HHS Names 6 Peptides It Won't Act Against. The Fine Print; Peptide API maker Hybio reports a 512% profit rise and plans to double its Wuhan peptide capacity. Updated daily.
HHS filed a notice for Federal Register public inspection on 28 October 2026 (publication set for 30 October), announcing a draft enforcement discretion policy for 503A compounding with certain peptide bulk drug substances. HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding with the six peptide bulk drug substances in its Appendix A, but only if strict conditions are met. Conditions include a patient-specific prescription, a registered original manufacturer, a certificate of analysis covering identity, purity, potency, impurities and endotoxins, single-ingredient products and adverse-event reporting. HHS says the policy aims to discourage research-use-only peptides from foreign suppliers. Comments run two weeks after publication. The policy is not binding and is not an FDA approval.
For research-community awareness only. Not legal advice.
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Peptide API maker Hybio reports a 512% profit rise and plans to double its Wuhan peptide capacity
Photo: Image: BioLabs Research
Shenzhen Hybio Pharmaceutical, a Chinese peptide API maker, reported nine-month 2026 revenue of RMB 1.24 billion, up 81.9%, and attributable net profit of RMB 436.6 million, up 512%, attributing the growth mainly to higher API sales, Peptide & Protein News reported on 26 October 2026. The same board meeting approved spending of up to RMB 380 million on a Wuhan expansion that the company says would add 10,000 kg a year of peptide capacity to the 10,000 kg already there, citing short upstream supply for incretin-class APIs. Environmental approval and a shareholder vote are still pending, and no start-up date was given. The planned equipment includes industrial preparative HPLC systems, the purification step behind the purity results a lot-level certificate of analysis reports.
DuPont adds a silica chromatography media as peptide purification capacity comes under pressure
Photo: Image: BioLabs Research
DuPont said on 22 October 2026 that it has launched AmberChrom SIL, a reverse-phase silica gel in C8 and C18 chemistries for purifying peptides at manufacturing scale, from crude purification through final high-purity polishing. The company said rising peptide demand is pushing manufacturers to build purification processes that reach demanding purity targets without giving up yield, and that the new media can be combined with its polymeric resins in a single workflow. Its performance claims come from company application studies, not independent data. Reverse-phase chromatography is the step that strips synthesis by-products from crude peptide, and the purity and impurity profile it delivers are the results a lot-level certificate of analysis reports.
