HXP056 standing amongfirst-tier candidatesand holding thepotential to be out-licenced. Benchen HUANG, CFAhuangbenchen@cmbi.com.hk 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 2026and expects to initiate PhaseIII clinical trial for osteosarcoma intheUS goingforward.C019199 is poised to fill the treatment gap for third-line andadvanced osteosarcoma, addressing a critical unmet medical need globally. 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 foradvancingitsinnovative drug portfolio. Byend-2025, Haixihad15 approvedgeneric drugproducts, among which 3 drugs have top 2 market positions. 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%/16.2%/ 14.9%YoY in 2026E/ 27E/ 28E, respectively. Contents Investment thesis...........................................................................3HXP056–potentially the world’s first oral drug for retinal diseases.........................................................................................................5Substantial opportunities for oral therapies inglobal ocular fundus diseasemarket.............................................................................................................................5HXP056 shows encouraging preclinical profile........................................................11Actively advancing HXP056 clinical development...................................................13C019199–a novel multi-mechanism immuno-modulator.........15Overview of C019199...................................................................................................15Market opportunity for C019199.................................................................................16Clinical development plan of C019199......................................................................17Overview of five main cancers that C019199 targets...............................................20Generic drugs as cash cow to support innovation....................26A growing list of approved generic drugs................................................................26A rich pipeline of generic drug candidates...............................................................33Competitive strengths and strategies of Haixi...........................35Robust, scalable and sustainable product portfolio and pipeline..........................35S