Sinolink: Oral Cyclopeptide Drug Proof-of-Concept Year, Opening of a Hundred Billion Dollar Market

Sinolink released a research report stating that oral cyclic peptides are the most certain forward layout direction in the peptide field after GLP-1. It is recommended to focus on leading companies in this field with core platform technology and clinical pipelines. Overseas, attention is recommended for Protagonist Therapeutics (PTGX): as the leader in the global oral cyclic peptide race, the company's two late-stage assets, ICOTYDE and Rusfertide, have entered the commercialization and regulatory approval stages respectively. Domestic focus is recommended for HANSOH PHARMA (03692): its HS-20118 is the first domestically developed IL-23R oral cyclic peptide to enter late-stage clinical trials, with global Phase II clinical trials underway, and is expected to have a first-mover advantage in the domestic oral cyclic peptide race. Sinolink's main points are as follows: The paradigm of oral cyclic peptides is officially established with the bridging of drug-like verification. By 2026, the oral cyclic peptide race has completed the crucial leap from "scientific concept" to "industrial reality", with drug-like properties being thoroughly verified. JNJ-2113 (Icotrokinra, marketed as ICOTYDE) was approved by the FDA in March 2026, becoming the world's first oral cyclic peptide targeting IL-23; Merck MK-0616 (Enlicitide) as the world's first oral cyclic peptide targeting PCSK9, demonstrated in Phase III clinical trials that a daily oral dose of 20mg reduced LDL-C by 59.7%. The efficacy was close to injectable monoclonal antibodies, with an NDA submission expected in 2026. These two assets have validated the dual advantage of oral cyclic peptides in the areas of autoimmunity and metabolism, marking a key transition from "injection-only" to "oral administration". A new drug paradigm is officially born from this. There is ample incremental space, and a scenario shift in chronic diseases opens up an exponential ceiling. The market commonly views oral cyclic peptides as "oral substitutes" for injectable antibodies, but their value goes far beyond just replacing existing treatments. On one hand, in chronic disease areas such as psoriasis, ulcerative colitis, and hyperlipidemia, where lifelong medication is needed, oral formulations have an irreplaceable advantage in compliance over subcutaneous injections, significantly lowering treatment barriers and potentially releasing an increment of about 50%-70% of patients who meet advanced treatment conditions but have not yet received treatment. On the other hand, cyclic peptides with molecular weights that fill the structural gap between small molecules (<500 Da) and antibodies (>5000 Da) not only have high affinity to cover the wide flat interface of protein-protein interactions (PPI), but also have the potential to target intracellular targets such as KRAS that were previously considered "undruggable". Rusfertide, as the first ferric mimic peptide (FIC molecule), has received priority review from the FDA, and the Chinese-made AUBE00 (pan-KRAS inhibitor) has entered Phase I clinical trials, indicating that oral cyclic peptides are creating an incremental treatment space that neither small molecules nor antibodies can cover. Pipeline resonance with business development marks the industrialization realization cycle The global cyclic peptide R&D pipeline is undergoing systematic expansion, with the number of projects in research increasing from 72 in 2021 to 93 YTD in 2026. The addition of 11 new projects in 2026 has set a new high in the past five years, and for the first time, it covers all stages from clinical application to market approval, indicating that the technology platform has entered a mature stage of progress. Industrial capital is verifying the platform's value with real money: the total value of global cyclic peptide BD transactions in 2026 YTD reached a historical high of $6.17 billion. Protagonist Therapeutics, as the fastest company advancing oral cyclic peptides clinically, has achieved a dual late-stage asset layout of "1 approved (ICOTYDE) + 1 NDA (Rusfertide, PDUFA scheduled for 2026 Q3)", with catalytic events expected to be intense in the next 18 months; domestically, HANSOH PHARMA's HS-20118, as the first domestically developed late-stage IL-23R oral cyclic peptide, has already demonstrated comparable early efficacy and excellent safety. The bank believes that in the next 3-5 years, oral cyclic peptides will enter a continued cycle of commercialization realization, and companies that master core ring-modifying technology and delivery platforms are expected to enjoy excess returns. Risk warnings Clinical trial progress falls short of expectations, new drug research results are below expectations, market promotion and sales fall short of expectations.